unni nalsar the fascinating world of patents seminar on industrial property, 25 th january 2007 at...
TRANSCRIPT
UNNI NALSAR
The Fascinating World of Patents
Seminar on Industrial Property 25th January 2007At Hotel International KochiOrganised by EU-India TIDP amp CUSAT
VK UnniAsst Professor - Law
NALSAR University of Law Hyderabadwwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
Patent law deals with new industrially applicable inventions
It envisages a very powerful and special mode of protection for inventions
The patentee is given a monopoly to work the invention for a period of around 20 years
Compared to other streams of IPR the property right granted is very strong
A patent is never granted in an automatic way there is a structured procedure for obtaining a patent
UNNI NALSAR
The Fascinating World of Patents
Patents can be given for products as well as processes
Here a monopoly is granted to the patentee for disclosing the details of the invention which he would have kept as a secret
The disclosure made by the patentee should enable a person skilled in the art to workmake the invention once the patent expires
This would mean that an adequate and enabling disclosure is a condition precedent for obtaining a patent
UNNI NALSAR
ldquoPatentsrdquo How it all started
The origins of patent law can be traced from the medieval times
It all started with the granting of ldquoLetters Patentrdquo which were in effect open letters with kingrsquos seal
The Letters Patent granted the rights to foreign weavers craftsmen so that they can practise their trade
The first letters patent was granted to a weaver who wanted to practise his trade in England
UNNI NALSAR
The Fascinating World of Patents
Justification for Patents It encourages research and invention Induces inventors to reveal their inventions
instead of keeping them as a secret It offers a reward for the effort of
developing inventions to the stage where it is commercially viable
Provides inducement to invest money in new lines of production which may not be profitable if too many people venture into it
UNNI NALSAR
The Fascinating World of Patents
The patent system guarantees a limited term of protection in return for the inventorrsquos willingness to disclose details of his invention and finally to abandon his property right in it
The conventional justification is that in a patent system inventors are rewarded for their time work and risk of capital by the grant of a patent
The society is also benefited by stimulating investment and employment because details of the invention are added to the store of available knowledge
UNNI NALSAR
The Fascinating World of Patents
Patentability Requirements The invention has to be novel It should involve an inventive step ie it
should be non-obvious It should be capable of industrial
application It should not be excluded specifically by the
statute
UNNI NALSAR
The Fascinating World of Patents
Novelty Invention must be new it must not already
have been available to the public An invention can be new only if it does not
form part of the ldquostate of artrdquo prior art The prior art comprises of all matters made
available to the public before the date of the invention whether by written oral description by use or in any manner
Prior publication could have occurred anywhere in the world
UNNI NALSAR
But disclosures that are made in confidence will not be considered as prior publication
Thus disclosures made in such circumstances wonrsquot have any bearing on the novelty of the invention
Case-law Visx Inc v Nidek Co Ltd (1999) FSR 405 here a prior oral
disclosure was made during a train journey But the disclosure was made in confidence so the invention did not loose novelty
UNNI NALSAR
The Fascinating World of Patents
How many acts of disclosures are needed Windsurfing Intl Inc v Tabur Marine (Great
Britain) Ltd (1985) RPC 59 Here the boat built by a boy which was used
in public only for 2 week ends at a beach was held as sufficient disclosure to pre-empt a later patent
Thus even a single act of disclosure can destroy the novelty of an invention
UNNI NALSAR
The Fascinating World of Patents
Lux Traffic Controls v Pike Signals Ltd (1993) RPC 107
Here the prototype of a traffic light control system was taken for field trial and the prototype was used in public
The court held that there is no need to prove that anybody actually saw the disclosure provided the relevant disclosure was in public
When a prototype is kept in public it is irrelevant whether a skilled person examined it or not
In such cases there is prior disclosure consequently there is loss of novelty
UNNI NALSAR
The Fascinating World of Patents
Facts of the case also play a very crucial role in determining whether a prior disclosure had taken place or not
In Pall Corp v Commercial Hydraulics (Bedford) Ltd (1990) FSR 329
Samples of a product were sent to some of its potential customers for testing The technical details construction of the product was impossible to be determined on such visual inspection Here the court held that there is no prior disclosure and thus there was no impact on the novelty
UNNI NALSAR
The Fascinating World of Patents
Inventive Step Inventive step means a feature of an invention
that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art
The use of the expression economic significance in the new law is interesting it is neither a classical patentability criterion nor does it have anything to do with inventions
UNNI NALSAR
Patents would not be available on the following grounds the mere discovery of a known substance which does not result
in the enhancement of the known efficacy of that substance the mere discovery of any new property or new use for a
known substance the mere use of a known process machine or apparatus unless
such known process results in a new product or employs at least employs one new reactant
One can argue that a minor alteration to an existing drug molecule resulting in enhancement of its known efficacy could lead to the grant of a patent on that molecule
UNNI NALSAR
The Fascinating World of Patents
Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel
International Ltd (1999) FSR 683 what was the problem which the invention
addressed how long had the problem existed how significant was the problem how widely known was the problem and
how many were likely to be seeking a solution
UNNI NALSAR
The Fascinating World of Patents
what prior art would have been known to those in the field
what other solutions were proposed prior to publication of the patent
what other factors were there that held back exploitation of the solution
how well has the product been received has the commercial success of the product been due
to its technical merits This decision leads to the position that commercial
success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)
UNNI NALSAR
The Fascinating World of Patents
Industrial Application Industrial application is another
requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from
copyright An invention is capable of industrial
application if it can be made or used in any kind of industry including agriculture
UNNI NALSAR
The Fascinating World of Patents
Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies
The above said exclusion doesnrsquot extend to products consisting of substances used in any such method
The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy
UNNI NALSAR
The Fascinating World of PatentsWhat are not patentable Sec 3
an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)
an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)
the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature
Sec 3[c]
UNNI NALSAR
The Fascinating World of Patents
the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)
ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy
Inserted by the 2005 amendment
UNNI NALSAR
The Fascinating World of Patents
a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)
the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)
Sec 3(g) has been omitted by the 2002 amendment
UNNI NALSAR
The Fascinating World of Patents
any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative
prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)
Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)
A mathematical or business method or a computer programme per se or algorithms Sec 3(k)
UNNI NALSAR
The Fascinating World of Patents
A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)
Method of performing a mental act or method of playing a game Sec 3(m)
Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional
knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)
UNNI NALSAR
The Fascinating World of Patents
Ownership of patents Normally it is the inventor who owns the
patent Incase the inventor has assigned the
patent the owner of the patent will be different
Disputes mainly arise over ownership of inventions between employees and employers
In India there is no provision which deals with employee-employer inventions
UNNI NALSAR
The Fascinating World of Patents
Rights of a patent holder (Sec 48) When a patent is for a product the patent
holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license
A patent is always territorial in nature In case of a process patent the patent
holder has the exclusive right to use or exercise the methodprocess in India
If any person violates any of these rights then there will be infringement
UNNI NALSAR
The Fascinating World of Patents
The following can be considered as the public interest provisions vis a vis the patent monopoly
Opposition of patents 1048710The Indian law provides for both pre grant and post
grant opposition As per Sec 25 (1) when an application for a patent has
been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)
UNNI NALSAR
The Fascinating World of Patents
The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a
period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)
The grounds can be many like lack of novelty obviousness insufficient description of the invention etc
Then the Controller of patents has to constitute an opposition board to consider this opposition
UNNI NALSAR
The Fascinating World of Patents
The opposition board has to hear both the parties and give its opinion to the controller
1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
Patent law deals with new industrially applicable inventions
It envisages a very powerful and special mode of protection for inventions
The patentee is given a monopoly to work the invention for a period of around 20 years
Compared to other streams of IPR the property right granted is very strong
A patent is never granted in an automatic way there is a structured procedure for obtaining a patent
UNNI NALSAR
The Fascinating World of Patents
Patents can be given for products as well as processes
Here a monopoly is granted to the patentee for disclosing the details of the invention which he would have kept as a secret
The disclosure made by the patentee should enable a person skilled in the art to workmake the invention once the patent expires
This would mean that an adequate and enabling disclosure is a condition precedent for obtaining a patent
UNNI NALSAR
ldquoPatentsrdquo How it all started
The origins of patent law can be traced from the medieval times
It all started with the granting of ldquoLetters Patentrdquo which were in effect open letters with kingrsquos seal
The Letters Patent granted the rights to foreign weavers craftsmen so that they can practise their trade
The first letters patent was granted to a weaver who wanted to practise his trade in England
UNNI NALSAR
The Fascinating World of Patents
Justification for Patents It encourages research and invention Induces inventors to reveal their inventions
instead of keeping them as a secret It offers a reward for the effort of
developing inventions to the stage where it is commercially viable
Provides inducement to invest money in new lines of production which may not be profitable if too many people venture into it
UNNI NALSAR
The Fascinating World of Patents
The patent system guarantees a limited term of protection in return for the inventorrsquos willingness to disclose details of his invention and finally to abandon his property right in it
The conventional justification is that in a patent system inventors are rewarded for their time work and risk of capital by the grant of a patent
The society is also benefited by stimulating investment and employment because details of the invention are added to the store of available knowledge
UNNI NALSAR
The Fascinating World of Patents
Patentability Requirements The invention has to be novel It should involve an inventive step ie it
should be non-obvious It should be capable of industrial
application It should not be excluded specifically by the
statute
UNNI NALSAR
The Fascinating World of Patents
Novelty Invention must be new it must not already
have been available to the public An invention can be new only if it does not
form part of the ldquostate of artrdquo prior art The prior art comprises of all matters made
available to the public before the date of the invention whether by written oral description by use or in any manner
Prior publication could have occurred anywhere in the world
UNNI NALSAR
But disclosures that are made in confidence will not be considered as prior publication
Thus disclosures made in such circumstances wonrsquot have any bearing on the novelty of the invention
Case-law Visx Inc v Nidek Co Ltd (1999) FSR 405 here a prior oral
disclosure was made during a train journey But the disclosure was made in confidence so the invention did not loose novelty
UNNI NALSAR
The Fascinating World of Patents
How many acts of disclosures are needed Windsurfing Intl Inc v Tabur Marine (Great
Britain) Ltd (1985) RPC 59 Here the boat built by a boy which was used
in public only for 2 week ends at a beach was held as sufficient disclosure to pre-empt a later patent
Thus even a single act of disclosure can destroy the novelty of an invention
UNNI NALSAR
The Fascinating World of Patents
Lux Traffic Controls v Pike Signals Ltd (1993) RPC 107
Here the prototype of a traffic light control system was taken for field trial and the prototype was used in public
The court held that there is no need to prove that anybody actually saw the disclosure provided the relevant disclosure was in public
When a prototype is kept in public it is irrelevant whether a skilled person examined it or not
In such cases there is prior disclosure consequently there is loss of novelty
UNNI NALSAR
The Fascinating World of Patents
Facts of the case also play a very crucial role in determining whether a prior disclosure had taken place or not
In Pall Corp v Commercial Hydraulics (Bedford) Ltd (1990) FSR 329
Samples of a product were sent to some of its potential customers for testing The technical details construction of the product was impossible to be determined on such visual inspection Here the court held that there is no prior disclosure and thus there was no impact on the novelty
UNNI NALSAR
The Fascinating World of Patents
Inventive Step Inventive step means a feature of an invention
that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art
The use of the expression economic significance in the new law is interesting it is neither a classical patentability criterion nor does it have anything to do with inventions
UNNI NALSAR
Patents would not be available on the following grounds the mere discovery of a known substance which does not result
in the enhancement of the known efficacy of that substance the mere discovery of any new property or new use for a
known substance the mere use of a known process machine or apparatus unless
such known process results in a new product or employs at least employs one new reactant
One can argue that a minor alteration to an existing drug molecule resulting in enhancement of its known efficacy could lead to the grant of a patent on that molecule
UNNI NALSAR
The Fascinating World of Patents
Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel
International Ltd (1999) FSR 683 what was the problem which the invention
addressed how long had the problem existed how significant was the problem how widely known was the problem and
how many were likely to be seeking a solution
UNNI NALSAR
The Fascinating World of Patents
what prior art would have been known to those in the field
what other solutions were proposed prior to publication of the patent
what other factors were there that held back exploitation of the solution
how well has the product been received has the commercial success of the product been due
to its technical merits This decision leads to the position that commercial
success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)
UNNI NALSAR
The Fascinating World of Patents
Industrial Application Industrial application is another
requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from
copyright An invention is capable of industrial
application if it can be made or used in any kind of industry including agriculture
UNNI NALSAR
The Fascinating World of Patents
Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies
The above said exclusion doesnrsquot extend to products consisting of substances used in any such method
The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy
UNNI NALSAR
The Fascinating World of PatentsWhat are not patentable Sec 3
an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)
an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)
the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature
Sec 3[c]
UNNI NALSAR
The Fascinating World of Patents
the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)
ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy
Inserted by the 2005 amendment
UNNI NALSAR
The Fascinating World of Patents
a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)
the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)
Sec 3(g) has been omitted by the 2002 amendment
UNNI NALSAR
The Fascinating World of Patents
