On October 13, 2020, McKool Smith secured a significant appellate victory for two Sanofi entities and Regeneron Pharmaceuticals, Inc. against Immunex Corp., an Amgen Inc. subsidiary. The United States Court of Appeals for the Federal Circuit affirmed McKool Smith’s inter partes review (IPR) victory on behalf of Sanofi and Regeneron, leaving intact an earlier February 2019 decision by the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office, which determined that all 17 claims of Immunex’s U.S. Patent No. 8,679,487 are invalid. There has been extensive media coverage of the decision.
Sanofi and Regeneron are represented by McKool Smith principal Lauren Fornarotto, who argued the Federal Circuit appeal in August 2020, and also served as lead counsel in the IPR and argued the hearing before the PTAB in November 2018. Along with Ms. Fornarotto, the McKool Smith Federal Circuit team included principals Mike McKool, John Garvish, Joel Thollander, and Geoff Smith, senior counsel Eric Hansen, and associate Matthew Cameron.
Media coverage can be found below:
- "Fed. Circ. Backs Sanofi, Regeneron PTAB Win over Amgen," Law360 (10-13-2020)
"The Federal Circuit on Tuesday upheld a Patent Trial and Appeal Board decision invalidating an Amgen unit's patent on treating inflammatory disorders, in a win for Sanofi and Regeneron, whose eczema and asthma treatment Dupixent was accused of infringement."
- "Amgen Loses Bid to Revive Antibody Patent in Regeneron Fight," Bloomberg Law (10-13-2020)"
The appeals court affirmed Patent Trial and Appeal Board decision that invalidated challenged claims of patent 8,679,487 owned by Amgen’s Immunex."
- "Fed Circuit backs PTAB's broad view of 'human antibodies' in Dupixent patent row," Reuters (10-13-2020)
"A federal appeals court has refused to revive an Amgen Inc patent on human antibodies that the company had accused rivals Sanofi and Regeneron of infringing with their eczema drug Dupixent.
The unanimous decision by a three-judge panel of the Federal Circuit U.S. Court of Appeals on Tuesday upheld a finding by the U.S. Patent Trial and Appeal Board that the disputed claims of the patent were obvious in light of prior art."
- "Amgen Patent Properly Nixed Based on What Antibodies are 'Human'," Bloomberg Law (10-13-2020)
"Amgen Inc. subsidiary Immunex Corp. failed to convince the Federal Circuit to revive its patent on a treatment for inflammatory disorders.
Sanofi-Aventis U.S. LLC, Genzyme Corp., and Regeneron Pharmaceuticals Inc. had successfully challenged the patent at the Patent Trial and Appeal Board. The board properly invalidated the patent after finding that “human antibody” may include antibodies that aren’t fully human, the U.S. Court of Appeals for the Federal Circuit held in a precedential opinion."