Request for Comments on USPTO-FDA Collaboration Initiatives to Promote Generic Drug and Biosimilar Competition

On November 7, the U.S. Patent and Trademark Office (USPTO) published a request for comments on areas for USPTO-FDA collaboration and engagement. The USPTO also announced a related public listening session to be held on Thursday, January 19, 2023.

As we have previously reported, President Biden issued an Executive Order in July 2021 on “Promoting Competition in the American Economy,” which directed the Secretary of Health & Human Services (HHS) to “write a letter to the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office enumerating and describing any relevant concerns of the FDA,” in order “to help ensure that the patent system, while incentivizing innovation, does not also unjustifiably delay generic drug and biosimilar competition beyond that reasonably contemplated by applicable law.” In response to President Biden’s Executive Order, the FDA and USPTO exchanged letters outlining specific initiatives for which the USPTO and FDA were to collaborate.

The USPTO states that its request for comments, and the scheduling public listening session, is “to obtain public input on areas for USPTO-FDA collaboration and engagement.” The USPTO is “seeking feedback from a broad group of stakeholders, including, but not limited to, patients and their caregivers, patient advocates, representatives from regulated industry, including companies that sell branded medicines, generics drugs and biosimilars, healthcare organizations, payors and insurers, academic institutions, public interest groups, and the general public.” Specifically, the USPTO seeks comments on the following questions with regards to the initiatives proposed by the USPTO, although the questions are not meant to be exhaustive:

1. What publicly available FDA resources should be included when training USPTO patent examiners on tools they can use to assess the patentability of claimed inventions?
2. What mechanisms could assist patent examiners in determining whether patent applicants or patent owners have submitted inconsistent statements to the USPTO and the FDA?
3. What are the opportunities and challenges related to the use of AIA proceedings to address the patentability of claims in pharmaceutical and biotechnological patents, including with respect to how such proceedings may intersect with Hatch-Waxman paragraph IV disputes and the Biologics Price Competition and Innovation Act “patent dance” framework that biosimilar applicants and reference product sponsors use to address any patent infringement concerns?
4. How can the USPTO and the FDA reinforce their collaboration and information exchange in relation to determining whether a patent qualifies for a patent term extension (PTE) and the length of any extension under 35 U.S.C. 156, as described in the Manual of Patent Examining Procedure § 2756?
5. What additional information would be useful to include on this web page?
6. What policy considerations or concerns should the USPTO and the FDA explore as they relate to method of use patents and, as applicable, associated FDA use codes, for example, “skinny labeling?”
7. What policy considerations or concerns should the USPTO and the FDA explore in relation to the patenting of risk evaluation and mitigation strategies associated with certain FDA-approved products? What other types of patent claims associated with FDA-regulated products raise policy considerations or concerns for the USPTO and the FDA to evaluate?
8. Apart from, or in conjunction with, the initiatives set forth in the USPTO Letter, what other steps could the USPTO and the FDA take collaboratively to address concerns about the 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?
9. What additional input on any of the initiatives listed in the USPTO Letter (1(a)-1(h)), or any other related suggestions for USPTO-FDA collaboration, should the agencies consider?