Journal of Intellectual Property Rights

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VOLUME 13

NUMBER 5

SEPTEMBER 2008

CODEN: JIPRFG 13(5) 389-556 (2008)

 

ISSN: 0971-5544

 

Special Issue

on
TRIPS and the Pharmaceutical Industry

 

 

CONTENTS

 

TRIPS Agreement and Public Health: An Overview of International Issues

395

        N S Gopalakrishnan

 

 

Doha Declaration and Public Health Issues

401

        N Lalitha

 

 

Indian Patent Law in the post-TRIPS Decade: S&T Policy Appraisal

414

        A D Damodaran

 

 

Transcending Differences: The Challenge for Pharmaceuticals in the Post-TRIPS Indian Patent Regime

424

        Feroz Ali Khader

 

 

Impact of TRIPS on Indian Pharmaceutical Industry

432

        Gopakumar G Nair

 

 

Data Exclusivity Provisions in India: Impact on Public Health

442

        Manthan D Janodia, Ajay Chauhan, Shuaib M Hakak, D Sreedhar, V S Ligade and
N Udupa

 

 

Appropriate Patent Rules in Developing Countries — Some Deliberations Based on Thai Legislation

447

        Jakkrit Kuanpoth

 

 

Compromising TRIPS: Brazil’s Approach to Tackle the HIV/AIDS Imbroglio

456

        M D Nair

 

 

Compulsory Licensing under Section 92A: Issues and Concerns

464

        Harshita Mathur

 

 

How to Control the United States Pharmaceutical API Market Using Patents on New Synthetic Intermediate Compounds

473

        Mark Pohl

 

 

Transplanting Bayh-Dole Act — Issues at Stake

480

        V C Vivekanandan

 

‘Exhausting’ Patent Rights in India: Parallel Imports and TRIPS Compliance

486

        Shamnad Basheer and Mrinalini Kochupillai

 

 

What’s ‘New’?  — Isn’t it Obvious?

498

        D Christopher Ohly

 

Traditional Knowledge, Intellectual Property Rights and Biodiversity Conservation: Critical Issues and Key Challenges

509

        A Damodaran

 

 

New Paradigms for Protection of Biodiversity

514

        Srividhya Ragavan

 

 

Legal Issues in Branding Medicinal Products

523

        Zakir Thomas

 

 

Institutions and Capacity Building for the Evolution of Intellectual Property Rights Regime in India: V — Analysis of Review of TRIPS Agreement and R&D Prospect in Indian Agriculture under IPR Regime

536

        Sudhir Kochhar

 

 

Annexure

 

548

Glossary

552

Author Index

  

Basheer Shamnad

486

 

 

Chauhan Ajay

442

 

 

Damodaran A

509

Damodaran A D

414

 

 

Gopalakrishnan N S

395

 

 

Hakak Shuaib M

442

 

 

Janodia Manthan D

442

 

 

Khader Feroz Ali

424

Kochhar Sudhir

536

Kochupillai Mrinalini

486

Kuanpoth Jakkrit

447

 

 

Lalitha N

401

Ligade V S

442

 

 

Mathur Harshita

464

 

 

Nair Gopakumar G

432

Nair M D

456

 

 

Ohly D Christopher

498

 

 

Pohl Mark

473

 

 

Ragavan Srividhya

514

 

 

Sreedhar D

442

 

 

Thomas Zakir

523

 

 

Udupa N

442

 

 

Vivekanandan V C

480

 

Keyword Index

 

Access and benefit sharing

536

Access to medicines

401

ANDA

473

Arbitrage

464

Article 39.3 of TRIPS

442

 

 

Bayh-Dole Act

480

Biodiversity

514

Bioprospecting

509

Bio-prospecting

514

Brazilian patent law

456

 

 

CBD

536

Compulsory license

395, 447

Compulsory licensing

401,432, 464

Data exclusivity

432 , 442

Doha Declaration

395 , 401

Drug patent

473

 

 

Exclusive marketing rights

432

Exclusive rights exhaustion

486

 

 

Generic name

523

 

 

HA Declaration

456

HIV/AIDS

401

 

 

Indian Patents Act 2005

480

Indian Patents law

414

Infringement

523

International exhaustion

447

Interregional exhaustion

486

Inventive step

498

IPR

395

 

 

Merck-INBio

514

 

 

