On November 15, 2022, the Berkeley Center for Law and Technology hosted a webinar to address the recent, unprecedented collaboration between the U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA). The webinar, entitled "The USPTO-FDA Collaboration: A Discussion of Recent Activity and Possible Next Steps," included two representatives from the USPTO—Deputy Commissioner Bob Bahr and Acting Vice Chief APJ Linda Horner—and three attorneys from Morrison Foerster—Stacy Cline Amin, Mehran Arjomand, and Jean Nguyen. Together the panelists discussed how both federal agencies are working together to improve the patent system in an effort to address drug pricing in the United States. The possible changes to the patent system have potentially far-reaching implications, not only in the life sciences, but also in other industries. But companies still have the opportunity to steer these possible changes by submitting written comments related to the USPTO-FDA collaboration by February 6, 2023, or by submitting written comments related to the USPTO examination and continuation practice by February 1, 2023. Key themes and takeaways from the webinar are detailed below.
On July 9, 2021, President Biden issued an Executive Order on Promoting Competition in the American Economy that called for action to ensure that the patent system does not unjustifiably delay generic drug and biosimilar competition beyond that reasonably contemplated by applicable law. The Order stirred up a series of letters, including a September 2021 letter from Acting FDA Commissioner Woodcock to the USPTO. Commissioner Woodcock stated that addressing drug competition and access to more affordable medicine was a top priority of the administration, the Department of Health and Human Services, and the FDA. To that end, Commissioner Woodcock raised several concerns about how the patent system is being misused through what she referred to as "patent thickets," "evergreening," and "product-hopping." She invited the USPTO to collaborate with the FDA to address drug pricing issues. USPTO Director Vidal responded positively in a July 2022 letter by providing potential USPTO initiatives to incentivize innovation in the pharmaceutical space without unnecessarily delaying access to low-cost medicines.
That exchange has led to the first steps in the agencies' collaboration. For example, Judge Horner noted the USPTO and the FDA are currently working together to assess and analyze patent exclusivity and drug approval data from approximately 10–15 drugs. Further, Judge Horner stated that the "first steps are to collaborate through information sharing and cross training." Notably, the USPTO hosted the FDA for a training event where the USPTO showcased how prior art determinations are made. The FDA, in turn, is now preparing training for the USPTO on locating publicly accessible FDA material for prior art determinations.
The collaboration also led to the USPTO publishing a Notice of Public Listening Session and Request for Comments on Joint USPTO-FDA Collaboration Initiatives on November 7, 2022.This upcoming listening session is an opportunity for public input from a broad group of public stakeholders on areas for USPTO-FDA collaboration and engagement. Areas for comment include:
- Publicly available FDA resources for USPTO patent examiner training;
- Tools for the USPTO and the FDA to identify inconsistent statements submitted to the two agencies;
- How America Invents Act (AIA) proceedings intersect with Hatch-Waxman Paragraph IV and BPCIA "patent dance" litigation;
- How the USPTO and the FDA can further collaborate with respect to patent term extension (PTE) determinations;
- Policy considerations or concerns regarding method of use patents, FDA use codes, and "skinny labeling";
- Policy considerations or concerns regarding risk evaluation and mitigation strategies (REMS) associated with certain FDA-approved products;
- "[C]oncerns 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"; and
- Any other comments related to the USPTO-FDA collaboration.
With such significant topics up for comment and both agencies at the table, those interested in the outcome should attend the upcoming January 19, 2023 Public Listening Session and submit comments. Those who wish to speak must register by January 5, while those who wish to attend but not speak must register by January 17. Further, the period for submitting written comments closes on February 6, 2023.
Duty of Disclosure and Duty of Reasonable Inquiry
A September 2021 letter from Senator Leahy and Senator Tillis to the USPTO arguably prompted the USPTO to publish another notice, a Notice on the Duties of Disclosure and Reasonable Inquiry, on July 29, 2022. The Notice clarified the duty of disclosure and duty of reasonable inquiry, namely (i) who has the duty to disclose material information, (ii) what material information must be disclosed, (iii) what is the duty of reasonably inquiry, and (iv) that deliberate schemes not in accordance with candor and good faith are prohibited. A MoFo blog post previously discussed this Notice.
The panel had the benefit of obtaining Deputy Commissioner Bahr's insight on two key aspects of the Notice. First, the Notice "has no real independent force in effect." Instead of changing the USPTO's position, "it simply informs the public of how the PTO sees these two [duties] as interplaying together in this particular area." Second, the duty of reasonable inquiry applies even when a patent practitioner has no actual knowledge of an FDA submission. As Deputy Commissioner Bahr explained, "the attorney should really know what is being said by a company to different agencies concerning the same invention." While there are no "per se rules" because "reasonable" depends on the exact circumstances, "if you have an invention and it's something that you know you're going to get FDA approval for, or need FDA approval for, there should be some check into what is being said to the different agencies."
The panelists also discussed potential enforcement mechanisms to ensure the duty of disclosure has teeth. Would inconsistent statements be considered false or misleading statements by the Department of Justice (DOJ), thereby allowing DOJ to employ traditional criminal tools, or tools under the Federal Food, Drug, and Cosmetic Act, to address the issue? While such DOJ enforcement would be unprecedented, Stacy Cline Amin noted that many actions the agencies have already taken would have been considered third rails in the past. And such scrutiny aligns with the DOJ's increased focus on enforcement in the life sciences industry.
