intellectual property rights & patent filing procedures

INTELLECTUAL PROPERTY RIGHTS

& STEPS IN PATENT GRANTING

DR.M.V.NAGABHUSHANAMPROFESSOR & HEAD OF THE DEAPRTMENT

DEPARTMENT OF PHARM. MANAGEMENT & REGULATORY AFFAIRSHINDU COLLEGE OF PHARMACY, GUNTUR A.P.

Industry size : 25.8 Bn USDExports : 13.2 Bn USD

Imports: 3.52 Billion USDIndustry is growing @ 20% p.a

Domestic Market 2011-2012: 12.6 Bn USD

4th Largest in world in terms of Volume & ranks 13th in terms of ValueExport of Biotech products & Biopharmaceuticals ~US $1.36 BnExport of Vaccines- US $507.9 million (US $ 42 Bn by year 2015)

Manufacturing Facilities 172 US FDA ApprovedIndia Stood First Globally with 2759 DMF filling Out of 7886 DMFs

US Pharmacopoeia has office in Hyderabad, IndiaUSFDA has country office in Delhi, Mumbai

9,000 manufacturing units in the country600,000 Retail & Wholesale Shops in India

153 EDQM certified facilities; 6th largest supplier of HIV drugs after Germany

Drugs from India are exported to more than 200 countriesVaccines from India are exported to more than 151 countries

Emerging markets India and China will figure in the top 10

pharma markets of the world by 2015, an Ernst & Young

report has said. The report has identified India as the

preferred choice for outsourcing in the area of late stage drug

discovery, shared services and complex manufacturing while

China has been the preferred market for building blocks and

intermediates.

PHARMA MANAGEMENT & REGULATORY AFFAIRS

INTELLECTUAL PROPERTY RIGHTS (IPR)

• Intellectual property rights (IPR) can be defined as

the rights given to people over the creation of

their minds. They usually give the creator an

exclusive right over the use of his/her creations for

a certain period of time.


CATEGORIES OF INTELLECTUAL PROPERTY


Intellectual Property rights

• Intellectual Property rights may be protected at

law in the same way as any other form of property.

Intellectual property laws vary from jurisdiction to

jurisdiction.


What is Intellectual Property?

• Intellectual property is an intangible creation of the

human mind, usually expressed or translated into a

tangible form that is assigned certain rights of property.

Examples of intellectual property include an author's

copyright on a book or article, a distinctive logo design

representing a soft drink company and its products,

unique design elements of a web site, or a patent on the

process to manufacture chewing gum.PHARMA MANAGEMENT & REGULATORY AFFAIRS

The different types of Intellectual Property Rights are:

• i. Patents• ii. Copyrights• iii. Trademarks• iv. Industrial designs• v. Protection of Integrated Circuits layout design• vi. Geographical indications of goods• vii. Biological diversity• viii. Plant varieties and farmers rights• ix. Undisclosed information

COPYRIGHT

• 1. Writings• 2. Paintings• 3. Musical works• 4. Dramatics works• 5. Audiovisual works• 6. Sound recordings• 7. Photographic works• 8. Broadcast• 9. Sculpture• 10. Drawings• 11. Architectural works etc.

PatentTrademark

Copyright

Design Registration

Trade Secret

Geographical Indications


INTELLECTUAL PROPERTY

INDUSTRIAL PROPERTY + COPY RIGHT

PATENTS DESIGNS TRADEMARKS Geographical Indications

PHARMACEUTICAL MANAGEMENT & REGULATORY AFFAIRS

Duration of Intellectual Property Rights in a nutshell

• Term of every patent will be 20 years from the date of filing of patent application,

• irrespective of whether it is filed with provisional or complete specification. Date of

• patent is the date on which the application for patent is filed.

• 2) Term of every trademark registration is 10 years from the date of making of the

• application which is deemed to be the date of registration.

• 3) Copyright generally lasts for a period of sixty years.PHARMA MANAGEMENT & REGULATORY AFFAIRS

Duration of Intellectual Property Rights in a nutshell

• 4) The registration of a geographical indication is valid for a period of 10 years.

• 5) The duration of registration of Chip Layout Design is for a period of 10 years counted

• from the date of filing an application for registration or from the date of first commercial

• exploitation anywhere in India or in any convention country or country specified by

• Government of India whichever is earlier.• 6) The duration of protection of registered varieties is different for

different crops namely• 18 years for trees and vines, 15 years for other crops and extant

varieties.

Global Intellectual Property Trends

• With over 3 million applications filed per year,

trademark protection is the most sought after

form of IP worldwide


Intellectual Property Trends – India

• During 2009-10, 34,287 patent applications were

filed, 6069 examined and 6168 patents granted.

The number of applications filed by the Indian

applicants was 7044.


CROCIN

Crocin sells more than 2.50 million pills each

day. That's nearly 30 every second, around-the

clock Internationally Crocin goes by the name

Panadol.


• Pfizer’s cough and cold syrup Corex is a leading brand in India with sales of $35.53 million (Rs 167 crore)


•

• Voveran, Novartis India’s flagship pain killer medicine, is the second leading brand with sales of $31.63 million (Rs 148.7 crore) with growth rate of 4 percent.


