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25 August 2022FeaturesBig PharmaJeanna Wacker and Tasha Francis Gerasimow

Navigating the murky waters of the Hatch-Waxman ‘safe harbour’

The Hatch-Waxman “safe harbour” is a valuable tool for companies looking to develop FDA-regulated products based on existing patented inventions. But the boundaries surrounding the safe harbour are not always so clear. Here, we’ll dive into the statutes and recent case law surrounding the provision to shed some light on its contours.

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18 July 2023   Generic drug makers are watching two cases that will determine whether pharmaceutical firms can deduct—rather than capitalise—legal fees for defending against patent infringement suits, say Carina Federico and Anne Li of Crowell & Moring.
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More on this story

Generics
Can pharma firms deduct fees in Hatch-Waxman suits?
18 July 2023   Generic drug makers are watching two cases that will determine whether pharmaceutical firms can deduct—rather than capitalise—legal fees for defending against patent infringement suits, say Carina Federico and Anne Li of Crowell & Moring.
Americas
Hatch-Waxman can’t offer ‘safe harbour’ defence in gene therapy case
6 January 2022   Sarepta Therapeutics won’t be able to rely on a “safe harbour” provision to protect its gene therapy invention from a patent infringement suit from biotech Regenxbio and the University of Pennsylvania, a Delaware court has ruled.
Americas
Skinny-label ruling will ‘decimate’ Hatch-Waxman, Fed Circuit told
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.

More on this story

Generics
Can pharma firms deduct fees in Hatch-Waxman suits?
18 July 2023   Generic drug makers are watching two cases that will determine whether pharmaceutical firms can deduct—rather than capitalise—legal fees for defending against patent infringement suits, say Carina Federico and Anne Li of Crowell & Moring.
Americas
Hatch-Waxman can’t offer ‘safe harbour’ defence in gene therapy case
6 January 2022   Sarepta Therapeutics won’t be able to rely on a “safe harbour” provision to protect its gene therapy invention from a patent infringement suit from biotech Regenxbio and the University of Pennsylvania, a Delaware court has ruled.
Americas
Skinny-label ruling will ‘decimate’ Hatch-Waxman, Fed Circuit told
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.

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