Thursday, October 04, 2007

HLR Files Infringement Suit against Indian Generics Over Boniva Patent

Hoffmann-La-Roche has filed patent infringement lawsuits in the US District Court for the District of New Jersey to safeguard its patent rights over Boniva, generically ibandronate sodium against Indian generic drug manufacturers, Dr. Reddy’s Laboratories Ltd. and Orchid Chemicals and Pharmaceuticals Ltd., both filed Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration seeking regulatory approval to market generic ibandronate before expiration of two Orange Book US Patent Nos. 7,192,938 (the ‘938 patent), expiring May 06, 2023, and 6,294,196 (the ‘196 patent), expiring October 07, 2019. However, Dr. Reddy’s has made Paragraph IV certification against the ‘196 patent, not the ‘938 patent. HLR also filed infringement complaints against Cobalt alleging infringement of four Orange Book US Patent Nos. ‘938 patent, ‘196 patent, 6,143,326 (the ‘326 patent), and 4,927,814 (the ‘814 patent).

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