TRIPS: ISSUES,IMPACT AND THE WAY FORWARD FOR INDIA

WHAT IS IPR AND TRIPS

IPRs: Anything which is a creation of human mind needs protection. It usually gives the creator an exclusive right over the use of his creations for a certain period of time.It gives an inventor the right for limited period to stop others from making, using or selling an invention without the permission of the inventor. Creations:1)Industrial Property2)Artistic and Literary Work 3)New Plants and Animals Industrial Property includes: inventions(patents), geographical indications,trademarks,industrial designs ,undisclosed information,trade secrets

What is IPR AND TRIPS

Artistic and Literary Work is protected through copyrights and neigbouring rights Protection of New plant and animal varieties either through patents or sui-generis system of our own(also for integrated circuits) TRIPS Agreement establishes minimum level of protection that each country in the WTO has to give to the intellectual property of fellow WTO member countries.India is complying with the TRIPS agreement 2005

TRIPS

Divided into seven parts containing 73 articles 1)Basic Provisions 2)Different Standards of IPR 3)Enforcements 4)Acquisition and Maintenance of IPRs 5)Dispute Settlement Process 6)Transitional Arrangements 7)Institutional Arrangements

Different Standards of IPRS

1) 2) 3) 4) 5) 6) 7) 8)

For the purpose of TRIPS Agreement, intellectual property refers to all categories of intellectual property that are the subject of Sections 1 to 7 of Part II of the TRIPS Agreement viz. Copyright and related rights Trademarks Geographical Indications Industrial Designs Patents Layout-Designs (Topographies) of Integrated Circuits Protection of undisclosed information Control of anti-competitive practices in contractual licences

Protection

Property Right INTELLECT PROPERTY RIGHT Idea Expression Copyright Idea Innovation Invention Patent Idea Quality + Identity trademark Idea appearance design Idea keep confidential no disclosure Trade Secrets

TRADEMARK (BRANDNAME)

Design (Packing Format + Style)

Copyright (printed matter & manner of presentation) Product

G.I. PATENT Trade Secret (novel formulation Know-how Knowprocess/combination)

Patents

A legal monopoly Granted for a limited time by the state For a jurisdiction (a limited area)

PATENT

Patent - a Property Right (A Bundle of Rights) can be given away (assigned) inherited sold bought licensed abandoned etc. Patent can be revoked by state by opponent in a suit Patent can be defended against infringement

What are inventions ?

$ $ $ $ $ $ $ $ $

New (Not Prior Art) Inventive Step (Technical Advancement or of Economic Significance or Both) Useful Art, process or method of manufacture machine, apparatus or other article substance produced by manufacture new and useful improvements of any of them Amendment 2002: A new product or process involving an inventive step (not obvious to a person skilled in the art) and capable of industrial application.

Patent - Patentability

An invention can be patented if it is Must involve INVENTIVE STEP (Indian Case-Anything which is of economic significance or technically superior or both) .NON-OBVIOUS to a person Skilled in the Art MUST DISTINGUISH from State of the Art (PRIOR ART)-New Must be USEFUL must have INDUSTRIAL APPLICATION

SKM

WHAT CANNOT BE PATENTED IN INDIA?

$ $ $ $ $ $ $ $

CONTRARY TO NATURAL LAWS CONTRARY TO MORALITY MERE IDEA/DISCOVERY MERE ADMIXTURE METHOD OF TESTING ? NEW USE OF A KNOWN MATERIAL METHOD OF AGRICULTURE PROCESS OF TREATING HUMAN BEINGS OR ANIMALS

$ $

ATOMIC ENERGY SUBSTANCES USED AS FOOD, MEDICINE OR DRUG

Patent Document

Bibliographic Information Date of Filing & Publication Name & Address of Applicant Title, Classification, Abstract, Drawing, Formula etc. Corresponding Priority Application /Patent

Technical Information State of Art Description Drawings

Claim(s)

Patents Data

99% Patents in World owned by Developed Countries 75% Patents Granted in India to Developed Countries Non-working of Patent by Developed Countries affects Technology Development Access to Modern Medicines Industrial Growth Essential Products at Affordable price Problem : 72 out of 650 Global Modern Medicines enter in India from 1983-1998 (15 Years) .Domestic drugs reformulations of drugs invented abroad.Cater to diseases of the WEST.What about drugs pertaining to diseases specific to developing Countries gonorrhoea,AIDS,Dengue,Malaria,Tuberculosis,Hepatitis C,among others

COPYRIGHTS

What is covered by Copyright ? The kinds of works covered by copyright include : literary works such as novels, poems, plays, reference works, newspapers and computer programs; databases; films, musical compositions, and choreography; artistic works such as paintings, drawings, photographs and sculpture; architecture; and advertisements, maps and technical drawings. Fair use clause

DISTINCTION

Copyright Expression of ideas Protection is specific and its protection scope is fairly narrow Patents novel idea itself when applied and useful. can cover a relatively broader scope including various applications or programs.

