Subject matter eligibility Archives -

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

Posted at 17:24h October 6, 2022 in Counterclaims, Declaratory Judgment, Section viii Carve-Out, Subject matter eligibility by Carlson Caspers

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 […]

Federal Circuit Doubles-Down on Vanda, Highlighting Limitations of § 101 Defense

Posted at 22:00h April 8, 2019 in Subject matter eligibility by Nathan D. Louwagie

Last week, the Federal Circuit reversed a decision from the District of Delaware that held that a method of treatment patent invalid under 35 U.S.C. § 101. Endo Pharms. Inc. et al. v. Teva Pharms. USA et al. The claim at issue recited: A method of treating pain in a renally impaired patient, comprising the steps […]

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

Posted at 19:56h October 4, 2018 in Biosimilar, Section 101, Subject matter eligibility by Caroline L. Marsili

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 […]