IPR Requirements – An International ComparisonIPR Requirements – An International Comparison

Prof. J. Vijaya RatnaProf. J. Vijaya RatnaAU College of Pharmaceutical SciencesAU College of Pharmaceutical Sciences

Andhra UniversityAndhra UniversityVisakhapatnam-530003Visakhapatnam-530003

INTELLECTUAL PROPERTY RIGHTSINTELLECTUAL PROPERTY RIGHTS

Contents :Contents :

1.1. IntroductionIntroduction

2.2. PurposePurpose

3.3. International ScenarioInternational Scenario

4.4. Indian ScenarioIndian Scenario

5.5. IPR in European Union IPR in European Union

6.6. IPR in USAIPR in USA

7.7. Some Important IPR related issues.Some Important IPR related issues.

8.8. Conclusion.Conclusion.

INTRODUCTIONINTRODUCTION

What is an intellectual property?What is an intellectual property?

Intellectual property is a right pervading Intellectual property is a right pervading some material object which is basically some material object which is basically a creation of intellect. It is a property in a creation of intellect. It is a property in fiction and is real like a real property fiction and is real like a real property such as a house or land.such as a house or land.

Why is it fictional?Why is it fictional?

For e.g., copy right is a right in some For e.g., copy right is a right in some creation of art, a manuscript of book creation of art, a manuscript of book or article or a recorded sound. But or article or a recorded sound. But such article is saleable or such article is saleable or transferable, subject to the copy right transferable, subject to the copy right of its author. A real property is not of its author. A real property is not created by intellect, is enjoyed by one created by intellect, is enjoyed by one owner only at any given time and the owner only at any given time and the right over it is real, obvious and easily right over it is real, obvious and easily enforceable. enforceable.

How many types of IPR are there?How many types of IPR are there?

Copy RightCopy Right Trade markTrade mark Geographical IndicationGeographical Indication Industrial DesignIndustrial Design PatentPatent Layout-Designs (Topographic) of Layout-Designs (Topographic) of

integrated (circuits)integrated (circuits) Protection of undisclosed informationProtection of undisclosed information

Attributes of IPRAttributes of IPR

IPR is a property in fiction and not in fact.IPR is a property in fiction and not in fact. It is a right in fact pervading some material It is a right in fact pervading some material

object or real propertyobject or real property It is saleable and transferable. The object It is saleable and transferable. The object

created by IPR is also saleable and created by IPR is also saleable and transferable but has a price that is different transferable but has a price that is different from the IPR pervading it.from the IPR pervading it.

It is confined or extended to some defined It is confined or extended to some defined period of its life. period of its life.

The IPR is more valuable than the article or The IPR is more valuable than the article or object in which the IPR is subsisting.object in which the IPR is subsisting.

Benefits of IPRBenefits of IPR

Safeguarding of Individual interests.Safeguarding of Individual interests. Progress of science & technology and Progress of science & technology and

development of the statedevelopment of the state Rising progress of societyRising progress of society Role of inventors recognizedRole of inventors recognized Growth of industriesGrowth of industries

Copy RightsCopy Rights Copy right is an exclusive right which an Copy right is an exclusive right which an

author acquires for his work of literary or, a author acquires for his work of literary or, a photograph, a motion picture etc. It is a photograph, a motion picture etc. It is a right to print, multiple, publish or sell a right to print, multiple, publish or sell a “work”.“work”.

Patent RightPatent Right Patent is an exclusive right granted to an Patent is an exclusive right granted to an

inventor or a discoverer to make, sell or use inventor or a discoverer to make, sell or use his invention or discovery. The patentee has his invention or discovery. The patentee has the power to exclude others from “using” the power to exclude others from “using” his invention even if he is not “using” it. his invention even if he is not “using” it.

Design RightDesign Right The term design means a feature of The term design means a feature of

shape, configuration, pattern, shape, configuration, pattern, ornament or composition of lines or ornament or composition of lines or colours applied to any article, two colours applied to any article, two dimensional or three dimensional.dimensional or three dimensional.

Trade mark RightTrade mark Right Some mark, symbol or pattern or Some mark, symbol or pattern or

other device, affixed to goods offered other device, affixed to goods offered for sale where by the goods can be at for sale where by the goods can be at once distinguished from similar goods once distinguished from similar goods of other manufacturers or other of other manufacturers or other dealers. dealers.

