USPTO Underscores Duty Of Disclosure Pertaining To FDA Submissions

Published date09 August 2022
Subject MatterIntellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Food and Drugs Law
Law FirmFoley & Lardner
AuthorMs Courtenay Brinckerhoff

The USPTO has issued a Federal Register Notice discussing how the duty of candor and good faith in dealing with the USPTO applies to "information and statements material to patentability ... received from or submitted to the FDA and other governmental agencies." The Notice was issued in accordance with a July 2021 Executive Order and in response to a September 2021 letter from Senators Leahy and Tillis, both of which expressed concerns that patent applicants may make "inappropriate conflicting statements" in submissions to the USPTO and FDA. In addition to discussing the duty of disclosure, the Notice emphasizes the "duty to perform an inquiry" before submitting a paper to the USPTO.

The Executive Order

The Notice cites President Biden's July 9, 2021, Executive Order on Promoting Competition in the American Economy,86 FR 36987 (2021), which "expressed concern that 'too often, patent and other laws have been misused to inhibit or delay'for years and even decades'competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs.'" The Executive Order called on the Secretary of Health and Human Services "to help ensure that the patent system, while incentivizing innovation, does not also unjustifiably delay generic drug and biosimilar competition beyond that reasonably contemplated by applicable law."

The Leahy-Tillis Letter

The Notice also cites the September 9, 2021 letter from Senators Leahy and Tillis to Mr. Andrew Hirshfeld, Performing the Functions and Duties of Director of the USPTO. The letter recognized that "strong intellectual property rights play an important role in the development of biopharmaceuticals, biosimilars, and treatments that save millions of lives every single year," but emphasized that patents "must meet all the requirements of patentability, including being non-obvious and not anticipated by any prior art."

The letter acknowledged the USPTO's July 2021 Notice that "reminded" applicants that "patent applications must properly present examples in a manner that clearly distinguishes between prophetic examples that describe predicted experimental results and working examples that report actual experimental results." (Read more about that Notice here.) Then the letter asked the USPTO to do more:

We are now requesting the PTO take steps to reduce patent applicants' making inappropriate conflicting statements in submissions to the PTO and other federal agencies. These conflicting statements too often are...

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