In a judgment published on August 9 2019, the District of New Jersey judge Claire Cecchi upheld the validity of Amgen's patents for the biologic medicine etanercept. The patents at issue were U.S. Patent No. 8,063,182 (covering the active ingredient etanercept, patent valid until November 2028) and U.S. Patent No. 8,163,522 (covering the method of manufacture for Enbrel®, valid until April 2029). The patent infringement action was brought by Amgen's affiliates Immunex Corporation and Amgen Manufacturing Limited, and Hoffmann-La Roche, the owner and licensor of the two patents.
The validity of the patents were challenged by Sandoz, who wants to launch a biosimilar version branded Erelzi. Sandoz did not dispute the infringement claim but argued that the asserted patents are invalid "due to lack of written description and enablement, obviousness, and obviousness-type double patenting". After an analysis of the patents, the Judge Cecchi rejected Sandoz's invalidity challenge.
The decision, at the moment, hands victory to Amgen in its long-running dispute against Novartis' entity Sandoz. The company says that it is "the first biosimilar company to receive FDA approval [in August 2016] for a biosimilar etanercept", adding that this patent dispute has prevented the launch of Erelzi.
Amgen said that both parties have reached an agreement concerning the preliminary injunction obtained in June 2018, which remains in place.
Sandoz said in its press release: "...We will appeal this decision, and look forward to presenting our case to the Federal Circuit and bringing Erelzi to US patients as soon as possible.” The statement also confirmed that both companies have agreed to expedite the appeal.
Amgen was represented by a team of lawyers from Sidley Austin, including IP stars David Pritikin, Vernon Winters and Jeffrey Kushan, while Winston & Strawn represented Sandoz. Both firms are ranked for patent litigation in the US.
A copy of the judgment can be found here.