National

486

Newness

498

Novel

498

Novelty

498

Para 6

395

Parallel imports

447, 486

Paris Convention

395

Passing off

523

Patentability issue

424

Patentability

432

Patentable subject matter

498

Patented portents

486

Patents

464

PCT

424

Pharmaceutical branding

523

Pharmaceutical economics

473

Pharmaceutical industry

432

Pharmaceutical patent

473

Post-2005 appraisal

414

Pre/post grant oppositions

432

Pre-grant opposition

424

Prior informed consent

536

R & D

464

R&D in agriculture

536

Regional

486

Research exemptions

432

 

 

S&T policies

414

Section 92A

464

Sui generis

509

Synthetic intermediate

473

 

 

Thai Patent Act

447

Therapeutic efficacy

498

Trademark law

523

TRIPS Agreement

432, 442, 536

TRIPS and AIDS drugs

456

TRIPS

395, 424, 447, 456, 464, 486

 

 

Valuation of biodiversity

514

Valuation

509

 

Journal of Intellectual Property Rights

Vol 13, September 2008, pp 395-400

 

TRIPS Agreement and Public Health: An Overview of International Issues

N S Gopalakrishnan

Received 24 June 2008

This paper deals with brief overview of the developments of international provisions on IPR related to public health. It discusses flexibilities before and after TRIPS Agreement and difficulties faced by developing countries in implementing TRIPS obligations and protecting public health. Also discussed are the reasons for the Doha Declaration and issues relating to implementation of Para 6 of the Declaration. Discusses the inadequacy in the compulsory licence based approach to solve public health crisis and argues for a more comprehensive approach to find a long term solution to the public health issues.

Keywords: TRIPS, Doha Declaration, Paris Convention, Para 6, compulsory licence, IPR

 

Journal of Intellectual Property Rights

Vol 13, September 2008, pp 401-413

 

 

Doha Declaration and Public Health Issues

N Lalitha

Received 7 July 2008

Adhering to the TRIPS Agreement in the pharmaceutical sector poses several questions before developing countries and least developed countries concerning public health. These are: Would the TRIPS Agreement and product patent regime affect access to medicines for the public? What are the options available for countries that face health crises? The Doha Declaration provides for access to medicines particularly by simplifying the compulsory licensing (CL) clause. A brief look at the countries that have utilized the CL option highlights that all such countries have been facing a rapidly spreading HIV/AIDS epidemic, medicines for which are produced under patents by multinationals. Hence, while some countries have actually issued a CL to a third party or a government department to produce or import the patented drug, some countries have used the CL option as a negotiating strategy to get a steep reduction in the price so as to facilitate access to medicines in the public health care. The amendments carried out by the Indian government also facilitate production of generic versions of patented drugs that would facilitate exports under the CL option as well. Though the Doha Declaration facilitates access to medicines, some of the free trade agreements are drafted in such a way that the least developed countries can not exercise the flexibilities. However, in order to facilitate the options available in the Doha Declaration, countries will have to incorporate the necessary changes in their national laws.

Keywords: Doha Declaration, compulsory licensing, HIV/AIDS, access to medicines

 

 

Journal of Intellectual Property Rights

Vol 13, September 2008, pp 414-423

 

 

Indian Patent Law in the post-TRIPS Decade: S&T Policy Appraisal

A D Damodaran

Received 17 June 2008

The basic objectives within which patent laws are enacted in any country are: (a) promotion of ‘R&D of possible industrial use’ through rigorous legal definition of inventions and their associated attributes in terms of patents and providing them limited monopoly in the form of intangible intellectual property rights through law (b) encouragement of national techno-economic advance by making such rights conditional upon local manufacture, thereby leading to rapid techno-economic development of the country and (c) controlling potential misuse of the limited monopoly rights through compulsory licensing measures serving ultimate societal progress. To quote from the US Trade Commission itself, the basic objective is ‘to promote innovation through proper balance of competition and patent law and policy’ (‘To promote Innovation: The Proper Balance of Competition and Patent Law Policy’, A report by the Federal Trade Commission, October 2003). In essence, contents of a patent law are ‘not created (per se) in the interest of the inventor, but in the interest of national economy. The rules and regulations of the patent system are not governed by the civil or common law but by political economy’, to quote the well-known Patent Attorney and scholar, P J Michel, a point substantiated later also by the Lord Swan Committee (1948).

