Specifically, the FDA and USPTO letters outline a number of initiatives that focus on areas in which the agencies’ functions overlap.

On November 7, 2022, the USPTO and FDA announced a public “Listening Session on Joint USPTO-FDA Collaboration Initiatives” to seek comments on how the two agencies can work together to promote greater access to medicines. The session will be held January 19, 2023, in the Clara Barton Auditorium at the USPTO, and the agencies have opened a docket on the eRulemaking Program website to receive comments on effective collaboration. Registration to speak at the listening session closes on January 5, 2023. Written comments will be accepted until February 6, 2023.

In September 2021, the FDA wrote a letter to the USPTO explaining the issues raised by patent thickets, patent evergreening and product hopping—all of which, FDA explains, are used to delay the approval of less expensive, generic versions of branded products. The USPTO responded by citing its intent to enhance collaboration with the agency, improve procedures for obtaining a patent, improve the PTAB challenge practice and improve public participation. Both agencies recognized the necessity for increased competition to promote greater access to medicines for American families, while striking the appropriate balance of incentivizing and protecting the research and development investments made to bring new drug products to market.

Specifically, the FDA and USPTO letters outline a number of initiatives that focus on areas in which the agencies’ functions overlap. For example, the agencies plan to enhance collaboration with other agencies on key technology areas, including pharmaceuticals and biologics. The USPTO will seek to create formal mechanisms to collaborate with other agencies such as the FDA. In particular, the USPTO will explore joint USPTO–FDA public engagement through listening sessions, dissemination of requests for comments and other procedures for collecting broader stakeholder input. Additionally, the USPTO will provide examiners with training, in collaboration with the FDA, on publicly available FDA resources that can be used in prior art searches and on the state of the art in the pharmaceutical and biopharma areas, and provide resources to the FDA to support its work on matters influenced by patent law and policy.

Furthermore, the intent of the public listening session is to obtain input on additional areas for USPTO and FDA collaboration, such as:

1. Publicly available FDA resources that should be included when training USPTO patent examiners to assess the patentability of claimed inventions;
2. Mechanisms to assist patent examiners in determining whether patent applicants have submitted inconsistent statements to the USPTO and FDA;
3. Opportunities and challenges related to the use of AIA proceedings to address the patentability of claims in pharmaceutical and biotechnological patents;
4. Collaboration and information exchange between the USPTO and FDA with respect to patent term extensions;
5. Additional information to provide the public regarding patent term extensions;
6. Policy considerations the USPTO and FDA should explore related to method of use patents and associated FDA use codes;
7. Policy considerations the USPTO and FDA should explore in relation to the patenting of risk evaluation and mitigation strategies associated with FDA-approved products; and
8. Steps, other than those set forth in the USPTO letter, the USPTO and FDA could take to collaboratively address concerns about potential misuse of patents to improperly delay competition or to promote greater availability of generic versions of scarce drugs that are no longer covered by patents.

Finally, this move by the FDA and USPTO is an opportunity to give valuable insight and feedback into a system that many deal with on a daily basis. Therefore, it is imperative to participate and share feedback on how the FDA and USPTO can work together to balance competition and protect research and development.

For More Information

If you have any questions about this Alert, please contact Frederick R. Ball, Patrick C. Gallagher, Ph.D., Irfan Malani, any of the attorneys in our Life Sciences and Medical Technologies Industry Group or the attorney in the firm with whom you are regularly in contact.

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