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16 May 2023Sarah Speight

Teva loses plea against GSK’s $235m ‘skinny label’ win

The US Supreme Court knocks back Teva’s challenge to GSK’s damages win | Decision issued despite US solicitor general warning that the earlier decision ‘threatens significant harm’ to the market.

Teva Pharmaceuticals has failed to convince the  US Supreme Court (SCOTUS) to hear its appeal against a win secured by rival  GlaxoSmithKline (GSK), in the latest round of the pair’s long-running ‘skinny labelling’ dispute.

The decision comes after  Teva challenged a lower court’s ruling to reinstate a $235 million jury award for GSK, which had originally sued Teva for infringement of its heart drug  Coreg (Carvedilol) with a ‘skinny label’ generic.

In its appeal, Teva presented the question: “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?”

It argued: “The profound implications of this case on the patent system, the pharmaceutical market, patients, and the federal government warrant this court’s intervention now.”

But SCOTUS denied Teva’s petition for a writ of certiorari, in a decision handed down yesterday, May 15.

Skinny labels

‘Skinny labelling’ is a commonplace but contentious practice allowed by the  Hatch-Waxman Act of 1984, in which generic drug makers may omit patent-protected indications in their labels, in a process called ‘carving-out’.

This enables them to enter the market before the brand-name drug’s patent for other indications expire. But many brand-name manufacturers oppose the practice because it reduces the prices of drugs overall.

GSK first took issue with Teva in 2014 over the latter’s generic version of its heart drug  Coreg (Carvedilol).

A Delaware jury  awarded GSK $235 million in 2017, which a judge subsequently overturned, only to have it  reinstated in 2021 by the US Court of Appeals for the Federal Circuit.

After Teva  petitioned for a rehearing en banc, the appeals court denied this in a split decision, with three out of nine Federal Circuit judges dissenting.

‘A suitable vehicle’

Teva appealed to SCOTUS for a writ of certiorari in July 2022, but the following month GSK urged SCOTUS to reject Teva’s petition.

SCOTUS then invited the US government to express its views on the case, and in response, solicitor general Elizabeth Prelogar backed Teva and urged the court to rehear the case.

In her brief filed in March 2023, she argued that the case provides a “suitable vehicle” to address the issue of skinny labelling and that, if allowed to stand, the Federal Circuit’s earlier decision “threatens significant harm to competition and to consumers”.

She cited dissenting Judge Kimberly Prost’s view, that the panel decision had “left unclear what future generic manufacturers ‘should do differently’ to avoid liability in similar circumstances”.

Prelogar added: “No reasonable jury could have concluded that the carved-out labelling for [GSK’s] generic carvedilol from 2007-2011 was itself evidence of intent to induce infringement.”

LSIPR has approached counsel for Teva and GSK, without immediate response.

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23 May 2023   Despite one judge’s insistence that the case was “narrow and fact dependent”, GSK v Teva could have wide-reaching implications for generic drugs, biosimilars, and how skinny labels are read, say Chad Landmon, Ross Blau, Gulrukh Haroon of Axinn, Veltrop & Harkrider.
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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

Big Pharma
23 May 2023   Despite one judge’s insistence that the case was “narrow and fact dependent”, GSK v Teva could have wide-reaching implications for generic drugs, biosimilars, and how skinny labels are read, say Chad Landmon, Ross Blau, Gulrukh Haroon of Axinn, Veltrop & Harkrider.
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

Big Pharma
23 May 2023   Despite one judge’s insistence that the case was “narrow and fact dependent”, GSK v Teva could have wide-reaching implications for generic drugs, biosimilars, and how skinny labels are read, say Chad Landmon, Ross Blau, Gulrukh Haroon of Axinn, Veltrop & Harkrider.
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.