• Phensedyl cough and cold syrup from Piramal

Healthcare is the third leading brand in India and it

registered a growth of over 50 percent.


• A human insulin product from Novo Nordisk— Human Mixtard 30/70 which stands fourth in the top 10 brands of India has registered a growth of just three percent, according to ORG-IMS Research.


•

• Franco- Indian Pharma’s anaemia drug Dexorange, Pfizer’s cough and cold syrup Corex have registered a doubledigit growth.


Introduction• 1856 - George Alfred DePenning, a civil engineer, is

supposed to have made the first application for a patent in India for his invention –

"An Efficient Punkah Pulling Machine" . • March 3- Petition to the Government of India for grant of

exclusive privileges for his inventions.• Sept. 2 – Submission of Specifications for his invention

along with drawings to illustrate its working.• These were accepted and the invention was granted the first ever Intellectual Property protection in India.

Department of Pharmaceutical Management And Regulatory Affairs

History of Patent Law


YEAR

ACTS

1856

THE ACT VI OF 1856 ON PROTECTION OF INVENTIONS BASED ON THE BRITISH PATENT LAW OF 1852. CERTAIN EXCLUSIVE PRIVILEGES GRANTED TO INVENTORS OF NEW MANUFACTURERS FOR A PERIOD OF 14 YEARS.

1859THE ACT MODIFIED AS ACT XV; PATENT MONOPOLIES CALLED EXCLUSIVE PRIVILEGES (MAKING. SELLING AND USING INVENTIONS IN INDIA AND AUTHORIZING OTHERS TO DO SO FOR 14 YEARS FROM DATE OF FILING SPECIFICATION).


• 1872 THE PATENTS & DESIGNS PROTECTION ACT.• 1883 THE PROTECTION OF INVENTIONS ACT.• 1888 CONSOLIDATED AS THE INVENTIONS & DESIGNS ACT.• 1911 THE INDIAN PATENTS & DESIGNS ACT.• 1972 THE PATENTS ACT (ACT 39 OF 1970) CAME INTO FORCE ON

20TH APRIL 1972.• 1999 ON MARCH 26, 1999 PATENTS (AMENDMENT) ACT, (1999)

CAME INTO FORCE FROM 01-01-1995.• 2002 THE PATENTS (AMENDMENT) ACT 2002 CAME INTO FORCE

FROM 2OTH MAY 2003• 2005 THE PATENTS (AMENDMENT) ACT 2005 EFFECTIVE FROM Ist

JANUARY 2005

History of Patent Law


Patent Filing Procedures• Step 1: Filing of Patent Application• Step 2: Publication• Step 3: Opposition (if any)• Pre grant Opposition ; Post grant Opposition• Step 4: Request for Examination• Step 5: First Examination Report• Step 6: Amendment of objections by the applicant• Step 7: Grant of Patent• Step 8: Renewal fees


HISTORY OF COPYRIGHT LAW 1847

• Copyright law entered India through an enactment.• According to the 1847 enactment, the term of copyright was for the lifetime

of the author + seventy years post-mortem.

Purpose: • Specifically reserves the subsistence of copyright in the author, and his right to

sue for its infringement to the extent available in law other than the 1847 Act.

Registration of copyright with the Home Office was mandatory for the enforcement of rights under the Act.


HISTORY OF COPYRIGHT LAW 1914:• Indian legislature enacted a new Copyright Act with few modifications

• First - Introduced criminal sanctions for copyright infringement (sections7 to 12).

• Second - Modified the scope of the term of copyright; under section 4

Act was continued with minor adaptations and modifications till the 1957 Act was brought into force on 24th January, 1958.

DEPARTMENT OF PHARMACEUTICAL MANAGEMENT AND REGULATORY AFFAIRS

COPYRIGHT ENFORCEMENT ADVISORY COUNCIL (CEAC)

• The Government has set up on November 6, 1991 a Copyright Enforcement Advisory Council (CEAC) to review the progress of enforcement of Copyright Act periodically and to advise the Government regarding measures for improving the enforcement of the Act.

Amendments: 1981

1984 1992 1994 1999 2010 2012

DEPARTMENT OF PHARMACEUTICAL MANAGEMENT AND REGULATORY AFFAIRS

HISTORY OF TRADEMARK LAW1940 - The Indian Trademarks Act was passed .

1958 - The Trademark and Merchandise Act, 1958

Purpose:• Enables the registration of trademarks so that the proprietor of the

trademark gets legal right to the exclusive use of the trademark.

Objective: • Easy registration and better protection of trademarks and for prevention

of the use of fraudulent marks on merchandise.

1999 – The Trademark Act 1999

Objective:• To confer the protection to the user of the trademark on his goods and

prescribe conditions on acquisition, and legal remedies for enforcement of trademark rights.DEPARTMENT OF PHARMACEUTICAL MANAGEMENT AND REGULATORY AFFAIRS

History of Geographical Indications1999 - Geographical Indications of Goods (Registration and

Protection) Act, 1999

2002 - The Geographical Indications of Goods (Registration and Protection) Rules, 2002

- deal with registration and better protection of geographical indications relating to goods.

