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

This course, presented by Brian Coggio and Kelly Del Dotto, 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 of 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.

The PTO's clarification stems from a July 9, 2021, executive order stating that the patent laws had been misused to inhibit or delay competition from generic drugs and biosimilars. Subsequently, a September 9, 2021, letter to Andrew Hirshfield, Director of the PTO, from Senators Leahy and Tillis stated that the PTO should take steps to reduce patent applicants' conflicting statements to the PTO and other government agencies.

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 be evaluated to ensure they are consistent with statements to the FDA or any other government agency, such as the EPA or the Department of Agriculture. Any failure can have adverse consequences for patent practitioners and their clients.

After reviewing the rules and consequences for their possible violation, the course will enumerate various steps that both patent and regulatory attorneys should take to ensure that the rules are not violated. These "takeaways" are not all-inclusive but will provide attendees with useful avenues that should be undertaken and lead to further discussion on how best to implement them in each organization.

Learning Objectives:

1. Discuss the new PTO rules on the "Duty of Disclosure and Reasonable Inquiry" as clarified by the PTO's notice on Vol. 87 (No. 145) of the Federal Register (July 29, 2022) and the dire consequences for violating these rules 

2. Outline procedures for following the new rules 

3. Avoid PTO investigations and findings of inequitable conduct in subsequent litigation

4. Navigate avenues that should be undertaken to follow the new rules and discuss how best to implement them in each organization