‘Wildcard’ Patents: Why A REVAMP-ed Proposal Might Work In 2017
Before election day, the idea of a new transferrable exclusivity incentive seemed like an extreme long shot for enactment. But now advocates think it has a real chance – and a strategy to redraft the idea to answer Democratic critics and avoid a high CBO score.
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Advocates for antibiotic incentives are hoping to attach 'wildcard' patent proposal to pending PAHPA reauthorization bill; New conditions on exclusivity are intended to make approach more politically viable – and assure favorable CBO score.
Regulatory incentives have been successful at attracting developers to antibiotic R&D, but significant medical advances have stubbornly remained rare. Now the pipeline has produced the first novel antibiotic to receive breakthrough status from US FDA and some Phase III trials are raising the efficacy bar to superiority.
Regulatory uncertainty could imperil the crop of emerging companies making a go of it in the incentive-laden US anti-infective space.