Fed. Circ. Ruling Is Troubling For Generic Drug Manufacturers

By Paul Dietze, Elizabeth Crompton and Scott Cunning (October 21, 2020, 5:18 PM EDT) -- A recent U.S. Court of Appeals for the Federal Circuit ruling 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.[1]

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...

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