Federal Circuit Affirms Noninfringement in BPCIA Case

Intellectual Property & Technology Law Journal
October 2019

New York Partner and Chair of Locke Lord’s Intellectual Property Department Alan Clement co-authored an article detailing the U.S. Court of Appeals for the Federal Circuit’s precedential opinion in Amgen Inc. et al. v. Sandoz Inc. et al. ― the U.S. Court that affirmed a district court’s finding of noninfringement in an action brought under the Biologics Price Competition and Innovation Act (BPCIA). The Amgen court affirmed the district court’s summary judgment that Sandoz’s biosimilar products — filgrastim and pegfilgrastim — do not infringe claim 7 of U.S. Patent No. 8,940,878 (the ’878 patent), and also held that the district court correctly denied a motion for continuance and correctly construed the claims of U.S. Patent No. 6,162,427 (the ’427 patent).

The authors examine the background of Amgen and provide insight on the Federal Circuit’s decision, ultimately noting that “The number of cases arising under the BPCIA still remains lower than expected, but is expected to increase in the near future. Precedential Federal Circuit opinions have been few and far between — when issued, they should be studied closely. The Amgen decision presents interesting holdings regarding claim construction and doctrine of equivalents in the context of biosimilars.”

To read the full article, click here.