USPTO Examination and Continuation Practice
The above-discussed letters, along with a June 2022 letter from a group of Senators identifying the patent thickets issue, arguably led to yet another Notice. On October 4, 2022, the USPTO published a Notice for Request for Comments on USPTO Initiatives to Ensure the Robustness and Reliability of Patent Rights. This Request for Comments (RFC) included questions from the Senators' letter and the USPTO initiatives proposed in Director Vidal's July 2022 letter related to:
- Specific sources of prior art not currently available through the Patents End-to-End Search system;
- Changes, if at all, to claim support and/or continuation practice;
- Changes, if at all, to request for continued examination (RCE) practice;
- Changes, if at all, to restriction, divisional, rejoinder, and/or non-statutory double patenting practice;
- How eliminating terminal disclaimers would affect patent prosecution strategies and patent quality;
- Whether filing a terminal disclaimer should be an admission of obviousness;
- Whether the USPTO should require a second look before issuing a continuation patent on a first office action;
- Whether there should be heightened examination requirements for continuation patents;
- Setting a time limit for filing continuation applications relative to the original application;
- Increasing up-front fees to reflect the actual cost of obtaining a patent; and
- Any other comments related to ensuring robustness and reliability of patent rights.
Deputy Commissioner Bahr named a number of ideas floating around at the USPTO: (i) "increas[ing] the sampling rate for continuation applications . . . we could possibly do a better job of making sure that the claims are fully supported by the original disclosure"; (ii) "increas[ing] the amount of examining time"; or (iii) "assigning cases after a certain number of continuations to a different examiner than examined the parent to ensure that those cases get a completely fresh look." Deputy Commissioner Bahr further discussed the USPTO's initiatives with comparing the USPTO examination and issuance practice for pharmaceutical patents to the practices by patent offices in other countries. Although this initiative is in its nascency and is a long-term project, he emphasized that the USPTO Office of International Legislative Affairs is familiar with patenting practices in other countries and coordinates with the USPTO's counterparts around the world. The duty of disclosure may extend beyond other U.S. government agencies like the FDA, so companies should ensure they make consistent statements both domestically and internationally.
Changes made in response to the RFC will likely have a significant impact on patent rights and procedures. As Judge Horner noted, any future rulemaking is not specific to just pharmaceutical patents but would also apply to all technologies. Interested parties should be sure to submit written comments before the comment period closes on February 1, 2023. Notably, the comment period for the USPTO examination and continuation practice Notice ends before the comment period for the USPTO-FDA collaboration Notice.
PTAB and the USPTO/FDA
Director Vidal's July 2022 letterresponsive to the FDA also mentioned improving the process for challenging issued patents before the Patent Trial and Appeal Board (PTAB). Director Vidal indicated that the USPTO will work with the FDA to study filings of AIA proceedings on Orange Book-listed patents and biologic patents.
Judge Horner noted that the "USPTO conducted internal studies . . . [that] showed that only 4% of all AIA petitions challenge orange book listed patents [and] only 2% of all AIA petitions challenged biologic patents . . . ." The "study also revealed [that] challenges to both Orange Book and biologic patents have decreased over time." Judge Horner noted that this is a unique area, with potential timing and estoppel implications due to Hatch-Waxman and the BPCIA. Nonetheless, the USPTO, according to Judge Horner, is exploring whether anything can be done "to facilitate" the use of these proceedings when it makes sense to do so.
The Notice of Public Listening Session and Request for Comments on Joint USPTO-FDA Collaboration Initiatives notes the intersection of AIA proceedings with Hatch-Waxman paragraph IV disputes and the BPCIA patent dance framework as being a discussion topic during the January 19, 2023 Public Listening Session. Some panelists noted that perhaps the Hatch-Waxman statutory framework makes PTAB challenges unattractive. This is an area that the USPTO and the FDA are hoping for comments on and even discussion of at the Public Listening Session. This area is important for companies in the life sciences industry to focus on, as it could be ripe for potential policy reform by the agencies and/or Congress.
Morrison Foerster panelists noted that there was not enough time to discuss other hot topics such as skinny labels, REMS patents, the Orange Book, and patent term extensions/adjustments, just to name a few. These topics as well as the ones discussed in the webinar are going to be on the agenda for the joint USPTO-FDA Public Listening Session on January 19, 2023, and potentially the subject of future webinars.
At Morrison Foerster, our FDA + Healthcare Regulatory and Compliance practice works seamlessly with our Patent Practice Group to ensure that life sciences companies remain compliant with all federal and state requirements. The USPTO and the FDA are working together in an unprecedented collaboration to reduce the cost of drugs, and the agencies are specifically calling on industry to inform the trajectory of the outlined initiatives. If your company is potentially affected by these ongoing changes, please contact MoFo's life sciences team so that we can ensure you have a chance to influence USPTO and FDA activity before it is too late.
Kai Mindick, a Law Clerk in our Austin office, contributed to the writing of this post.
Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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