Patent trouble

Sarah Hiddleston (Frontline)

ON January 29, the Madras High Court began hearing arguments on a series of writ petitions filed by the Swiss pharmaceutical multinational Novartis AG and its Indian subsidiary Novartis India against the Indian government, the Cancer Patients Aid Association (CPAA) and four Indian generic drug manufacturers: Natco, Cipla, Hetero and Ranbaxy. The petitions plead against the rejection by the Chennai Patent Office last year of a patent application for Novartis' anti-cancer drug Gleevec and submit that Section 3(d) of the Indian patents Act, Patents Act, 1970, which provided one of several grounds for rejecting the patent application, is invalid, illegal and unconstitutional.

In March 2005, India amended its Patents Act to comply with the 1995 World Trade Organisation's (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, which requires 20-year patent protection for innovative medicines while allowing for public health safeguards. This included Section 3(d), a provision that is unique to Indian law and was included to protect public health. It states that patents would not be given for new forms, uses or minor modifications of existing drugs unless they differ significantly with regard to efficacy.

Between the signing of the 1995 TRIPS agreement and the amendment of the Act, patent applications were collected in a mailbox, to be reviewed once the agreement came into force. One of these was the 1997 application filed by Novartis AG in the Chennai Patent Office for imatinib mesylate, brand-named Gleevec, on the grounds that the beta crystalline salt form (mesylate) of the base imatinib was a new invention. Rights for exclusive access to the Indian market were obtained in 2003, and on that basis manufacturers of generic drugs were forced to withdraw their product from the market.

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