Purpose: • Provide legal protection to Indian Geographical Indications which in turn

boost exports.

According to the Act:

The term 'geographical indication' (in relation to goods) means "an indication which identifies such goods as agricultural goods, natural goods or manufactured goods as originating, or manufactured in the territory of a country, or a region or locality in that territory.

What is a Geographical Indication?• It is an indication• It originates from a definite geographical territory.• It is used to identify agricultural, natural or

manufactured goods• The manufactured goods should be produced or

processed or prepared in that territory.• It should have a special quality or reputation or

other characteristics


Examples of Geographical Indication

• Solapur Chaddar

• Solapur Terry Towel

• Basmati Rice

• Darjeeling Tea

• Kanchipuram Silk Saree

• Alphanso Mango

• Nagpur OrangePHARMA MANAGEMENT & REGULATORY AFFAIRS

JURISDICTION OF OFFICES

PHARMACEUTICAL MANAGEMENT & REGULATORY AFFAIRS

Organization Structure – IP Offices

What is Patent?

• Patent is a grant for an invention by the Government to

the inventor in exchange for full disclosure of the

invention. A patent is an exclusive right granted by law to

applicants / assignees to make use of and exploit their

inventions for a limited period of time (generally 20 years

from filing).


57

PATENT • A Legal Right• Conferred by the state• To an applicant / inventor• For Disclosing a New

invention• To make, use, sell or license the invention• For a limited period

Pharmaceutical Management & Regulatory Affairs

PATENTS• As on date, India is fully in compliance with its

international obligations under the TRIPs Agreement.

• The Patents Act 1970 has undergone three amendments – 1999, 2002 & 2005.

• Introduction of product patent protection for food,

pharmaceutical and chemical inventions.

* New amendment effective from January 01, 2005


PATENTING OF PHARMACEUTICALS• New Chemical Entities• Process for preparing the new chemical entity• Pharmaceutical Intermediates• Pharmaceutical compositions of new

compounds• New pharmaceutical compositions of old

compounds• Process for preparing new compositions• First pharmaceutical use of a known compound• Second or new pharmaceutical use of a known

compound.PHARMA MANAGEMENT & REGULATORY AFFAIRS

60

CRITERIA FOR GRANTING A PATENT• New (Novelty)

i.e invention must be new and not known earlier.• Useful (Capable of Industrial application)

i.e. invention must work and should not be only theoretical

• Unobvious (Involve an inventive step)i.e. must involve some effort on part of inventor


WHAT CANNOT BE PATENTED• According to Indian Patent Act 1970,following inventions

are not patentable

• Invention which is contrary to well established natural laws

• Primary use of invention is injurious to public health

• Mere discovery of scientific principle or the formulation of an abstract theory


Arrangement or rearrangement or duplication of known devices

A method of agriculture or horticulture

Any process for the medicinal, surgical, curative, prophylactic or other treatment of human beings or any process for similar treatment of animals or plants

A presentation of information

A mathematical or business method or a computer programme or algorithms


WHAT CANNOT BE PATENTED

Office Territorial Jurisdiction

• Patent Office Branch, Mumbai• The States of Maharashtra, Gujarat, Madhya

Pradesh,• Goa and Chhattisgarh and the Union Territories of• Daman and Diu & Dadra and Nagar Haveli• Patent Office Branch, Chennai• The States of Andhra Pradesh, Karnataka, Kerala,

Tamil• Nadu and the Union Territories of Pondicherry and• Lakshadweep.PHARMA MANAGEMENT & REGULATORY AFFAIRS

Office Territorial Jurisdiction• Patent Office Branch, New Delhi• The States of Haryana, Himachal Pradesh, Jammu

and• Kashmir, Punjab, Rajasthan, Uttar Pradesh,

Uttaranchal,• Delhi and the Union Territory of Chandigarh.• Patent Office, Kolkata The rest of India


LICENSING AND THE GOVERNMENTOr

How to negotiate a successful partnership.

Pharma Management & Regulatory AffairsPHARMA MANAGEMENT & REGULATORY AFFAIRS

What is a License?

• A contract between licensor and licensee.

• Licensor grants to licensee the right to practice the technology claimed in the licensed patent

• Licensor agrees not to sue licensee for infringing licensor’s patent


Types Of Patent Applications• 1) Ordinary Application• 2) Application for Patent of Addition (granted for

Improvement or Modification of the• already patented invention, for an unexpired term of the

main patent).• 3) Divisional Application (in case of plurality of inventions

disclosed in the main• application).• 4) Convention application, claiming priority date on the

basis of filing in Convention• Countries.• 5) National Phase Application under PCT.

How is a patent obtained?• File an application for patent With one of the patent offices based on

territorial jurisdiction of the place of office or residence of the applicant /agent

• Pay the required fee• Information concerning application form and details of fee available at• www.ipindia.nic.in• Guidelines for applicants also available on this website• The Patent Office then Conducts searches to ascertain the prerequisites• - Publishes the application• - Conducts in-depth examination• - Raises objection to the application• - Grants the patentPHARMA MANAGEMENT & REGULATORY AFFAIRS

Patent Grant Procedure Filing of patent application

Publication after 18 months

Pre Grant Opposition /Representation by any person. Request for examination

Examination: Grant or Refusal

Publication of Grant of patent

Post Grant Opposition to grant of patent (Constitution of Opposition Board)

Early Publication

Decision By Controller

Who can apply for Patent?

