AIPLA Comments on Joint USPTO-FDA Collaboration Initiatives

Written February 28, 2023

Arlington, VA. February 28, 2023 - The American Intellectual Property Law Association (AIPLA) submitted comments to the United States Patent and Trademark Office (USPTO) in response to the USPTO’s Request for Comments on Joint USPTO-FDA Collaboration Initiatives.

The comments expressed support for the USPTO and FDA efforts to train patent examiners on publicly available FDA information and resources to supplement, but not replace, current patent searching requirements and criteria. AIPLA cautioned, however, against importing or conflating the FDA laws, practices, and standards directed to product safety and efficacy into satisfying the requirements for patent protection.

AIPLA also expressed support of a patent examiner’s need to know about inconsistent statements that can affect his or her determination of patentability.  But the comments reflected AIPLA’s concern that any attempt to share information between the USPTO and FDA in determining whether patent applicants or owners have submitted inconsistent statements, regardless of mechanism, will create significant burdens on both agencies and could provide a significant risk to trade secret protection. AIPLA also noted that inconsistent statements do not appear to be a widespread problem and thus expressed belief that the existing duty of candor to the USPTO provides the necessary deterrent not to make a material, inconsistent statement.


To view the complete comments, please download the comment letter posted to the right of this page.