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Cephalon, Inc. v. Dr. Reddy’s Laboratories LTD. and Dr. Reddy’s Laboratories, Inc.
In the ongoing battle to keep generic drugs off the market, Cephalon, Inc. filed suit against Dr. Reddy Laboratories, Ltd. (“DRL”) claiming patent infringement on its TREANDA patent arising from DRL’s filing of an Abbreviated New Drug Application (“ANDA”) to sell generic versions of TREANDA, which is Cephalon’s innovative treatment for chronic lymphocytic leukemia and non-Hodgkin’s lymphoma, prior to the expiration of the ‘863 patent. The ‘863 patent will expire on January 12, 2026.
According to the complaint, Cephalon has been selling, promoting, distributing and marketing TREANDA in the United States since 2008. DRL filed an ANDA with the U.S. Food and Drug Administration (“FDA”) seeking approval to manufacture and sell powder for infusion containing 25mg of bendamustine HCL and 100mg bendamustine HCL (“DRL’s Bendamustine Product”) prior to the expiration of Cephalon’s ‘524 patent, ‘190 patent, and ‘863 patent. DRL also filed certification with the FDA alleging that the claims of the aforementioned patents are invalid, unenforceable and/or would not be infringed by the manufacture, use, importation, sale, or offer for sale of DRL’s Bendamustine Product (“DRL’s Paragraph IV Certification).
Cephalon claims that DRL’s Bendamustine Product is covered by one or more claims of the ‘863 patent and that DRL’s commercial manufacture and sale of DRL’s Bendamustine Product would infringe one or more claims of the ’863 patent and that they would be substantially and irreparably harmed by DRL’s infringing activities.
This suit represents another suit in the ongoing battle of pharmaceutical companies filing lawsuits to keep generic drugs off the market and their response to ANDA filings by generic-drug makers.