Journal of Intellectual Property Rights Vol 9, May 2004, pp 226-241 WTO-TRIPS Obligations and Patent Amendments in India: A Critical Stocktaking† K D Raju* Amity Institute of Global Legal Education and Research, E-25, Defence Colony, New Delhi 110 024 Received 22 February 2004;revised 6 April 2004 Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement was one of the most contentious issues in the Uruguay Round of multilateral trade negotiations, which was concluded in 1994 at Marrakech. The commitments under the TRIPS Agreement compelled In- dia to amend its patent regime in 1999, 2002 and 2003 (the Amendment Bill lapsed due to the dissolution of the present Lok Sabha). This paper examines the amendments in the Indian pat- ent system in consequence of TRIPS Agreement, and Indian reaction to the same in substantial and procedural levels. India opted for the setting up of a ‘mail box’ and has taken Exclusive Marketing Rights (EMR) route for the transitional period. The second section analyses the im- plications of transitional period and to suggest further options available to India. It also looks into the new provisions included in the Patents (Amendment) Bill 2003. This paper, based on a review of amendments to the Indian law, concludes that the Indian patents regime is inadequate to meet the challenges posed by the TRIPS Agreement. It also puts forward some suggestions to improve the patent regime in the country as a whole. Keywords: TRIPS Agreement, Patent amendment, Mailbox and EMR The GATT was originally conceived in the most contentious issues in the Uruguay early post-war years. The purpose was to Round (UR) of multilateral trade negotia- establish a legal framework for` interna- tions, which was concluded among 125 tional trade in goods. In the beginning, in- nations, including India, in April 1994 at tellectual property protection was outside Marrakech. Almost a decade after coming the GATT agenda, but it did take notice of into effect, the TRIPS Agreement remains a intellectual property protection in Article controversial but forceful legacy of the UR IX1 and Article XX.2 The Agreement on trade agreements.4 However, the Agree- Trade- Related Aspects of Intellectual ment leaves considerable room to deal with Property Rights (TRIPS)3 was one of the the national level issues, such as the defini- tion of an invention, exception to exclusive _________________ rights, compulsory licensing, etc. The † The views expressed in this paper are personal TRIPS Agreement provides a three-stage and should not be attributed to the institutions which the author is associated with. time frame for developing countries to *E-mail: [email protected] comply with its obligations. They are: RAJU: WTO-TRIPS OBLIGATIONS AND PATENT AMENDMENTS IN INDIA 227 1. Introduction of a ‘mailbox’ facil- 2. Trade Marks Act, 1999 ity starting from 1995 to receive 3. Designs Act, 2000 product patent application in the field of pharmaceuticals till 31 4. Copyright (Amendment) Act, December 2004. An Exclusive 1999 Marketing Rights (EMRs) for a 5. Protection of Plant Varieties and period of five years or till the Farmers’ Rights Act, 2001 product patent is granted or pat- ent application is rejected. 6. Geographical Indications of Goods (Registration and Protec- 2. Other rights related to rights of tion) Act, 1999 patentee, term of patent protec- tion, compulsory licensing, rever- 7. Semiconductor Integrated Cir- sal of burden of proof, etc., are to cuits Layout Designs Act, 2000 be complied with by 1 January This stocktaking acquires special sig- 2000. nificance in the wake of the US putting 3. Introduction of product patent India in the priority watch list under protection in all fields of technol- ‘Special 301’6 provision of the Trade Act, ogy from 1January 2005 includ- alleging poor intellectual property protec- ing food, drugs, pharmaceuticals tion in India.7 The US pharmaceutical and chemicals. industry alleges that it currently loses India has complied with most of the more than $ 1.7 billion annually because obligations and the remaining will be ful- of India’s insufficient intellectual prop- 8 filled with the passing of Patent erty protection. The western perspective (Amendment) Bill 2003.5 The TRIPS of the Agreement is that, “Intellectual Agreement covers seven major IPR areas, property has become one of the most viz., patent, copyrights and related rights, valuable assets of a large and growing trademarks, geographical indications, in- number of domestic and international 9 dustrial designs, layout designs (topogra- corporations.” phies) of integrated circuits, and protec- tion of undisclosed information. India TRIPS Agreement and Patents made a series of amendments to its exist- (Amendment) Act, 2002: A Compara- ing laws and