any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative
prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)
Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)
A mathematical or business method or a computer programme per se or algorithms Sec 3(k)
UNNI NALSAR
The Fascinating World of Patents
A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)
Method of performing a mental act or method of playing a game Sec 3(m)
Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional
knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)
UNNI NALSAR
The Fascinating World of Patents
Ownership of patents Normally it is the inventor who owns the
patent Incase the inventor has assigned the
patent the owner of the patent will be different
Disputes mainly arise over ownership of inventions between employees and employers
In India there is no provision which deals with employee-employer inventions
UNNI NALSAR
The Fascinating World of Patents
Rights of a patent holder (Sec 48) When a patent is for a product the patent
holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license
A patent is always territorial in nature In case of a process patent the patent
holder has the exclusive right to use or exercise the methodprocess in India
If any person violates any of these rights then there will be infringement
UNNI NALSAR
The Fascinating World of Patents
The following can be considered as the public interest provisions vis a vis the patent monopoly
Opposition of patents 1048710The Indian law provides for both pre grant and post
grant opposition As per Sec 25 (1) when an application for a patent has
been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)
UNNI NALSAR
The Fascinating World of Patents
The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a
period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)
The grounds can be many like lack of novelty obviousness insufficient description of the invention etc
Then the Controller of patents has to constitute an opposition board to consider this opposition
UNNI NALSAR
The Fascinating World of Patents
The opposition board has to hear both the parties and give its opinion to the controller
1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
Patents can be given for products as well as processes
Here a monopoly is granted to the patentee for disclosing the details of the invention which he would have kept as a secret
The disclosure made by the patentee should enable a person skilled in the art to workmake the invention once the patent expires
This would mean that an adequate and enabling disclosure is a condition precedent for obtaining a patent
UNNI NALSAR
ldquoPatentsrdquo How it all started
The origins of patent law can be traced from the medieval times
It all started with the granting of ldquoLetters Patentrdquo which were in effect open letters with kingrsquos seal
The Letters Patent granted the rights to foreign weavers craftsmen so that they can practise their trade
The first letters patent was granted to a weaver who wanted to practise his trade in England
UNNI NALSAR
The Fascinating World of Patents
Justification for Patents It encourages research and invention Induces inventors to reveal their inventions
instead of keeping them as a secret It offers a reward for the effort of
developing inventions to the stage where it is commercially viable
Provides inducement to invest money in new lines of production which may not be profitable if too many people venture into it
UNNI NALSAR
The Fascinating World of Patents
The patent system guarantees a limited term of protection in return for the inventorrsquos willingness to disclose details of his invention and finally to abandon his property right in it
The conventional justification is that in a patent system inventors are rewarded for their time work and risk of capital by the grant of a patent
The society is also benefited by stimulating investment and employment because details of the invention are added to the store of available knowledge
UNNI NALSAR
The Fascinating World of Patents
Patentability Requirements The invention has to be novel It should involve an inventive step ie it
should be non-obvious It should be capable of industrial
application It should not be excluded specifically by the
statute
UNNI NALSAR
The Fascinating World of Patents
Novelty Invention must be new it must not already
have been available to the public An invention can be new only if it does not
form part of the ldquostate of artrdquo prior art The prior art comprises of all matters made
available to the public before the date of the invention whether by written oral description by use or in any manner
Prior publication could have occurred anywhere in the world
UNNI NALSAR
But disclosures that are made in confidence will not be considered as prior publication
Thus disclosures made in such circumstances wonrsquot have any bearing on the novelty of the invention
Case-law Visx Inc v Nidek Co Ltd (1999) FSR 405 here a prior oral
disclosure was made during a train journey But the disclosure was made in confidence so the invention did not loose novelty
UNNI NALSAR
The Fascinating World of Patents
How many acts of disclosures are needed Windsurfing Intl Inc v Tabur Marine (Great
Britain) Ltd (1985) RPC 59 Here the boat built by a boy which was used
in public only for 2 week ends at a beach was held as sufficient disclosure to pre-empt a later patent
Thus even a single act of disclosure can destroy the novelty of an invention
UNNI NALSAR
The Fascinating World of Patents
Lux Traffic Controls v Pike Signals Ltd (1993) RPC 107
Here the prototype of a traffic light control system was taken for field trial and the prototype was used in public
The court held that there is no need to prove that anybody actually saw the disclosure provided the relevant disclosure was in public
When a prototype is kept in public it is irrelevant whether a skilled person examined it or not
In such cases there is prior disclosure consequently there is loss of novelty
UNNI NALSAR
The Fascinating World of Patents
Facts of the case also play a very crucial role in determining whether a prior disclosure had taken place or not
In Pall Corp v Commercial Hydraulics (Bedford) Ltd (1990) FSR 329
Samples of a product were sent to some of its potential customers for testing The technical details construction of the product was impossible to be determined on such visual inspection Here the court held that there is no prior disclosure and thus there was no impact on the novelty
UNNI NALSAR
The Fascinating World of Patents
Inventive Step Inventive step means a feature of an invention
that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art
The use of the expression economic significance in the new law is interesting it is neither a classical patentability criterion nor does it have anything to do with inventions
UNNI NALSAR
Patents would not be available on the following grounds the mere discovery of a known substance which does not result
in the enhancement of the known efficacy of that substance the mere discovery of any new property or new use for a
known substance the mere use of a known process machine or apparatus unless
such known process results in a new product or employs at least employs one new reactant
One can argue that a minor alteration to an existing drug molecule resulting in enhancement of its known efficacy could lead to the grant of a patent on that molecule
UNNI NALSAR
The Fascinating World of Patents
Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel
International Ltd (1999) FSR 683 what was the problem which the invention
addressed how long had the problem existed how significant was the problem how widely known was the problem and
how many were likely to be seeking a solution
UNNI NALSAR
The Fascinating World of Patents
what prior art would have been known to those in the field
what other solutions were proposed prior to publication of the patent
what other factors were there that held back exploitation of the solution
how well has the product been received has the commercial success of the product been due
to its technical merits This decision leads to the position that commercial
success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)
UNNI NALSAR
The Fascinating World of Patents
Industrial Application Industrial application is another
requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from
copyright An invention is capable of industrial
application if it can be made or used in any kind of industry including agriculture
UNNI NALSAR
The Fascinating World of Patents
Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies
The above said exclusion doesnrsquot extend to products consisting of substances used in any such method
The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy
UNNI NALSAR
The Fascinating World of PatentsWhat are not patentable Sec 3
an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)
an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)
the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature
Sec 3[c]
UNNI NALSAR
The Fascinating World of Patents
the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)
ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy
Inserted by the 2005 amendment
UNNI NALSAR
The Fascinating World of Patents
a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)
the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)
Sec 3(g) has been omitted by the 2002 amendment
UNNI NALSAR
The Fascinating World of Patents
any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative
prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)
Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)
A mathematical or business method or a computer programme per se or algorithms Sec 3(k)
UNNI NALSAR
The Fascinating World of Patents
A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)
Method of performing a mental act or method of playing a game Sec 3(m)
Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional
knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)
UNNI NALSAR
The Fascinating World of Patents
Ownership of patents Normally it is the inventor who owns the
patent Incase the inventor has assigned the
patent the owner of the patent will be different
Disputes mainly arise over ownership of inventions between employees and employers
In India there is no provision which deals with employee-employer inventions
UNNI NALSAR
The Fascinating World of Patents
Rights of a patent holder (Sec 48) When a patent is for a product the patent
holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license
A patent is always territorial in nature In case of a process patent the patent
holder has the exclusive right to use or exercise the methodprocess in India
If any person violates any of these rights then there will be infringement
UNNI NALSAR
The Fascinating World of Patents
The following can be considered as the public interest provisions vis a vis the patent monopoly
Opposition of patents 1048710The Indian law provides for both pre grant and post
grant opposition As per Sec 25 (1) when an application for a patent has
been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)
UNNI NALSAR
The Fascinating World of Patents
The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a
period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)
The grounds can be many like lack of novelty obviousness insufficient description of the invention etc
Then the Controller of patents has to constitute an opposition board to consider this opposition
UNNI NALSAR
The Fascinating World of Patents
The opposition board has to hear both the parties and give its opinion to the controller
1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
ldquoPatentsrdquo How it all started
The origins of patent law can be traced from the medieval times
It all started with the granting of ldquoLetters Patentrdquo which were in effect open letters with kingrsquos seal
The Letters Patent granted the rights to foreign weavers craftsmen so that they can practise their trade
The first letters patent was granted to a weaver who wanted to practise his trade in England
UNNI NALSAR
The Fascinating World of Patents
Justification for Patents It encourages research and invention Induces inventors to reveal their inventions
instead of keeping them as a secret It offers a reward for the effort of
developing inventions to the stage where it is commercially viable
Provides inducement to invest money in new lines of production which may not be profitable if too many people venture into it
UNNI NALSAR
The Fascinating World of Patents
The patent system guarantees a limited term of protection in return for the inventorrsquos willingness to disclose details of his invention and finally to abandon his property right in it
The conventional justification is that in a patent system inventors are rewarded for their time work and risk of capital by the grant of a patent
The society is also benefited by stimulating investment and employment because details of the invention are added to the store of available knowledge
UNNI NALSAR
The Fascinating World of Patents
Patentability Requirements The invention has to be novel It should involve an inventive step ie it
should be non-obvious It should be capable of industrial
application It should not be excluded specifically by the
statute
UNNI NALSAR
The Fascinating World of Patents
Novelty Invention must be new it must not already
have been available to the public An invention can be new only if it does not
form part of the ldquostate of artrdquo prior art The prior art comprises of all matters made
available to the public before the date of the invention whether by written oral description by use or in any manner
Prior publication could have occurred anywhere in the world
UNNI NALSAR
But disclosures that are made in confidence will not be considered as prior publication
Thus disclosures made in such circumstances wonrsquot have any bearing on the novelty of the invention
Case-law Visx Inc v Nidek Co Ltd (1999) FSR 405 here a prior oral
disclosure was made during a train journey But the disclosure was made in confidence so the invention did not loose novelty
UNNI NALSAR
The Fascinating World of Patents
How many acts of disclosures are needed Windsurfing Intl Inc v Tabur Marine (Great
Britain) Ltd (1985) RPC 59 Here the boat built by a boy which was used
in public only for 2 week ends at a beach was held as sufficient disclosure to pre-empt a later patent
Thus even a single act of disclosure can destroy the novelty of an invention
UNNI NALSAR
The Fascinating World of Patents
Lux Traffic Controls v Pike Signals Ltd (1993) RPC 107
Here the prototype of a traffic light control system was taken for field trial and the prototype was used in public
The court held that there is no need to prove that anybody actually saw the disclosure provided the relevant disclosure was in public
When a prototype is kept in public it is irrelevant whether a skilled person examined it or not
In such cases there is prior disclosure consequently there is loss of novelty
UNNI NALSAR
The Fascinating World of Patents
Facts of the case also play a very crucial role in determining whether a prior disclosure had taken place or not
In Pall Corp v Commercial Hydraulics (Bedford) Ltd (1990) FSR 329
Samples of a product were sent to some of its potential customers for testing The technical details construction of the product was impossible to be determined on such visual inspection Here the court held that there is no prior disclosure and thus there was no impact on the novelty
UNNI NALSAR
The Fascinating World of Patents
Inventive Step Inventive step means a feature of an invention
that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art
The use of the expression economic significance in the new law is interesting it is neither a classical patentability criterion nor does it have anything to do with inventions
UNNI NALSAR
Patents would not be available on the following grounds the mere discovery of a known substance which does not result
in the enhancement of the known efficacy of that substance the mere discovery of any new property or new use for a
known substance the mere use of a known process machine or apparatus unless
such known process results in a new product or employs at least employs one new reactant
One can argue that a minor alteration to an existing drug molecule resulting in enhancement of its known efficacy could lead to the grant of a patent on that molecule
UNNI NALSAR
The Fascinating World of Patents
Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel
International Ltd (1999) FSR 683 what was the problem which the invention
addressed how long had the problem existed how significant was the problem how widely known was the problem and
how many were likely to be seeking a solution
UNNI NALSAR
The Fascinating World of Patents
what prior art would have been known to those in the field
what other solutions were proposed prior to publication of the patent
what other factors were there that held back exploitation of the solution
how well has the product been received has the commercial success of the product been due
to its technical merits This decision leads to the position that commercial
success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)
UNNI NALSAR
The Fascinating World of Patents
Industrial Application Industrial application is another
requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from
copyright An invention is capable of industrial
application if it can be made or used in any kind of industry including agriculture
UNNI NALSAR
The Fascinating World of Patents
Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies
The above said exclusion doesnrsquot extend to products consisting of substances used in any such method
The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy
UNNI NALSAR
The Fascinating World of PatentsWhat are not patentable Sec 3
an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)
an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)
