COVID-19 Impacting Patent Litigation, From Exclusivity Forfeiture To Launch Delays

Pandemic poses new hurdles for Hatch-Waxman and BPCIA litigants as they navigate US FDA approval times, sponsor filing deadlines and biosimilar launch dates.

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COVID-19 Raises Numerous Questions In Biopharma Patent Litigation

The COVID-19 pandemic raises a host of questions for biopharma companies engaged in patent litigation, such as whether generic manufacturers can avoid forfeiture of 180-day exclusivity and whether biosimilar sponsors might agree to delay product launches.

Goodwin Procter attorneys discussed the challenges in navigating Hatch-Waxman and biologic litigation during the pandemic in a 23 April webinar. One issue for abbreviated new drug application sponsors is whether...

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