Supreme Court Pressed to Consider ‘Skinny Labeling’ Case

The U.S. Solicitor General is asking the Supreme Court to consider a case — Teva Pharmaceuticals v. GlaxoSmithKline (GSK) — that highlights the pharmaceutical industry’s ongoing dispute over “skinny labeling.”

In a 29-page amicus brief, Solicitor General Elizabeth Barchas Prelogar, who is the fourth-ranking person at the Department of Justice and responsible for conducting and supervising all Supreme Court litigation on behalf of the U.S., pointed to a 2020 appeals court finding in favor of GSK over Teva’s use of skinny labeling.

The practice of skinny labeling lets generics makers produce a drug for narrow indications not covered by the reference product’s patent. While it’s currently allowed under the 1984 Hatch-Waxman Act, skinny labeling is facing several legal challenges from drugmakers seeking to preserve exclusivity on their brand-name biologics — some of which are among the world’s costliest drugs.

The appeals court panel ruled that Teva “induced infringement” of GSK’s patent by pressing doctors to prescribe its generic version of a cardiac medicine rather than GSK’s brand-name congestive heart failure drug Coreg (carvedilol). The Solicitor General argues that if the ruling against Teva stands, the potential to make lower-cost generic medicines available could be “seriously jeopardized.”

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