• The inventor may make an application, either alone or jointly with another, or his/their assignee

• or legal representative of any deceased inventor or his assignee.


Specifications• Provisional Application for patent may be accompanied by the

provisional specification. It should contain the description of invention with drawing, if required. It is not necessary to include Claim. However, the complete specification should be fairly based on the matter disclosed in the provisional specification and should be filed within 12 months.

• If the complete specification is not filed within 12 months the application is deemed to have been abandoned. Usually a provisional specification is filed to establish priority of the invention in case the disclosed invention is only at a conceptual stage and a delay is expected in submitting full and specific description of the invention. Although, a patent application accompanied with provisional specification does not confer any legal patent rights to the applicants, it is, however, a very important document to establish the earliest ownership of an invention. specification


Complete specification• The complete specification is an essential document in the

filing of patent application along with the drawing to be attached according to the necessity. Complete specification should fully describe the invention with reference to drawing, if required, disclosing the best method known to the applicant and end with Claim/Claims defining the scope of protection sought.. The specification must be written in such a manner that person of ordinary skill in the relevant field, to which the invention pertains, can understand the invention.


• Normally, it should contain the following matter-• Title of invention,• 2) Field of invention,• 3) Background of invention with regard to the drawback associated

with known art,• 4) Object of invention,• 5) Statement of invention,• 6) A summary of invention,• 53• 7) A brief description of the accompanying drawing,• 8) Detailed description of the invention with reference to

drawing/examples,• 9) Claim(s),

Complete specification


What is e-Filing?

• E-filing is a service provided by the Intellectual Property Office, India in order to enable

• customers to apply for a patent on-line allowing from the User’s browser for the User to:

• • Complete an electronic application form • Provide the associated attachments • Complete

• the necessary payment details


COPY RIGHT

• Copy right is a exclusive right which an author acquires for

his work of literary or artistic nature such as book, a

painting, a sculpture, a photograph, a motion picture..etc

• It is a right to print, multiple, publish or sell a work.

Pharma Management & Regulatory AffairsPHARMA MANAGEMENT & REGULATORY AFFAIRS

COPYRIGHT

• The economic right given to creators of literary and artistic works.

• Includes the rights to: Reproduce the work Make copies Perform or display the work publicly


Copyright holders have the right to……stop other parties from… 1. Making copies of the work. 2. Making changes to the work or creating new works

based on the original work. 3. Distributing the work. 4. Publishing the work. 5. Licensing the work to others.6. Otherwise exploiting the work.


Duration of copy right protection• Original literary, dramatic, artistic or musical

works: the life time of the author + period of 70 yrs from the end of the year in which the author dies

• Computer generated works: 50 yrs from the date of creation of work.

• Sound recordings: 50 yrs from the end of year in which it was made or published.

• Broadcasts: 50 yrs from the end of year of broadcast

• Typographical arrangement of published editions: 25 yrs from the year of 1st publication


WHAT IS A VALID COPYRIGHT NOTICE?• A copyright should contain:1. The word “Copyright”2. A “c” in a circle (©)3. The date of publication, AND4. The name of either the author or the owner of all

the rights5. “All Rights Reserved”• EXAMPLE: A Year in Provence. Copyright © 1989

by Peter Mayle. All Rights Reserved.


HOW TO REGISTER YOUR WORK

• Registering a copyright is a simple process:– Fill out the appropriate form for the type of work you are

registering.– Enclose a deposit of one or two samples of the work

(depending on what type of work it is)– Pay the fee per registration (if you are registering several

works that are part of one series, you may register the works together as a group registration).


TRADEMARK• Trademarks are commercial source indicators, distinctive

signs that identify certain goods or services produced or provided by a specific person or enterprise.

• Trademark helps consumers to identify and purchase a product or service based on whether its specific characteristics and quality – as indicated by its unique trademark – meet their needs

• Must prosecute infringement of trademark or risk losing the mark yourself!!


What is Trademark?

• A trade mark (popularly known as brand name) in layman’s language is a visual symbol which

• may be a word signature, name, device, label, numerals or combination of colours used by one

• undertaking on goods or services or other articles of commerce to distinguish it from other

• similar goods or services originating from a different undertaking.

Key Features of Trademark

• · Trademark must be Distinctive• · Trademark must be used in Commerce

What is Trademark?• The selected mark should be capable of being represented graphically

(that is in the paper• form).• · It should be capable of distinguishing the goods or services of one

undertaking from• those of others.• · It should be used or proposed to be used mark in relation to goods or

services for the• purpose of indicating or so as to indicate a connection in the course of

trade between the• goods or services and some person have the right to use the mark with

or without identity• of that person.

Types of Trademark

• Trademark,• · Servicemark,• · Collectivemark,• · Certification Mark

Functions of Trademark

• Trademark performs four functions –• · It identifies the goods / or services and its

origin;• · It guarantees its unchanged quality;• · It advertises the goods/services;• · It creates an image for the goods/ services.

