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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.

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More on this story

Big Pharma
Navigating the murky waters of the Hatch-Waxman ‘safe harbour’
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
Teva urges Fed Circuit to save skinny label law from ‘nullification’
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
Fed Circuit reinstates $235m verdict against Teva
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
Navigating the murky waters of the Hatch-Waxman ‘safe harbour’
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
Teva urges Fed Circuit to save skinny label law from ‘nullification’
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
Fed Circuit reinstates $235m verdict against Teva
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.

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