Novartis' Patent Case in India

India's Intellectual Property Appellate Board has ruled that Novartis' patent on the cancer drug Gleevec is not valid in that country. The decision marks the third time in four years that Novartis has failed in attempts to legally enforce its patent on the drug.

Concurring with earlier decisions, the board ruled that Gleevec is nothing but a crystal modification of an older drug that was initially patented in 1993 and therefore does not qualify as a new invention. Under patenting rules that India began implementing in 2005, only drugs invented after 1995 are eligible for patent protection.

Novartis says it is "reviewing the decision and will look at the various options available." Gleevec, a company spokeswoman says, already enjoys patent protection in 40 countries. "We believe the same should be the case in India," she says.

Ever since the legal battle over the Gleevec patent began in India, the case has been more about principles than money. Novartis claims it has been supplying Gleevec free of charge to 11,000 Indian patients who could otherwise not afford it and that only 1% of the patients who take the drug in India actually pay for it. Gleevec is one of the most effective drugs for treating chronic myeloid leukemia.

Health activists such as Doctors Without Borders and India's Cancer Patient Aid Association see the Gleevec case in terms of the impact it could have on drug pricing. A win for Novartis would force India's generic pharmaceutical companies to stop producing and exporting their own versions of Gleevec and, more important, dissuade them from launching generic versions of other drugs in the future.

A Doctors Without Borders spokesman tells C&EN that the group is still reviewing the latest decision. "We feel it is not a full victory," he says.