Supreme Court Denies Teva’s Challenge to $235M GSK Award in Patent Dispute
BIOMARKER
1. Teva Pharmaceuticals' appeal for a hearing at the U.S. Supreme Court has been denied in a patent dispute case with GlaxoSmithKline (GSK).
2. The denial means Teva will have to pay GSK a $235 million settlement following a ruling by the U.S. Federal Circuit Court of Appeals.
3. The dispute centers around Teva's alleged infringement of GSK's patent for the beta-blocker drug Coreg (carvedilol) with its generic version.
4. The lawsuit involves the practice of "skinny labeling," where generic medications secure regulatory approval for indications not covered by the brand-name drug's label.
5. GSK sees the Supreme Court decision as validation, stating its belief in the importance of intellectual property for fostering innovation in medicine and vaccines.
6. The legal battle started in 2014 when GSK filed a lawsuit against Teva for violating Coreg's patent protections.
7. The initial ruling in 2017 awarded GSK a $235 million payout, which was later overturned in 2018.
8. In the appellate court ruling, evidence was found to support Teva's "induced infringement" of Coreg's patent, based on its promotional materials.
9. The Supreme Court's denial raises concerns about the future of the skinny label practice and its impact on generic drug development and lower drug costs.
10. The Biden administration and the Department of Justice have expressed concerns that the ruling could jeopardize the skinny label pathway.