In fact, the Indian Patents and Designs Act, 1911 enacted under the erstwhile colonial regime basically served to protect imported machineries and technologies against possible indigenous reverse engineering by Indians or other foreign trade/manufacturing agencies working in India. The First Patent Enquiry Committee Report (1949) and subsequently the 1970 Patents Act meticulously formulated through the Justice Rajagopal Ayyangar Committee Report (1959), however, reversed this process thereby giving rise to development of India as an ‘advanced developing country’. Consequent to India joining the WTO in 1995, the Act has now been made TRIPS compliant. A first level S&T appraisal of the post-TRIPS decade seems to indicate that major policy initiatives are needed to retain the past gains and to put the nation-building process truly on the forward path, failing which the existing ‘knowledge barriers’ may become even wider beyond our scientific-technological capabilities.

Keywords : Indian Patents law, Post-2005 appraisal, S&T policies

 

 

Journal of Intellectual Property Rights

Vol 13, September 2008, pp 424-431

 

 

Transcending Differences: The Challenge for Pharmaceuticals in the
Post-TRIPS Indian Patent Regime

Feroz Ali Khader

Received 2 June 2008

In the absence of a universal patent law with global jurisdiction , members of the World Trade Organisation (WTO), have adopted and legislated national laws in their respective countries though some what different interpretations of the TRIPS Agreement. While the Patent Cooperation Treaty (PCT) was the first attempt for a near harmonized system by accepting a common application, PCT has little use during the prosecution phase of patent applications. One of the important issues which have been differently interpreted is related to the patentability criteria and exceptions to patentability dealt with under Articles 27.2 and 27.3 of the TRIPS Agreement. Thus Section 3(d) of the Indian Patents Act has turned out to be a contentious issue, the resolution of which may have serious consequences on inventions related to pharmaceuticals. The Novartis case on the Gleevec patents is a case in point. While the Act provides for granting of patents even for known substances if substantial enhancement of activity vis-a-vis known activity is established, in practical terms several obstacles to a fair assessment of what is substantial has turned out to be difficult. The provision for pre-grant opposition in the Indian Patents Act has led to a large number of applications from patent groups, pharmaceutical companies and non-governmental organizations. These and related matters are discussed in detail in this paper.

Keywords: TRIPS, PCT, patentability issue, pre-grant opposition

 

 

Journal of Intellectual Property Rights

Vol 13, September 2008, pp 432-441

 

 

Impact of TRIPS on Indian Pharmaceutical Industry

Gopakumar G Nair

Received 30 May 2008

After India became a founder member of WTO and acceded to the TRIPS Agreement, the product patent regime was reintroduced in India after a gap of 35 years. The significance of the new IP regime on pharmaceutical industry in India, the amendment to the Patents Act, 1970, in fulfillment of the obligations to comply with TRIPS, related developments in other fields of IP as well as enforcement of new IP/Patent regime on the pharmaceutical industry are comprehensively discussed herein. The regulatory interfaces of patents in the Indian and international context are also briefly dealt with.

The historical evolution of IP with specific reference to patent regime in India is dealt with. Significance of IP such as patents, trademarks, industrial designs, trade secret and data exclusivity are elaborated. The key elements of the TRIPS Agreement which led to the three consecutive amendments to the Patents Act, 1970 are highlighted. The significance of the patent amendments in 1999, 2002 and 2005 and their highlights as well as the need for such amendments in fulfillment of TRIPS obligations have been described herein. Finally, the impact of post-TRIPS scenario in Indian pharmaceutical industry with specific reference to the international operations and the regulatory interfaces has been analysed. The related fields like biodiversity and plant varieties are also touched with.

Keywords:   TRIPS Agreement, pharmaceutical industry, compulsory licensing, data exclusivity, exclusive marketing rights, research exemptions, pre/post grant oppositions, patentability

 

 

Journal of Intellectual Property Rights

Vol 13, September 2008, pp 442-446

 

 

Data Exclusivity Provisions in India: Impact on Public Health

 

Manthan D Janodia, Ajay Chauhan, Shuaib M Hakak, D Sreedhar, V S Ligade and N Udupa

Received 24 June 2008

One of the contentious issues of intellectual property rights is related to data exclusivity. Data exclusivity relates to protection of data generated by the innovator from disclosure to third party in order to prevent ‘unfair commercial use’. The debate has serious implications for pharmaceutical companies where substantial amount of data is generated during discovery and development of a new drug. The data is in the form of clinical trials data, reports of pharmacological and toxicological profile of drug, its use and indications etc. This data which is submitted to regulatory authorities of concerned countries for marketing approval is generally referred by regulatory authorities for approval of generic medicine. Multinational companies based in developed countries argue that this data generated during drug discovery and development needs to be protected in the form of ‘data exclusivity’ which is mandated under Article 39.3 of TRIPS Agreement. Developing countries state that ‘data exclusivity’ is not mandatory according to TRIPS Agreement. So far India has not provided for ‘data exclusivity’. India’s position on ‘data exclusivity’ with respect to other countries of the world is subject to recommendations and suggestions of the committee set up by the Government of India to look into issue of ‘data exclusivity’ which is discussed in this article.