the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature
Sec 3[c]
UNNI NALSAR
The Fascinating World of Patents
the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)
ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy
Inserted by the 2005 amendment
UNNI NALSAR
The Fascinating World of Patents
a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)
the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)
Sec 3(g) has been omitted by the 2002 amendment
UNNI NALSAR
The Fascinating World of Patents
any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative
prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)
Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)
A mathematical or business method or a computer programme per se or algorithms Sec 3(k)
UNNI NALSAR
The Fascinating World of Patents
A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)
Method of performing a mental act or method of playing a game Sec 3(m)
Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional
knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)
UNNI NALSAR
The Fascinating World of Patents
Ownership of patents Normally it is the inventor who owns the
patent Incase the inventor has assigned the
patent the owner of the patent will be different
Disputes mainly arise over ownership of inventions between employees and employers
In India there is no provision which deals with employee-employer inventions
UNNI NALSAR
The Fascinating World of Patents
Rights of a patent holder (Sec 48) When a patent is for a product the patent
holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license
A patent is always territorial in nature In case of a process patent the patent
holder has the exclusive right to use or exercise the methodprocess in India
If any person violates any of these rights then there will be infringement
UNNI NALSAR
The Fascinating World of Patents
The following can be considered as the public interest provisions vis a vis the patent monopoly
Opposition of patents 1048710The Indian law provides for both pre grant and post
grant opposition As per Sec 25 (1) when an application for a patent has
been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)
UNNI NALSAR
The Fascinating World of Patents
The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a
period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)
The grounds can be many like lack of novelty obviousness insufficient description of the invention etc
Then the Controller of patents has to constitute an opposition board to consider this opposition
UNNI NALSAR
The Fascinating World of Patents
The opposition board has to hear both the parties and give its opinion to the controller
1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
Justification for Patents It encourages research and invention Induces inventors to reveal their inventions
instead of keeping them as a secret It offers a reward for the effort of
developing inventions to the stage where it is commercially viable
Provides inducement to invest money in new lines of production which may not be profitable if too many people venture into it
UNNI NALSAR
The Fascinating World of Patents
The patent system guarantees a limited term of protection in return for the inventorrsquos willingness to disclose details of his invention and finally to abandon his property right in it
The conventional justification is that in a patent system inventors are rewarded for their time work and risk of capital by the grant of a patent
The society is also benefited by stimulating investment and employment because details of the invention are added to the store of available knowledge
UNNI NALSAR
The Fascinating World of Patents
Patentability Requirements The invention has to be novel It should involve an inventive step ie it
should be non-obvious It should be capable of industrial
application It should not be excluded specifically by the
statute
UNNI NALSAR
The Fascinating World of Patents
Novelty Invention must be new it must not already
have been available to the public An invention can be new only if it does not
form part of the ldquostate of artrdquo prior art The prior art comprises of all matters made
available to the public before the date of the invention whether by written oral description by use or in any manner
Prior publication could have occurred anywhere in the world
UNNI NALSAR
But disclosures that are made in confidence will not be considered as prior publication
Thus disclosures made in such circumstances wonrsquot have any bearing on the novelty of the invention
Case-law Visx Inc v Nidek Co Ltd (1999) FSR 405 here a prior oral
disclosure was made during a train journey But the disclosure was made in confidence so the invention did not loose novelty
UNNI NALSAR
The Fascinating World of Patents
How many acts of disclosures are needed Windsurfing Intl Inc v Tabur Marine (Great
Britain) Ltd (1985) RPC 59 Here the boat built by a boy which was used
in public only for 2 week ends at a beach was held as sufficient disclosure to pre-empt a later patent
Thus even a single act of disclosure can destroy the novelty of an invention
UNNI NALSAR
The Fascinating World of Patents
Lux Traffic Controls v Pike Signals Ltd (1993) RPC 107
Here the prototype of a traffic light control system was taken for field trial and the prototype was used in public
The court held that there is no need to prove that anybody actually saw the disclosure provided the relevant disclosure was in public
When a prototype is kept in public it is irrelevant whether a skilled person examined it or not
In such cases there is prior disclosure consequently there is loss of novelty
UNNI NALSAR
The Fascinating World of Patents
Facts of the case also play a very crucial role in determining whether a prior disclosure had taken place or not
In Pall Corp v Commercial Hydraulics (Bedford) Ltd (1990) FSR 329
Samples of a product were sent to some of its potential customers for testing The technical details construction of the product was impossible to be determined on such visual inspection Here the court held that there is no prior disclosure and thus there was no impact on the novelty
UNNI NALSAR
The Fascinating World of Patents
Inventive Step Inventive step means a feature of an invention
that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art
The use of the expression economic significance in the new law is interesting it is neither a classical patentability criterion nor does it have anything to do with inventions
UNNI NALSAR
Patents would not be available on the following grounds the mere discovery of a known substance which does not result
in the enhancement of the known efficacy of that substance the mere discovery of any new property or new use for a
known substance the mere use of a known process machine or apparatus unless
such known process results in a new product or employs at least employs one new reactant
One can argue that a minor alteration to an existing drug molecule resulting in enhancement of its known efficacy could lead to the grant of a patent on that molecule
UNNI NALSAR
The Fascinating World of Patents
Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel
International Ltd (1999) FSR 683 what was the problem which the invention
addressed how long had the problem existed how significant was the problem how widely known was the problem and
how many were likely to be seeking a solution
UNNI NALSAR
The Fascinating World of Patents
what prior art would have been known to those in the field
what other solutions were proposed prior to publication of the patent
what other factors were there that held back exploitation of the solution
how well has the product been received has the commercial success of the product been due
to its technical merits This decision leads to the position that commercial
success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)
UNNI NALSAR
The Fascinating World of Patents
Industrial Application Industrial application is another
requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from
copyright An invention is capable of industrial
application if it can be made or used in any kind of industry including agriculture
UNNI NALSAR
The Fascinating World of Patents
Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies
The above said exclusion doesnrsquot extend to products consisting of substances used in any such method
The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy
UNNI NALSAR
The Fascinating World of PatentsWhat are not patentable Sec 3
an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)
an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)
the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature
Sec 3[c]
UNNI NALSAR
The Fascinating World of Patents
the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)
ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy
Inserted by the 2005 amendment
UNNI NALSAR
The Fascinating World of Patents
a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)
the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)
Sec 3(g) has been omitted by the 2002 amendment
UNNI NALSAR
The Fascinating World of Patents
any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative
prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)
Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)
A mathematical or business method or a computer programme per se or algorithms Sec 3(k)
UNNI NALSAR
The Fascinating World of Patents
A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)
Method of performing a mental act or method of playing a game Sec 3(m)
Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional
knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)
UNNI NALSAR
The Fascinating World of Patents
Ownership of patents Normally it is the inventor who owns the
patent Incase the inventor has assigned the
patent the owner of the patent will be different
Disputes mainly arise over ownership of inventions between employees and employers
In India there is no provision which deals with employee-employer inventions
UNNI NALSAR
The Fascinating World of Patents
Rights of a patent holder (Sec 48) When a patent is for a product the patent
holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license
A patent is always territorial in nature In case of a process patent the patent
holder has the exclusive right to use or exercise the methodprocess in India
If any person violates any of these rights then there will be infringement
UNNI NALSAR
The Fascinating World of Patents
The following can be considered as the public interest provisions vis a vis the patent monopoly
Opposition of patents 1048710The Indian law provides for both pre grant and post
grant opposition As per Sec 25 (1) when an application for a patent has
been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)
UNNI NALSAR
The Fascinating World of Patents
The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a
period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)
The grounds can be many like lack of novelty obviousness insufficient description of the invention etc
Then the Controller of patents has to constitute an opposition board to consider this opposition
UNNI NALSAR
The Fascinating World of Patents
The opposition board has to hear both the parties and give its opinion to the controller
1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
The patent system guarantees a limited term of protection in return for the inventorrsquos willingness to disclose details of his invention and finally to abandon his property right in it
The conventional justification is that in a patent system inventors are rewarded for their time work and risk of capital by the grant of a patent
The society is also benefited by stimulating investment and employment because details of the invention are added to the store of available knowledge
UNNI NALSAR
The Fascinating World of Patents
Patentability Requirements The invention has to be novel It should involve an inventive step ie it
should be non-obvious It should be capable of industrial
application It should not be excluded specifically by the
statute
UNNI NALSAR
The Fascinating World of Patents
Novelty Invention must be new it must not already
have been available to the public An invention can be new only if it does not
form part of the ldquostate of artrdquo prior art The prior art comprises of all matters made
available to the public before the date of the invention whether by written oral description by use or in any manner
Prior publication could have occurred anywhere in the world
UNNI NALSAR
But disclosures that are made in confidence will not be considered as prior publication
Thus disclosures made in such circumstances wonrsquot have any bearing on the novelty of the invention
Case-law Visx Inc v Nidek Co Ltd (1999) FSR 405 here a prior oral
disclosure was made during a train journey But the disclosure was made in confidence so the invention did not loose novelty
UNNI NALSAR
The Fascinating World of Patents
How many acts of disclosures are needed Windsurfing Intl Inc v Tabur Marine (Great
Britain) Ltd (1985) RPC 59 Here the boat built by a boy which was used
in public only for 2 week ends at a beach was held as sufficient disclosure to pre-empt a later patent
Thus even a single act of disclosure can destroy the novelty of an invention
UNNI NALSAR
The Fascinating World of Patents
Lux Traffic Controls v Pike Signals Ltd (1993) RPC 107
Here the prototype of a traffic light control system was taken for field trial and the prototype was used in public
The court held that there is no need to prove that anybody actually saw the disclosure provided the relevant disclosure was in public
When a prototype is kept in public it is irrelevant whether a skilled person examined it or not
In such cases there is prior disclosure consequently there is loss of novelty
UNNI NALSAR
The Fascinating World of Patents
Facts of the case also play a very crucial role in determining whether a prior disclosure had taken place or not
In Pall Corp v Commercial Hydraulics (Bedford) Ltd (1990) FSR 329
Samples of a product were sent to some of its potential customers for testing The technical details construction of the product was impossible to be determined on such visual inspection Here the court held that there is no prior disclosure and thus there was no impact on the novelty
UNNI NALSAR
The Fascinating World of Patents
Inventive Step Inventive step means a feature of an invention
that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art
The use of the expression economic significance in the new law is interesting it is neither a classical patentability criterion nor does it have anything to do with inventions
UNNI NALSAR
Patents would not be available on the following grounds the mere discovery of a known substance which does not result
in the enhancement of the known efficacy of that substance the mere discovery of any new property or new use for a
known substance the mere use of a known process machine or apparatus unless
such known process results in a new product or employs at least employs one new reactant
One can argue that a minor alteration to an existing drug molecule resulting in enhancement of its known efficacy could lead to the grant of a patent on that molecule
UNNI NALSAR
The Fascinating World of Patents
Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel
International Ltd (1999) FSR 683 what was the problem which the invention
addressed how long had the problem existed how significant was the problem how widely known was the problem and
how many were likely to be seeking a solution
UNNI NALSAR
The Fascinating World of Patents
what prior art would have been known to those in the field
what other solutions were proposed prior to publication of the patent
what other factors were there that held back exploitation of the solution
how well has the product been received has the commercial success of the product been due
to its technical merits This decision leads to the position that commercial
success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)
UNNI NALSAR
The Fascinating World of Patents
Industrial Application Industrial application is another
requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from
copyright An invention is capable of industrial
application if it can be made or used in any kind of industry including agriculture
UNNI NALSAR
The Fascinating World of Patents
Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies
The above said exclusion doesnrsquot extend to products consisting of substances used in any such method
The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy
UNNI NALSAR
The Fascinating World of PatentsWhat are not patentable Sec 3
an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)
an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)
the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature
Sec 3[c]
UNNI NALSAR
The Fascinating World of Patents
the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)
ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy
Inserted by the 2005 amendment
UNNI NALSAR
The Fascinating World of Patents
a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)
the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)
Sec 3(g) has been omitted by the 2002 amendment
UNNI NALSAR
The Fascinating World of Patents
any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative
prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)
Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)
A mathematical or business method or a computer programme per se or algorithms Sec 3(k)
UNNI NALSAR
The Fascinating World of Patents
A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)
Method of performing a mental act or method of playing a game Sec 3(m)
Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional
knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)
UNNI NALSAR
The Fascinating World of Patents
Ownership of patents Normally it is the inventor who owns the
patent Incase the inventor has assigned the
patent the owner of the patent will be different
