Tear down the wall: why requiring the FDA and the PTO to share information will improve the decision-making of both agencies.

Abstract

An invisible wall separates the U.S. Food and Drug Administration (FDA) from the U.S. Patent and Trademark Office (PTO). This wall blocks inter-agency communication, depriving the PTO of information relevant to patent applications and depriving the FDA of information relevant to drug-approval applications. Consequently, it is too easy for a drug company to tell the PTO 'our drug is new' (in hopes of speeding a patent grant) while telling the FDA 'our drug is not new' (in hopes of speeding drug approval). Better communication between the FDA and PTO would increase agency accuracy by preventing inconsistent representations, and would increase agency efficiency by avoiding informational asymmetry and duplication of effort. Presidents Obama and Trump created enhanced mechanisms that allow the PTO to receive information from counterparts in foreign countries and from industry about what is truly innovative. It would also be helpful for the PTO to enjoy the expertise of its own sister agency, located down the road. Despite scholarly and governmental proposals to mandate cooperation between the FDA and the PTO, such coordination remains limited in practice. This article proposes to break through the invisible wall between the FDA and the PTO, and to open pathways for communication between the two agencies.