The PREVAIL Act aims to significantly alter PTAB proceedings, shifting the balance of power back in favor of patent holders while addressing concerns about generic drug pricing.
With a close 11-10 vote, the Senate Judiciary Committee passed the PREVAIL Act, which brings substantial modifications to the inter partes review system impacting innovation.
Sen. Coons' friendly amendment allows a broader range of entities, including generic-drug makers and patient groups, to file IPR/PGR petitions, addressing drug pricing issues.
Key changes include raising the burden of proof to 'clear and convincing evidence,' enforcing strict timelines for PTAB decisions, and enhancing judge independence.
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