FDA Reexamination: Increased Communication Between the FDA and USPTO to Improve Patent Quality

Abstract

Communication between the U.S. Patent and Trademark Office (PTO) and the Food and Drug Administration (FDA) is sorely lacking. This lack of communication has created issues where firms will make significantly different statements to the FDA that directly conflict with statements made to the PTO. This problem has not gone unnoticed by President Biden who has signed an executive order asking the FDA and PTO to enhance collaborative efforts. Similarly, Senators Leahy and Tillis have noted this conflict and asked the PTO to take action.

The current solution to this problem is to invalidate the patent by using the inequitable conduct doctrine. However, this doctrine does not work well when it comes to FDA information. Specifically, FDA information is usually confidential and not easily available to the public, thus is hidden to interested parties. Additionally, FDA information is usually generated long after the patent has issued. Finally, the PTO is not staffed with examiners who know how to gather, interpret and analyze FDA information with an eye towards patentability.

Increased communication between the FDA and PTO could result in stronger patents, even absent active deception by the patent applicant. There is usually a significant lag period between patent issuance and FDA approval. More information is learned during this lag period through clinical trials and additional experiments. Communication between the FDA and PTO could help bring this information to the PTO’s attention to help tailor claim scope remove those embodiments that were later shown to be non-functional.

Creation of a new FDA reexamination would address some of the issues associated with lack of FDA and PTO communication. FDA reexamination could mirror aspects of both the ex parte reexamination procedure as well as supplemental examination. Specifically, FDA reexamination would automatically occur after approval of a related FDA drug application. Information from the FDA would automatically be sent to the PTO in regard to any related patents covered by the FDA drug approval. At the PTO, the FDA information will be reviewed by a team of three senior examiners to determine if a substantial new question of patentability exists. At least one of these examiners will have the ability to analyze and interpret the FDA clinical data with an eye towards patentability. If a substantial new question of patentability is found, then the typical Director requested reexamination procedure would ensue.

Keywords: patent, reexamination, USPTO, PTO, post-grant review, IPR, inter partes review, examination