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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Can pharma firms deduct fees in Hatch-Waxman suits?

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Generics

Can pharma firms deduct fees in Hatch-Waxman suits?

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.

Big Pharma

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

More on this story

Generics

Can pharma firms deduct fees in Hatch-Waxman suits?

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.

Big Pharma

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