A patent application filed in India by the Swiss pharmaceutical company, Novartis ag, has been rejected.
The company had filed for an Indian patent for the crystalline version of their off-patent anti-cancer drug, Gleevec. Rejecting the application, the office of the controller general of patents, designs and trademarks in Chennai said the product was a derivative of a known substance.
The ruling came as a big victory for Hyderabad-based Natco Pharma Ltd, which makes the generic version of Gleevec, used for treating chronic myeloid leukaemia.
The Indian company had contended that the crystalline version of the drug did not have any enhanced efficacy over the original salt. It also claimed that such a patent was invalid under the Indian Patent Act 2005. Natco had carried out extensive experiments to show that the crystalline form was not superior. The patent office concurred with the company's findings.
Meanwhile, the Cancer Patients Aid Association has challenged Novartis' exclusive marketing right for Gleevec in India, in the Supreme Court. The exculsive rights make the cost of treatment for patients of myeloid leukaemia about ten times higher.
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