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
Share

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 […]

Section VIII Carve-Outs Remain Viable in the Wake of GSK v. Teva

Posted at 20:45h January 14, 2022 in Inducement, Section viii Carve-Out by Nathan D. Louwagie
Share

Last week, Judge Andrews from the District of Delaware granted Defendant Hikma’s motion to dismiss Plaintiff Amarin’s induced infringement claims related to the drug Vascepa®. Amarin Pharma, Inc. v. Hikma Pharm. USA Inc. Amarin sells Vascepa® for two indications: severe hypertriglyceridemia (the “SH indication”) and cardiovascular risk reduction (the “CV indication”). Hikma received FDA approval […]

FEDERAL CIRCUIT SIGNALS CHANGE IN COURSE IN “SKINNY LABEL” SAGA

Posted at 21:56h February 10, 2021 in Damages, Inducement, Section viii Carve-Out by Carlson Caspers
Share

As predicted in our October 29th post, Teva sought rehearing en banc of the Federal Circuit’s re-instatement of a $235 million jury verdict against it for induced infringement despite its “skinny label” carve out of the patented use.  In the original ruling the Federal Circuit held that Teva was liable for damages during a period […]

“Skinny Labels” Leave the Door Open for Significant Damage Awards

Posted at 19:52h October 29, 2020 in Damages, Inducement, Section viii Carve-Out by Hannah Mosby
Share

On October 9th, we wrote about a potentially significant Federal Circuit decision concerning “skinny” labels in GSK v. Teva.  Today we write to discuss another important facet of this decision: guidance concerning the availability of lost profits in the generic drug context.  This case involved GlaxoSmithKline’s (“GSK’s”) patent covering the use of carvedilol (sold as […]

CAFC Limits Ability of Generics to Rely on Section viii Indication Carve-Outs

Posted at 16:05h October 9, 2020 in Inducement, Section viii Carve-Out by Caroline L. Marsili
Share

Last Friday (GSK v. Teva), a split panel of the Federal Circuit (“CAFC”) may have drastically limited the effectiveness of Section viii carve-outs when it reinstated a $235 million jury verdict against Teva, concluding that substantial evidence supported the jury’s finding of induced infringement.  Patent owner GlaxoSmithKline (“GSK”) sued Teva in the District of Delaware […]