14 Jan 2008

Patents of Pharmaceutical and health issues in India

The Patent Act was amended in 2005 by the Amendment Act, 2005 which brought within the purview of the Patent Act, product patent. Product patent was introduced in order to meet a WTO commitment to recognize foreign product patents. The signing of the Doha Declaration forced India to reformulate its patent law, by amending Section 3(d) of the Patents Act, 1970 that contains a key public health safeguard. The patent law does not allow patents merely on the “discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process.” Patents can be awarded only when there is a substantive improvement of the existing drug formulation, something ‘new’ in the right sense of the word. India's recent position on patents means that it is going to make its products extremely expensive and out of reach for its own people and their brethren within the developing world. The pharmaceutical industry produces high quality products of almost all therapeutic groups and exports the generic produce to the developing and developed countries at most competitive prices. The developing countries are now apprehending difficulties in importing pharmaceuticals from India because of the tight provisions in regard to the compulsory licences for effective role of the domestic enterprises in the patented products.

The government rejected the patent application for the cancer drug Imatinib mesylate, marketed under the brand name Gleevec/Glivec in many countries to Novartis in January 2006. A possibly scary outcome was prevented: in countries where Novartis has obtained a patent, Gleevec is sold at $2,600 per patient per month. In contrast, the generic versions of Gleevec are available for less than $200 per patient per month in India.

Dr. Yusuf K Hamied, Chairman and Managing Director of Cipla Limited and a leading scientist in his recent Paper ‘Trading in Death’ has made strong observations on the new Indian Patent Law keeping the critical health scenario in India in view :

“The truth is that health in India is in a permanent and perpetual crisis. The disease profile is as follows : 80 million cardiac patients, 80 million afflicted with mental illness, 60 million diabetics, 50 million asthmatics, 50 million hepatitis B cases, and one in three Indians is a latent carrier of TB. The World Bank has said that India will have 35 million HIV cases by 2015, or approximately half of all the AIDS cases in the world. Given these facts, the patent regime in this country should be devised so that the utmost priority is granted to securing the people's rights of access to affordable and quality healthcare, without monopoly”.

Thus, the much awaited pronouncement of the Intellectual Property Appellant Board on the Novaritis and Gleevec matter, which will lay to rest India’s stand with respect to the obligations that it needs to meet under the WTO and TRIPS agreements as well as the Doha Declaration.

Isn’t this clear enough for, the Indian Legislative to wake up and take care of its own?

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