Monday, January 22, 2007

Novartis in India - An Update

Novartis has been strongly criticised of late for its stance on production of generic versions of the leukaemia drug, Glivec, in India.

And now a petition has been launched by Medicins Sans Frontieres (MSF) to oppose the case and its potential to prevent the production of cheaper generic versions of the drug. In a press release, MSF International Council President, Dr Christophe Fournier, said, "This key source of medicines cannot be allowed to dry up."

In an earlier post, Novartis and the Challenge to Indian Patent Law, a background to the dispute was provided, together with a brief analysis of the claims.

Novartis had obtained exclusive marketing rights for 5 years for its cancer drug, Glivec (marketed as Gleevec in the US) , but because it was decided that the invention was not an invention, the exclusive marketing rights were withdrawn (new form of a known substance). Section 3(d) of the Indian Patents Act, which provides that "the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance" will not be sufficiently inventive to warrant patentability. In other words, India is refusing to allow Swiss-type claims. And this is what Novartis wants to challenge, arguing that the law is not TRIPS compliant (Art 27(1)) and is unconstitutional. However, arguably TRIPS does not go as far as mandating the protection of new use, as discussed on IPMed previously. The case will be heard in Madras, 29 January.

To accompany the petition, MSF has also provided a backgrounder as well as a timeline for the case. Commentators have suggested that it may bring the same kind of pressure that saw the end to the South African litigation (which also involved Novartis among others) over HIV medicines in 2001.

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