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14 July 2022Americas

Teva takes long-running ‘skinny label’ suit to SCOTUS

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

Teva Pharmaceuticals USA has urged the US Supreme Court to overturn a US Court of Appeals for the Federal Circuit decision which has allegedly "blown a hole in the carefully calibrated regime governing the modern prescription-drug marketplace”.

Teva’s petition, filed Monday, July 11 and docketed yesterday, July 13, centres on ‘skinny labelling’, a commonplace practice under the Hatch-Waxman Act where generic drug makers exclude patent-protected indications from generic labels, in a process called “carving-out”.

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

In the second round, in August 2021, the Federal Circuit reinstated the $235 million verdict against Teva after 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.

At the time, in a dissenting opinion, Circuit Judge Sharon Prost warned that her colleagues’ “missteps throw a wrench into Congress’s design for enabling quick public access to generic versions of unpatented drugs with unpatented uses”.

Teva appealed for rehearing but, in February this year, a split Federal Circuit declined to rehear the generic drug labelling dispute.

Now, Teva has taken its appeal to the US’ highest court, alleging that the result of the Federal Circuit’s decision is to “allow a narrow patent on one way of using a drug to completely block any generic competition, potentially for years—precisely the opposite of what Congress prescribed”.

“The panel majority held that even though Teva’s skinny label carved out GSK’s sole patented use, Teva could nonetheless be held liable for inducement based on stray sections of the label providing information about unpatented uses,” said the petition.

Teva argued that the decision has created “competition-killing uncertainty” that will hurt the US healthcare system.

It added: "The majority’s decision eviscerates the element of inducement liability that has for 70 years distinguished between inducement and non-inducement—the requirement that a defendant actively encourage an infringing use … rather than merely ‘mention' or ‘describe’ claim elements.”

Teva urged the court to grant review, citing the importance of this issue to patients, payors (including the federal government), and prescription-drug competition.

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More on this story

Americas
8 September 2022   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.
Big Pharma
4 October 2022   Court opens door for US solicitor general to file a brief | Hard fought ‘skinny label’ case centres on a generic medicine maker excluding patent-protected indications from its labels.
article
16 May 2023   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.

More on this story

Americas
8 September 2022   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.
Big Pharma
4 October 2022   Court opens door for US solicitor general to file a brief | Hard fought ‘skinny label’ case centres on a generic medicine maker excluding patent-protected indications from its labels.
article
16 May 2023   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.