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Can US FDA Share Drug Sponsor’s Information With Patent & Trademark Office?

 
• By Brenda Sandburg

Patent office could request information from FDA that is material to patentability, speakers at USPTO-FDA ‘listening session’ advise the agencies. Information exchange raises questions about trade secret protection and burdens on agencies.

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Stakeholders recommend FDA share drug sponsor's information with USPTO • Source: Nielsen Hobbs; Pink Sheet | Shutterstock images

Stakeholders are advocating that the US Food and Drug Administration share information with the US Patent and Trademark Office to ensure patents are not issued to improperly delay generic drug and biosimilar competition.

During a 19 January “listening session” convened by the agencies, speakers suggested specific information the FDA could share with patent examiners with the goal of making sure that applicants do...

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