MARKS

• Trademarks® , ™– A trademark identifies tangible good or product of a company or individual.

• Servicemarks ®, SM

– A service mark identifies the service s of a provider. Marks used by a company can

function as both.

• Trade names

– Once a trade name was used to denote any mark descriptive of a good or service.

– Today, it is a company business name.


An Example of Copyright AND Trademark

• The gold-colored top of the New York Life building is in the public domain and anyone can photograph it.

• However, that image also functions as a trademark for the New York Life Company, and a competing company could not use the image as a representation of their company’s goods or services..


TRADE SECRETS

• Any information that may be used in the operation of a business and that is sufficiently valuable to afford an actual or potential economic advantage.

• Examples: Formula for Coca-Cola; compilations of information that provides a competitive advantage (customer databases), advertising strategies


Geographical indications•An indication used to identify agricultural, natural or manufactured goods originating from a definite territory in India.•It should have a special quality or characteristics or reputation based upon the climatic or production characteristics unique to the geographical location.•Examples of Geographical Indications in India are Darjeeling Tea, Kanchipuram Silk Saree, Alphonso Mango, Nagpur Orange, Kolhapuri Chappal, Bikaneri Bhujia, etc.


• The registration of a Geographical Indication is for a period of ten years.

• Renewal is possible for further periods of 10 years each.

• A trade mark is a sign which is used in the course of trade and it distinguishes goods or services of one enterprise from those of other enterprises.

• Geographical Indication is used to identify goods having special characteristics originating from a definite geographical territory.

Geographical indications

Legislative Framework of IP Administration

CONTROLLER GENERAL OF PATENTS, DESIGNS AND TRADEMARKS

(CGPDTM)

T M REGISTRY

DESIGN OFFICE

G.I. REGISTRY

Head OfficeKOLKATA

BranchDELHI

BranchCHENNAI

BranchMUMBAI

Head OfficeMUMBAI

DELHI

KOLKATA

CHENNAI

A’BAD

IPTI ,NIIPM, P.I.S. Nagpur

KOLKATA

PATENT OFFICE

CHENNAI


Law and Regulations

• Patents Act, 1970– Amended in

• 1999• 2002• 2005

• Patents Rules, 2003– Amended in

• 2005• 2006


Legislative Measures -Patents

• From 1.1.1995– Mail-Box for pharmaceutical and agrochemicals products– Exclusive Marketing Rights

• From 1.1.2000– Patent term increased to 20 years – Definition of invention – inclusion of inventive step– Reversal of burden of proof – on the infringer– Mandatory compulsory licence provision for food, drugs and

chemicals removed– Right of patentee (importation also included)

• From 1.1.2005– Product patents for food, chemical and pharmaceutical

We have met our international commitments


100

Patent Law - Salient Features• Both product and process patent provided• Term of patent – 20 years• Examination on request• Both pre-grant and post-grant opposition • Fast track mechanism for disposal of appeals• Provision for protection of bio-diversity and traditional

knowledge• Publication of applications after 18 months with facility for

early publication• Substantially reduced time-lines


101

Safeguards in the Patent Law

• Compulsory license to ensure availability of drugs at reasonable prices

• Provision to deal with public health emergency

• Revocation of patent in public interest and also on security considerations


Scope of Patentability Under The Patents Act


What is an Invention?

“Invention” means a new product or process involving an inventive step and capable of industrial application


Patentable subject matterInvention must

* Relates to a process or product or both

* Be new (novel)

* Involves an inventive step

* Be capable of industrial application


“New” means

Invention must not bePublished in India or elsewhere

In prior public knowledge or prior public use with in India

Claimed before in any specification in India


Inventive stepA feature of an invention that

• Involves technical advance as compared to the existing knowledge or

• Have economic significance or both and

* Makes the invention not obvious to a person skilled in the art


Industrial application means

Invention is capable of being made or used in any kind of

industry


Section 3 exclusionsSection 3(a) • Frivolous inventions• Inventions contrary to well established natural

laws

Examples Machine that gives more than 100% performance Perpetual machine


Section 3 exclusionsSection 3(b)

Commercial exploitation or primary use of inventions, which isContrary to

public order or Morality

Examples– Gambling machine, – Device for house-breaking ,


Section 3 exclusionsSection 3(b) Commercial exploitation or primary use of inventions , which

Causes serious Prejudice to health or human, animal, plant life or to the environment

Examples Biological warfare material or device,

weapons of mass destruction Terminator gene technology, Embryonic stem cell


Checks and Balances Section 3(b)Excludes patents on

• GMOs – exploitation of which could be contrary public order or morality or prejudicial to human, animal or plant life or health or to the environment

Effect : Only genetically modified micro-organisms (GMOs) which do not fall under section 3 (b) are patentable.


Section 3 exclusions Section 3 ( c )• Mere Discovery of a Scientific Principle or• formulation of an Abstract Theory or• discovery of any living thing or • discovery of non–living substance occurring in nature

ExamplesNewton’s Laws Superconducting Phenomenon as such Property of certain material to withstand mechanical shockDiscovery of micro-organism Discovery of natural gas or a mineral


Checks and Balances Section 3(c)Excludes patents on

•Naturally occurring Micro-organisms

Effect Genetically modified microorganisms (GMOs) are however, patentable.

