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3 December 2020AmericasSarah Morgan

Teva urges Fed Circuit to save skinny label law from ‘nullification’

Teva has urged the US Court of Appeals for the Federal Circuit to rehear its dispute with  GlaxoSmithKline (GSK) en banc, claiming that if the decision is upheld, “every skinny-labelled generic is at risk”.

In a petition filed on Wednesday, December 2, Teva argued that the full Federal Circuit must “restore consistency to this Court’s precedents, and save the carve-out statute from nullification”.

According to Teva, the court’s decision means that the section of the Hatch-Waxman act which allows generic drugmakers to sell patent-protected goods for unpatented indications is a “dead letter”.

In October, the Federal Circuit  revived a 2017 jury verdict ordering Teva to pay $235 million over its sale of a generic version of GSK’s heart drug Coreg (carvedilol). Teva had described its skinny-labelled product as the generic equivalent of GSK’s product.

“If that can be inducement, as the majority held, every skinny-labelled generic is at risk, and the carve-out statute is a dead letter,” warned Teva.

The October decision was a split ruling, with Chief Judge Sharon Prost dissenting.

“The majority’s holding undermines this purpose by creating infringement liability for any generic entering the market with a skinny label, and by permitting infringement liability for a broader label that itself did not actually cause any direct infringement. Congress did not intend either of these consequences,” she said in her dissent.

Teva went on to claim that under decades of precedent, merely marketing the skinny-labelled product does not induce infringement.

In its petition, Teva argued that under the court’s redefinition of inducement, “every generic on the market with a skinny label is at risk, and no generic will risk using a skinny label in the future”.

Copycat litigation

The drugmaker warned that copycat litigation has already begun, with “a generic that launched last month with a carve-out already faces a new inducement suit, seeking lost profits and an injunction”.

Teva added that the US Supreme Court had explained, in Caraco Pharmaceutical Laboratories v Novo Nordisk, that one of Congress’s essential purposes in designing a generic approval procedure was to “speed the introduction of low-cost generic drugs to the market”.

It concluded: “The majority’s holding undermines this purpose by creating infringement liability for any generic entering the market with a skinny label, and by permitting infringement liability for a broader label that itself did not actually cause any direct infringement. Congress did not intend either of these consequences.”

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More on this story

Americas
5 January 2021   One of the architects of the Hatch-Waxman Act has urged judges to reverse a decision which he says nullifies a key provision of the generic drug legislation.
Americas
10 August 2021   The US Court of Appeals for the Federal Circuit has reinstated a $235 million verdict against Teva in a split decision which could have major implications for skinny label generics.
Generics
12 October 2021   Teva Pharmaceuticals has once again petitioned the US Court of Appeals for the Federal Circuit to reconsider its decision in a dispute over generic drug labelling which held that the drugmaker infringed GlaxoSmithKline’s Coreg heart drug.

More on this story

Americas
5 January 2021   One of the architects of the Hatch-Waxman Act has urged judges to reverse a decision which he says nullifies a key provision of the generic drug legislation.
Americas
10 August 2021   The US Court of Appeals for the Federal Circuit has reinstated a $235 million verdict against Teva in a split decision which could have major implications for skinny label generics.
Generics
12 October 2021   Teva Pharmaceuticals has once again petitioned the US Court of Appeals for the Federal Circuit to reconsider its decision in a dispute over generic drug labelling which held that the drugmaker infringed GlaxoSmithKline’s Coreg heart drug.

More on this story

Americas
5 January 2021   One of the architects of the Hatch-Waxman Act has urged judges to reverse a decision which he says nullifies a key provision of the generic drug legislation.
Americas
10 August 2021   The US Court of Appeals for the Federal Circuit has reinstated a $235 million verdict against Teva in a split decision which could have major implications for skinny label generics.
Generics
12 October 2021   Teva Pharmaceuticals has once again petitioned the US Court of Appeals for the Federal Circuit to reconsider its decision in a dispute over generic drug labelling which held that the drugmaker infringed GlaxoSmithKline’s Coreg heart drug.