The USPTO will host a “Public Listening Session” on January 19, 2023, focused on proposed USPTO-FDA collaborative initiatives pursuant to President Biden’s Executive Order on “Advancing Competition in the American Economy” to “promote a better access to medicine for American families”. The listening session will take place days before public comment is expected on the USPTO’s “proposed initiatives to enhance the robustness and trustworthiness of patents,” which were issued under the same executive order. .
As I wrote in my article on proposed “robustness and reliability” initiatives, the USPTO is under pressure from Congress to fix perceived problems with pharmaceutical patents. Stakeholders should not miss these opportunities to help the USPTO address Congressional concerns without undermining the strong tradition of promoting innovation and competition of the US patent system.
USPTO-FDA Collaboration Discussion Topics
The Federal Register Notice announcing the public listening session outlines the following possible discussion topics.
1. What publicly available FDA resources should be included when training USPTO patent examiners on the tools they can use to assess the patentability of claimed inventions?
2. What mechanisms could help patent examiners determine whether applicants or patentees have submitted conflicting statements to the USPTO and the FDA? Please explain if there are any privacy issues with these mechanisms and, if so, how these issues might be resolved.
See also the Federal Register Notice of July 29, 2022 on “Duties of Disclosure and Reasonable Inquiry During Examination, Reexamination, and Reissue, and for Proceedings before the Trial and Appeal Board in of patents”.
3. What are the opportunities and challenges of using AIA procedures to address the patentability of claims in pharmaceutical and biotechnology patents, including how these procedures may intersect with the Hatch-Waxman disputes in paragraph IV and Biologics Price Competition and Innovation Act the “patent dance” framework that biosimilar applicants and reference product sponsors use to address any patent infringement concerns?
According USPTO Statisticsin June 2021, only 4% of all AIA trials challenged patents listed in the Orange Book.
4. How can the USPTO and FDA enhance their collaboration and exchange of information in determining whether a patent is eligible for a patent term extension (PTE) and the duration of any extension under 35 USC 156 . ..?
5. The FDA is already publishing PTE applications on www.regulations.govand the USPTO publishes the PTE applications on its Patent Center Portal …. The USPTO also recently provided centralized access to a list of PTE applications filed over the past five years here. …. What additional information would be useful to include on this web page?
The list of PTE applications includes PTE applications filed as recently as August 10, 2022. It will be interesting to see how often it is updated. The list also includes requests that have been granted.
6. What policy considerations or concerns should the USPTO and FDA explore with respect to patent use methods and, if any, associated FDA use codes, including with respect to generic, 505(b)(2) drugs and biosimilar candidates that do not seek approval (i.e., seek to exclude from their labeling) method of use information protected by a patent (sometimes referred to as “skinny labelling”)?
Maybe the USPTO refers to patents like these.
7. What policy considerations or concerns should the USPTO and FDA explore regarding the patenting of risk assessment 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 FDA to evaluate?
8. Independently or in conjunction with the initiatives set out in the USPTO Letter [to FDA]what other actions could the USPTO and FDA take in collaboration to address concerns about potential misuse of patents to unduly delay competition or to promote greater availability of generic versions of rare 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?
According to the Federal Register notice, the USPTO is interested in “comments from a broad group of stakeholders, including, but not limited to, patients and their caregivers, patient advocates, representatives of the regulated industry, including companies that sell brand name drugs, generic drugs and biosimilars, healthcare organizations, payers and insurers, academic institutions, public interest groups and the general public. »
Share your comments
The Federal Register notice outlines the process for requesting to participate in the listening session as a speaker (including submitting remarks in advance), requesting to attend the listening session in person as a member of the public and register to attend the online listening session. The USPTO will also accept written comments on Discussion Topics submitted through the Federal Electronic Rulemaking Portal by February 6, 2023.
The content of this article is intended to provide a general guide on the subject. Specialist advice should be sought regarding your particular situation.
Comments are closed.