enacted new legislations in tive Analysis consonance with the TRIPS commit- ments. They are: The Concept of Invention Article 27(1) of the TRIPS Agree- 1. Patents (Amendment) Act, 2002 ment provides that: and Patents (Amendment) Bill ⎯Patents shall be available for any in- 2003 (lapsed due to the dissolu- ventions, whether product or process, in tion of the Lok Sabha). all fields of technology; and 228 J INTELLEC PROP RIGHTS, MAY 2004 ⎯Patent rights shall be enjoyable without or contrary to public order or morality or discrimination in the field of technology. which causes serious prejudice to human, The TRIPS Agreement does not spec- animal or plant life or health or to the en- ify what an ‘invention’ is; national laws vironment, is also not patentable. Mere can define this concept according to the arrangement, rearrangement or duplica- standards generally applied. But all these tion of a known device cannot be pat- are subject to normal tests of novelty and ented.13 Mere discovery of a scientific inventiveness capable of industrial appli- principle or the formulation of an abstract cation. theory or “discovery of any living thing There is no obligation under the TRIPS or non-living substance occurring in na- Agreement to adopt an expansive concept ture” is not acceptable. of ‘invention.’ While implementing Arti- The new clause (j)14 excludes plants cle 27(1), each country should carefully and animals other than micro-organisms consider the economic, legal and ethical in whole or any part thereof including aspects involved in the patenting of living seeds, varieties and species and essen- materials or certain types thereof. tially biological processes for production There is no uniform definition avail- or propagation of plants and animals. able which relates to the distinction be- Sub-section (k) excludes a mathematical, tween ‘invention’ and ‘discovery.’ Ac- business method, computer program or cording to the basic principles of patent algorithms. Sub-section (l) excludes “a law, the former is patentable and the latter literary, dramatic, musical or artistic work is not. A ‘discovery’ is commonly con- or any other aesthetic creation whatsoever sidered to mean the mere recognition of includes cinematographic works and tele- what already exists. It means that India vision productions. Sub-section (m) ex- can legitimately follow a definition of cludes ‘a mere scheme or rule or method invention that broadly excludes materials of performing mental act or method of pre-existing in nature. For instance, Ar- playing game.” Presentation of informa- gentine patents law excludes from the tion and topography are included in sub- concept of invention “any kind of living sections (n) and (o). Traditional knowl- materials or substance already existing in edge or traditionally known component is nature” (Article 6g).10 excluded from patenting. This provision Indian Practice and Exceptions to Patentability may adequately check the piracy of huge The Indian Patents (Amendment) Act, Indian traditional knowledge in the 11 2002 defines an ‘invention.’ Section 3 sphere of Ayurvedic medicines. of the Act enumerates what are not ‘in- In addition to what is not an ‘inven- ventions’ and those inventions, which are tion’, national laws can establish excep- not patentable. An invention that is frivo- tions to the patentability of invention that lous or contrary to well-established natu- would otherwise be protectable. There ral laws cannot be patentable.12 An inven- are three permissible exceptions to the tion intended to commercial exploitation basic rule on patentability.15 Broad ex- RAJU: WTO-TRIPS OBLIGATIONS AND PATENT AMENDMENTS IN INDIA 229 emptions from patentability remain, to tended use or commercial exploitation of protect public order or morality, prevent which could be contrary to law or moral- environmental deterioration and protect ity or which causes serious prejudice to animal, human or plant life. This is an human, animal or plant life or health or to area where India can enjoy some room to environment.” manoeuvre. The same applies to thera- A few judicial decisions are also avail- peutic and surgical methods for treatment able for considering the determination of of humans or animals.16 invention. An “invention is the act or op- The controversial exemptions are in eration of finding out something new; the Article 27 (3) (b) for biotechnological process of contriving and producing inventions. It exempts plants and ani- something not previously known or exist- mals, essentially biological processes for ing, by the exercise of independent inves- the production of plants and animals. The tigation and experiment.”20 TRIPS Agreement permits the patenting Section 2(8) of the Patents and Designs of micro-organisms and