Teva takes $235 mln 'skinny label' dispute with GSK to U.S. Supreme Court

The logo of Teva Pharmaceutical Industries is seen during a news conference in Tel Aviv
The logo of Teva Pharmaceutical Industries is seen in Tel Aviv, Israel February 19, 2019. REUTERS/Amir Cohen
  • Court found Teva's generic label induced doctors to infringe GSK patent
  • Teva says decision creates uncertainty, threatens U.S. healthcare

(Reuters) - Teva Pharmaceuticals USA Inc has asked the U.S. Supreme Court to overturn its $235 million loss in a closely watched patent dispute with GlaxoSmithKline LLC, arguing in a petition made public Wednesday that the case threatens an important protection for generic drugmakers.

The case could be important for the future of so-called "skinny labels," which allow generic drugmakers to avoid patent claims if the generic's government-mandated drug label omits potentially infringing uses of the brand-name drug.

A U.S. appeals court ruled last year that Teva's label for its generic version of GSK's heart drug Coreg still induced doctors to infringe a GSK patent. Teva told the Supreme Court that the decision undermines a federal law meant to encourage low-cost generics and creates "competition-killing uncertainty" that will hurt the U.S. healthcare system.

GSK declined to comment, citing ongoing litigation. Teva did not immediately respond to a request for comment.

The U.S. Food and Drug Administration initially approved Coreg to treat hypertension, ventricular dysfunction after a heart attack and congestive heart failure. GSK's patent on the drug expired in 2007, but it maintained a patent on a method of using it to treat heart failure until 2015.

A Delaware jury found in 2017 that Teva's label encouraged doctors to use its generic version of Coreg to treat heart failure in a way that infringed the patent.

A judge later overturned the verdict, but the Federal Circuit reinstated it in 2020 and affirmed that decision after a rehearing last year, despite Teva's argument that it had carved out the infringing use based on the FDA's instructions.

Three Federal Circuit judges dissented in February from the appeals court's decision not to hold a full-court rehearing and said that "no skinny-label generic is safe" after the decision. Fellow generic drug makers Apotex Inc, Mylan NV, and Novartis' SandozInc filed briefs in support of rehearing the case.

Teva's Wednesday petition said that the uncertainty created by the ruling would wreak "havoc" on the federal scheme for generic drugs and discourage the use of skinny labels.

"The ramifications of such an outcome are enormous," Teva said. "Skinny-label launches are extraordinarily common, and they save patients and the federal government billions."

The case is Teva Pharmaceuticals USA Inc v. GlaxoSmithKline LLC, U.S. Supreme Court, No. 22-37.

For Teva: William Jay of Goodwin Procter

For GSK: not available

(NOTE: This story has been updated to clarify Sandoz's earlier court brief urging a rehearing in the case.)

Read more:

Teva loss in $235 mln GSK case tees up 'skinny label' fight at Supreme Court

GSK's $235 million verdict revived against Teva, again

U.S. appeals court revives Glaxo $235.5 million verdict against Teva

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Blake Brittain reports on intellectual property law, including patents, trademarks, copyrights and trade secrets, for Reuters Legal. He has previously written for Bloomberg Law and Thomson Reuters Practical Law and practiced as an attorney. Contact: 12029385713