Disputes mainly arise over ownership of inventions between employees and employers
In India there is no provision which deals with employee-employer inventions
UNNI NALSAR
The Fascinating World of Patents
Rights of a patent holder (Sec 48) When a patent is for a product the patent
holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license
A patent is always territorial in nature In case of a process patent the patent
holder has the exclusive right to use or exercise the methodprocess in India
If any person violates any of these rights then there will be infringement
UNNI NALSAR
The Fascinating World of Patents
The following can be considered as the public interest provisions vis a vis the patent monopoly
Opposition of patents 1048710The Indian law provides for both pre grant and post
grant opposition As per Sec 25 (1) when an application for a patent has
been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)
UNNI NALSAR
The Fascinating World of Patents
The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a
period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)
The grounds can be many like lack of novelty obviousness insufficient description of the invention etc
Then the Controller of patents has to constitute an opposition board to consider this opposition
UNNI NALSAR
The Fascinating World of Patents
The opposition board has to hear both the parties and give its opinion to the controller
1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
Patentability Requirements The invention has to be novel It should involve an inventive step ie it
should be non-obvious It should be capable of industrial
application It should not be excluded specifically by the
statute
UNNI NALSAR
The Fascinating World of Patents
Novelty Invention must be new it must not already
have been available to the public An invention can be new only if it does not
form part of the ldquostate of artrdquo prior art The prior art comprises of all matters made
available to the public before the date of the invention whether by written oral description by use or in any manner
Prior publication could have occurred anywhere in the world
UNNI NALSAR
But disclosures that are made in confidence will not be considered as prior publication
Thus disclosures made in such circumstances wonrsquot have any bearing on the novelty of the invention
Case-law Visx Inc v Nidek Co Ltd (1999) FSR 405 here a prior oral
disclosure was made during a train journey But the disclosure was made in confidence so the invention did not loose novelty
UNNI NALSAR
The Fascinating World of Patents
How many acts of disclosures are needed Windsurfing Intl Inc v Tabur Marine (Great
Britain) Ltd (1985) RPC 59 Here the boat built by a boy which was used
in public only for 2 week ends at a beach was held as sufficient disclosure to pre-empt a later patent
Thus even a single act of disclosure can destroy the novelty of an invention
UNNI NALSAR
The Fascinating World of Patents
Lux Traffic Controls v Pike Signals Ltd (1993) RPC 107
Here the prototype of a traffic light control system was taken for field trial and the prototype was used in public
The court held that there is no need to prove that anybody actually saw the disclosure provided the relevant disclosure was in public
When a prototype is kept in public it is irrelevant whether a skilled person examined it or not
In such cases there is prior disclosure consequently there is loss of novelty
UNNI NALSAR
The Fascinating World of Patents
Facts of the case also play a very crucial role in determining whether a prior disclosure had taken place or not
In Pall Corp v Commercial Hydraulics (Bedford) Ltd (1990) FSR 329
Samples of a product were sent to some of its potential customers for testing The technical details construction of the product was impossible to be determined on such visual inspection Here the court held that there is no prior disclosure and thus there was no impact on the novelty
UNNI NALSAR
The Fascinating World of Patents
Inventive Step Inventive step means a feature of an invention
that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art
The use of the expression economic significance in the new law is interesting it is neither a classical patentability criterion nor does it have anything to do with inventions
UNNI NALSAR
Patents would not be available on the following grounds the mere discovery of a known substance which does not result
in the enhancement of the known efficacy of that substance the mere discovery of any new property or new use for a
known substance the mere use of a known process machine or apparatus unless
such known process results in a new product or employs at least employs one new reactant
One can argue that a minor alteration to an existing drug molecule resulting in enhancement of its known efficacy could lead to the grant of a patent on that molecule
UNNI NALSAR
The Fascinating World of Patents
Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel
International Ltd (1999) FSR 683 what was the problem which the invention
addressed how long had the problem existed how significant was the problem how widely known was the problem and
how many were likely to be seeking a solution
UNNI NALSAR
The Fascinating World of Patents
what prior art would have been known to those in the field
what other solutions were proposed prior to publication of the patent
what other factors were there that held back exploitation of the solution
how well has the product been received has the commercial success of the product been due
to its technical merits This decision leads to the position that commercial
success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)
UNNI NALSAR
The Fascinating World of Patents
Industrial Application Industrial application is another
requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from
copyright An invention is capable of industrial
application if it can be made or used in any kind of industry including agriculture
UNNI NALSAR
The Fascinating World of Patents
Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies
The above said exclusion doesnrsquot extend to products consisting of substances used in any such method
The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy
UNNI NALSAR
The Fascinating World of PatentsWhat are not patentable Sec 3
an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)
an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)
the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature
Sec 3[c]
UNNI NALSAR
The Fascinating World of Patents
the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)
ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy
Inserted by the 2005 amendment
UNNI NALSAR
The Fascinating World of Patents
a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)
the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)
Sec 3(g) has been omitted by the 2002 amendment
UNNI NALSAR
The Fascinating World of Patents
any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative
prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)
Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)
A mathematical or business method or a computer programme per se or algorithms Sec 3(k)
UNNI NALSAR
The Fascinating World of Patents
A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)
Method of performing a mental act or method of playing a game Sec 3(m)
Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional
knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)
UNNI NALSAR
The Fascinating World of Patents
Ownership of patents Normally it is the inventor who owns the
patent Incase the inventor has assigned the
patent the owner of the patent will be different
Disputes mainly arise over ownership of inventions between employees and employers
In India there is no provision which deals with employee-employer inventions
UNNI NALSAR
The Fascinating World of Patents
Rights of a patent holder (Sec 48) When a patent is for a product the patent
holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license
A patent is always territorial in nature In case of a process patent the patent
holder has the exclusive right to use or exercise the methodprocess in India
If any person violates any of these rights then there will be infringement
UNNI NALSAR
The Fascinating World of Patents
The following can be considered as the public interest provisions vis a vis the patent monopoly
Opposition of patents 1048710The Indian law provides for both pre grant and post
grant opposition As per Sec 25 (1) when an application for a patent has
been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)
UNNI NALSAR
The Fascinating World of Patents
The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a
period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)
The grounds can be many like lack of novelty obviousness insufficient description of the invention etc
Then the Controller of patents has to constitute an opposition board to consider this opposition
UNNI NALSAR
The Fascinating World of Patents
The opposition board has to hear both the parties and give its opinion to the controller
1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
Novelty Invention must be new it must not already
have been available to the public An invention can be new only if it does not
form part of the ldquostate of artrdquo prior art The prior art comprises of all matters made
available to the public before the date of the invention whether by written oral description by use or in any manner
Prior publication could have occurred anywhere in the world
UNNI NALSAR
But disclosures that are made in confidence will not be considered as prior publication
Thus disclosures made in such circumstances wonrsquot have any bearing on the novelty of the invention
Case-law Visx Inc v Nidek Co Ltd (1999) FSR 405 here a prior oral
disclosure was made during a train journey But the disclosure was made in confidence so the invention did not loose novelty
UNNI NALSAR
The Fascinating World of Patents
How many acts of disclosures are needed Windsurfing Intl Inc v Tabur Marine (Great
Britain) Ltd (1985) RPC 59 Here the boat built by a boy which was used
in public only for 2 week ends at a beach was held as sufficient disclosure to pre-empt a later patent
Thus even a single act of disclosure can destroy the novelty of an invention
UNNI NALSAR
The Fascinating World of Patents
Lux Traffic Controls v Pike Signals Ltd (1993) RPC 107
Here the prototype of a traffic light control system was taken for field trial and the prototype was used in public
The court held that there is no need to prove that anybody actually saw the disclosure provided the relevant disclosure was in public
When a prototype is kept in public it is irrelevant whether a skilled person examined it or not
In such cases there is prior disclosure consequently there is loss of novelty
UNNI NALSAR
The Fascinating World of Patents
Facts of the case also play a very crucial role in determining whether a prior disclosure had taken place or not
In Pall Corp v Commercial Hydraulics (Bedford) Ltd (1990) FSR 329
Samples of a product were sent to some of its potential customers for testing The technical details construction of the product was impossible to be determined on such visual inspection Here the court held that there is no prior disclosure and thus there was no impact on the novelty
UNNI NALSAR
The Fascinating World of Patents
Inventive Step Inventive step means a feature of an invention
that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art
The use of the expression economic significance in the new law is interesting it is neither a classical patentability criterion nor does it have anything to do with inventions
UNNI NALSAR
Patents would not be available on the following grounds the mere discovery of a known substance which does not result
in the enhancement of the known efficacy of that substance the mere discovery of any new property or new use for a
known substance the mere use of a known process machine or apparatus unless
such known process results in a new product or employs at least employs one new reactant
One can argue that a minor alteration to an existing drug molecule resulting in enhancement of its known efficacy could lead to the grant of a patent on that molecule
UNNI NALSAR
The Fascinating World of Patents
Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel
International Ltd (1999) FSR 683 what was the problem which the invention
addressed how long had the problem existed how significant was the problem how widely known was the problem and
how many were likely to be seeking a solution
UNNI NALSAR
The Fascinating World of Patents
what prior art would have been known to those in the field
what other solutions were proposed prior to publication of the patent
what other factors were there that held back exploitation of the solution
how well has the product been received has the commercial success of the product been due
to its technical merits This decision leads to the position that commercial
success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)
UNNI NALSAR
The Fascinating World of Patents
Industrial Application Industrial application is another
requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from
copyright An invention is capable of industrial
application if it can be made or used in any kind of industry including agriculture
UNNI NALSAR
The Fascinating World of Patents
Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies
The above said exclusion doesnrsquot extend to products consisting of substances used in any such method
The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy
UNNI NALSAR
The Fascinating World of PatentsWhat are not patentable Sec 3
an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)
an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)
the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature
Sec 3[c]
UNNI NALSAR
The Fascinating World of Patents
the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)
ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy
Inserted by the 2005 amendment
UNNI NALSAR
The Fascinating World of Patents
a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)
the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)
Sec 3(g) has been omitted by the 2002 amendment
UNNI NALSAR
The Fascinating World of Patents
any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative
prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)
Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)
A mathematical or business method or a computer programme per se or algorithms Sec 3(k)
UNNI NALSAR
The Fascinating World of Patents
A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)
Method of performing a mental act or method of playing a game Sec 3(m)
Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional
knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)
UNNI NALSAR
The Fascinating World of Patents
Ownership of patents Normally it is the inventor who owns the
patent Incase the inventor has assigned the
patent the owner of the patent will be different
Disputes mainly arise over ownership of inventions between employees and employers
In India there is no provision which deals with employee-employer inventions
UNNI NALSAR
The Fascinating World of Patents
Rights of a patent holder (Sec 48) When a patent is for a product the patent
holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license
A patent is always territorial in nature In case of a process patent the patent
holder has the exclusive right to use or exercise the methodprocess in India
If any person violates any of these rights then there will be infringement
UNNI NALSAR
The Fascinating World of Patents
The following can be considered as the public interest provisions vis a vis the patent monopoly
Opposition of patents 1048710The Indian law provides for both pre grant and post
grant opposition As per Sec 25 (1) when an application for a patent has
been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)
UNNI NALSAR
The Fascinating World of Patents
The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a
period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)
The grounds can be many like lack of novelty obviousness insufficient description of the invention etc
Then the Controller of patents has to constitute an opposition board to consider this opposition
UNNI NALSAR
The Fascinating World of Patents
The opposition board has to hear both the parties and give its opinion to the controller
1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
But disclosures that are made in confidence will not be considered as prior publication
Thus disclosures made in such circumstances wonrsquot have any bearing on the novelty of the invention
Case-law Visx Inc v Nidek Co Ltd (1999) FSR 405 here a prior oral
disclosure was made during a train journey But the disclosure was made in confidence so the invention did not loose novelty
UNNI NALSAR
The Fascinating World of Patents
How many acts of disclosures are needed Windsurfing Intl Inc v Tabur Marine (Great
Britain) Ltd (1985) RPC 59 Here the boat built by a boy which was used
in public only for 2 week ends at a beach was held as sufficient disclosure to pre-empt a later patent
Thus even a single act of disclosure can destroy the novelty of an invention
UNNI NALSAR
The Fascinating World of Patents
Lux Traffic Controls v Pike Signals Ltd (1993) RPC 107
Here the prototype of a traffic light control system was taken for field trial and the prototype was used in public
The court held that there is no need to prove that anybody actually saw the disclosure provided the relevant disclosure was in public
When a prototype is kept in public it is irrelevant whether a skilled person examined it or not
In such cases there is prior disclosure consequently there is loss of novelty
UNNI NALSAR
The Fascinating World of Patents
Facts of the case also play a very crucial role in determining whether a prior disclosure had taken place or not
In Pall Corp v Commercial Hydraulics (Bedford) Ltd (1990) FSR 329
