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…

Generic’s Counterclaims for Non-Infringement are Proper Despite Covenant Not to Sue From Brand

CNS, Counterclaims, Covenant, Exclusivity, Forfeiture, Jurisdiction, Non-infringement, Trigger

On April 9, 2014, in Purdue Pharmaceutical Products, L.P. v. TWi Pharmaceuticals, Inc., Civ. No. 12-5311 (D.N.J.), Judge Jose L. Linares of the United States District Court for the District of New Jersey ruled that a generic drug company who is not a first-filer has standing to assert a counterclaim for non-infringement despite the issuance…