Glivec Essay

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Introduction The Novartis case can be traced to 1997 when a patent application was filed by Novartis AG for the α-crystalline of imatinib mesylate (brand name Glivec) which was a slightly different version of their 1993 patent, a vital anti-leukaemia drug, filed in the Chennai (Madras) Patent Office. The petitioner claimed that they had invented the beta crystalline salt from the free base of imatinib. In 2003, Glivec was granted EMR in the Indian market. Novartis obtained orders preventing some of the generic manufacturers from producing the generic equivalents of Glivec in India. Soon, Novartis was selling Gleevec at USD 2666 per patient per year.15 Generic companies had been selling their generic versions at USD 177 to 266 per patient per month. Pre-grant oppositions were filed by Natco Pharma Ltd., M/s Cipla Ltd., M/s Hetro Drugs Ltd., M/s Cancer Patient Aid Association and M/s Ranbaxy Laboratories Ltd., India and in an order dated January 25, 2006, the Assistant Controller of Patents and Designs, Chennai Patent Office rejected the Novartis application. History of Glivec in India 1993: The base compound of Glivec, imatinib, is invented and patented worldwide. There is no patent filed in India at this time, as India does not have patent laws for pharmaceutical products. 1995: India joins the World Trade Organization (WTO) and begins its mandated 10-year transition period to bring its patent laws into alignment with TRIPS. JULY 1998: Novartis files a mailbox application in India for imatinib mesylate in crystalline form, the active ingredient of Glivec, in accordance with India’s provisions for obtaining patents. DECEMBER 2001: Novartis obtains marketing approval for Glivec in India. APRIL 2002: Glivec is launched in India. SEPTEMBER 2002: Novartis launches the Glivec International Patient Assistance Program (GIPAP) in India. NOVEMBER 2003: Novartis is

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