INDUSTRIAL DESIGNS

An industrial design is the ornamental or aesthetic aspect of an article. The design may consist of three-dimensional features, such as the shape or surface of an article, or of two-dimensional features, such as patterns, lines or color. Industrial designs are applied to a wide variety of products of industry and handicraft: from technical and medical instruments to watches, jewelry, and other luxury items; from housewares and electrical appliances to vehicles and architectural structures; from textile designs to leisure goods. To be protected under most national laws, an industrial design must appeal to the eye. This means that an industrial design is primarily of an aesthetic nature, and does not protect any technical features of the article to which it is applied.

TRADEMARK

A registered trademark or a mark used in relation to goods for the purpose of indicating or so as to indicate a connection in the course of trade between the goods and some person having the right as proprietor to use the mark. A mark used or proposed to be used in relation to goods for the purpose of indicating or so as to indicate a connection in the course of trade between the goods and some person having the right, either as proprietor or as a registered user, to use the mark whether with or without any indication of the identity of the person, and includes a certification trade mark registered as such under the provisions of Chapter VIII.

TRADEMARK(Private Rights)

A trademark is a distinctive sign which identifies certain goods or services as those produced or provided by a specific person or enterprise. Its origin dates back to ancient times, when craftsmen reproduced their signatures, or marks on their artistic or utilitarian products. Over the years these marks evolved into todays system of trademark registration and protection. The system helps consumers identify and purchase a product or service because its nature and quality, indicated by its unique trademark, meets their needs.

TRADEMARK

A trademark provides protection to the owner of the mark by ensuring the exclusive right to use it to identify goods or services, or to authorize another to use it in return for payment. The period of protection varies, but a trademark can be renewed indefinitely beyond the time limit on payment of additional fees. Trademark protection is enforced by the courts, which in most systems have the authority to block trademark infringement

TRADEMARKS

What kinds of trademarks can be registered ? The possibilities are almost limitless. Trademarks may be one or a combination of words, letters, and numerals. They may consist of drawings, symbols, three-dimensional signs such as the shape and packaging of goods, audible signs such as music or vocal sounds, fragrances, or colors used as distinguishing features. In addition to trademarks identifying the commercial source of goods or services, several other categories of marks exist. Collective marks are owned by an association whose members use them to identify themselves with a level of quality and other requirements set by the association. Examples of such associations would be those representing accountants, engineers, or architects. Certification marks are given for compliance with defined standards, but are not confined to any membership. They may be granted to anyone who can certify that the products involved meet certain established standards. The internationally accepted ISO 9000 quality standards are an example of such widely recognized certifications.

GEOGRAPHICAL INDICATIONS

Geographical Indications of goods are defined as that aspect of industrial property which refer to the geographical indication referring to a country or to a place situated therein as being the country or place of origin of that product. Typically, such a name conveys an assurance of quality and distinctiveness which is essentially attributable to the fact of its origin in that defined geographical locality, region or country.

GEOGRAPHICAL INDICATIONS

India, as a member of the World Trade Organization (WTO), enacted the Geographical Indications of Goods (Registration & Protection) Act, 1999 which is likely to be operationalized soon with the notification of the Rules. Geographical Indications of Goods (Registration & Protection) Act, 1999 Geographical Indications of Goods (Registration & Protection) Rules, 2002

GEOGRAPHICAL INDICATIONS

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 Community rights

GEOGRAPHICAL INDICATIONS

Examples of possible Indian Geographical Indications Basmati Rice Darjeeling Tea Kanchipuram Silk Saree Alphanso Mango Nagpur Orange Kolhapuri Chappal Bikaneri Bhujia Agra Petha Goa Feni

Evolution of TRIPS Agreement

Evolution of IPR under the GATT/WTO Issue of Reverse Engineering and Piracy(Developing Countries) Dispute Settlement for benefit of developing countries.Possibility of retaliation WIPO had many treaties to administer and not all were members of the various treaties Super 301(US Imposing trade sanctions for weak IPRs in other countries) set aside by Multilateral Trade Negotiations.However,nothing in the WTO to stop countries from imposing egregious trade sanctions