Section 3 exclusions

Section3 (d) 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


Section 3 exclusionsSection3 (d) ExplanationFor the purposes of this clause,• salts, esters, ethers, polymorphs, • metabolites, pure form, particle size,• isomers, mixture of isomers, • complexes, combinations and other derivatives of known

substances shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.

Examples– Crystalline forms of known substance


Checks and BalancesSection 3 (d) Explanation

Effect Salts, esters, ethers, polymorphs, metabolite, pure

forms, particle size, isomers, complexes, combinations and derivatives of a known substance with enhanced efficacy are patentable

Section 3 exclusionsSection3 (d)

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.

Examples– New use of Aspirin for heart ailments,– Mere new uses of Neem



Section 3(e)Substance obtained by mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance

Examples Combiflam [Paracetamol (Antipyretic) + Brufen (analgesic)] Solution of sugar and color additives in water to form a soft drink

However,A mixture resulting into synergistic properties of mixture of ingredients however, may be patentable - Soap, Detergents, lubricants etc


Checks and Balances Section 3 ( e )

Effect Substance obtained by mere admixture resulting

only in the aggregation of the properties of the components thereof or

a process for producing such substanceare not patentable

However Synergistic formulations are patentable


Section 3 ( f )Mere arrangement or re-arrangement or duplication of known devices, each functioning independently of one another in a known way

ExamplesA Bucket fitted with torch,An Umbrella with fanA Clock and radio in a single cabinetA flour-mill provided with sieving


Section 3(h) Method of Agriculture or Horticulture

ExamplesCultivation of algae , Producing new form of a known plant, Preparation of an improved soil

However, Agricultural Equipments are patentable



Section 3(i) Any process for medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or a similar treatment of animals to render them free of disease or to increase their economic value or that of their products

Examples Removal of cancer tumor Removal of dental plaque and carries Surgical processes Processes relating to therapy Method of vaccination, Blood transfusion


However ,Treatment performed on tissues or fluids permanently removed from the body Surgical,therapeutic or diagnostic Apparatus or instrumentsare patentable PHARMA MANAGEMENT & REGULATORY AFFAIRS

Section3 exclusions

Section 3(j) Plants & animals in whole or any part

thereof other than microorganisms, but including seeds, varieties an d species and essentially biological process for production or propagation of plants & animals


Section 3 exclusionsSection 3(j)• Plants & animals in whole• Parts of plants & animals• Seeds• Varieties & species• Essentially biological processes for

propagation or production of the animals & plants


Checks and Balances Section 3(j)Excludes patents on • Plants and animals in whole or any parts thereof,

…… including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals

Examples– Clones and new varieties of plants– A process for production of plants or animals if

it consists entirely of natural phenomena such as crossing or selection

– Essentially biological Process


Section 3(k) * mathematical method or * business method or * algorithms or * computer programme per se

Examples– Computer program by itself or as a record on a carrier

However – New calculating machine – combination of hardware and software is patentable



Section 3(l) A literary,dramatic, musical or artistic work or any other aesthetic creation including cinematographic work and television productions These subject-matters fall under the copyright protection



Section 3(m) A mere scheme or rule or method of performing mental act or method of playing game

Examples•Scheme for learning a language •Method for solving a crossword puzzle, •Method of learning a language •Method of teaching /learning

However,•Novel apparatus for playing game or carrying out a scheme is patentable



Section 3 (n)Presentation of information

Examples Any manner or method of expressing information

whether by spoken words Visual displaysymbolsdiagrams

Information recorded on a carrier



Section 3 (o)Topography of integrated circuits.

ExamplesMask works - circuits layout



Section 3 (p)Inventions which are Traditional Knowledge or an aggregation or duplication of known properties of traditionally known component or components

ExamplesTraditional Knowledge already in public domain- Wound healing property of Haldi

However, Any value-addition using Traditional Knowledge leading to a new process or product ,which is novel with inventive step and industrial applicability, gExtraction of Azadirachtin from Neem

can be patented



Section 4Inventions falling within Section 20(1) of the Atomic Energy Act, 1962 are not patentable

EffectInventions relating to compounds of Uranium, Beryllium, Thorium, Plutonium, Radium, Graphite, Lithium and more as notified by Central Govt. from time to time.

