Novartis received patent for second-line CML therapy drug

The Chennai Patent Office lately published Indian Patent No. 237430 issued to Novartis for anti-cancer drug Nilotinib, globally marketed as Tasigna. In October 2007, the United States FDA approved Nilotinib for chronic myelogenous leukaemia (CML) second-line therapy for patients who are resistant or tolerant to Imatinib Mesylate (marketed as Gleevac). The patent is granted against the mail-box Application No. 3003/CHENP/2004 claiming priority from British Application Nos. 0215676.8 and 0229893.3. We reported about Nilotinib pending patent application in early 2008 (read here). In July 2008, we also reported an advertisement by leading generic manufacturer Cipla announcing introduction of new drugs that likely included Nilotinib generic version (read here). Nilotinib belongs to the class of tyrosine kinase inhibitors. Other tyrosine kinase inhibitors that are granted patents in India include Dasatinib (IN203937 issued against the Application No. IN/PCT/2001/01138/MUM), Sunitinib (IN209251 issued against the Application No. IN/PCT/2002/00785/DEL), Lapatinib (IN221017) and Sorafenib (IN215758 issued against the Application No. 1633/MUMNP/2007). Gefitinib patent application (841/DEL/1996) was rejected by the Delhi Patent Office following pre-grant oppositions filed by Natco Pharma and JM Pharmaceuticals.