Amgen Takes Sandoz to Court Over Enbrel Biosimilar Efforts

March 10, 2016

Amgen is taking Novartis’s biosimilar division to court over alleged patent infringement for seeking FDA approval to produce a generic version of its blockbuster drug Enbrel.

Amgen contends that Novartis’ Sandoz unit infringed five of its patents on Enbrel when it filed an ABLA last year seeking FDA approval to produce a biosimilar of the product. The FDA accepted Sandoz’s application last fall.

Filed in the U.S. District Court for the District of New Jersey, the lawsuit contends that Sandoz’s efforts not only endanger Amgen’s patents on the drug, but also violate the Biologics Price Competition and Innovation Act. The latter accusation is because Sandoz allegedly withheld certain documents from Novartis when following the BPCIA’s notification requirements and later refused to engage in patent negotiations mandated under the law.