India adopted new patent regulations in January 2005. One provision, Section 3(d), states that molecules covered by patents dated prior to 1995 are not eligible for new product patents.

The Chennai patent office rejected Novartis' January 2006 application  for Gleevec, a cancer treatment cocktail, because it was not significantly different from an already-existing compound. The rejection came after the Cancer Patients Aid Association and five Indian drug makers filed pre-grant objections; their argument was that Gleevec, patented in the U.S. in 1993, was not patentable under the new Indian law.

The Novartis case is before the Madras High Court. Novartis originally had argued Section 3(d) as unconstitutional, a violation of India's obligations under TRIPS, the international Trade Related Aspects of Intellectual Property Rights. But last month, Novartis shifted its argument to lack of guidelines in 3(d) as allowing "arbitrary exercises of power" by the patent agency.

Novartis has said that it gives away Gleevec to 99% of the patients in India who receive it, and that the legal battle is not intended to block access to affordable drugs, but to protect the company's intellectual property, as well as ensuring incentives for R&D.

Various interests groups run the predictable gamut of support or revulsion at the Novartis legal challenge.

Right now, at least one card is stacked against Novartis: one of the appellate board members on the case is Shri S. Chandrasekaran, whom you no doubt recall is the feisty former head of the Indian patent office. Fact may catch up to the local rumor that Novartis will request a more unbiased judge to replace Chandrasekaran.

Concerned that a win by Novartis would raise the cost of drugs in India, Health Minister Ramados raised the specter of compulsory licensing in his remarks: "India has not used compulsory licensing so far, so we shouldn't be pushed towards that."

Thailand recently pulled a compulsory licensing stunt. TRIPS does have a loophole that allows for compulsory licensing upon declaring a public health crisis.