Unjustifiable Delays In Generic Competition? Biopharma Contends There Is No Problem

As the US Patent and Trademark Office and Food and Drug Administration pursue initiatives to promote greater access to medicines, one factor is central to the debate: what constitutes an unjustifiable delay in the entry of generic drugs and biosimilars to the market?

Representatives of the biopharma industry countered claims that companies are misusing the patent system to delay competition. Speaking at a public “listening session” on USPTO-FDA proposed initiatives last month, they...