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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Genentech's delay in requesting an injunction, as well as its licensing deals with Mylan, Celltrion and Pfizer, show it won't suffer irreparable harm from sales of Amgen's biosimilar, judge says.
In ongoing patent litigation with Genentech, Amgen may need to reveal its counsel's advice on whether it should launch, while Genentech must produce its settlement agreements with Mylan, Celltrion, and Pfizer.
Our infographic illustrates the recommendations in FDA’s COVID-19 pandemic recovery and preparedness plan, ranging from strengthening the EUA process to managing the backlog of pending inspections.