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
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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

Posted at 21:18h October 4, 2019 in Declaratory Judgment by Carlson Caspers
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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 […]

Federal Circuit Holds That a Customer Does Not Have Standing For a Declaratory Judgment

Posted at 15:15h June 28, 2018 in Declaratory Judgment, Standing by Shelleaha Jonas
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The Federal Circuit recently held that a healthcare provider did not have standing to bring a declaratory judgment action where its only interest was as a purchaser of potential generic versions of the patented drug. AIDS Healthcare Foundation v. Gilead Sciences, Inc., No. 2016-2475 (Fed. Cir. May 11, 2018).  The court held that absent direct […]

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

Posted at 15:08h August 12, 2016 in Declaratory Judgment by Carlson Caspers
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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 […]