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.