Geographical Indications :Geographical Indications : Geographical indications are, Geographical indications are,

indications which identify a set of indications which identify a set of goods as originating in the territory, goods as originating in the territory, where a given quality, reputation or where a given quality, reputation or other characteristic of the goods is other characteristic of the goods is essentially attributable to its essentially attributable to its geographical origin.geographical origin.

INDUSTRIALINDUSTRIAL DESIGNS :DESIGNS : These are designs that are These are designs that are

independently created and are new or independently created and are new or original, such as textile designs.original, such as textile designs.

Layout – Design (Topographic) of Layout – Design (Topographic) of integrated circuitsintegrated circuits

A right is given to the author over a A right is given to the author over a layout – design, or over an integrated layout – design, or over an integrated circuit in which a protected layout is circuit in which a protected layout is incorporated. incorporated.

Protection of undisclosed Protection of undisclosed informationinformation

Natural and legal persons have right to Natural and legal persons have right to prevent government or government prevent government or government agencies from disclosing the data / agencies from disclosing the data / information lodged with them. information lodged with them.

Purpose of IPRPurpose of IPR

Encourage scientific script Encourage scientific script Encourage R&D in the case of drugsEncourage R&D in the case of drugs Bring down prices in the case of Bring down prices in the case of

drugsdrugs Make life easier and happierMake life easier and happier

International scenarioInternational scenarioInternational convention and treaties relating International convention and treaties relating

to IPRto IPR The world intellectual property organization The world intellectual property organization

(WIPO) established in 1967, Geneva (WIPO) established in 1967, Geneva International Convention for the protection International Convention for the protection

of New varieties of plants, (UPOV) 1961-of New varieties of plants, (UPOV) 1961-came into force in 1968.came into force in 1968.

Patent cooperation treaty (PCP), 1970, Patent cooperation treaty (PCP), 1970, came into force in 1978came into force in 1978

The Budapest Treaty on the International The Budapest Treaty on the International recognisation of the deposit of micron recognisation of the deposit of micron organisms for the purposes of patent organisms for the purposes of patent procedure.procedure.

European Patent convention 1973European Patent convention 1973

International convention for the International convention for the protection of new varieties of patentsprotection of new varieties of patents

Madrid Agreement relating to Madrid Agreement relating to International registration of Mark.International registration of Mark.

The Madrid Agreement for the The Madrid Agreement for the protection of false or misleading protection of false or misleading indications of sources of goods.indications of sources of goods.

Trade mark law treaty – 1996.Trade mark law treaty – 1996. Lisbon Agreement for the protection Lisbon Agreement for the protection

of Appellation of Origin and their of Appellation of Origin and their International Registration.International Registration.

Universal Copyright convention 1971Universal Copyright convention 1971 International Convention for the International Convention for the

protection of performers and protection of performers and producers of phonograms and producers of phonograms and broadcasting organization.broadcasting organization.

WIPO copy right treatyWIPO copy right treaty WIPO Performances and phonograms WIPO Performances and phonograms

treaty.treaty. Conventions for protection of Conventions for protection of

producers phonograms against producers phonograms against unauthorized implications of their unauthorized implications of their phonograms.phonograms.

Treaty of International Registration Treaty of International Registration of Audio-Visual works, Genevaof Audio-Visual works, Geneva

The Hague agreement relating to The Hague agreement relating to International Deposit of Industrial International Deposit of Industrial designs.designs.

Locarno Agreement Locarno Agreement TRIPS AgreementTRIPS Agreement

INDIAN SCENARIOINDIAN SCENARIO

Indian Patent Act 1970Indian Patent Act 1970 Fast progress of Indian Fast progress of Indian

Pharmaceutical IndustryPharmaceutical Industry Reverse EngineeringReverse Engineering

Indian Patent Act Indian Patent Act 19701970

Patent period 5 to 10 Patent period 5 to 10 yearsyears

Allowed new Allowed new processes to be processes to be patentedpatented

Compulsory licensing Compulsory licensing in all casesin all cases

Onus of burden of Onus of burden of proof on person proof on person allegingalleging

Plants, animals and Plants, animals and microbes not microbes not patentablepatentable

TRIPSTRIPS Patent period valid for Patent period valid for

20 years20 years Allows products and Allows products and

process to be process to be patentedpatented

Compulsory licensing Compulsory licensing in emergencies onlyin emergencies only

Reversal of burden of Reversal of burden of proofproof

Some varieties Some varieties patentable patentable

Patent in DetailPatent in Detail

What is a patent?What is a patent? A patent is an exclusive right granted A patent is an exclusive right granted

by a country to the owner of an by a country to the owner of an invention to make use, manufacture invention to make use, manufacture and market the invention, provided the and market the invention, provided the invention satisfies certain conditions invention satisfies certain conditions stipulated in the law. The grant is stipulated in the law. The grant is given in the form of an certificate for given in the form of an certificate for the disclosing the invention and it is the disclosing the invention and it is valid for a limited period of time.valid for a limited period of time.