WIPO

The World Intellectual Property Organization (WIPO) is an international organization dedicated to promoting the use and protection of works of the human spirit. These works intellectual property are expanding the bounds of science and technology and enriching the world of the arts. Through its work, WIPO plays an important role in enhancing the quality and enjoyment of life, as well as creating real wealth for nations. With headquarters in Geneva, Switzerland, WIPO is one of the 16 specialized agencies of the United Nations systems of organizations. It administers 23 international treaties dealing with different aspects of intellectual property protection. The Organization counts 179 nations as member states.

IP Protection Treaties Berne Convention for the protection of literary and artistic works Brussels Convention relating to the distribution of programme-carrying signals transmitted by satellite Convention for the protection of producers of phonograms against unauthorized duplication of their phonograms Madrid Agreement for the repression of false or deceptive indications of source on goods Nairobi Treaty on the protection of Olympic symbol Paris Convention for the protection of Industrial Property(PCT) Patent Law Treaty (PLT) Rome Convention for the protection of performers, producers of phonograms and broadcasting organizations Trademark Law Treaty (TLT) WIPO Copyright Treaty (WCT) WIPO performances and phonograms Treaty (WPPT) Budapest Treaty on the deposit of microorganisms for purpose of patent protection(1977) creates a union of countries operating common rules on filing samples of patented microorganisms.Administered by WIPO. UPOV:UNION FOR PROTECTION OF NEW PLANT VARIETIES,gives patent like rights to plant breeders working in formal seed industry.

Patent Cooperation Treaty (PCT) Benefit of Filing International Application

Seeking Protection Simultaneously More Decision Time to Enter National Phase Strength of Invention through Search and Examination Opportunity to have Foreign Counterparts 75% Rebate in Fees for Natural Persons of India

BR AZI CA L NA FR DA AN DEN CE MAR K

Why Do We Need IPRS

Promotes Innovation and Research Coase Theorem:If there is no transaction cost private bargaining can take place without help of IPRs(legal rules).Otherwise third party intervention is required Economic attributes of goods(non rival and with some degree of excludability) New Ideas=Non Rivarly=Increasing Returns=Imperfect Competition

WHY DO WE NEED PATENTS

Rewards to Inventor Motivates / stimulates inventive research Encourages maximum disclosure to enable further research and technology development

Why Do We Need Patents

Transferring into public property after expiry of term or cessation of Patent Encouragement for Improvement of Technology

Legislations in India

Patents - Patent Act, 1970 (+ amendments),TRIPS 2005 Design - The Design Act, 1911 Trademarks Trade & Merchandise Marks Act, 1958 + 1999 Copyrights The Copyright Act (1957 as amended from time to time) Protection of Plants and animals-Farmers Right bill,2001 and Seeds bill,2002 Layout Design of - Bills are passed Integrated Circuits, in Parliament Geographical Indications, follow up in progress Convention on Biodiversity etc.

Authorities In India

Controller General of Patents, Designs and Trademarks under Department of Industrial Development, Ministry of Industry __________________________ Copyrights registration Under Ministry of HRD/Education

PATENTS ACTS IN INDIA

Patents Act 1856,1911 Patents Act 1970 Patents (Amendment) Act 1999 Patent (Amendment) 2002 TRIPS Amndment 2005(Provision for Process and Product Patent)

PATENTS ACTS

Patent System Introduced in 1856

Comprehensive Patents & Designs Act, 1911 Uniform Term of Patent for 16 Years No Discrimination on Nature of Invention

Basics of The Patents Act 1970 Reduce Term (7 Years) Drug and Food

Differential Term of Patent

Full Term (14 Years) Other Inventions Restriction of Product Patent Product Patent Not Allowable on Drug, Food & Chemical Produced by Chemical Process Process Patent Allowable on Any Kind of Inventions Compulsory License & License of Right with More Grounds

PRECEDENCE OF PROCESS PATENTS

Federal Republic of Germany: 1967 Japan Spain United Kingdom : 1976 : 1992 : 1918-1949

Only Process Patent exists in Egypt, Netherlands, Hungary, Norway, Poland and Russia Federation.

