GSK v. Teva’s Continued Ripple Effects | Axinn, Veltrop & Harkrider LLP
As we continue to assess the ripple effects from the Supreme Court’s denial of certiorari in GlaxoSmithKline v Teva Pharms USA (GSK v Teva), a recent decision by Judge Andrews in the U.S. District Court for the District of Delaware sheds further light on how courts may view induced infringement claims against skinny labels and litigation strategies that parties may engage in as a result. Specifically, on September 8, 2023, Judge Andrews adopted Magistrate Judge Sherry R. Fallon’s recommendation that the complaint be dismissed, which asserted induced infringement of method claims directed to a use carved out of the ANDA product’s label. Zogenix, Inc. v. Apotex Inc., C.A. Nos. 21-1252-RGA, slip op. (D. Del. Sept. 8, 2023). In the case, Apotex moved to dismiss, arguing that its ANDA directed to Fintepla® (fenfluramine) does not induce infringement of U.S. Patent No. 11,406,606 (“the ‘606 patent”) because Apotex’s ANDA contained a section viii statement to the ‘606 patent and a corresponding “skinny” label that removed references to administering fenfluramine with stiripentol.
Judge Andrews adopted the recommendation to dismiss the complaint because the proposed skinny label does not “encourage[] or instruct[] an infringing use.” Although Zogenix attempted to rely on the warnings section in Apotex’s label, Judge Andrews found that “warnings are not instructions.” In addition, Judge Andrews found that the label could not induce infringement when, at most, it had information relating to both infringing and non-infringing uses.
The Zogenix decision highlights the critical role that section viii statements and skinny labels can play in allowing generic companies to quickly dispose of patent litigation in order to promptly bring their products to market. Although we certainly need to keep an eye on future cases as the ramifications of GSK v. Teva continue to trickle down, pharmaceutical companies should continue to evaluate early motions to dispose of inducement claims when skinny labels are used.
“I agree with the Magistrate Judge that Plaintiffs’ reliance on the warning language in § 12.1 is unavailing. In brief, warnings are not instructions.
www.ded.uscourts.gov/…