What is patentable?What is patentable?

Novelty – it must be newNovelty – it must be new Inventiveness – it must involve an Inventiveness – it must involve an

inventive stepinventive step Usefulness – It must have industrial Usefulness – It must have industrial

application.application.

What is the use of a patent?What is the use of a patent?

Patents give the patentee Patents give the patentee (proprietor) the right to take legal (proprietor) the right to take legal action to prevent other people action to prevent other people exploiting a patented invention exploiting a patented invention without the proprietors permission.without the proprietors permission.

Identification of Patentable Identification of Patentable invention?invention?

A process for the production of a new A process for the production of a new compound or composition.compound or composition.

An improvement of an existing An improvement of an existing process for a known compound or process for a known compound or composition. composition.

Development of a new machine, Development of a new machine, device or an improved machine.device or an improved machine.

Simplicity of an invention is not a bar Simplicity of an invention is not a bar on its patentabilityon its patentability

Eligibility for applying for a patentEligibility for applying for a patent

Any person whether a citizen of India Any person whether a citizen of India or not, or not,

Who can claim to be true and first Who can claim to be true and first inventor of the inventioninventor of the invention

Or his assignee Or his assignee Or his legal representativeOr his legal representative either alone or jointly with another either alone or jointly with another

personperson

Time of applicationTime of application

At the earliest possible time after At the earliest possible time after developing the invention at the developing the invention at the laboratory levellaboratory level

Documents Required Documents Required

Appropriate application formAppropriate application form Patent specification- provisional or Patent specification- provisional or

completecomplete Drawings (if any) Drawings (if any) Prescribed feePrescribed fee

Patent SpecificationPatent Specification

It is a document which contains the It is a document which contains the scientific and technical details of the scientific and technical details of the invention proposed to be protected.invention proposed to be protected.

Date of the patent Date of the patent

The date of the patent is the date of The date of the patent is the date of filing of complete specification.filing of complete specification.

Cost of filing for a patentCost of filing for a patent The government charges for filing patent The government charges for filing patent

application in India application in India For individualsFor individuals -- Rs. 1500/-Rs. 1500/- For legal entitiesFor legal entities -- Rs. 5000 /-Rs. 5000 /- Sealing of patent (at the time of grant)Sealing of patent (at the time of grant) For individualsFor individuals -- Rs. 1500/-Rs. 1500/- For legal entitiesFor legal entities -- Rs. 5000/-Rs. 5000/- First schedule gives particulars of fees in First schedule gives particulars of fees in

different situations.different situations. Second schedule gives particulars of Second schedule gives particulars of

different forms used in applications for different forms used in applications for patents.patents.

The patent amendment act 1999, 26th march The patent amendment act 1999, 26th march 19991999

ObjectiveObjective: To give exclusive marketing rights : To give exclusive marketing rights whenever the applicant is eligible to them. TRIPS whenever the applicant is eligible to them. TRIPS require member countries of WTO without product require member countries of WTO without product patents should pass a law regarding EMR.patents should pass a law regarding EMR.

EMR are granted if a patent application covering EMR are granted if a patent application covering the new drug have been filed in any WTO country the new drug have been filed in any WTO country after 1st January 1995. A patent on the product after 1st January 1995. A patent on the product should have been obtained.should have been obtained.

Marketing approvals for the product should have Marketing approvals for the product should have been obtained in any member country.been obtained in any member country.

A patent application covering the product should A patent application covering the product should have been filed after 1st January 1995 in the have been filed after 1st January 1995 in the country where EMR is sought.country where EMR is sought.

The application should be in prescribed format and The application should be in prescribed format and should be submitted with prescribed fee.should be submitted with prescribed fee.

The Patent rules 2003The Patent rules 2003

The patents rules 2005The patents rules 2005

Scope of patentability:Scope of patentability: Products as well as processes can be Products as well as processes can be

patented.patented. ““Mere new use” doesn’t qualify as Mere new use” doesn’t qualify as

patentable.patentable.

