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8 September 2022AmericasMuireann Bolger

Generic maker urges review of $235m skinny label decision

A split Federal Circuit revived a 2017 jury verdict that Teva had infringed GSK drug | Israeli pharma firm warns of threat to availability of low-cost generic medicines.

Teva Pharmaceuticals has urged the US Supreme Court to revisit a judgment in its long-running ‘skinny label’ dispute with Glaxosmithkline (GSK) to prevent what it describes as an erosion of the “foundational principles of patent law.”

The Israeli pharma company filed the petition for a writ of certiorari yesterday, September  7.

In October 2020, a split Federal Circuit revived a 2017 jury verdict ordering Teva to pay $235 million over the sale of its generic version of GSK’s drug, Coreg (carvedilol).

The generic drug maker has warned that the decision, if upheld, will upset “a careful legislative compromise that ensures ready access to low-cost generic medicines”.

Teva claimed it was protected under the Hatch-Waxman Act because its generic product’s ‘skinny label’ excluded patent-protected uses of Coreg, even though it may have been prescribed and used for infringing purposes.

The act allows generic drugmakers to sell patent-protected goods for unpatented indications, and the drugmaker has warned that the ruling will trigger lawsuits against generic drug manufacturers that exclude patent-protected indications from generic labels, a process referred to as ‘carving-out’.

A misapplication of precedent

The practice is commonplace for generic drug manufacturers and remained unchallenged for years before Teva v GSK made its way through the US court system.

In its 2020 ruling, the Federal Circuit held that drug makers were free to sell generic treatments, as long as they don’t promote uses for the drug that were pioneered by the original manufacturer.

Teva insisted this week it had been within its rights to adopt an FDA-drafted ‘skinny label’, and that the Federal Circuit has erred.

“That is more than just a misapplication of settled precedent: it is an about-face, because it adopts what was previously a dissenting view and allows a jury to find active inducement in virtually any carveout case,” argued Teva.

“The Federal Circuit’s new rule makes any regulatory change irrelevant, because its decision gave no weight to the Hatch-Waxman statute or regulations,” the petition added.

“The Federal Circuit has replaced a regime of predictability and certainty with one of doubt and risk. The result will be less competition and higher prices. This court should intervene without delay,” said the pharma company.

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More on this story

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.
Americas
14 July 2022   Generics giant’s petition cites the cost of medicine and first-principles of innovation.

More on this story

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.
Americas
14 July 2022   Generics giant’s petition cites the cost of medicine and first-principles of innovation.

More on this story

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.
Americas
14 July 2022   Generics giant’s petition cites the cost of medicine and first-principles of innovation.