Samples of a product were sent to some of its potential customers for testing The technical details construction of the product was impossible to be determined on such visual inspection Here the court held that there is no prior disclosure and thus there was no impact on the novelty
UNNI NALSAR
The Fascinating World of Patents
Inventive Step Inventive step means a feature of an invention
that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art
The use of the expression economic significance in the new law is interesting it is neither a classical patentability criterion nor does it have anything to do with inventions
UNNI NALSAR
Patents would not be available on the following grounds the mere discovery of a known substance which does not result
in the enhancement of the known efficacy of that substance the mere discovery of any new property or new use for a
known substance the mere use of a known process machine or apparatus unless
such known process results in a new product or employs at least employs one new reactant
One can argue that a minor alteration to an existing drug molecule resulting in enhancement of its known efficacy could lead to the grant of a patent on that molecule
UNNI NALSAR
The Fascinating World of Patents
Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel
International Ltd (1999) FSR 683 what was the problem which the invention
addressed how long had the problem existed how significant was the problem how widely known was the problem and
how many were likely to be seeking a solution
UNNI NALSAR
The Fascinating World of Patents
what prior art would have been known to those in the field
what other solutions were proposed prior to publication of the patent
what other factors were there that held back exploitation of the solution
how well has the product been received has the commercial success of the product been due
to its technical merits This decision leads to the position that commercial
success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)
UNNI NALSAR
The Fascinating World of Patents
Industrial Application Industrial application is another
requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from
copyright An invention is capable of industrial
application if it can be made or used in any kind of industry including agriculture
UNNI NALSAR
The Fascinating World of Patents
Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies
The above said exclusion doesnrsquot extend to products consisting of substances used in any such method
The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy
UNNI NALSAR
The Fascinating World of PatentsWhat are not patentable Sec 3
an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)
an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)
the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature
Sec 3[c]
UNNI NALSAR
The Fascinating World of Patents
the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)
ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy
Inserted by the 2005 amendment
UNNI NALSAR
The Fascinating World of Patents
a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)
the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)
Sec 3(g) has been omitted by the 2002 amendment
UNNI NALSAR
The Fascinating World of Patents
any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative
prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)
Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)
A mathematical or business method or a computer programme per se or algorithms Sec 3(k)
UNNI NALSAR
The Fascinating World of Patents
A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)
Method of performing a mental act or method of playing a game Sec 3(m)
Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional
knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)
UNNI NALSAR
The Fascinating World of Patents
Ownership of patents Normally it is the inventor who owns the
patent Incase the inventor has assigned the
patent the owner of the patent will be different
Disputes mainly arise over ownership of inventions between employees and employers
In India there is no provision which deals with employee-employer inventions
UNNI NALSAR
The Fascinating World of Patents
Rights of a patent holder (Sec 48) When a patent is for a product the patent
holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license
A patent is always territorial in nature In case of a process patent the patent
holder has the exclusive right to use or exercise the methodprocess in India
If any person violates any of these rights then there will be infringement
UNNI NALSAR
The Fascinating World of Patents
The following can be considered as the public interest provisions vis a vis the patent monopoly
Opposition of patents 1048710The Indian law provides for both pre grant and post
grant opposition As per Sec 25 (1) when an application for a patent has
been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)
UNNI NALSAR
The Fascinating World of Patents
The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a
period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)
The grounds can be many like lack of novelty obviousness insufficient description of the invention etc
Then the Controller of patents has to constitute an opposition board to consider this opposition
UNNI NALSAR
The Fascinating World of Patents
The opposition board has to hear both the parties and give its opinion to the controller
1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
How many acts of disclosures are needed Windsurfing Intl Inc v Tabur Marine (Great
Britain) Ltd (1985) RPC 59 Here the boat built by a boy which was used
in public only for 2 week ends at a beach was held as sufficient disclosure to pre-empt a later patent
Thus even a single act of disclosure can destroy the novelty of an invention
UNNI NALSAR
The Fascinating World of Patents
Lux Traffic Controls v Pike Signals Ltd (1993) RPC 107
Here the prototype of a traffic light control system was taken for field trial and the prototype was used in public
The court held that there is no need to prove that anybody actually saw the disclosure provided the relevant disclosure was in public
When a prototype is kept in public it is irrelevant whether a skilled person examined it or not
In such cases there is prior disclosure consequently there is loss of novelty
UNNI NALSAR
The Fascinating World of Patents
Facts of the case also play a very crucial role in determining whether a prior disclosure had taken place or not
In Pall Corp v Commercial Hydraulics (Bedford) Ltd (1990) FSR 329
Samples of a product were sent to some of its potential customers for testing The technical details construction of the product was impossible to be determined on such visual inspection Here the court held that there is no prior disclosure and thus there was no impact on the novelty
UNNI NALSAR
The Fascinating World of Patents
Inventive Step Inventive step means a feature of an invention
that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art
The use of the expression economic significance in the new law is interesting it is neither a classical patentability criterion nor does it have anything to do with inventions
UNNI NALSAR
Patents would not be available on the following grounds the mere discovery of a known substance which does not result
in the enhancement of the known efficacy of that substance the mere discovery of any new property or new use for a
known substance the mere use of a known process machine or apparatus unless
such known process results in a new product or employs at least employs one new reactant
One can argue that a minor alteration to an existing drug molecule resulting in enhancement of its known efficacy could lead to the grant of a patent on that molecule
UNNI NALSAR
The Fascinating World of Patents
Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel
International Ltd (1999) FSR 683 what was the problem which the invention
addressed how long had the problem existed how significant was the problem how widely known was the problem and
how many were likely to be seeking a solution
UNNI NALSAR
The Fascinating World of Patents
what prior art would have been known to those in the field
what other solutions were proposed prior to publication of the patent
what other factors were there that held back exploitation of the solution
how well has the product been received has the commercial success of the product been due
to its technical merits This decision leads to the position that commercial
success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)
UNNI NALSAR
The Fascinating World of Patents
Industrial Application Industrial application is another
requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from
copyright An invention is capable of industrial
application if it can be made or used in any kind of industry including agriculture
UNNI NALSAR
The Fascinating World of Patents
Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies
The above said exclusion doesnrsquot extend to products consisting of substances used in any such method
The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy
UNNI NALSAR
The Fascinating World of PatentsWhat are not patentable Sec 3
an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)
an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)
the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature
Sec 3[c]
UNNI NALSAR
The Fascinating World of Patents
the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)
ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy
Inserted by the 2005 amendment
UNNI NALSAR
The Fascinating World of Patents
a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)
the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)
Sec 3(g) has been omitted by the 2002 amendment
UNNI NALSAR
The Fascinating World of Patents
any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative
prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)
Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)
A mathematical or business method or a computer programme per se or algorithms Sec 3(k)
UNNI NALSAR
The Fascinating World of Patents
A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)
Method of performing a mental act or method of playing a game Sec 3(m)
Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional
knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)
UNNI NALSAR
The Fascinating World of Patents
Ownership of patents Normally it is the inventor who owns the
patent Incase the inventor has assigned the
patent the owner of the patent will be different
Disputes mainly arise over ownership of inventions between employees and employers
In India there is no provision which deals with employee-employer inventions
UNNI NALSAR
The Fascinating World of Patents
Rights of a patent holder (Sec 48) When a patent is for a product the patent
holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license
A patent is always territorial in nature In case of a process patent the patent
holder has the exclusive right to use or exercise the methodprocess in India
If any person violates any of these rights then there will be infringement
UNNI NALSAR
The Fascinating World of Patents
The following can be considered as the public interest provisions vis a vis the patent monopoly
Opposition of patents 1048710The Indian law provides for both pre grant and post
grant opposition As per Sec 25 (1) when an application for a patent has
been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)
UNNI NALSAR
The Fascinating World of Patents
The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a
period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)
The grounds can be many like lack of novelty obviousness insufficient description of the invention etc
Then the Controller of patents has to constitute an opposition board to consider this opposition
UNNI NALSAR
The Fascinating World of Patents
The opposition board has to hear both the parties and give its opinion to the controller
1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
Lux Traffic Controls v Pike Signals Ltd (1993) RPC 107
Here the prototype of a traffic light control system was taken for field trial and the prototype was used in public
The court held that there is no need to prove that anybody actually saw the disclosure provided the relevant disclosure was in public
When a prototype is kept in public it is irrelevant whether a skilled person examined it or not
In such cases there is prior disclosure consequently there is loss of novelty
UNNI NALSAR
The Fascinating World of Patents
Facts of the case also play a very crucial role in determining whether a prior disclosure had taken place or not
In Pall Corp v Commercial Hydraulics (Bedford) Ltd (1990) FSR 329
Samples of a product were sent to some of its potential customers for testing The technical details construction of the product was impossible to be determined on such visual inspection Here the court held that there is no prior disclosure and thus there was no impact on the novelty
UNNI NALSAR
The Fascinating World of Patents
Inventive Step Inventive step means a feature of an invention
that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art
The use of the expression economic significance in the new law is interesting it is neither a classical patentability criterion nor does it have anything to do with inventions
UNNI NALSAR
Patents would not be available on the following grounds the mere discovery of a known substance which does not result
in the enhancement of the known efficacy of that substance the mere discovery of any new property or new use for a
known substance the mere use of a known process machine or apparatus unless
such known process results in a new product or employs at least employs one new reactant
One can argue that a minor alteration to an existing drug molecule resulting in enhancement of its known efficacy could lead to the grant of a patent on that molecule
UNNI NALSAR
The Fascinating World of Patents
Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel
International Ltd (1999) FSR 683 what was the problem which the invention
addressed how long had the problem existed how significant was the problem how widely known was the problem and
how many were likely to be seeking a solution
UNNI NALSAR
The Fascinating World of Patents
what prior art would have been known to those in the field
what other solutions were proposed prior to publication of the patent
what other factors were there that held back exploitation of the solution
how well has the product been received has the commercial success of the product been due
to its technical merits This decision leads to the position that commercial
success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)
UNNI NALSAR
The Fascinating World of Patents
Industrial Application Industrial application is another
requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from
copyright An invention is capable of industrial
application if it can be made or used in any kind of industry including agriculture
UNNI NALSAR
The Fascinating World of Patents
Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies
The above said exclusion doesnrsquot extend to products consisting of substances used in any such method
The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy
UNNI NALSAR
The Fascinating World of PatentsWhat are not patentable Sec 3
an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)
an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)
the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature
Sec 3[c]
UNNI NALSAR
The Fascinating World of Patents
the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)
ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy
Inserted by the 2005 amendment
UNNI NALSAR
The Fascinating World of Patents
a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)
the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)
Sec 3(g) has been omitted by the 2002 amendment
UNNI NALSAR
The Fascinating World of Patents
any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative
prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)
Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)
A mathematical or business method or a computer programme per se or algorithms Sec 3(k)
UNNI NALSAR
The Fascinating World of Patents
A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)
Method of performing a mental act or method of playing a game Sec 3(m)
Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional
knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)
UNNI NALSAR
The Fascinating World of Patents
Ownership of patents Normally it is the inventor who owns the
patent Incase the inventor has assigned the
patent the owner of the patent will be different
Disputes mainly arise over ownership of inventions between employees and employers
In India there is no provision which deals with employee-employer inventions
UNNI NALSAR
The Fascinating World of Patents
Rights of a patent holder (Sec 48) When a patent is for a product the patent
holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license
A patent is always territorial in nature In case of a process patent the patent
holder has the exclusive right to use or exercise the methodprocess in India
If any person violates any of these rights then there will be infringement
UNNI NALSAR
The Fascinating World of Patents
The following can be considered as the public interest provisions vis a vis the patent monopoly
Opposition of patents 1048710The Indian law provides for both pre grant and post
grant opposition As per Sec 25 (1) when an application for a patent has
been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)
UNNI NALSAR
The Fascinating World of Patents
The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a
period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)
The grounds can be many like lack of novelty obviousness insufficient description of the invention etc
Then the Controller of patents has to constitute an opposition board to consider this opposition
UNNI NALSAR
