Generic drug patent cases disrupted by COVID-19

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Generic drug patent cases disrupted by COVID-19

By Sandra Levy - 03/23/2020

Attorneys are concerned about meeting tight deadlines with regard to generic drug patent disputes, amid coronavirus-related disruptions to federal courts, according to a Bloomberg Law report.

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. But those schedules are under pressure with courts limiting access and attorneys cutting back on travel, the report said.

Stay expirations open the door for the generic product to be approved by the Food and Drug Administration and potentially launch in the U.S. market. There also is a concern brand companies could have trouble accessing the courts to ask for an injunction to block sales, the report said.

The disruptions have “put an extra level of stress on these drug patent cases to figure out how to get things done in the timeframe,” Bruce Wexler, the global co-chair of the intellectual property practice at Paul Hastings said.

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