Keywords: Data Exclusivity, TRIPS Agreement, Article 39.3 of TRIPS

 

 

Journal of Intellectual Property Rights

Vol 13, September 2008, pp 447-455

 

 

Appropriate Patent Rules in Developing Countries - Some Deliberations
Based on Thai Legislation

Jakkrit Kuanpoth

Received 25 May 2008

TRIPS Agreement mandates adequate and effective protection for all inventions regardless of the field of technology. The fundamental questions are whether the extent of protection of pharmaceuticals will be beneficial for the socio-economic development of developing countries and how can the impact of the new system be monitored and controlled in the interests of the concerned countries and their populations. Under the Thai Patent Law, Section 46.50 provides for the grant of compulsory licenses, which in practical terms are difficult to implement so much so that no such licenses have been granted since 1979 when the Act came into force. Lack of know-how to work the patent in Thailand has also been a serious deterrent. Provision of a requirement for working of patented inventions is also part of the Thai Act. Section 36(2) of the Thai Patent Law authorizes parallel imports into Thailand if the products are marketed abroad by the patentee or his licensee. Section 9 (4) of the Act adopts the principle that methods of treatment are not patentable. Section 31 permits opposition to be filed after the application is published by the Patent Office. The implication of TRIPS and the Thai Patent Act on the pharmaceutical sector and on the patients in Thailand are discussed in this paper.

 

 

Journal of Intellectual Property Rights

Vol 13, September 2008, pp 456-463

 

 

Compromising TRIPS: Brazil’s Approach to Tackle the HIV/AIDS Imbroglio

M D Nair

Received 1 August 2008

The General Agreement on Tariffs and Trade (GATT), of which the TRIPS Agreement was an integral part, mandates the implementation of a harmonized patent system applicable to all member countries. Patents are instruments which provide exclusive rights for a limited period on the patentee for dealing with the product or process of his innovation and prevents others from using them without due authorization. These rights often result in monopolistic pricing of drugs making them unaffordable to large number of populations particularly from economically backward developing countries. A very relevant case is that of HIV/AIDS drugs which are not available at affordable prices to millions of patients living in African, Latin American and South East Asian countries. This article is an attempt to understand the strategies adopted by one such affected country, Brazil. The compulsory licenses provisions under Articles 30, 31 of TRIPS as well as Para 6 of the DOHA Declaration of 2001 which proclaims that public interest will supercede private interests particularly in the area of health and drugs are yet to make an impact on the problem. Whether the Brazilian model is tenable across the cross section of countries similarly affected is yet to be established. Other strategies for making the required drugs available for the control of this and similar life threatening and intractable diseases also need to be explored side by side.

Keywords: TRIPS, Brazilian patent law, TRIPS and AIDS, drugs, HA Declaration

 

 

Journal of Intellectual Property Rights

Vol 13 September 2008, pp 464-472

 

 

Compulsory Licensing under Section 92A: Issues and Concerns

Harshita Mathur

Received 8 May 2008

As the patents laws continually soar in dynamic transition, burning controversy that rages up is compulsory licensing under Section 92A of the Indian Patents Act enabling exportation of patented drugs. This dissertation is a research-based factual analysis of patents as a real barrier to the accessibility to drugs and the extent to which compulsory licensing remodels the situation, in reference to the latest legal development- Natco v Pfizer which has hauled the key provisions before the legal eye for severe scrutiny. This paper is an endeavour to analyse the issue of patents v patients in the light of a possible outcome of this potentially landmark case.

