Hatch-Waxman can’t offer ‘safe harbour’ defence in gene therapy case

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.

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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.

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.

Big Pharma

Fed Circuit spurns bid to review Hatch-Waxman Act venue limits

27 January 2021 The US Court of Appeals for the Federal Circuit has dismissed an attempt by Valeant Pharmaceuticals to overturn a ruling that restricted where Hatch-Waxman Act patent lawsuits can be filed.

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.

Generics

Can pharma firms deduct fees in Hatch-Waxman suits?

Big Pharma

Fed Circuit spurns bid to review Hatch-Waxman Act venue limits

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.

Generics

Can pharma firms deduct fees in Hatch-Waxman suits?

Big Pharma

Fed Circuit spurns bid to review Hatch-Waxman Act venue limits