“I’m Listening,” Says the PTO

In the wake of President Biden’s July 2021 Executive Order—Promoting Competition in the American Economy—and the exchange of letters between the Patent and Trademark Office (USPTO) and FDA, the USPTO announced recently a “public listening session” in collaboration with FDA to seek comments on how the agencies can work together to promote greater access to medicines.  That session will be held on January 19, 2023, and the agencies have opened a docket to receive comments on effective collaboration.  Registration to speak at the conference closes on January 5, 2023.  Written comments will be accepted until February 6, 2023.

As a brief reminder, the July 9, 2021 Executive Order directed FDA to write a letter to the USPTO describing concerns about uses of the patent system to delay generic and biosimilar competition.  FDA’s September 2021 letter explains the issues raised by patent thickets, patent evergreening, and product-hopping—all of which, FDA explains, are used to delay approval of less expensive, generic versions of branded products.  The USPTO responded to FDA’s letter on July 6, 2022, citing its intent to enhance collaboration with other agencies; improve procedures for obtaining a patent; improve the PTAB challenge practice; and improve public participation.  Both letters recognized the need for “robust and reliable patents” to “incentivize and protect” the research and development investment made to bring new drug products to market, but they also cite the importance of increased competition.  More information about these letters can be found in our July 21, 2022 blog post.

The intent of the “listening session” is to obtain input on additional areas for USPTO and FDA collaboration.  The agencies are seeking broad feedback from patients, healthcare providers, and industry alike.   The PTO asks stakeholders to consider several questions (while emphasizing that this list is not all-inclusive).  Specifically, the PTO seeks feedback on:

• Publicly available FDA resources that should be included when training USPTO patent examiners to assess the patentability of claimed inventions;
• Mechanisms to assist patent examiners in determining whether patent applicants have submitted inconsistent statements to the USPTO and the FDA;
• Opportunities and challenges related to the use of AIA proceedings to address the patentability of claims in pharmaceutical and biotechnological patents;
• Collaboration and information exchange between the USPTO and the FDA with respect to patent term extensions;
• Additional information to provide the public regarding patent term extensions;
• Policy considerations the USPTO and FDA should explore related to method of use patents and associated FDA use codes;
• Policy considerations the USPTO and FDA should explore in relation to the patenting of risk evaluation and mitigation strategies (REMS) associated with FDA-approved products;
• 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;
• Any additional input on any of the initiatives listed in the USPTO Letter.

The USPTO, in collaboration with FDA, is waiting to hear from you, so provide your comments before the docket closes in February.  In the words of the esteemed Dr. Frasier Crane, the USPTO says: “I’m listening.”