Non Patentable inventions


Stages from filing to grant of a patent


Obtaining a patent

• File an application for patent– With one of the patent offices based on territorial

jurisdiction of the place of office or residence of the applicant /agent

– Pay the required fee• Information concerning application form and details

of fee available at www.ipindia.nic.in • Guidelines for applicants also available on this

website


http://www.ipindia.nic.in/

Formality Check

• An Examiner checks the formal requirements before accepting the application and the fee – this is done immediately

• Issue of application number and the cash receipt – this is done the same day

• In case of receipt of application by post, cash receipt, application number is sent by post within 2-3 days


Publication

• Application is kept secret for a period of 18 months from the date of filing

• In 19th month, the application is published in the official journal – this journal is made available on the website weekly

• Applicant has an option to get his application published before 18 months also

• In that case, application is published within one month of the request


Request for Examination

• Application is examined on request• Request for examination can be made either

by the applicant or by a third party• A period of 48 months, from the date of filing,

is available for making request for examination


Examination

• Application is sent to an Examiner within 1 month from the date of request for examination

• Examiner undertakes examination w.r.t.– whether the claimed invention is not prohibited

for grant of patent – whether the invention meets the criteria of

patentability

Issue of FER

• A period of 1 to 3 months is available to Examiner to submit the report to the Controller

• 1 month’s time available to Controller to vet the Examiner’s report

• First Examination Report (FER) containing gist of the objections is issued within 6 months from the date of filing of request


Response from the Applicant

• 12 months’ time, from the date of issue of FER, is available to the applicant to meet the objections

• If objections are met, grant of patent is approved by the Controller – within a period of 1 month


Pre-grant Opposition

• After publication, an opposition can be filed within a period of 6 months

• Opportunity of hearing the opponent is also available


Examination of Pre-grant Opposition

• Opposition (documents) is sent to the applicant

• A period of 3 months is allowed for receipt of response


Consideration of Pre-grant Opposition

• After examining the opposition and the submissions made during the hearing, Controller may – Either reject the opposition and grant the patent – Or accept the opposition and modify/reject the

patent application • This is to be done within a period of 1 month

from the date of completion of opposition proceedings

Grant of a Patent

• A certificate of patent is issued within 7 days

• Grant of patent is published in the official journal

STAGES - FILING TO GRANT OF PATENT

PUBLICATION OF APPLICATION

REQUEST FOR EXAMINATION

GRANT OF PATENT

3rd Party Representation

Revocation/Amendment

OPPOSITION

• PROMPTLY AFTER 18 MONTHS FROM P.D.

• WITHIN 48 MONTHS FROM F.D.

• ALL OBJECTIONS TO BE COMPLIED WITHIN 12 MONTHS

• IF P.S.IS FILED C.S. TO BE FILED WITHIN 12MONTHS

• WITHIN 12 MONTHS

FILING OF APPLICATIONPROVNL. / COMPLETE

Decision of Controller

EXAMINATION-ISSUE OF FER

Appeal

Appellate BoardPHARMA MANAGEMENT & REGULATORY AFFAIRS

Renewal Fee

• To be paid within 3+6 months from date of recording in the register [sec 142 (4) ]

• No fee for 1st and 2nd year• Renewal fee, on yearly basis, is required to be paid for 3rd

to 20th for keeping the patent in force• Delay upto six months from due date permissible on

payment of fee for extension of time • Patent lapses if renewal fee is not paid within the

prescribed period


Indian Drug Regulatory System: Government of India

Ministry of Health & Family Welfare

DGHS

Central Drugs Standard Control

Organization (CDSCO)

Ministry of Science & Technology

Indian Council of Medical Research(ICMR)

Council of Scientific & Industrial Research

(CSIR)

BARC(Radioactive)

Ministry of Chemicals & Petrochemicals

National Pharmaceutical

Pricing Authority (NPPA)

Department of Chemical &

Petrochemicals (DCP)

Department of Pharmaceuticals

Ministry of Commerce &

Industry

Patent Office

Dept. of Commerce &

Pharmexil

Controller General of

Patent

DGFT

Ministry of Environment &

Forest

GEAC-[Genetic Engineering

Approval Committee]

Department of Biotechnology

r-DNA Advisory Committee

Review Committee

Genetic Manipulation


Regulatory/Apex/Committee Functions

CDSCO Central Drugs Standard Control Organization (1948)

Laying down standards, Clearance of new drugs, CLAA items, Banning Drugs, Clinical Trails etc.

ICMR Indian Council of Medical Research (1911)

Formulates, Coordinates and Promotes biomedical research & Ethical Principles

GEAC Genetic Engineering Approval Committee (1989)

Manufacture, Use, Import of Hazards Microorganisms/Genetically Engineered Organisms or Cells

DBT Department of Biotechnology (1986) It promote transgenic research, molecular biology of human genetic disorders, brain research, and commercialization of diagnostic kits and vaccines for communicable diseases

AERB Atomic Energy Review Board (1983) Promotes Radio therapy & Research, Safety review for Gamma Irradiators (Devices)

BARC Bhabha Atomic Research Centre (1967)

Promotes Isotopes application in Medicine & also monitoring usage of radioactive materials

DTAB Drug Technical Advisory Board (1950) To advise Central & State Govt. on Technical Matters arising out of the Drugs & Cosmetics

RCGM Review Committee on Genetic Manipulation (1989)

No Objection Certificate for Clinical Trial & also r-DNA strains,

DCC Drug Consultative Committee (since 1951)

Advisory Committee to DTAB and Central & State Govt. for uniform implementation of Various provisions of the ActPHARMA MANAGEMENT & REGULATORY AFFAIRS

Introduction to Ministry of Health & Family Welfare (MOH&FW)

• MOH&FW comprises 04 departments each of which is headed by a Secretary to the Govt. of India – Department of Health & Family welfare – Department of AYUSH – Department of Health Research – Department of AIDS Control

• CDSCO is a separate division comes under DGHS, headed by DCG(I)

• Public health is one of the major objectives of Govt. of India and to achieve this it is important that drugs/vaccines are available to the public are Quality, Safety, Purity and Efficacious.