Compulsory Licensing:Compulsory Licensing: After 3yrs of After 3yrs of patent life, compulsory licensing will patent life, compulsory licensing will be given if public health criteria be given if public health criteria demand it.demand it.

European UnionEuropean Union USAUSA IndiaIndia The Expression “inventive The Expression “inventive

step” is used in Germany, UK step” is used in Germany, UK and under the European and under the European patent convention.patent convention.

Meaning: Invention must involve Meaning: Invention must involve an inventive step, an inventive step, which ,having regard to the which ,having regard to the state of the art, must not be state of the art, must not be obvious to a person skilled in obvious to a person skilled in the art.the art.

Problem – solution approachProblem – solution approach Identifying the closest prior Identifying the closest prior

art i.e. the most relevant art i.e. the most relevant prior art.prior art.

Determining the objective Determining the objective technical problemtechnical problem

Examining whether the Examining whether the claimed solution is obvious.claimed solution is obvious.

Is there any teaching in the Is there any teaching in the prior art that prior art that wouldwould (not (not simply could) have prompted simply could) have prompted a skilled person to the a skilled person to the solution.solution.

Non-obviousness is used Non-obviousness is used in USA .“person having in USA .“person having ordinary skill in the art” ordinary skill in the art” would not know this would not know this solution-then it is non solution-then it is non obviousobvious

e.g. peanut butter, jelly e.g. peanut butter, jelly sandwitches with crimped sandwitches with crimped edges instead of crusts edges instead of crusts not patentable. not patentable.

Graham factors:Graham factors: The scope and content of The scope and content of

the prior art.the prior art. The level of ordinary skill The level of ordinary skill

in the prior artin the prior art The differences between The differences between

the claimed invention and the claimed invention and prior art.prior art.

Objective evidence of non Objective evidence of non oblivious nessoblivious ness

Factors in step 4 area)Factors in step 4 area)

A. commercial success A. commercial success

B. Long left but unsolved needB. Long left but unsolved need

C. Failure of others C. Failure of others

Patentable subject Patentable subject mattermatter

What are not inventionsWhat are not inventionsDiscoveries scientific Discoveries scientific theories and theories and mathematical methodsmathematical methodsAesthetic creationsAesthetic creationsSchemes, rules and Schemes, rules and methods for performing methods for performing mental acts, playing mental acts, playing games or doing business, games or doing business, and programmes for and programmes for computers.computers.Presentation of Presentation of informationinformation

Any new and useful Any new and useful processes machine, processes machine, manufacture or manufacture or composition of matter or composition of matter or any new and useful any new and useful improve meant thereof is improve meant thereof is patentable.patentable.

A process must produce A process must produce a concrete, useful and a concrete, useful and tangible result in order to tangible result in order to be patentable. be patentable.

What are not inventions What are not inventions literally works, literally works, compositions of music, compositions of music, compilations of data, compilations of data, legal documents, legal documents, (Insurance policies) and (Insurance policies) and forms of energy are not forms of energy are not patentable.patentable.

Inventions not Inventions not patentable were patentable were defineddefined

Eg: an invention Eg: an invention which is which is frivolous or which frivolous or which claims anything claims anything obviously contrary to obviously contrary to well established well established natural lawsnatural laws A method of A method of agriculture or agriculture or horticulture“Inventionhorticulture“Invention” means a new ” means a new product or process product or process involving an inventive involving an inventive step and capable of step and capable of industrial application.industrial application.

NoveltyNoveltyAbsolute novelty Absolute novelty

requirementrequirement

NoveltyNoveltyAn invention is not An invention is not patentable if it is patentable if it is already known already known relative novelty is relative novelty is present. A grace present. A grace period exists for period exists for protecting an inventor protecting an inventor or his successor in or his successor in title from a title from a publication of the publication of the invention beforeinvention before

the filing datathe filing data

NoveltyNoveltyAn invention must be An invention must be novel. novel.

European European unionunion

USAUSA INDIAINDIA

InventershipInventership

The right to a European The right to a European patent belongs to the patent belongs to the inventor or his successor inventor or his successor in title, according to file in title, according to file principle.principle.

The applicant for a The applicant for a European patent need not European patent need not be the inventorbe the inventor

An inventor is the one An inventor is the one with “Intellectual with “Intellectual domination over the domination over the inventive process, inventive process, and not werely one and not werely one who assists in its who assists in its reduction to practice.reduction to practice.