The Fascinating World of Patents
The opposition board has to hear both the parties and give its opinion to the controller
1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
Facts of the case also play a very crucial role in determining whether a prior disclosure had taken place or not
In Pall Corp v Commercial Hydraulics (Bedford) Ltd (1990) FSR 329
Samples of a product were sent to some of its potential customers for testing The technical details construction of the product was impossible to be determined on such visual inspection Here the court held that there is no prior disclosure and thus there was no impact on the novelty
UNNI NALSAR
The Fascinating World of Patents
Inventive Step Inventive step means a feature of an invention
that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art
The use of the expression economic significance in the new law is interesting it is neither a classical patentability criterion nor does it have anything to do with inventions
UNNI NALSAR
Patents would not be available on the following grounds the mere discovery of a known substance which does not result
in the enhancement of the known efficacy of that substance the mere discovery of any new property or new use for a
known substance the mere use of a known process machine or apparatus unless
such known process results in a new product or employs at least employs one new reactant
One can argue that a minor alteration to an existing drug molecule resulting in enhancement of its known efficacy could lead to the grant of a patent on that molecule
UNNI NALSAR
The Fascinating World of Patents
Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel
International Ltd (1999) FSR 683 what was the problem which the invention
addressed how long had the problem existed how significant was the problem how widely known was the problem and
how many were likely to be seeking a solution
UNNI NALSAR
The Fascinating World of Patents
what prior art would have been known to those in the field
what other solutions were proposed prior to publication of the patent
what other factors were there that held back exploitation of the solution
how well has the product been received has the commercial success of the product been due
to its technical merits This decision leads to the position that commercial
success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)
UNNI NALSAR
The Fascinating World of Patents
Industrial Application Industrial application is another
requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from
copyright An invention is capable of industrial
application if it can be made or used in any kind of industry including agriculture
UNNI NALSAR
The Fascinating World of Patents
Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies
The above said exclusion doesnrsquot extend to products consisting of substances used in any such method
The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy
UNNI NALSAR
The Fascinating World of PatentsWhat are not patentable Sec 3
an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)
an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)
the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature
Sec 3[c]
UNNI NALSAR
The Fascinating World of Patents
the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)
ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy
Inserted by the 2005 amendment
UNNI NALSAR
The Fascinating World of Patents
a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)
the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)
Sec 3(g) has been omitted by the 2002 amendment
UNNI NALSAR
The Fascinating World of Patents
any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative
prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)
Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)
A mathematical or business method or a computer programme per se or algorithms Sec 3(k)
UNNI NALSAR
The Fascinating World of Patents
A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)
Method of performing a mental act or method of playing a game Sec 3(m)
Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional
knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)
UNNI NALSAR
The Fascinating World of Patents
Ownership of patents Normally it is the inventor who owns the
patent Incase the inventor has assigned the
patent the owner of the patent will be different
Disputes mainly arise over ownership of inventions between employees and employers
In India there is no provision which deals with employee-employer inventions
UNNI NALSAR
The Fascinating World of Patents
Rights of a patent holder (Sec 48) When a patent is for a product the patent
holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license
A patent is always territorial in nature In case of a process patent the patent
holder has the exclusive right to use or exercise the methodprocess in India
If any person violates any of these rights then there will be infringement
UNNI NALSAR
The Fascinating World of Patents
The following can be considered as the public interest provisions vis a vis the patent monopoly
Opposition of patents 1048710The Indian law provides for both pre grant and post
grant opposition As per Sec 25 (1) when an application for a patent has
been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)
UNNI NALSAR
The Fascinating World of Patents
The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a
period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)
The grounds can be many like lack of novelty obviousness insufficient description of the invention etc
Then the Controller of patents has to constitute an opposition board to consider this opposition
UNNI NALSAR
The Fascinating World of Patents
The opposition board has to hear both the parties and give its opinion to the controller
1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
Inventive Step Inventive step means a feature of an invention
that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art
The use of the expression economic significance in the new law is interesting it is neither a classical patentability criterion nor does it have anything to do with inventions
UNNI NALSAR
Patents would not be available on the following grounds the mere discovery of a known substance which does not result
in the enhancement of the known efficacy of that substance the mere discovery of any new property or new use for a
known substance the mere use of a known process machine or apparatus unless
such known process results in a new product or employs at least employs one new reactant
One can argue that a minor alteration to an existing drug molecule resulting in enhancement of its known efficacy could lead to the grant of a patent on that molecule
UNNI NALSAR
The Fascinating World of Patents
Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel
International Ltd (1999) FSR 683 what was the problem which the invention
addressed how long had the problem existed how significant was the problem how widely known was the problem and
how many were likely to be seeking a solution
UNNI NALSAR
The Fascinating World of Patents
what prior art would have been known to those in the field
what other solutions were proposed prior to publication of the patent
what other factors were there that held back exploitation of the solution
how well has the product been received has the commercial success of the product been due
to its technical merits This decision leads to the position that commercial
success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)
UNNI NALSAR
The Fascinating World of Patents
Industrial Application Industrial application is another
requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from
copyright An invention is capable of industrial
application if it can be made or used in any kind of industry including agriculture
UNNI NALSAR
The Fascinating World of Patents
Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies
The above said exclusion doesnrsquot extend to products consisting of substances used in any such method
The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy
UNNI NALSAR
The Fascinating World of PatentsWhat are not patentable Sec 3
an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)
an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)
the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature
Sec 3[c]
UNNI NALSAR
The Fascinating World of Patents
the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)
ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy
Inserted by the 2005 amendment
UNNI NALSAR
The Fascinating World of Patents
a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)
the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)
Sec 3(g) has been omitted by the 2002 amendment
UNNI NALSAR
The Fascinating World of Patents
any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative
prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)
Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)
A mathematical or business method or a computer programme per se or algorithms Sec 3(k)
UNNI NALSAR
The Fascinating World of Patents
A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)
Method of performing a mental act or method of playing a game Sec 3(m)
Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional
knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)
UNNI NALSAR
The Fascinating World of Patents
Ownership of patents Normally it is the inventor who owns the
patent Incase the inventor has assigned the
patent the owner of the patent will be different
Disputes mainly arise over ownership of inventions between employees and employers
In India there is no provision which deals with employee-employer inventions
UNNI NALSAR
The Fascinating World of Patents
Rights of a patent holder (Sec 48) When a patent is for a product the patent
holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license
A patent is always territorial in nature In case of a process patent the patent
holder has the exclusive right to use or exercise the methodprocess in India
If any person violates any of these rights then there will be infringement
UNNI NALSAR
The Fascinating World of Patents
The following can be considered as the public interest provisions vis a vis the patent monopoly
Opposition of patents 1048710The Indian law provides for both pre grant and post
grant opposition As per Sec 25 (1) when an application for a patent has
been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)
UNNI NALSAR
The Fascinating World of Patents
The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a
period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)
The grounds can be many like lack of novelty obviousness insufficient description of the invention etc
Then the Controller of patents has to constitute an opposition board to consider this opposition
UNNI NALSAR
The Fascinating World of Patents
The opposition board has to hear both the parties and give its opinion to the controller
1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
Patents would not be available on the following grounds the mere discovery of a known substance which does not result
in the enhancement of the known efficacy of that substance the mere discovery of any new property or new use for a
known substance the mere use of a known process machine or apparatus unless
such known process results in a new product or employs at least employs one new reactant
One can argue that a minor alteration to an existing drug molecule resulting in enhancement of its known efficacy could lead to the grant of a patent on that molecule
UNNI NALSAR
The Fascinating World of Patents
Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel
International Ltd (1999) FSR 683 what was the problem which the invention
addressed how long had the problem existed how significant was the problem how widely known was the problem and
how many were likely to be seeking a solution
UNNI NALSAR
The Fascinating World of Patents
what prior art would have been known to those in the field
what other solutions were proposed prior to publication of the patent
what other factors were there that held back exploitation of the solution
how well has the product been received has the commercial success of the product been due
to its technical merits This decision leads to the position that commercial
success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)
UNNI NALSAR
The Fascinating World of Patents
Industrial Application Industrial application is another
requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from
copyright An invention is capable of industrial
application if it can be made or used in any kind of industry including agriculture
UNNI NALSAR
The Fascinating World of Patents
Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies
The above said exclusion doesnrsquot extend to products consisting of substances used in any such method
The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy
UNNI NALSAR
The Fascinating World of PatentsWhat are not patentable Sec 3
an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)
an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)
the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature
Sec 3[c]
UNNI NALSAR
The Fascinating World of Patents
the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)
ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy
Inserted by the 2005 amendment
UNNI NALSAR
The Fascinating World of Patents
a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)
the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)
Sec 3(g) has been omitted by the 2002 amendment
UNNI NALSAR
The Fascinating World of Patents
any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative
prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)
Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)
A mathematical or business method or a computer programme per se or algorithms Sec 3(k)
UNNI NALSAR
The Fascinating World of Patents
A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)
Method of performing a mental act or method of playing a game Sec 3(m)
Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional
knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)
UNNI NALSAR
The Fascinating World of Patents
Ownership of patents Normally it is the inventor who owns the
patent Incase the inventor has assigned the
patent the owner of the patent will be different
Disputes mainly arise over ownership of inventions between employees and employers
In India there is no provision which deals with employee-employer inventions
UNNI NALSAR
The Fascinating World of Patents
Rights of a patent holder (Sec 48) When a patent is for a product the patent
holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license
A patent is always territorial in nature In case of a process patent the patent
holder has the exclusive right to use or exercise the methodprocess in India
If any person violates any of these rights then there will be infringement
UNNI NALSAR
The Fascinating World of Patents
The following can be considered as the public interest provisions vis a vis the patent monopoly
Opposition of patents 1048710The Indian law provides for both pre grant and post
grant opposition As per Sec 25 (1) when an application for a patent has
been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)
UNNI NALSAR
The Fascinating World of Patents
The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a
period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)
The grounds can be many like lack of novelty obviousness insufficient description of the invention etc
Then the Controller of patents has to constitute an opposition board to consider this opposition
UNNI NALSAR
The Fascinating World of Patents
The opposition board has to hear both the parties and give its opinion to the controller
1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
Nine-point test to analyze obviousnessLandmark case in UK Haberman v Jackel
International Ltd (1999) FSR 683 what was the problem which the invention
addressed how long had the problem existed how significant was the problem how widely known was the problem and
how many were likely to be seeking a solution
UNNI NALSAR
The Fascinating World of Patents
what prior art would have been known to those in the field
what other solutions were proposed prior to publication of the patent
what other factors were there that held back exploitation of the solution
how well has the product been received has the commercial success of the product been due
to its technical merits This decision leads to the position that commercial
success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)
UNNI NALSAR
The Fascinating World of Patents
Industrial Application Industrial application is another
requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from
copyright An invention is capable of industrial
application if it can be made or used in any kind of industry including agriculture
UNNI NALSAR
The Fascinating World of Patents
Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies
The above said exclusion doesnrsquot extend to products consisting of substances used in any such method
The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy
UNNI NALSAR
The Fascinating World of PatentsWhat are not patentable Sec 3
an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)
an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)
the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature
Sec 3[c]
UNNI NALSAR
The Fascinating World of Patents
the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)
ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy
Inserted by the 2005 amendment
UNNI NALSAR
The Fascinating World of Patents
a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)
the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)
Sec 3(g) has been omitted by the 2002 amendment
UNNI NALSAR
The Fascinating World of Patents
any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative
prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)
Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)