Effect of The Patents Act, 1970

Substantial Development of Public Sector

and Small Scale Unit

Increases Collaborative Research in National Laboratories Reduces Activity of Multi National Companies Criticized by Multi National Companies for Narrow Protection

Why EMR brought in the Patents (Amendment) Act, 1999

To meet obligation under TRIPs Agreement by 1.1.2000 when Product Patents to certain Area of Technology can not be Provided

What is providing in EMR ? Provides a means by which application of Product Patents for such invention can be filed and to be kept in Mail Box Delay the application on Product Patent upto 1.1.2005 Grant of EMR under certain conditions for 5 Years

Effects

 39 Modern Medicines Enter in India from 1995-2000  Filing of Patent Applications Gains Tremendous Momentum  Applications on Drug Patent Increases Three Folds  Filling of 15 EMR Applications  8,500 Applications in Mail Box Waiting for Product Patent  Interest of Global Protection through PCT Increases in India  Waiting 72,000 Applications in PCT Pipeline to Enter in India

TRIPS 2005

 

Highlights Product patents and process patents Duration of Term of Patent - Extended to 20 years For all process/product including currently valid patents Invention/inventive step definitions as per TRIPs Micro organisms mathematical or business method or computer program with applications/ utility (except by itself) traditional knowledge

 Scope widened 

  

Traditional Knowledge - Excluded (as such) from Patentability PCT - Provisions & Procedures introduced

Depository for Biological - Budapest Treaty compliance

 Compulsory Licence - specified and defined (with Provisions and without 3 year restriction) includes Doha Declaration Licence of Right - Deleted Quantum of Royalties- open for negotiation - taking into account the economic value of the use of the patent - not more than adequate remuneration

 Waxman-Hatch Type - Regulatory approval related provision / working during life of patent without restriction allowed Reversal of burden of proof Parallel Imports Provisions - In case of process patent

- Incorporated

 Publication Examination

- On 18 months (DOA or DOP) - Only on request (48 months)

Appellate Board - introduced

APPLICATIONS OF PATENTS BY INDIANS AND FOREIGNERS

Year 1992-1993 1993-1994 1994-1995 1995-1996 1996-1997 1997-1998 1998-1999 1999-2000 2000-2001 2001-2002 2002-2003

Indians

Foreigners 1228 1266 1741 1606 1661 1926 2247 2206 2179 2371 2620 2239 2603 3589 5430 6901 8229 6707 2618 6324 8221 8822

Total 3467 3869 5330 7036 8562 10155 8954 4824 8503 10592 11442

India and IPR

India is complying with most if not all of the provisions of the TRIPS,2005.Some also call our regime as TRIPS Plus Regime. Product and Process Patents Even generic drug manufacturers who have mailbox applications can keep producing provided they pay reasonable royalty New formulations are combinations of old processes.Not specifying pharmaceuticals substance as a new chemical entity could allow formulations,isomers and other incrementally modified drugs to be considered as new inventions (Production of such drugs may become difficult in India After India has complied with TRIPS 2005).Generic drugs will be produced and can cater to demands in foreign counties like US and Canada.

India and IPRs

Farmers right,breeders right and researchers right protected through Plant Variety & farmers right bill 2001 and seeds policy 2002. Compulsory licenses can be issued to the third party(right to produce) if patent holder violates patent conditions like selling products at high prices, not making the inventions available sufficiently or in national emergency situation in any domestic or foreign WTO member country/ies.When a country issues CL it has to pay adequate remuneration to the patent holder.CL for copyrighted works and other IPRs also.

Examples of Compulsory Licenses

National Public Radio was granted CL for non commercial educational broadcasting use of repertoires of the American Society of Composers,Authors and Publishers and Broadcast Music,Inc. Clean Air Act provides for compulsory licensing of patents related to air pollution National Institute of Health is examining CLs in order to facilitate broader dissemination of biotechnology research tools.

India and IPRs

97% of drugs in India are off patents and none of the drugs on the essential medicines list are on patents Drugs however have to cater to diseases prevalent in India like dengue,malaria,tuberculosis and AIDS.Product patents will be useful if it leads to research and development for the supply of new drugs relevant to its disease profile Compulsory licensing and competition policies can deal with the egregious impact of the TRIPS agreement

India and IPRs

Under DSP in the WTO retaliatory action can be taken within or across the sectors. Advantages in India:It has cheaper,yet highly skilled labour,low clinical trials and fixed asset costs. Pre Grant opposition that would enable a member of public to challenge a patent application before it is granted has been restored. Parallel imports cannot be challenged in the DSP of the WTO.