Keywords: Patents, TRIPS, compulsory licensing, Section 92A, arbitrage, R & D

 

 

Journal of Intellectual Property Rights

Vol 13, September 2008, pp 473-479

 

 

How to Control the United States Pharmaceutical API Market Using Patents on New Synthetic Intermediate Compounds

Mark Pohl

Received 17 June 2008

The multinational pharmaceutical industry now out-sources a much higher volume of active pharmaceutical ingredients from manufacturers in non-regulated markets such as Brazil, India and China. This economic change presents an opportunity for API manufacturers to potentially control the market in the United States for certain APIs, by capitalizing on a particular provision of US patent law. This paper reviews this law, examines several actual case studies under this law, and provides a check list of characteristics useful to identify the most valuable Active Pharmaceutical Ingredients (API) manufacturing opportunities.

Keywords: ANDA, pharmaceutical patent, drug patent, pharmaceutical economics, synthetic intermediate

 

 

Journal of Intellectual Property Rights

Vol 13, September 2008, pp 480-485

 

 

Transplanting Bayh-Dole Act- Issues at Stake

V C Vivekanandan

Received 4 August 2008

The Intellectual Property Regime in India is in the midst of transition with TRIPS mandated provisions finding their way into the existing laws and also looking at comparative regimes for newer legislations. One of the serious issues is that of public funded research and its direction in terms of protection. The dominant argument is that to reap the benefits through licensing these rights to create resources for themselves, a protection system is needed. It is argued that such rewards will fund their activities in an environment where State funding is shrinking. In this context there have been efforts to bring in a legislation on the lines of the Bayh-Dole Act of US to push forward ‘patenting efforts’ of public funded research and also to bring in academic–industry linkage. The Act in US itself is 25 years old and has come under the scanner of various critiques. In the Indian context it needs a critical analysis whether such a transplant will work. This article focuses on the issues at stake in bringing in such a transplant. It also traces the background of Bayh-Dole Act in US, its impact in the last two decades, its appropriateness in the Indian scenario and critical issues involved with such efforts to transplant.

Keywords: Bayh-Dole Act, Indian Patents Act 2005, Public Funded Research & Development (Protection, Utilization &  Regulation of Intellectual Property) Bill 2007

 

 

Journal of Intellectual Property Rights

Vol 13, September 2008, pp 486-497

 

 

‘Exhausting’ Patent Rights in India: Parallel Imports and TRIPS Compliance

Shamnad Basheer

and

Mrinalini Kochupillai

Received 15 July 2008

India’s amendment to her patent regime in 20051 to introduce pharmaceutical product patents attracted unprecedented attention, both domestically and globally. While multinational pharmaceutical companies were concerned that the Act withered away their exclusive rights, civil society activists decried the new product patent regime, fearing that it would cause steep hikes in the price of life saving drugs. This politicization of patent law produced some interesting results; most recently, a recent Delhi High Court case that denied an injunction to a multinational patentee on the ground that it sold a more ‘expensive’ drug than the infringing generic manufacturer.2

While some provisions in the new patent regime, such as Section 3(d) continue to attract a lot of attention, others have been lost in the legalese. One such provision is Section 107A(b) dealing with parallel imports, which, if read in a strict literal manner could have far reaching implications for the rights of a patentee. This paper aims to highlight this particular provision, which has thus far not attracted the attention it deserves. It explores the ambiguities inherent in this section and discusses the gaps in the Indian law pertaining to exhaustion and parallel imports. Lastly, it goes on to suggest statutory amendments in order to remove ambiguities inherent in the section and expand the scope of exhaustion envisaged therein, whilst at the same time remaining TRIPS compliant.The paper is divided into four sections: The first section explains the concept of exhaustion/parallel importation in relation to patents. Section two examines the ambiguities inherent in Section 107A(b). It also explores the gaps in the law relating to exhaustion in India and assesses the TRIPS compatibility of the current provision. The third section recommends a creative way of interpreting the current statutory provision so as to remove the ambiguities, and balance out the rights of patentees and parallel importers in an optimal manner without violating the TRIPS Agreement. The final section recommends statutory amendments to Section 107A(b).

 

Keywords: Parallel imports, TRIPS, exclusive rights exhaustion, patented portents, national, regional and interregional exhaustion

 

 

Journal of Intellectual Property Rights

Vol 13 September 2008, pp 498-508

 

 

What’s ‘New’? - Isn’t it Obvious?

