Post-Grant Review May Impact Biosimilars Litigation

Law360, New York (November 17, 2014, 10:54 AM EST) -- Post-grant review, created by the America Invents Act, is likely to have an impact on biosimilars litigation. PGR may prove to be an important forum for companies that do not want to wait until after filing their biosimilar applications to challenge the validity of relevant patents. PGRs are particularly attractive as challengers can raise almost any ground of invalidity that could be raised in a district court action, a broader claim construction is applied, the standard of proving invalidity is lower for a PGR than in district court ("preponderance of the evidence" vs. "clear and convincing"), settlement is possible, and a final decision is reached faster. Additionally, the costs associated with a PGR trial are considerably lower than the costs associated with a district court litigation....

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