India and IPRs

Strengthening the provisions relating to national security to guard against patenting abroad of dual use technology Bolar provisions Beyond 2005:New forms of older drugs :Difficult to patent(polymorphs),generic drug market will flourish atleast in short run

India and IPRs

Patenting of software embedded in hardware Pharma exports :lot of potential ,cater to generic markets abroad. Indian patent fees is the lowest(approximately 60 US dollars)

TRIPs plus Regime Subject Matter TRIPS-plus Provision Why is this TRIPS-plus

Plants

Extension of standards of protection,such as reference to UPOV,no possibility of making exclusion from patentability of life forms,reference to highest international standards Same as plant

No reference to UPOV in TRIPS agreement;TRIPS allows countries to exclude plants and animals from patent protection;highest international standards is vague Same as plant

Animals Micro-Organisms BioTech

Requirements to accede No reference to Budapest treaty Budapest treaty Requirement to protect biotechnological inventions No reference to biotechnology to TRIPs

TRIPS & AGRICULTURE(Adopted SuiGeneris Sytem) Plant Varieties and Farmers Rights act(2001) and Seeds policy,2002:Caters to Farmers Rights(farmers variety and derived variety),Breeders Right and Researchers Rights Biological Diversity Act 2003+Convention on Biological Diversity(BENEFIT SHARING) Farmers right to save,use,exchange and sell seeds(however not entitled to sell branded seed of a protected variety under the brand name).

Article 27.3

Article 27.3(b):Microorganisms,non-biological and microbiological processes can be patented.

TRIPS AND HEALTH:Doha Declaration on November 2001 Addressing public health problems for developing & least developed countries especially for HIV/AIDS, Tuberculosis, Malaria and other epidemics. Recognition of IPR protection with simultaneous consideration of unaffordable prices of patented medicines. Implementing measures for protection of public health and promotion to access medicines subject to respecting Most Favoured Nations (MFN) treatment to nationals and non-nationals. Rights of members to determine grounds of compulsory licences, define national emergencies & exhaustion rights. Methodology to assist countries with no technological capabilities.

TRIPS and Health

Affordability of medicines and vaccines(improving health infrastructure) Health outcomes more a function of availability of clean drinking water,sanitation and sewage treatment. Drugs for neglected diseases Availability of new drugs in less time period Domestic production vs R&D 95% already generics so price increase is relevant for 15-20 new drugs that arrive on international market every year.

TRIPS AND WELFARE

Globally there are only 15-20 new molecules(new drug substances) introduced annually.The total number of drug molecules in the market will rise rather slowly in the years after introduction of product patents and will never exceed 23 %(may fall also).Thus 75-80 % of the drugs in the market will be out of patents. Product Patents and Prices(Weak Relation) Affordability of medicines(increase purchasing power,more hospitals and clinics,adept distribution system and trained medical practioners ).Do not blame the Product patent regime only

TRIPS and WELFARE

Weak relation between Innovation,FDI,Profits,Technology Transfer and IPR Duplicacy and IPRs(Chinese example) Respite to 49 LDCs who do not have to comply with the TRIPS provisions till 2016 but denied access to imported generics.

TRIPS:THE WAY FORWARD FOR INDIA

For Use of Industries Follow weekly Publication of Patent in Gazette of India Make License Agreement with Applicant for Working with Right Avoid Penalty for Infringing the Right of Patent Holder Show Encouragement for Further Research & Development Utilize Potential Manpower to Stop Brain Drain

Use Of Technical Information

Lapsed Patent Patent granted from countries other than India Non-patent literature Animals and Plants not patentable under Indian Law Compulsory licence

Some Suggestions

Competition policy,compulsory licensing( can act as a tool of public policy to negotiate reasonable prices from producers) and jurisprudence of drugs control authority. Solution to patent barriers:patent pool,automatic licensing,utility models for patenting Use of the DSP of the WTO

What to Do ?

Suggestions Share Benefit of Patent System Utilize Resource through Organized R&D Activities(from 6-8 % at present to atleast 12 % of their sales)why?Cost of Developing New drug 1000 crores of rupees+skilled manpower+Risk

WHAT TO DO

Government role in promoting R&D Capture Global Market Judiciously Earn Profit through Open Markets In negotiations if we argue that TRIPS is a non trade issue developed nations would retort that so is giving subsidies in agriculture. Protectionism surfaces through standards but there are gains in unilateral liberalization for all(promoting R&D internationally)