PHM-Exch> Case by Novarts in Supreme Court of India Jeopardizes the Lives of Millions

[amit sen]

Dear All,

This is disturbing news on the IP and Access to Medicines front in India.

In Solidarity,

Amit Sengupta
(Peoples Health Movement - India)
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Case by Novarts in Supreme Court Jeopardizes the Lives of Millions
 
The Supreme Court of India is presently hearing a case, that has the potential to decide the entire course of the generic drug industry and the future of access to new medicines in India . The court is hearing an appeal by the Swiss Multinational Corporation, Novartis, against the decision of the Indian Patent office to deny a patent to its drug  Imatinib Besylate (which Novartis sells under the Brand name of Gleevec). Imatinib is a life-saving drug for patients suffering from Chronic Myeloid Leukemia (a form of blood cancer). Novartis has lost its appeals against the decision of the Indian Patent office at the IPAB (Intellectual Property Appellate Board) and subsequently in the Chennai High Court.
 
If Novartis’ plea is upheld it will mean that leukemia patients shall be forced to be a victim of monopoly pricing by Novartis, which sells the drug at a cost of Rs.1,20,000 (approx. US$ 2,700) for a month’s supply. In contrast, nine Indian companies are now selling the drug at a cost of Rs.8,000 to 9,000 (approx. US$  175 - 200) for a month’s supply. Leukemia patients need to take imatinib life-long. The Supreme Court’s decision will decide whether tens of thousands of leukemia patients will live or die, as 99% of those on imatinib produced by Indian companies will just not be able to afford the price of Gleevec.
 
The impact of the present case, moreover, shall not be limited only to leukemia patients who need to take imatinib. At the heart of the case is the challenge that Novartis has mounted against a key section of the Indian Patents Act – Section 3 (d). This section of the Indian Act does not allow patents on minor alterations to existing drugs. The section was introduced in the amended Patent Act in 2005 to prevent the practice of evergreening – a practice by which drug manufacturers prolong the patent life of a drug by making minor alterations to an already existing drug. Imatinib’s original patent was filed 18 years ago. The version for which Novartis is now claiming a patent is merely a different crystalline form, from the one that was patented in 1993 – when the Indian Patent Act did not allow the patenting of medicinal products. Section 3(d) has been instrumental in safeguarding generic drug production in India , not just in the case of Imatinib
 but in a number of other cases involving life-saving anti-cancer and anti-HIV/AIDS medicines.

A judgment in favour of Novartis is also likely to have serious adverse impact, not just on India but on a number of countries across the world that depend on Indian generic medicines.

For earlier details of the Novartis case,
please see: http://novartisboycott.org/
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