On July 1, 2020, the United States Court of Appeals for the Federal Circuit affirmed the judgment of the United States District Court for the District of New Jersey in favor of Sidley clients Amgen and Immunex on the validity of two patents that describe and claim its blockbuster rheumatoid arthritis drug Enbrel® and methods for making it.
Enbrel® has brought life-changing relief to thousands of patients who suffer from rheumatoid arthritis and other debilitating diseases. It was the first fusion protein approved by the United States Food and Drug Administration, and it is the world’s fifth-best-selling biologic drug.
Sandoz subsidiaries of the global biopharma company Novartis challenged the validity of these patents in conjunction with efforts to launch a competing copy of Enbrel®. Amgen affiliates Immunex and Amgen Manufacturing, along with the owner and licensor of the two patents, Hoffmann-La Roche, brought the patent infringement action in Federal Court against Sandoz. Before trial, Sandoz acknowledged that its biosimilar infringes seven patent claims. The trial took nearly a month. In its decision, the district court rejected all of Sandoz’s defenses. In this widely followed appeal, in which Sandoz was supported by several biosimilars industry amici, the Federal Circuit decision rejected each of the invalidity theories that Sandoz raised on appeal and affirmed the judgment in favor of Amgen/Immunex.
Working in close collaboration with Amgen’s talented team of in-house intellectual property litigators, Connie Trela and Steve Horowitz represented Amgen/Immunex on appeal, with Vern Winters, who served as co-lead trial counsel in the district court, and Jeff Kushan playing material strategy roles in the appeal. Additional Sidley team members at trial included David Pritikin (retired), Peter Choi, Sona De, Joshua Fougere, Sam Tiu, Frank Volpe, Richard Chen, Sue Wang, and Brooke Böll.