Can US FDA Share Drug Sponsor’s Information With Patent & Trademark Office?
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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FDA, USPTO Collaboration Could Expand Review Of Pharma Patents, Explore ‘Skinny Label’ Policy
The two agencies are pursuing initiatives to address instances of patents being used improperly to delay competition. FDA may play greater role in PTAB proceedings and training patent examiners.
USPTO Faces Growing Pressure To Enter Battle Over Drug Pricing
Members of Congress, companies and government agencies want the Patent Office to change policies that they say impede generic drug competition. The latest effort is focused on PTO’s discretionary denial of inter partes review petitions, which is the subject of a bipartisan congressional letter and cert petition to the US Supreme Court.
Supreme Court Seems Ready To Uphold Ruling Against Amgen’s Anti-PCSK9 Antibody Patents
Justices question what Amgen’s invention covers in its dispute with Sanofi. They appear inclined to uphold Federal Circuit’s standard for enablement despite potential negative impact on genus claims.