Immunex Corp., et al. v. Sandoz Inc.

Sidley Austin successfully represented Amgen in the patent appeal. Goodwin Procter LLP represented Sandoz Inc.

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.

The Sidley & Austin team representing Amgen/Immunex on appeal was led by Connie Trela (Picture) and Steve Horowitz, 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.

Involved fees earner: Brooke Böll – Sidley Austin LLP; Richard Chen – Sidley Austin LLP; Peter Choi – Sidley Austin LLP; Sona De – Sidley Austin LLP; Joshua Fougere – Sidley Austin LLP; Steven Horowitz – Sidley Austin LLP; Jeffrey Kushan – Sidley Austin LLP; Samuel Tiu – Sidley Austin LLP; Constantine Trela Jr – Sidley Austin LLP; Frank Volpe – Sidley Austin LLP; Sue Wang – Sidley Austin LLP; Vernon Winters – Sidley Austin LLP;

Law Firms: Sidley Austin LLP;

Clients: Amgen; Immunex Corporation;

Author: Ambrogio Visconti