Section VIII Statement Does Not Create “a Case or Actual Controversy” to Establish Subject Matter Jurisdiction for Declaratory Judgment Counterclaim

Counterclaims, Declaratory Judgment, Section viii Carve-Out, Subject matter eligibility

Judge Richard Andrews of the District of Delaware dismissed counterclaims lodged by two generic drug manufacturers, finding that no justiciable declaratory judgment controversy arises for an ANDA filer who only submits statements pursuant to 21 U.S.C. § 355(j)(2)(A)(viii) (“Section viii statements”). In re: Entresto (Sacubitril/Valsartan) Patent Litigation, No. 20-md-02930 (D. Del. Sept. 27, 2022). This…

Statutory Disclaimer Removes the District Court’s Authority to Invalidate Patent Claims

Declaratory Judgment

In a recent decision, the Federal Circuit held that the district court lacked authority to “disinter” and declare claims invalid where the patent owner had statutorily disclaimed the claims. Sanofi-Aventis U.S., LLC v. Dr. Reddy’s Labs., Inc., 933 F.3d 1367 (Fed. Cir. 2019). The case concerns the drug cabazitaxel, marketed as Jevtanta®, which is used…

Delaware Recognizes Declaratory Judgment Action Concerning Biosimilar Applicant’s Failure to Give Notice of Commercial Marketing

Declaratory Judgment

The District of Delaware recently held that branded biologic companies may pursue a private cause of action to address a biosimilar applicant’s anticipated violation of the commercial marketing notice requirement under 42 U.S.C. § 262(1)(8)(A). In Amgen Inc. et al. v. Hospira, Inc., Civ. Action No. 15-839 (D. Del.), the Plaintiffs filed a patent infringement…