Amgen and Sandoz to Meet in Court for New BPCIA Dispute over Enbrel Biosimilar

Amgen, Hoffmann-La Roche and Immunex have filed a complaint in the District of New Jersey against Sandoz alleging patent infringement of the plaintiffs’ etanercept (ENBREL) patents under the BPCIA provisions of 35 U.S.C. § 271.  The plaintiffs are also seeking declaratory judgment of patent infringement on the grounds that Sandoz refused to engage in the “patent dance.”  According to Amgen,  Etanercept is a biologic therapeutic designed to mediate tumor necrosis factor (“TNF”) receptor binding, which is implicated in a number of different autoimmune diseases particularly rheumatoid arthritis and psoriasis.

Sandoz recently filed an aBLA seeking FDA approval for a biosimilar version of ENBREL under the BPCIA’s aBLA pathway, which allows Sandoz to take advantage of Enbrel’s clinical testing data in much the same way a traditional generic can under the ANDA pathway.  The patents-in-suit, U.S. Patent Nos. 8,063,182, 8,163,522, 7,915,225, 8, 119,605 and 8,722,631 are collectively owned and exclusively licensed by the plaintiffs and generally pertain to the etanercept molecule, drug products and methods of use.

The complaint filed by plaintiffs can be found here.

Stay tuned to Big Molecule Watch for more updates on this developing story.