shutterstock_2162525475_jonathan-weiss
shutterstock_2162525475_jonathan-weiss
4 October 2022Big PharmaStaff writer

SCOTUS invites govt comment on Teva clash

The US Supreme Court has asked the US government to weigh in on whether the court should hear the ‘skinny-label’ dispute between Teva and GSK.

Back in July, Teva had petitioned the Supreme Court to overturn a US Court of Appeals for the Federal Circuit decision which Teva claimed had "blown a hole in the carefully calibrated regime governing the modern prescription-drug marketplace”.

The dispute centres on the common practice of ‘skinny labelling’ where generic drug makers exclude patent-protected indications from generic labels, in a process called “carving-out”.

GSK’s heart drug Coreg (Carvedilol)—which has been approved for treating hypertension, congestive heart failure (CHF), and left ventricular dysfunction (LVD)—is at the centre of the clash.

In 2007, GSK’s patents on the use of Coreg for treating hypertension and LVC had expired. But GSK’s patent on Coreg for the treatment of CHF remained valid, requiring Teva to issue a skinny label and carve out the use of its generic product.

The  US Food and Drug Administration (FDA), in 2010, ordered Teva to update its label so it could be “identical in content to the approved [GSK Coreg] labelling” and include the indication for treatment of heart failure, after GSK patents covering other uses of Coreg were delisted from the Orange Book.

Then, in 2014, GSK sued Teva over its generic version of heart drug Coreg (Carvedilol). Coreg has been approved for treating hypertension, congestive heart failure (CHF), and left ventricular dysfunction (LVD).

Now, the Federal Circuit has twice ruled that Teva’s label on a generic version of Coreg (Carvedilol) led doctors to prescribe the generic for an infringing use.

In August last year, the Federal Circuit reinstated the $235 million verdict against Teva. A 2-1 majority found that Teva had induced infringement by failing to carve-out a patent-protected use of the drug on its generic label.

In February this year, a split Federal Circuit declined to rehear the dispute. Teva subsequently appealed against the decision to the Supreme Court.

In response to Teva’s petition, GSK has  urged the Supreme Court to reject the petition, claiming that Supreme Court has considered the issue of induced infringement “at least four times over the last approximately 15 years”.

“This fact-bound case presents no new issues in those areas of law, and was properly decided by the appellate court under those authorities,” argued GSK’s defence lawyers. “Certiorari should be denied.”

Now, the US solicitor general has been invited to file a brief in this case expressing the views of the US.

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More on this story

Americas
14 July 2022   Generics giant’s petition cites the cost of medicine and first-principles of innovation.
Big Pharma
25 August 2022   Teva’s petition relies on a “blatantly misleading” question, argues GSK | Case presents “no new issues” that haven’t already been decided.

More on this story

Americas
14 July 2022   Generics giant’s petition cites the cost of medicine and first-principles of innovation.
Big Pharma
25 August 2022   Teva’s petition relies on a “blatantly misleading” question, argues GSK | Case presents “no new issues” that haven’t already been decided.

More on this story

Americas
14 July 2022   Generics giant’s petition cites the cost of medicine and first-principles of innovation.
Big Pharma
25 August 2022   Teva’s petition relies on a “blatantly misleading” question, argues GSK | Case presents “no new issues” that haven’t already been decided.