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# Teva Asks Supreme Court to Hear Coreg ‘Skinny Label’ Appeal
- URL: https://www.fdaweb.com/teva-asks-supreme-court-to-hear-coreg-skinny-label-appeal/
- Published: 2022-07-14T12:00:00.000Z
- Updated: 2026-09-14T17:51:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152278

Teva is asking the Supreme Court to hear its appeal of a U.S. Court of Appeals for the Federal Circuit decision in a case involving a so-called “skinny label” for a generic form of the heart drug Coreg (carvedilol). The Teva [filing](https://www.supremecourt.gov/DocketPDF/22/22-37/229830/20220711182924194%5Fcert%20petition.pdf?ref=fdaweb.com) says the question it wants the court to answer is: If a generic drug’s FDA-approved label carves out all of the language that the brand manufacturer has identified as covering its patented uses, can the generic manufacturer be held liable on a theory that its label still intentionally encourages infringement of those carved-out uses.

“A divided panel of the Federal Circuit has blown a hole in the carefully calibrated regime governing the modern prescription drug marketplace,” Teva writes. “The result is to allow a narrow patent on one way of using a drug to completely block any generic competition, potentially for years, precisely the opposite of what Congress prescribed” in the Hatch-Waxman amendments.

Teva says it launched a generic version of an off-patent medication that had one patented use and two unpatented uses. It used a skinny label that carved out all the language that GlaxoSmithKline had identified as covering its single patented use.

“Seven years later, right before the last remaining patent on that use expired, GSK sued Teva, and a jury awarded GSK $235 million,” Teva says. “The district court appropriately set aside that verdict.”

Teva says the appeals court majority [held](https://www.fdaweb.com/labeling-carve-out-court-decision-explained/) that even though Teva’s skinny label carved out GSK’s sole patented use, Teva could nonetheless be held liable for inducement based on stray sections of the label providing information about unpatented uses.

“The consequences of the majority’s decision are enormous,” Teva concludes. “Generic versions of no-longer-patented drugs with patented uses launch with a skinny label almost half the time, saving patients and the federal government billions. Now all those launches are at risk.”