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5 January 2021AmericasRory O'Neill

Skinny-label ruling will ‘decimate’ Hatch-Waxman, Fed Circuit told

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.

Former Congressman Harry Waxman was just one of several parties, including academics and generic manufacturers, to file amicus briefs at the US Court of Appeals of the Federal Circuit, calling for the reversal of the court’s decision in GSK v Teva.

The fear expressed by Waxman, and other amici such as Apotex and Mylan, is that drug companies could keep generics off the market by filing new patents covering novel uses of their drugs.

Last October, the Federal Circuit reinstated a $235 million judgment finding Teva liable for inducing doctors to infringe GlaxoSmithKline (GSK) patents covering heart drug Coreg (carvedilol).

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.

But a 2-1 majority of a Federal Circuit panel accepted evidence that Teva had induced doctors to infringe the patent by prescribing generic carvedilol for patent-infringing purposes.

The decision has been met with protest from academics and generic drug companies, who say it undermines the Hatch-Waxman Act and congressional intent. Teva has asked the Federal Circuit to review the decision en banc.

In his brief, Waxman said Congress had “plainly anticipated the exact situation involved in this case” and included provisions to protect market access for skinny label generics.

“The majority’s decision thus threatens to decimate the compromise at the heart of the Hatch-Waxman Act, which in turns threatens to undermine the generic pharmaceutical industry,” Waxman said.

He added: “Generic drugs saved the US nearly $2.2 trillion over the past ten years, but if the majority’s decision stands, name-brand companies like GlaxoSmithKline will be encouraged to file serial patents for novel methods of use and effectively bar generics from entering the market indefinitely.”

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Big Pharma
25 August 2022   Safe harbour provisions can be relied on but their boundaries are still being defined, explain Jeanna Wacker and Tasha Francis Gerasimow of Kirkland & Ellis.
Americas
3 December 2020   Teva has urged the US Court of Appeals for the Federal Circuit to rehear its dispute with GlaxoSmithKline en banc, claiming that if the decision is upheld, “every skinny-labelled generic is at risk”.
Big Pharma
6 October 2020   In a victory for GlaxoSmithKline, the US Court of Appeals for the Federal Circuit has revived a 2017 jury verdict ordering Teva to pay $235 million over the drug Coreg.

More on this story

Big Pharma
25 August 2022   Safe harbour provisions can be relied on but their boundaries are still being defined, explain Jeanna Wacker and Tasha Francis Gerasimow of Kirkland & Ellis.
Americas
3 December 2020   Teva has urged the US Court of Appeals for the Federal Circuit to rehear its dispute with GlaxoSmithKline en banc, claiming that if the decision is upheld, “every skinny-labelled generic is at risk”.
Big Pharma
6 October 2020   In a victory for GlaxoSmithKline, the US Court of Appeals for the Federal Circuit has revived a 2017 jury verdict ordering Teva to pay $235 million over the drug Coreg.

More on this story

Big Pharma
25 August 2022   Safe harbour provisions can be relied on but their boundaries are still being defined, explain Jeanna Wacker and Tasha Francis Gerasimow of Kirkland & Ellis.
Americas
3 December 2020   Teva has urged the US Court of Appeals for the Federal Circuit to rehear its dispute with GlaxoSmithKline en banc, claiming that if the decision is upheld, “every skinny-labelled generic is at risk”.
Big Pharma
6 October 2020   In a victory for GlaxoSmithKline, the US Court of Appeals for the Federal Circuit has revived a 2017 jury verdict ordering Teva to pay $235 million over the drug Coreg.