Analysis

Generics Catch A Break With Hikma's Skinny Label Win

By Dani Kass (January 6, 2022, 10:26 PM EST) -- Generic-drug makers have spent more than a year voicing concerns that the Federal Circuit's holding in GlaxoSmithKline v. Teva threatened their ability to sell generic drugs that leave patent-protected indications off the label, but a Delaware federal judge this week quelled some of those fears by quickly throwing out a challenge to such "skinny labels."

The Federal Circuit majority — which has twice ruled that Teva induced physicians to infringe a patent-protected use of GSK's drug Coreg — claimed in an August ruling that it was doing a case-specific analysis and had no interest in trying to alter skinny label law....

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