January 2015
No DJ Jurisdiction Before Filing of FDA Application for Biosimilar Product
| Judges: Dyk, Taranto (author), Chen |
| [Appealed from N.D. Cal., Judge Chesney] |
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 could seek a DJ if and when it filed an FDA application under the BPCIA.
The Court stated that without adopting a categorical rule, the present case did not meet the requirements of immediacy and reality. The Court highlighted the fact that Sandoz had not yet filed for FDA approval of its biosimilar product and was still engaged in ongoing clinical trials. The Court reasoned that “[a]ny dispute about patent infringement is at present subject to significant uncertainties—concerning whether it will actually arise and if so what specific issues will require decision.” Id. at 11. The Court specifically noted that if Sandoz’s Phase III trial uncovered problems, it could further delay any future FDA application, eliminating the FDA application altogether, or causing Sandoz to alter its product before filing its FDA application. These uncertainties, the Court noted, could alter the content of any patent dispute, and Sandoz had not demonstrated that the possibilities for changing or eliminating the patent dispute were so unlikely to arise that they should play no significant role in the Article III determination. The Court stated, “In the pre-application context presented here, we conclude that the events exposing Sandoz to infringement liability ‘may not occur as anticipated, or indeed may not occur at all,’ and that ‘further factual development would significantly advance’ a court’s ability to identify and define the issues for resolution.” Id. at 12 (quoting Texas v. United States, 523 U.S. 296, 300 (1988); Nat’l Park Hospitality Ass’n v. Dep’t of Interior, 538 U.S. 803, 812 (2003)).
The Court noted that its conclusion was consistent with its decisions under the Hatch-Waxman Act, which have focused on the presence of an application for FDA approval. “[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.” Id. at 13. The Court also noted that Congress had not specifically provided for pre-application suits.
Finally, the Court explained that Sandoz had not shown it would suffer an immediate and substantial adverse impact from not being able to secure a patent adjudication before filing an application for FDA approval, noting that Sandoz could not presently enter the market, separate and apart from the ’182 and ’522 patents. The Court was not persuaded by Sandoz’s arguments that it was investing in a production facility in Europe and that the potential American market influenced its decision to expand, noting that Sandoz did not argue that it would suspend its plan until a patent adjudication occurred or upon receiving an adverse judgment. Thus, “[t]o the extent that particular hardships can affect the overall evaluation,” the Court found “none in the circumstances of this case that override the contingency problems that lead us to conclude that Sandoz does not meet the Article III requirements of immediacy and reality.” Id. at 14-15.
