Multinational pharmaceutical company Sanofi Aventis and Debiopharm, SA has sued Dabur Pharma and its subsidiary, Dabur Oncology plc of UK, in a US court for challenging the patents on Sanofi's Eloxatin, an injectable drug (Oxaliplatin) used in the treatment of bowel cancer.The case was filed in the US District Court for the District of New Jersey in response to Dabur Oncology Plc filing of an abbreviated new drug application (ANDA) for Oxaliplatin with Para IV certification. Para IVs are generic drug marketing applications filed with the US Food and Drug Administration (FDA) with patent challenges. As per the US rules, when an ANDA is filed with Para IV certification, it has to be notified to the patent holder. The patent holder can then sue the challenger within 45 days of notification, and the USFDA will refrain from approving any generic copies of the drug for the next 30 months. "Dabur disputes the charges of infringement and intend to vigorously challenge these allegations and are confident of asserting non-infringement of the two patents," the company said in a press release today. The complaint alleges that the filing of the applications has infringed, and the proposed products will infringe US patent no. 5,338,874 and US patent no 5,716,988. Oxaliplatin had sales of approximately 1.7 billion Euros (US $ 2.3 billion) and its generic versions are available in several European markets, the release added.
