Sandoz, Inc. v. Amgen, Inc., ____F.___ (Fed. Cir. Dec. 5, 2014) (Dyk, TARANTO, Chen) (N.D. Cal.: Chesney) (3 of 5 stars)
Federal Circuit affirms dismissal of declaratory judgment complaint based on lack of case or controversy.
Amgen markets the drug Enbrel®, which has the active ingredient protein etanercept, as a therapy for rheumatoid arthritis. Sandoz began efforts to seek FDA approval of its own etanercept drug as a biosimilar to Enbrel® under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). When Sandoz’s Phase III trial began (which is expected to run through 2015) and before it filed an application for FDA approval of its new drug, Sandoz filed suit a DJ action against Amgen and Hoffmann-La Roche, who owned the patents at issue, alleging that Amgen wrongly asserts that the patents covered etanercept.
Federal Circuit determined that Sandoz’s complaint did not present a case or controversy and failed MedImmune’s “immediacy and reality” requirement because the only possible activity that could create exposure to potential liability was “future activity requiring FDA approval that had not yet been sought.” Slip Op. at 10. Amgen had not asserted infringement by Sandoz’s activities and any number of drug modifications might “eliminate a genuine patent dispute,” even under the FDA’s new biosimilarity standard. Id. at 12.
Federal Circuit declined to review the district court’s alternative holding that Sandoz’s DJ suit was barred by the BPCIA, leaving open the question of whether an application filed under the BPCIA forecloses a DJ action regarding infringement under § 271(a).