No DJ Jurisdiction Before Filing Of FDA Application For Biosimilar Product

In Sandoz Inc. v. Amgen Inc., No. 14-1693 (Fed. Cir. Dec. 5, 2014), the Federal Circuit affirmed the district court's finding of no DJ jurisdiction where Sandoz Inc. ("Sandoz") had not yet filed an application with the FDA seeking approval to market its biosimilar product. The Court declined to address the district court's interpretation of the Biologics Price Competition and Innovation Act of 2009 ("BPCIA") and its conclusion that the BPCIA precluded the suit.

Hoffman-La Roche Inc. ("Hoffman-La Roche") owns U.S. Patent Nos. 8,063,182 ("the '182 patent"), which claims specified proteins and related pharmaceutical compositions, and 8,163,522 ("the '522 patent"), which claims specified polynucleotides, vectors and cells containing specified polynucleotides, and methods of using host cells containing specified polynucleotides. Amgen Inc. ("Amgen") is the exclusive licensee of the '182 and '522 patents, and markets the biological drug product Enbrel® as a therapy for rheumatoid arthritis. Sandoz, seeking to market its biosimilar product, sued Amgen and Hoffman-La Roche for a DJ that the '182 and '522 patents were invalid and unenforceable, and would not be infringed by Sandoz's product. On the same day it filed suit, Sandoz began a Phase III trial for its product that was to be...