Amgen (AMGN) Announces KYPROLIS Patents Upheld Against Generic Manufacturer
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Amgen (NASDAQ: AMGN) today announced that the U.S. District Court in Delaware issued a decision upholding the validity of patent claims from three patents that protect Amgen's multiple myeloma therapy KYPROLIS® (carfilzomib). Today's decision will prevent Cipla Limited, and Cipla USA, Inc. (collectively "Cipla") from making, using, selling, offering to sell, or importing its generic version of KYPROLIS until expiration of these three U.S. patents. The latest patent expiry is in December 2027.
Onyx Therapeutics, Inc., an indirect, wholly-owned subsidiary of Amgen Inc., brought a patent infringement suit against Cipla in 2016. The decision comes after the Delaware court held a bench trial in May 2019. Prior to trial, Cipla acknowledged that its generic product would infringe all of the asserted claims, leaving only the issue of validity of the asserted patents to be addressed by the court.
KYPROLIS is approved for the treatment of patients with relapsed or refractory multiple myeloma who previously received one to three lines of other therapy. KYPROLIS is also indicated in combination with dexamethasone or with lenalidomide plus dexamethasone. Three patents that are the subject of the decision are: U.S. Patent No. 7,417,042, U.S. Patent No. 7,737,112 and U.S. Patent No. 8,207,125.
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