THE PHARMA REVIEW (DECEMBER, 2007 - JANUARY, 2008)

TRIPS - Patent Amendments - Prices of Patented Drugs

T. Vedavathi, A. Radha Krishna and J. Vijaya Ratna

Abstract: Smt. Indira Gandhi, our late ex-prime minister said pharmaceuticals should not be subjected to patenting as such a measure would amount to profiteering over life and death. This statement of Smt. Indira Gandhi characterized the philosophy of the government and of the elite with respect to protection of intellectual property rights in the 70s and 80s. The philosophy of the Indian Patent Act 1970 was that while encouragement to innovation is necessary to promote scientific research it should not be done at the cost of public health. But there was a drastic change in the thinking of the world and in the thinking of the Indian government itself from the 70's to the 90's. India opened its trade doors to the world. Economic reforms were started in 1991 with the objective of globalization. India became a member of WTO in 1995 and had to comply with the requirements of TRIPS, i.e. Trade Related Issues of Intellectual Property Rights. India as a developing country got 10 years as transition period to become compliant with TRIPS and with this objective India amended its Patent Act of 1970 five times.

The Doha ministerial conference of WTO in November 2001 was a big turning point for the developing countries with respect to TRIPS compliance issues. This conference declared that TRIPS is flexible. As per the Doha declaration, a government may make such amendments to its patents act, which while helping it to become TRIPS compliant, also allow it to support its public health. Some of the flexibilities offered in TRIPS are:

1. compulsory licensing
2. parallel importation
3. provisions relating to patentable subject matter
4. research exception and
5. competition and the control of anti competitive practices.

Between 1995 and 2005 India amended its Patent Act five times to make Indian patent law TRIPS compliant. But India utilized the flexibilities offered by the Doha declaration and provided in its 5th amendment to the Indian Patents Act, 1970, an opportunity to prevent the ‘evergreening’ of patents which MNC's do to extend the life cycle of their patented drugs. Government of India also provided a provision for “pre grant opposition” of patents in its Patent Act with a view to curtail patents on trivial matters. The provision to prevent evergreening has come in the form of Sec. 3(d) of the amended act.

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