Digest of Sandoz Inc. v Amgen Inc., No. 2014-1693 (Fed. Cir. Dec. 5, 2014) (precedential). On appeal from N.D. Cal. Before Dyk, Taranto and Chen.

Procedural Posture: CAFC affirmed district court’s dismissal for lack of Article III controversy of Sandoz’s declaratory judgment lawsuit that Amgen’s two patents directed to biologic arthritis drug Enbrel are invalid and unenforceable, and will not be infringed if Sandoz uses, offers to sell or sells, or imports a “biosimilar” drug.

  • Subject Matter Jurisdiction under Declaratory Judgment Act: CAFC stated that the inquiry should focus “on related questions of timing and contingency regarding the existence and content of any needed patent adjudication, as well as current concrete harms to the declaratory-judgment plaintiff from delaying an adjudication.” CAFC determined that Sandoz failed to allege an injury having “sufficient immediacy and reality to create subject matter jurisdiction.” Sandoz was in a Phase III clinical trial when it filed the suit, had not yet sought FDA approval for the drug, and Amgen had not suggested Sandoz’s activities were infringing. “Any 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.” The “events exposing Sandoz to infringement liability ‘may not occur as anticipated, or indeed may not occur at all,’” precluding the existence of an actual controversy. Sandoz also “has not shown that it will suffer an immediate and substantial adverse impact from not being able to seek or secure a patent adjudication before filing an application for FDA approval.”