PTAB Mylan Decision Could Be Boon To Drug Innovators

By Katherine Helm, Blaine Hackman and Mark Stewart (November 12, 2020, 4:53 PM EST) -- The Leahy-Smith American Invents Act created the Patent Trial and Appeal Board and granted it the statutory discretion to deny institution of a trial when parallel litigation is underway in district court.[1]

Discretionary denials have emerged as a tool for the PTAB to further the policy goals of the AIA and ensure that instituted trials can be adequately resourced and decided in a timely manner.[2]

So too are discretionary denials a tool for innovator pharmaceutical companies holding new drug applications, or NDAs, to fend off PTAB review of patents challenged by generic drug manufacturers holding abbreviated new drug applications, or ANDAs,...

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