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ARTICLE · 31 OCTOBER 2023

Will The FDA-PTO Collaboration Pay Off?

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Since President Biden's July 2021 executive order directing the FDA Commissioner to collaborate with the PTO on potential misuse of the patent system, I've been skeptical...

United StatesIntellectual Property

Since President Biden's July 2021 executive order directing the FDA Commissioner to collaborate with the PTO on potential misuse of the patent system, I've been skeptical as to whether such efforts will have any impact on the number and quality of the patents that are issued by the PTO or any corresponding benefit to reduce drug pricing. After all, don't PTO Examiners already have access to all of the public prior art that would be relevant when reviewing patent applications, and hasn't FDA sworn off all but a ministerial role in evaluating patents? A recent FDLI webinar addressing the collaboration indicates that the answers to my questions are "maybe" and, unfortunately, still "yes."

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