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

 
• By Brenda Sandburg

As Congress prepares to again debate patent reforms, brand industry says allegations of ‘patent thickets’ and extended market exclusivity are based on inaccurate or misleading data. They assert there is no need for PTO and FDA to institute systemic policy changes.

Drug competition
Patent system is not being misused to unjustifiably delay drug competition, biopharma reps tell USPTO and FDA • Source: Shutterstock

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...

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