A mathematical or business method or a computer programme per se or algorithms Sec 3(k)
UNNI NALSAR
The Fascinating World of Patents
A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)
Method of performing a mental act or method of playing a game Sec 3(m)
Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional
knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)
UNNI NALSAR
The Fascinating World of Patents
Ownership of patents Normally it is the inventor who owns the
patent Incase the inventor has assigned the
patent the owner of the patent will be different
Disputes mainly arise over ownership of inventions between employees and employers
In India there is no provision which deals with employee-employer inventions
UNNI NALSAR
The Fascinating World of Patents
Rights of a patent holder (Sec 48) When a patent is for a product the patent
holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license
A patent is always territorial in nature In case of a process patent the patent
holder has the exclusive right to use or exercise the methodprocess in India
If any person violates any of these rights then there will be infringement
UNNI NALSAR
The Fascinating World of Patents
The following can be considered as the public interest provisions vis a vis the patent monopoly
Opposition of patents 1048710The Indian law provides for both pre grant and post
grant opposition As per Sec 25 (1) when an application for a patent has
been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)
UNNI NALSAR
The Fascinating World of Patents
The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a
period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)
The grounds can be many like lack of novelty obviousness insufficient description of the invention etc
Then the Controller of patents has to constitute an opposition board to consider this opposition
UNNI NALSAR
The Fascinating World of Patents
The opposition board has to hear both the parties and give its opinion to the controller
1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
what prior art would have been known to those in the field
what other solutions were proposed prior to publication of the patent
what other factors were there that held back exploitation of the solution
how well has the product been received has the commercial success of the product been due
to its technical merits This decision leads to the position that commercial
success of the invention especially when it satisfies a long felt want can make an invention non-obvious (inventive)
UNNI NALSAR
The Fascinating World of Patents
Industrial Application Industrial application is another
requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from
copyright An invention is capable of industrial
application if it can be made or used in any kind of industry including agriculture
UNNI NALSAR
The Fascinating World of Patents
Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies
The above said exclusion doesnrsquot extend to products consisting of substances used in any such method
The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy
UNNI NALSAR
The Fascinating World of PatentsWhat are not patentable Sec 3
an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)
an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)
the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature
Sec 3[c]
UNNI NALSAR
The Fascinating World of Patents
the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)
ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy
Inserted by the 2005 amendment
UNNI NALSAR
The Fascinating World of Patents
a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)
the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)
Sec 3(g) has been omitted by the 2002 amendment
UNNI NALSAR
The Fascinating World of Patents
any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative
prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)
Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)
A mathematical or business method or a computer programme per se or algorithms Sec 3(k)
UNNI NALSAR
The Fascinating World of Patents
A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)
Method of performing a mental act or method of playing a game Sec 3(m)
Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional
knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)
UNNI NALSAR
The Fascinating World of Patents
Ownership of patents Normally it is the inventor who owns the
patent Incase the inventor has assigned the
patent the owner of the patent will be different
Disputes mainly arise over ownership of inventions between employees and employers
In India there is no provision which deals with employee-employer inventions
UNNI NALSAR
The Fascinating World of Patents
Rights of a patent holder (Sec 48) When a patent is for a product the patent
holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license
A patent is always territorial in nature In case of a process patent the patent
holder has the exclusive right to use or exercise the methodprocess in India
If any person violates any of these rights then there will be infringement
UNNI NALSAR
The Fascinating World of Patents
The following can be considered as the public interest provisions vis a vis the patent monopoly
Opposition of patents 1048710The Indian law provides for both pre grant and post
grant opposition As per Sec 25 (1) when an application for a patent has
been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)
UNNI NALSAR
The Fascinating World of Patents
The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a
period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)
The grounds can be many like lack of novelty obviousness insufficient description of the invention etc
Then the Controller of patents has to constitute an opposition board to consider this opposition
UNNI NALSAR
The Fascinating World of Patents
The opposition board has to hear both the parties and give its opinion to the controller
1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
Industrial Application Industrial application is another
requirement for patentability The invention has to be worked industrially This requirement distinguishes patents from
copyright An invention is capable of industrial
application if it can be made or used in any kind of industry including agriculture
UNNI NALSAR
The Fascinating World of Patents
Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies
The above said exclusion doesnrsquot extend to products consisting of substances used in any such method
The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy
UNNI NALSAR
The Fascinating World of PatentsWhat are not patentable Sec 3
an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)
an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)
the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature
Sec 3[c]
UNNI NALSAR
The Fascinating World of Patents
the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)
ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy
Inserted by the 2005 amendment
UNNI NALSAR
The Fascinating World of Patents
a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)
the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)
Sec 3(g) has been omitted by the 2002 amendment
UNNI NALSAR
The Fascinating World of Patents
any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative
prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)
Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)
A mathematical or business method or a computer programme per se or algorithms Sec 3(k)
UNNI NALSAR
The Fascinating World of Patents
A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)
Method of performing a mental act or method of playing a game Sec 3(m)
Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional
knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)
UNNI NALSAR
The Fascinating World of Patents
Ownership of patents Normally it is the inventor who owns the
patent Incase the inventor has assigned the
patent the owner of the patent will be different
Disputes mainly arise over ownership of inventions between employees and employers
In India there is no provision which deals with employee-employer inventions
UNNI NALSAR
The Fascinating World of Patents
Rights of a patent holder (Sec 48) When a patent is for a product the patent
holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license
A patent is always territorial in nature In case of a process patent the patent
holder has the exclusive right to use or exercise the methodprocess in India
If any person violates any of these rights then there will be infringement
UNNI NALSAR
The Fascinating World of Patents
The following can be considered as the public interest provisions vis a vis the patent monopoly
Opposition of patents 1048710The Indian law provides for both pre grant and post
grant opposition As per Sec 25 (1) when an application for a patent has
been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)
UNNI NALSAR
The Fascinating World of Patents
The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a
period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)
The grounds can be many like lack of novelty obviousness insufficient description of the invention etc
Then the Controller of patents has to constitute an opposition board to consider this opposition
UNNI NALSAR
The Fascinating World of Patents
The opposition board has to hear both the parties and give its opinion to the controller
1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
Industrial application doesnrsquot cover methods of human or animal bodies by surgery or therapy or of diagnosis practised on human or animal bodies
The above said exclusion doesnrsquot extend to products consisting of substances used in any such method
The word treatment and diagnosis imply an illness or disease of some kind and doesnrsquot include pregnancy
UNNI NALSAR
The Fascinating World of PatentsWhat are not patentable Sec 3
an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)
an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)
the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature
Sec 3[c]
UNNI NALSAR
The Fascinating World of Patents
the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)
ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy
Inserted by the 2005 amendment
UNNI NALSAR
The Fascinating World of Patents
a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)
the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)
Sec 3(g) has been omitted by the 2002 amendment
UNNI NALSAR
The Fascinating World of Patents
any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative
prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)
Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)
A mathematical or business method or a computer programme per se or algorithms Sec 3(k)
UNNI NALSAR
The Fascinating World of Patents
A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)
Method of performing a mental act or method of playing a game Sec 3(m)
Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional
knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)
UNNI NALSAR
The Fascinating World of Patents
Ownership of patents Normally it is the inventor who owns the
patent Incase the inventor has assigned the
patent the owner of the patent will be different
Disputes mainly arise over ownership of inventions between employees and employers
In India there is no provision which deals with employee-employer inventions
UNNI NALSAR
The Fascinating World of Patents
Rights of a patent holder (Sec 48) When a patent is for a product the patent
holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license
A patent is always territorial in nature In case of a process patent the patent
holder has the exclusive right to use or exercise the methodprocess in India
If any person violates any of these rights then there will be infringement
UNNI NALSAR
The Fascinating World of Patents
The following can be considered as the public interest provisions vis a vis the patent monopoly
Opposition of patents 1048710The Indian law provides for both pre grant and post
grant opposition As per Sec 25 (1) when an application for a patent has
been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)
UNNI NALSAR
The Fascinating World of Patents
The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a
period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)
The grounds can be many like lack of novelty obviousness insufficient description of the invention etc
Then the Controller of patents has to constitute an opposition board to consider this opposition
UNNI NALSAR
The Fascinating World of Patents
The opposition board has to hear both the parties and give its opinion to the controller
1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of PatentsWhat are not patentable Sec 3
an invention which is frivolous or which claims anything contrary to well established natural laws Sec 3 (a)
an invention where the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human animal or plant life or health or to the environment Sec 3(b)
the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non living substance occurring in nature
Sec 3[c]
UNNI NALSAR
The Fascinating World of Patents
the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)
ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy
Inserted by the 2005 amendment
UNNI NALSAR
The Fascinating World of Patents
a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)
the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)
Sec 3(g) has been omitted by the 2002 amendment
UNNI NALSAR
The Fascinating World of Patents
any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative
prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)
Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)
A mathematical or business method or a computer programme per se or algorithms Sec 3(k)
UNNI NALSAR
The Fascinating World of Patents
A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)
Method of performing a mental act or method of playing a game Sec 3(m)
Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional
knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)
UNNI NALSAR
The Fascinating World of Patents
Ownership of patents Normally it is the inventor who owns the
patent Incase the inventor has assigned the
patent the owner of the patent will be different
Disputes mainly arise over ownership of inventions between employees and employers
In India there is no provision which deals with employee-employer inventions
UNNI NALSAR
The Fascinating World of Patents
Rights of a patent holder (Sec 48) When a patent is for a product the patent
holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license
A patent is always territorial in nature In case of a process patent the patent
holder has the exclusive right to use or exercise the methodprocess in India
If any person violates any of these rights then there will be infringement
UNNI NALSAR
The Fascinating World of Patents
The following can be considered as the public interest provisions vis a vis the patent monopoly
Opposition of patents 1048710The Indian law provides for both pre grant and post
grant opposition As per Sec 25 (1) when an application for a patent has
been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)
UNNI NALSAR
The Fascinating World of Patents
The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a
period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)
The grounds can be many like lack of novelty obviousness insufficient description of the invention etc
Then the Controller of patents has to constitute an opposition board to consider this opposition
UNNI NALSAR
The Fascinating World of Patents
The opposition board has to hear both the parties and give its opinion to the controller
1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process machine or apparatus unless such known process results in a new product or employs at least one new reactant Sec 3 (d)
ExplanationmdashFor the purposes of this clause salts esters ethers polymorphs metabolites pure form particle size isomers mixtures of isomers complexes combinations and other derivatives of known substance shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy
Inserted by the 2005 amendment
UNNI NALSAR
The Fascinating World of Patents
a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)
the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)
Sec 3(g) has been omitted by the 2002 amendment
UNNI NALSAR
The Fascinating World of Patents
any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative
prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)
Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)
A mathematical or business method or a computer programme per se or algorithms Sec 3(k)
UNNI NALSAR
The Fascinating World of Patents
A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)
Method of performing a mental act or method of playing a game Sec 3(m)
Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional
knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)
UNNI NALSAR
The Fascinating World of Patents
Ownership of patents Normally it is the inventor who owns the
patent Incase the inventor has assigned the
patent the owner of the patent will be different
Disputes mainly arise over ownership of inventions between employees and employers
In India there is no provision which deals with employee-employer inventions
UNNI NALSAR
The Fascinating World of Patents
Rights of a patent holder (Sec 48) When a patent is for a product the patent
holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license
A patent is always territorial in nature In case of a process patent the patent
holder has the exclusive right to use or exercise the methodprocess in India
If any person violates any of these rights then there will be infringement
UNNI NALSAR
The Fascinating World of Patents
The following can be considered as the public interest provisions vis a vis the patent monopoly
Opposition of patents 1048710The Indian law provides for both pre grant and post