 

D Christopher Ohly

Received 17 July 2008

A new approach to Section 3(d) of Indian patent law using common principles of statutory construction suggests that Section 3(d) should be viewed as a proviso to the general definition of an invention in the Indian Patents Act. As such Section 3(d) should be strictly construed. The term ‘mere discovery’ should encompass only natural things merely observed and not non-natural substances that result from human endeavour. The term ‘efficacy’ used as an exception to the proviso should be broadly construed to include more than ‘therapeutic efficacy’. Construed in this traditional manner Section 3(d) may well comply with TRIPS.

Keywords: Therapeutic efficacy, novel, patentable subject matter, newness, novelty, inventive step

 

 

Journal of Intellectual Property Rights

Vol 13, September 2008, pp 509-513

 

 

Traditional Knowledge, Intellectual Property Rights and Biodiversity Conservation: Critical Issues and Key Challenges

A Damodaran

Received 20 May 2008

Based on a survey of the major national and international initiatives undertaken to protect Traditional Knowledge (TK) since 1990s, the paper states that the task of reconciling TRIPS with CBD and other related TK laws is fraught with difficulties. After examining various IPRs in relation to TK, the paper argues that there are clear limits to which former can accommodate the latter especially when it comes to positive protection of TK and related cultural expressions. The main argument in this paper is that sui generis legislations are more effective for the protection of TK and related cultural expressions. A sui generis legislation that views TK as a composite resource, having both economic and cultural features has a better prospect of ensuring protection of TK, besides enabling benefit sharing. By having international regulations that harmonize protection measures, it is guaranteed that national efforts at protection are not wasted due to absence of reciprocity.

Keywords: Sui generis, bioprospecting, valuation

 

 

Journal of Intellectual Property Rights

Vol 13, September 2008, pp 514-522

 

 

New Paradigms for Protection of Biodiversity

Srividhya Ragavan

Received 14 June 2008

The most successful bioprospecting venture was established in 1989 in Costa Rica. Interestingly, the distinction of being a forerunner in exploiting bioprospecting goes to India. In 1979, a full decade before Costa Rica, India established the Tropical Botanic Garden and Research Institute (TBGRI) at Trivandrum. Yet, the TBGRI venture with the Kani tribes, which had the potential to become a beacon of bioprospecting success, is showcased as the exemplar of failure. In this era of trade regime, this paper asserts, bioprospecting ventures are important tools for developing countries. Countries like India and organizations like TBGRI should learn from their failures and take leadership roles to evolve techniques to maximize returns by using biodiversity resources. With this as the background, this paper propounds three theoretical models for assigning bio-value to biotechnology products.

Keywords: Biodiversity, bio-prospecting, Merck-INBio, valuation of biodiversity

 

 

Journal of Intellectual Property Rights

Vol 13 September 2008, pp 523-535

 

 

Legal Issues in Branding Medicinal Products

 

Zakir Thomas

Received 8 July 2008

Branding of a drug raises important trademark principles. Some of the important trademark law decisions have come up in the area of pharmaceutical branding. This article examines these decisions, practises in the market and analyses legal issues surrounding trademark in pharmaceutical field.

Keywords: Pharmaceutical branding, generic name, infringement, passing off, trademark law

 

 

Journal of Intellectual Property Rights

Vol 13, September 2008, pp 536-547

 

 

Institutions and Capacity Building for the Evolution of Intellectual Property Rights Regime in India: V – Analysis of Review of TRIPS Agreement and
R&D Prospect in Indian Agriculture under IPR Regime

Sudhir Kochhar

Received 11 July 2008

The TRIPS Agreement provides for product patent protection in all fields of technology including food substances pharmaceuticals and agrochemicals. The aim is to provide level playing field for developed and developing economies to promote economic development and alleviation of poverty. Yet the protection of trade-related intellectual property rights through public disclosure and their exclusive use under the control of the innovator may not be a sufficient, stand-alone measure to induce and achieve higher food and agricultural production. There is need to simultaneously recognize other relevant areas and mechanisms of global, regional and local importance and to harmonize world trade system with evolutionary necessities including socio-economics and the environment – sustainable development, environment protection, climate change, conservation of and access to biodiversity, biosafety, food safety, ethical issues related to manipulation of biological materials for improvement and development, issues of equity and commercial benefit sharing as pitted against intellectual property protection and royalties under the TRIPS Agreement, etc. This paper attempts to discuss review of TRIPS Agreement particularly in relation to patentability of bioresources and its harmonization with access and benefit sharing regime. R&D prospect in Indian agriculture under IPR regime is also discussed.

Keywords: TRIPS Agreement, CBD, access and benefit sharing, prior informed consent, R&D in agriculture