Fed. Circ. Teva Ruling May Shake Up Skinny Label Strategies

By Daniel Knauss, Cameron Vanderwall and Michelle Rhyu (September 1, 2021, 4:15 PM EDT) -- Generic and biosimilar companies often employ a congressionally approved skinny label strategy to carve out patented method-of-use indications to launch generic drugs that have noninfringing uses.

But in October 2020, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA Inc., the U.S. Court of Appeals for the Federal Circuit reversed a judgment as a matter of law decision by U.S. District Judge Leonard Stark of the U.S. District Court for the District of Delaware, reinstating a jury's verdict that Teva infringed GSK's patented method of using its Coreg drug product, even though Teva's product was initially launched with a skinny label that carved...

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