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…

Takeaways from Carlson Caspers’ Presentation at the 2018 Midwest IP Institute

Biosimilar, Section 101, Subject matter eligibility

Last week, Carlson Caspers’ attorneys Caroline Marsili presented a CLE at the 2018 Midwest IP Institute addressing (1) subject matter eligibility under 35 U.S.C. § 101, (2) biosimilar applicants’ use of IPR proceedings and their standing to appeal PTAB decisions, and (3) the CRISPR patent battles.  Slides from this presentation summarizing the state of the…