Court dismisses Novartis' challenge to Indian patent law

A court in Chennai has rejected Novartis' challenge to Indian patent law, following a conflict over a patent for cancer drug Glivec (imatinib mesylate).

In January 2006, the Chennai patent office rejected a patent application for Glivec, ruling that it was only a minor variation on a known molecule (imatinib base) under section 3d of Indian patent law.

In 1993, Novartis patented imatinib base in several western countries but this was only a "scientific patent" for a drug that was not active in that form at that time. "The company did not yet know how to make the drug work in practice," according to a Novartis spokeswoman.

In May 2006, Novartis filed two lawsuits at the Madras High Court, one specifically for Glivec and the other to challenge the constitutionality of section 3d of Indian patent law. The court has rejected the section 3d challenge, claiming it is not competent to rule on Indian law's compliance with World Trade Organisation (WTO) intellectual property rules.

The Novartis spokeswoman, who "disagrees" with the court's decision, said that the company would not make any more challenges to section 3d, either in the supreme court of India or to the WTO. The other lawsuit, which specifically concerns Glivec, is ongoing, but no date has been set for an outcome.

Novartis recently failed in its objection to the appointment of a former controller general of the Indian Patent Office - directly involved in refusing Novartis' patent in January 2006 - to the Intellectual Property Appellate Board, she said.

Several non-governmental organisations, including Medicins Sans FrontiEres which launched a petition, had supported India, saying that questioning national patent policy could hold up the production of generic medicines - including low-cost HIV drugs widely used in emerging countries.

Several Indian companies, including Cipla, Ranbaxy and Hetero, produce a generic version of Glivec.