A patent application A patent application must be filed in the must be filed in the name of the name of the inventors.inventors.

True and first inventor True and first inventor does not include either the does not include either the first importer of an first importer of an invention into India, or a invention into India, or a person to whom an person to whom an inventions first inventions first communicated from out communicated from out

side Indiaside India. .

Inventership is Inventership is traditionally not traditionally not classified as a classified as a patentability criterion.patentability criterion.

The naming of the The naming of the inventors is very inventors is very important for the important for the validity of the patent. validity of the patent.

UtilityUtilityPatent law does not Patent law does not test utility, but an test utility, but an invention must have invention must have industrial applicability industrial applicability to be patentable.to be patentable.

Industrial applicability Industrial applicability is a patentability is a patentability requirement.requirement.

UtilityUtilityUtility is a patentability Utility is a patentability requirementrequirement

.This is to prevent the .This is to prevent the patenting of inoperative patenting of inoperative devices such as devices such as perpetual motion perpetual motion machines.machines.

Utility is a corresponding Utility is a corresponding requirement. requirement.

UtilityUtility

Utility is required.Utility is required.

PRIOR ARTPRIOR ART

Prior art or state of the art is all information that has been disclosed to the public in any form before a given date.

Prior art does not include Prior art does not include information kept information kept secret ,whether from secret ,whether from trade secrecy or just a trade secrecy or just a simple lack of interesting simple lack of interesting publication .publication .

According to the According to the European patent European patent convention, oral convention, oral disclosures also form disclosures also form

prior artprior art

Secrete prior art, Secrete prior art, such as secrete files, such as secrete files, qualifies as prior art qualifies as prior art in certain in certain

circumstances.circumstances.

All other countries other All other countries other than USA use a first – to – than USA use a first – to – file system, regardless of file system, regardless of who the first inventor who the first inventor was, the person who file a was, the person who file a patent application first is patent application first is the one who can be the one who can be granted a the patent for granted a the patent for

the invention.the invention.

The USA uses a First-The USA uses a First-to-invent system. to-invent system.

PERSONAL SKILLED IN THE ARTPERSONAL SKILLED IN THE ART

The “person having ordinary skill in the art” is a legal fiction found in many The “person having ordinary skill in the art” is a legal fiction found in many patent laws through the world. This fictional person is considered to havepatent laws through the world. This fictional person is considered to have normal skills and knowledge in a particular technical field, without being a normal skills and knowledge in a particular technical field, without being a genius. He or she mainly serves as a reference for determining or atleast genius. He or she mainly serves as a reference for determining or atleast

evaluating whether an invention is non obvious or not in (In US patent laws) or evaluating whether an invention is non obvious or not in (In US patent laws) or does involve an inventive step or not. (In European patent laws). If it would does involve an inventive step or not. (In European patent laws). If it would

have been obivious for the fictional person to come up with the invention while have been obivious for the fictional person to come up with the invention while starting from the prior art then the particular invention is considered not starting from the prior art then the particular invention is considered not

patentable.patentable.

Also used in sufficiency of Also used in sufficiency of

disclosure.disclosure. Used in evaluating Used in evaluating whether two technical whether two technical means are equivalent means are equivalent PHOSITA is a test of PHOSITA is a test of

‘obviousness’‘obviousness’

Bio piracy1) Monsanto Patents Chapati-1996 Unilever / Monsanto were granted a patent

(EP518577)for claims to have invented the use of flour to make traditional kinds of Indian

bread such as Chapatis. They also got patent No. 6, 098,905 for “Atta” in August 2000.

2) Ricetech Patent Basmati riceBoth they were achieved by using trivial, obvious modifications of unique

Indian crop varieties.

3.Genecor Company discovered “ Extremephiles” (tiny organism that are able to survive and thieve in exctreme environmental condition) in Kenya, Cloned and

sold to Procter and Gamble, Procter and Gamble used “extremophiles” as critical ingredients in the

manufacture of a detergent known as “tide”.

ConclusionConclusion IPR awareness is a “must” for every IPR awareness is a “must” for every

one.one. Creativity must be encouraged in Creativity must be encouraged in

everyone.everyone. Industry and Academic interaction is Industry and Academic interaction is

needed.needed. Pursuit of Research and Pursuit of Research and

Development Essential.Development Essential.