Avoiding Consequences for Noncompliance with New PTO Rules Requiring Coordination of Submissions to Government Agencies

Upcoming

Program Number

3486

Program Date

2024-05-16

CLE Credits

This course is designed to alert patent practitioners with the PTO rules on the “Duty of Disclosure and Reasonable Inquiry” as clarified by the PTO’s notice in Vol. 87 (No. 145) of the Federal Register (July 29, 2022). This course will also address the dire consequences for violating these rules. Most importantly, the course will outline procedures for ensuring that patent practitioners and their clients follow these rules, and thus prevent any PTO investigations and findings of inequitable conduct in subsequent litigation.

Accordingly, the rules, as clarified, state that patent practitioners have an affirmative duty to conduct a reasonable investigation (“duty of inquiry”) to ensure that all statements to the PTO and other government agencies are consistent (“duty of disclosure”). These requirements are particularly pertinent when prosecuting patents that cover a drug, biologic or medical device that require FDA approval. The duty of inquiry requires that statements made to the PTO must be evaluated to ensure they are consistent with statements to the FDA or any other government agency, such as the EPA or Department of Agriculture. Any failure can have adverse consequences to patent practitioners and their clients. After reviewing the rules and consequences for their possible violation, the course will enumerate various steps that should be taken by both patent and regulatory attorneys to ensure that the rules are not violated.