US-based Amgen has filed a case against Sanofi and Aventisub, formerly doing business as Aventis Pharmaceuticals and Regeneron Pharmaceuticals, in the US District Court of Delaware, over patent infringement.
The patent infringement lawsuit is for the US patent numbers 8,563,698, 8,829,165, and 8,859,741.
Owned by Amgen, the patents describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9.
Amgen intends to get an injunction to prevent the infringing manufacture, use and sale of Sanofi and Regeneron’s alirocumab, a monoclonal antibody targeting PCSK9.
Sanofi and Regeneron recently announced the completion of Phase III trials for alirocumab and plan to get regulatory approval to market it in the US.
In August, Amgen submitted a biologics license application to US Food and Drug Administration (FDA) for evolocumab, its own investigational human monoclonal antibody to PCSK9, for the treatment of high cholesterol.
Earlier this month, the FDA approved the biologics licence application (BLA) for review for Amgen’s investigational bispecific T-cell engager (BiTE) antibody construct, blinatumomab.
The company has submitted BLA for the treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).
The firm also submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for approval to market blinatumomab for the treatment of adults with Ph relapsed/refractory B-precursor ALL.
Established in 1980, Amgen develops and manufactures human therapeutics.
Image: One of the many buildings at Amgen headquarters in Thousand Oaks, California. Photo: courtesy of Coolcaesar.