부산대학교 도서관

Communication between the United States Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) is sorely lacking. This lack of communication has created issues when firms make significantly different statements to the FDA that directly conflict with statements made to the USPTO. This problem has not gone unnoticed by President Biden, who has signed an executive order asking the FDA and USPTO to enhance collaborative efforts. Similarly, Senators Leahy and Tillis have noted this conflict and asked the USPTO 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 hidden to interested parties. Additionally, FDA information is usually generated long after the patent has issued. Finally, the USPTO 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 USPTO 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 USPTO could help bring this information to the USPTO's attention to help tailor claim scope by removing those embodiments that were later shown to be nonfunctional. Creation of a new FDA Reexamination would address some of the issues associated with the lack of FDA and USPTO 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 USPTO in regard to any related patents covered by the FDA drug approval. At the USPTO, the FDA information would 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 would 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. [ABSTRACT FROM AUTHOR]