152PHARMA MANAGEMENT & REGULATORY AFFAIRS

153

Snapshot - Indian Pharmaceutical Industry


Goa

New Delhi

Chennai

CDSCO North Zone (Ghaziabad)

Kolkata.

CDSCO West Zone (Mumbai)

CDSCO South Zone (Chennai)

CDSCO East Zone (Kolkata)

CDSCO, HQ

• HyderabadAhmedabad

*New Zonal Offices : 2 (Ahmedabad & Hyderabad)*Sub- Zonal Office : 3*Port Offices/Airports : 11*Central Laboratories : 6

35 SLAs= 29 States+ 6 UTs

Bengaluru

Geographical Location of CDSCO

Chandigarh

J&KHQ

154

Functions of CDSCOApproval of new drugs and clinical trials

Import Registration and Licensing

License approving of Blood Banks, LVPs, Vaccines, r-DNAproducts & some Medical Devices (CLAA Scheme)

Amendment to D &C Act and Rules

Banning of drugs and cosmetics

Grant of Test License, Personal License, NOCs for Export

Testing of New Drugs


Functions of State Licensing Authorities

Licensing of Manufacturing Site for Drugs including API and Finished Formulation

Licensing of Establishment for sale or distribution of Drugs

Approval of Drug Testing Laboratories

Monitoring of Quality of Drugs and Cosmetics marketed in the country

Investigation and prosecution in respect of contravention of legal provision

Recall of sub-standard drugs


Principles of GLP and Regulatory requirements

Objectives of GLP • GLP makes sure that the data submitted are a true

reflection of the results that are obtained during the study.• GLP also makes sure that data is traceable.• Promotes international acceptance of tests.


What is GLP?• Good Laboratory Practice (GLP) deals with the organization, process and conditions under which

laboratory studies are planned, performed, monitored, recorded, reported & archived. GLP practices are intended to promote the quality and validity of test data (part 58 CFR 21). OR

• GLP is a quality system concerned with the organizational process and the conditions under which non clinical health & environmental safety studies are planned, performed, monitored, recorded, archived & reported. (Ref. Jurg P. Seiler-Switzerland, GLP, 2nd edition by Springer publication, 2005, Page 61).

• Schedule L-I regulations and guidelines have a significant impact on the daily operation of an analytical laboratory.

• GLP is a regulation. It is not only good analytical practice. Good analytical practice is important, but it is not enough. For example, the laboratory must have a specific organizational structure and procedures to perform and document laboratory work. The objective is not only quality of data but also traceability and integrity of data. But the biggest difference between GLP and Non-GLP work is the type and amount of documentation.


Pharmaceutical product Submitted to regulatory authority

Verification

Repetition of experiment or Reconstruction of all activities activities (Direct confirmation) (Indirect confirmation)

Judgment taken Accept / Reject


http://www.google.co.in/imgres?imgurl=http://www.nutricaplabs.com/images/capsuleManufacturer.jpg&imgrefurl=http://www.nutricaplabs.com/capsule-manufacturer.aspx&h=250&w=380&sz=22&tbnid=P16k1giuF3mFXM:&tbnh=81&tbnw=123&prev=/images?q=capsules+images&zoom=0&q=capsules+images&hl=en&usg=__TB1xEHv50OEccH3w63ZexUFPrkk=&sa=X&ei=SKoJTcPJBpCsugPuqIngBQ&ved=0CCEQ9QEwAg

http://www.canstockphoto.com/orange-and-green-tablets-1836074.html

GLP Concerns as Per WHO TRS 957 2010 Guidelines

Part 1 Management and infrastructure

• Organization and management• Quality management system• Control of documentation• Records• Data-processing equipment• Personnel• Premises• Equipment, instruments and

other devices• Contracts

Part 2 Materials, equipment, instruments

and other devices• Reagents• Reference substances

and reference materials• Calibration, verifi cation

of performance and• qualification of

equipment, instruments and other devices

• Traceability

Part 3 Working procedures

• Incoming samples• Analytical

worksheet• Validation of

analytical procedures

• Testing• Evaluation of test

results• Certificate of

analysis• Retained samples

Part 4Safety

• General rules


GLP Concerns as Per Schedule L1 (Rule 74, 78 & 150E), Drugs & Cosmetics Act 1940

GLP

Internal Quality System Audits

General Requirements Premises

Personal

Equipments

Chemicals and Reagents

Quality SystemMicrobiological Cultures

Reference Materials

Maintenance, Calibration, and

Validation of Equipments

Good House Keeping and SafetyManagement Review

Standard Operating Procedures

Protocols and Specifications Archive

Raw Data

Storage and Archival


Intellectual Property & the Pharma Industry - Introducing Marty the Medicine.mp4PHARMA MANAGEMENT & REGULATORY AFFAIRS

Intellectual property rights and their effects on essential commodities.mp4


Intellectual Property Rights-An introduction.mp4
