Patent protest

Possible drug price hike: apex court acts on appeals

Published: Wednesday 15 September 2004

the Supreme Court (sc) has issued two notices to the Union government, within a span of two weeks, over the grant of exclusive marketing rights (emrs) to pharmaceutical companies under the Indian Patents Act, 2002. The notices have been issued in response to two writ petitions challenging the emrs on the ground that they have made drugs less accessible by causing a hike in their prices, violating people's right to life under the Indian Constitution.

India is the only country yet to introduce a product patent regime for drugs. Granting of emrs is a transitional arrangement in the process. emrs grant the exclusive right to sell a product for a shorter duration compared to the product patent regime. They are also easier to obtain.

The notice served on August 6, 2004, concerns the petition filed by Cancer Patients Aid Association (cpaa), a non-governmental organisation based in Mumbai. The cpaa has challenged the emrs granted to Novartis India Limited to sell Gleevec, used for treating Chronic Myeloid Leukemia (cml). Treatment with the drug earlier costed Rs 9,000-12,000 per month but now costs Rs 1,20,000 per month, it claims. Respondents to the notice have to reply in four weeks. They include the Union of India, the Controller General of Patents, Designs and Trade Marks, Drug Controller General of India, Novartis ag, Switzerland, Novartis India Limited, India and the National Pharmaceutical Pricing Authority.

Earlier, on July 26, the sc sent a notice to the Union of India, the Union ministry of health and family welfare and the Union ministry of law and justice to respond within six weeks to a petition filed by a New Delhi-based trust, People's Livelihood Development Trust (pldt). The appeal challenges the product patent regime, likely to be enforced in the country from January 1, 2005, as well as the emrs.

pldt contends that the product patent regime would increase the prices of essential medicines. It compares the prices of many drugs sold in the Indian market with those of the patented versions sold in other markets. A strip of 10 tablets of the drug amlodipine besylate, which is used for treating patients of cardiovascular diseases, is sold as Amlodac for Rs 7.8 in India. The patented version of the drug is sold by Pfizer as Norvasc in Pakistan. A strip of 10 tablets of Norvasc would cost Rs 200.34 in India, the petition points out.

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