Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Trade Related Aspects of Intellectual Property Rights and Pharmaceuticals: The Impact of Extended Protection on India ***

Viraj Mehta (Abschlußjahr: 2004)

Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs), which came into effect from 1st January 1995, is to date most comprehensive multilateral agreement of Intellectual Property Rights (IPRs). TRIPs requires all World Trade Organization members to provide minimum standards of protection for a wide range of IPRs including copyright, patents, trademarks, industrial designs, geographical indications, semiconductor topographies and undisclosed information. The most sensitive part of TRIPs is regarding product patent issue in various fields of technology including pharmaceuticals and this part gave rise to an acrimonious debate between the developed countries and less developed countries (LDCs). No country was more actively involved in opposing this component of General Agreement on Tariffs and Trade (GATT) than India and no part of TRIPs was, and continues to be, more sensitive than the proposal to require product patent for pharmaceutical innovations.

On one hand, patent is reviewed as 'innovation encouraging' by means of giving exclusive marketing rights to the patent owner and thus providing optimal incentive to invest in the research and development to discover, test and bring innovations to market. On the other hand, many poor developing economies claim that patent protection for pharmaceuticals will result in substantially higher prices for medicines, with adverse consequences for the health and well being of their citizens.

This thesis focuses on impact of extended patent protection for pharmaceuticals in India. Before TRIPs came in to existence, India was not recognizing product patents in pharmaceuticals and agricultural sector, but only process was patentable. When India is approaching deadline for product patent recognition, future consequences are still not predictable. Price for medicines are likely to increase while generic industry will have no adverse effects. Large pharmaceutical companies have already invested in R & D, while smaller players have to move to either generic market or have to look for contract manufacturing. It is unlikely that low labor cost in India will be able to attract MNCs to choose India as preferred location for R & D, looking towards centralize nature of R & D. Contract manufacturing, mergers and co-marketing alliances will likely to be successful in terms of foreign investments. It is also expected that better patent protection will divert more R & D efforts towards developing countries needs.

Pages: 79