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Federal Circuit Ruling Is Troubling For Generic Drug Manufacturers


  • October 22, 2020

Paul Dietze, Elizabeth Crompton, and Scott Cunning wrote in Law360 about a recent Federal Circuit ruling that "has potentially troublesome implications for manufacturers of generic drugs."

"In GlaxoSmithKline LLC v. Teva Pharmaceuticals USA Inc., the Federal Circuit reinstated a jury verdict finding Teva liable for inducing infringement of GlaxoSmithKline's Reissue Patent No. 40,000, or RE '000," they wrote. "The decision addresses inducement in the context of skinny labeling, the statutory practice by which a generic carves out certain indications from its label to seek approval for fewer than all approved uses of the branded drug product." 

"These carveouts permit the generic drug company to market its products for only the remaining indications and thereby avoid infringing method of use patents," they continued. "But in the words of the dissent, the majority's opinion 'nullifies Congress's provision for skinny labels.' Although the ruling should have only limited applicability due to the unique procedural posture of this case, it creates uncertainty for drug makers who had been following both the letter and the spirit of the law."

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