The Swiss drug manufacturer Novartis has procured patent protection over another of its anti-cancer drug, called Nilotinib (Patent No. 237430) from the Indian Patent office. This is a superior version of Gleevec (imatinib mesylate), in beta crystalline form and is used as second line therapy for patients who have developed resistance for Gleevec in treatment of chronic mylogenous leukemia. It is believed by experts to be more potent and having fewer side effects than Gleevec. Gleevec is alpha crystalline form of imatinib mesylate, which was denied patent and the matter is pending for framing of issues in the Supreme Court. Novartis markets the beta form drug as ‘Tasigna’, which has been approved in US three years ago (US Patent No. 7,169,791).

The application for the beta form was filed under the mail box application system in 2004, numbered 3003/CHENP/2004 in the Chennai Patent Office. In view of the initial reports of resistance in the Gleevec registration trials, the scientists came up with Nilotinib just a year after launching Gleevec. Tasigna results showed statistically significant improvement over Gleevec in every measure of efficacy in the studies unveiled in December 2009. With the approvals granted to the drug in about eighty countries including US and EU, Novartis is now planning to file worldwide applications for approvals for Tasigna for treatment of adult patients suffering with leukemia.

So far, no Indian company has opposed the said patent.