Bloomberg Law
March 23, 2020, 10:01 AM

Virus Delays Stir Deadline Concerns in Generic Drug Patent Cases

Matthew Bultman
Matthew Bultman

New coronavirus-related disruptions to federal courts are causing attorneys’ concerns about meeting tight deadlines unique to generic drug patent disputes.

Under the Hatch-Waxman Act, a patent infringement lawsuit by a brand company typically triggers a 30-month stay on federal approval of generic drugs.

Many judges create drug patent trial schedules to allow the cases to be completed within that time frame, attorneys said. But those schedules are under pressure with courts limiting access and attorneys cutting back on travel.

Stay expirations open the door for the generic product to be approved by the U.S. Food and Drug Administration and potentially ...

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