grant opposition As per Sec 25 (1) when an application for a patent has
been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)
UNNI NALSAR
The Fascinating World of Patents
The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a
period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)
The grounds can be many like lack of novelty obviousness insufficient description of the invention etc
Then the Controller of patents has to constitute an opposition board to consider this opposition
UNNI NALSAR
The Fascinating World of Patents
The opposition board has to hear both the parties and give its opinion to the controller
1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance Sec 3 (e)
the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way Sec 3(f)
Sec 3(g) has been omitted by the 2002 amendment
UNNI NALSAR
The Fascinating World of Patents
any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative
prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)
Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)
A mathematical or business method or a computer programme per se or algorithms Sec 3(k)
UNNI NALSAR
The Fascinating World of Patents
A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)
Method of performing a mental act or method of playing a game Sec 3(m)
Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional
knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)
UNNI NALSAR
The Fascinating World of Patents
Ownership of patents Normally it is the inventor who owns the
patent Incase the inventor has assigned the
patent the owner of the patent will be different
Disputes mainly arise over ownership of inventions between employees and employers
In India there is no provision which deals with employee-employer inventions
UNNI NALSAR
The Fascinating World of Patents
Rights of a patent holder (Sec 48) When a patent is for a product the patent
holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license
A patent is always territorial in nature In case of a process patent the patent
holder has the exclusive right to use or exercise the methodprocess in India
If any person violates any of these rights then there will be infringement
UNNI NALSAR
The Fascinating World of Patents
The following can be considered as the public interest provisions vis a vis the patent monopoly
Opposition of patents 1048710The Indian law provides for both pre grant and post
grant opposition As per Sec 25 (1) when an application for a patent has
been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)
UNNI NALSAR
The Fascinating World of Patents
The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a
period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)
The grounds can be many like lack of novelty obviousness insufficient description of the invention etc
Then the Controller of patents has to constitute an opposition board to consider this opposition
UNNI NALSAR
The Fascinating World of Patents
The opposition board has to hear both the parties and give its opinion to the controller
1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
any method of agriculture or horticulture Sec 3(h) any process for the medicinal surgical curative
prophylactic diagnostic therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products Sec 3(i)
Plants and animals in whole or in any part thereof other than microorganisms and essentially biological processes for the production or propagation of plants and animals Sec 3(j)
A mathematical or business method or a computer programme per se or algorithms Sec 3(k)
UNNI NALSAR
The Fascinating World of Patents
A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)
Method of performing a mental act or method of playing a game Sec 3(m)
Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional
knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)
UNNI NALSAR
The Fascinating World of Patents
Ownership of patents Normally it is the inventor who owns the
patent Incase the inventor has assigned the
patent the owner of the patent will be different
Disputes mainly arise over ownership of inventions between employees and employers
In India there is no provision which deals with employee-employer inventions
UNNI NALSAR
The Fascinating World of Patents
Rights of a patent holder (Sec 48) When a patent is for a product the patent
holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license
A patent is always territorial in nature In case of a process patent the patent
holder has the exclusive right to use or exercise the methodprocess in India
If any person violates any of these rights then there will be infringement
UNNI NALSAR
The Fascinating World of Patents
The following can be considered as the public interest provisions vis a vis the patent monopoly
Opposition of patents 1048710The Indian law provides for both pre grant and post
grant opposition As per Sec 25 (1) when an application for a patent has
been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)
UNNI NALSAR
The Fascinating World of Patents
The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a
period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)
The grounds can be many like lack of novelty obviousness insufficient description of the invention etc
Then the Controller of patents has to constitute an opposition board to consider this opposition
UNNI NALSAR
The Fascinating World of Patents
The opposition board has to hear both the parties and give its opinion to the controller
1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
A literary dramatic artistic musical works cinematographic films television productions Sec 3(l)
Method of performing a mental act or method of playing a game Sec 3(m)
Presentation of information Sec 3(n) Integrated circuits Sec 3(o) An invention which in effect is traditional
knowledge or is an aggregation or duplication of known properties of a traditionally known component Sec 3(p)
UNNI NALSAR
The Fascinating World of Patents
Ownership of patents Normally it is the inventor who owns the
patent Incase the inventor has assigned the
patent the owner of the patent will be different
Disputes mainly arise over ownership of inventions between employees and employers
In India there is no provision which deals with employee-employer inventions
UNNI NALSAR
The Fascinating World of Patents
Rights of a patent holder (Sec 48) When a patent is for a product the patent
holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license
A patent is always territorial in nature In case of a process patent the patent
holder has the exclusive right to use or exercise the methodprocess in India
If any person violates any of these rights then there will be infringement
UNNI NALSAR
The Fascinating World of Patents
The following can be considered as the public interest provisions vis a vis the patent monopoly
Opposition of patents 1048710The Indian law provides for both pre grant and post
grant opposition As per Sec 25 (1) when an application for a patent has
been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)
UNNI NALSAR
The Fascinating World of Patents
The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a
period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)
The grounds can be many like lack of novelty obviousness insufficient description of the invention etc
Then the Controller of patents has to constitute an opposition board to consider this opposition
UNNI NALSAR
The Fascinating World of Patents
The opposition board has to hear both the parties and give its opinion to the controller
1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
Ownership of patents Normally it is the inventor who owns the
patent Incase the inventor has assigned the
patent the owner of the patent will be different
Disputes mainly arise over ownership of inventions between employees and employers
In India there is no provision which deals with employee-employer inventions
UNNI NALSAR
The Fascinating World of Patents
Rights of a patent holder (Sec 48) When a patent is for a product the patent
holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license
A patent is always territorial in nature In case of a process patent the patent
holder has the exclusive right to use or exercise the methodprocess in India
If any person violates any of these rights then there will be infringement
UNNI NALSAR
The Fascinating World of Patents
The following can be considered as the public interest provisions vis a vis the patent monopoly
Opposition of patents 1048710The Indian law provides for both pre grant and post
grant opposition As per Sec 25 (1) when an application for a patent has
been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)
UNNI NALSAR
The Fascinating World of Patents
The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a
period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)
The grounds can be many like lack of novelty obviousness insufficient description of the invention etc
Then the Controller of patents has to constitute an opposition board to consider this opposition
UNNI NALSAR
The Fascinating World of Patents
The opposition board has to hear both the parties and give its opinion to the controller
1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
Rights of a patent holder (Sec 48) When a patent is for a product the patent
holder has the exclusive right to make use sell distribute such article or permit his agent to do so or issue a license
A patent is always territorial in nature In case of a process patent the patent
holder has the exclusive right to use or exercise the methodprocess in India
If any person violates any of these rights then there will be infringement
UNNI NALSAR
The Fascinating World of Patents
The following can be considered as the public interest provisions vis a vis the patent monopoly
Opposition of patents 1048710The Indian law provides for both pre grant and post
grant opposition As per Sec 25 (1) when an application for a patent has
been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)
UNNI NALSAR
The Fascinating World of Patents
The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a
period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)
The grounds can be many like lack of novelty obviousness insufficient description of the invention etc
Then the Controller of patents has to constitute an opposition board to consider this opposition
UNNI NALSAR
The Fascinating World of Patents
The opposition board has to hear both the parties and give its opinion to the controller
1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
The following can be considered as the public interest provisions vis a vis the patent monopoly
Opposition of patents 1048710The Indian law provides for both pre grant and post
grant opposition As per Sec 25 (1) when an application for a patent has
been published but has not been granted any person may in writing represent by way of opposition to the Controller against the grant of the patent (pre-grant opposition)
UNNI NALSAR
The Fascinating World of Patents
The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a
period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)
The grounds can be many like lack of novelty obviousness insufficient description of the invention etc
Then the Controller of patents has to constitute an opposition board to consider this opposition
UNNI NALSAR
The Fascinating World of Patents
The opposition board has to hear both the parties and give its opinion to the controller
1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
The Indian law also provides for post grant opposition After the grant of patent but before the expiry of a
period of one year from the date of grant any interested person may give notice of opposition to the Controller Sec 25 (2)
The grounds can be many like lack of novelty obviousness insufficient description of the invention etc
Then the Controller of patents has to constitute an opposition board to consider this opposition
UNNI NALSAR
The Fascinating World of Patents
The opposition board has to hear both the parties and give its opinion to the controller
1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
The opposition board has to hear both the parties and give its opinion to the controller
1048710Thus the Controller can either maintain amend or revoke the patent after the said proceedings
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
Compulsory Licensing The aim or purpose of this provision is to ensure hat
the patented invention is worked on a commercial scale in India to the fullest extend possible and also to protect the interests of people developing the invention
Grounds for compulsory licensing can be classified the grounds into two categories (private and public)
Those that can be invoked directly by a private company like Dr REDDYrsquoS Torrent this is known as a licence on lsquoprivate grounds and those that can only be invoked by or with the help of the government known as a licence on lsquopublic groundsrsquo
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents Sec 84 deals with compulsory licensing on private
grounds After 3 years from the grant of the patent any person
shall apply to the controller to issue him a compulsory license to work the patent
The grounds for making such application are The reasonable requirement of the public with respect
to the invention are not satisfied Patented invention is not available to the public at a
reasonably affordable price Invention is not worked in the territory of India
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents Thus if the controller is satisfied that
these conditions are not being met he will grant a compulsory license upon the terms he may think fit
Sections 86-89 deals with the procedures to be followed while granting a compulsory license
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
The license shall be non exclusive and non transferable and generally it is granted to cater to the Indian market
The license shall be for the balance term of the patent or for a shorter term
Compulsory Licensing on Public Grounds If the central govt is satisfied that a compulsory
license shall be granted for any patent because of circumstances arising out of national emergency extreme urgency public non commercial use then it shall grant such license at anytime after the grant of the patent (Sec 92)
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents If the controller feels that because of national
emergency extreme urgency and public non commercial uses which includes cases like AIDS tuberculosis Malaria epidemics he shall immediately grant a compulsory license without following the procedures provided under the Act
This beneficial provision can be really helpful in the case of emergencies
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems Sec 92A (By virtue of 2005 amendment)
However there should be a compulsory licence granted by such country or such country should allow importation of the patented pharmaceutical products from India
Sec 92A incorporates the 2003 August 30 decision of TRIPS Council into the Indian law
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of PatentsGovernment use of inventions The government is free to use a patented invention without
running the risk of being sued for infringement By virtue of Sections 99-103 the Central Government or
any authorised person can use an invention for the purposes of the Central Government State Government PSU provided adequate compensation is paid
Sec 47 also deals with government use of inventions and as per this provision a patented invention may be imported or manufactured by or on behalf of the Government for its own use here there is no mention of any compensation to be paid to the patent holder
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of PatentsBolar Exception Sec 107A (a) This provided for a research exemption as an exception to the
general rules of patent infringement This research exception enables a manufacturer of generic
drugs to use a patented invention to obtain marketing approval without the patent owners permission before the patent expires
Thus even in cases where there is a product patent for a drug molecule an Indian generic drug maker can use the patented invention in order to gain marketing approval for their own version of that drug molecule
The generic drug maker can then market their own version of the patented drug as soon as the patent expires
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
Parallel Importation Sec 107A (b) As per Sec 107A (b) it is not an infringement to import a
patented product if the exporter of such patented product is duly authorised under the law of that country to produce and sell or distribute the product
Thus India Indian companies can import drugs from least developed countries by basing their operations in those countries because least developed countries will not have any patent protection until the year 2016
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
Revocation of patents These proceedings can be instituted at any time after
the grant of the patent while the patent is in force Revocation can be made by the 1The Controller (Sections 65 and 85) or 2The Appellate Board (Section 64(1) or 3The High Court (Sections 64(1) when raised in a
counter claim for patent infringement and 64(4) or 4The Central Government [Section 66 revocation in
public interest]
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg
UNNI NALSAR
The Fascinating World of Patents
Revocation of Patents (Sec 85) When a compulsory license has been granted after 2
years from the date of such grant any interested person central govt can apply before the controller to revoke the patent
The grounds are reasonable requirements of the public with respect to the invention not satisfied patented invention is not available to the public at a reasonably affordable price
UNNI NALSAR
The Fascinating World of Patents
Thank You Very Much
VK Unni
Asst Professor - Law
NALSAR University of Law Hyderabad
wwwnalsaracin
E-mail unninalsarlawunivorg