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 completed before Sandoz filed any application for FDA approval. The district court dismissed the case, determining that there was no Article III controversy and that the suit was barred by the BPCIA. Sandoz appealed.

"[W]e have found no justiciability where a declaratory-judgment plaintiff had not filed an application for the FDA approval required to engage in the arguably infringing activity." Slip op. at 13.

On appeal, the Federal Circuit affirmed the district court's finding of no subject matter jurisdiction, explaining that DJ jurisdiction is a fact-specific inquiry and that there is no bright-line rule. Rather, the Court asks "whether the facts alleged, under all the circumstances, show that there is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment." Slip op. at 6 (quoting MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118, 127 (2007)). Applying this "all the circumstances" standard, the Court concluded that Sandoz's complaint did not present a case or controversy. The Court noted it was not addressing other questions that may arise, including whether Sandoz...