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…

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

Inducement, Section viii Carve-Out

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…

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

Damages, Inducement, Section viii Carve-Out

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

Inducement, Section viii Carve-Out

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…