Issues in Patenting Biopharmaceuticals
N. Lalitha
Biotechnology has fruitful solutions to some of the diseases that have remained mystery. But as the development in this field advances, the intellectual property protection governing the innovations in biotechnology also becomes complicated. Resource-rich countries that are making inroads in this field try to zealously guard the innovations through broad and multiple patents. While the TRIPS Agreement recognises the patentability of micro-organisms, because of the moral and ethical issues concerning the micro-organisms, national governments have chosen to carefully define micro-organisms. Indian government has defined areas that are ‘not patentable’ and also has appointed a committe to look into the patentability of micro-organisms. However, liberal patentability criteria followed by developed nations create broad patents and thereby impede research and innovations in this area.
Bibliography
1. Patents and Biopharmaceuticals in India: Emerging Issues (with Diana Joseph), Tailoring Biotechnologies, Vol. 3, Issue 3, Winter 2007/2008.
2. A status report on the French Pharmaceutical Industry (with Samira Guennif) forthcoming in Journal of Health Management, 10 (2) 2007.
lalitha_tamilNadu.pdf — 3. N. Lalitha, Tamil Nadu Government Intervention and Prices of Medicines, Economic and Political Weekly, Vol. 43, No. 1, January 05-11, 2008.
4. TRIPS Plus Agreements and Issues in Access to Medicines in Developing Countries (with Samira Guennif), Journal of Intellectual Property Rights, Vol. 12, pp. 471-479, September 2007.
N. Lalitha, Associate Professor at Gujarat Institute of Development Research, Ahmedabad, holds a PhD in Economics from the Institute for Social and Economic Change, Bangalore. She has been a visiting scholar at the University of California, Berkeley (2001), the University of British Columbia (2004), and Maison des Sciences de l'Homme (MSH), Paris (2004, 2006). Lalitha is the lead co-ordinator of the programme ‘Globalisation and Public Health in Developing Countries: Access to Essential Drugs under Stringent Intellectual Property Rights Regime’, selected by the International Programme for Advanced Studies, MSH, Paris. She has a keen interest in understanding the various intellectual property rights issues impacting the health care sector of India and has published articles in this field that have appeared in referred journals in India and abroad.
Personal publications
lalitha_drug_policy.pdf — N. Lalitha, Drug Policy 2002: Prescriptions for Symptoms, Economic and Political Weekly, July 27, 2002, pp. 3102-3555.
lalitha_pharma_industry.pdf — N. Lalitha, Indian Pharmaceutical Industry in WTO Regime. A SWOT Analysis, Economic and Political Weekly, August 24, 2002, pp. 3542-3555.
A recent paper in French on patenting issues in India
http://www.cairn.info/revue-internationale-de-droit-economique-2007-2-p-185.htm
gueniff_chaisse_brevet.pdf — French version in PDF format available on Zimmermann's Shared Web (Login) page.
Samira Guennif et Julien Chaisse
L’ÉCONOMIE POLITIQUE DU BREVET AU SUD:
Variations indiennes sur le brevet pharmaceutique
Revue Internationale de Droit Economique, tome XXI, 2, année 2007/2
pp. 185 à 210
The rationale behind patenting of an invention can be traced to the community of interests between the society and the inventor. For the society, an individual can be guaranteed access to new, safe and efficient therapies and obtain full disclosure of an invention to promote innovation. For the inventor, he (or she) benefits from a monopoly for the use of the product or process and recover the resources devoted to research and development. Accordingly, patents induce innovation in a sector where firms are exposed to problems of appropriation. This compromise between diverging interests was always at the heart of modifications made in patent protection in developed countries ; since the granting of patents on processes alone to ensure the diffusion of innovation and the growth of a competitive pharmaceutical industry, to the granting of patents to both processes and products from the fifties onwards. In the eighties, bowing to constant pressure from the pharmaceutical industry, the term of a patent was extended to twenty years in developed countries. As of the same period, we witness a strengthening of patent regimes in the world, especially in developing countries with the ratification of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) in 1994. Beginning 1st January 1996, developed countries amended their national legislation to comply with TRIPS while a twenty-year moratorium was provided for least developing countries. Yet, other developing countries have benefited from a ten-year moratorium, which ended in 1st January 2006, and have or are amending their patent law to be compliance with the agreement. At this occasion, there has been sharp questioning and criticism, and disputes arise. While it has been constantly reminded to developing countries that the TRIPS is not inconsistent with the aims of industrial development and public health, there have been expressions of acute fear and sharp protests from Brazil, India and even the “African group” within the World Trade Organization. The flexibility provided for in the agreement fail to reassure developing countries. The aim of this article is precisely to shed light on the ins and outs of the extension of intellectual property rights (IPR) to developing countries, by scrutinizing the particular pattern followed by India, which brings about feasible industrial and sanitary improvements while the country is progressively currently amending with delay its patent law to comply with TRIPS. To understand better the stakes involved in the ratification of the TRIPS agreement in India, we will begin by establishing that opting for a stringent intellectual property regime is not without consequences. It determines the extent of progress achieved in the industrial and health sectors both in the developed as well as developing countries. In particular, through the implementation of a weak IPR regime in the past, India has largely contributed recently to the access of patients infected by HIV/AIDS to treatments through sharp reduction of prices. Then, we shall see how the TRIPS establishes a strong IPR system that aims to reconcile protection of innovation and public health promotion by providing for “exceptions” at the global level. Finally, after having dealt in detail with Indian reticence and tardiness in making its legislation TRIPS compliance, we will analyse the legal path followed by India to carry on improvements regarding access to medicines.
Keywords: WTO, TRIPS, patent, India, medicine.