Legal Alert: What to Know About the USPTO's Duty of Candor Guidance Regarding FDA Submissions

By now you have seen multiple reports discussing the PTO's Notice of July 29, 2022, relating to the duties of candor and good faith. Federal Register, Vol. 87, No. 145, July 29, 2022. The Notice purports to clarify "the 'duty of disclosure' and duty of reasonable inquiry' owed to the USPTO and American public" and specifically addresses these duties as they relate to life sciences technologies — in particular, with respect to "information and statements material to patentability including, but not limited to, those received from or submitted to the FDA and other governmental agencies." "Information and statements" may include, among other items, information that "refutes, or is inconsistent with, a position that the applicant takes in" either "opposing an argument of unpatentability relied on by the Office" or "asserting an argument of patentability."

In view of this notice, life sciences companies should consider involving U.S. patent counsel in the review of relevant FDA submissions for possible inconsistencies with PTO filings and determination of the appropriate course of action where material inconsistencies are found to exist.

The Notice extends these duties broadly to "each individual associated with the filing and prosecution of a patent application" and "each individual associated with the patent owner in a reexamination proceeding." Such individuals include each inventor named in the application, each attorney or agent who prepares or prosecutes the application, and "every other person who is substantively involved in the preparation or prosecution of the application and who is associated with the inventor, the applicant, an assignee, or anyone to whom there is an obligation to assign the application." The duty also extends to "patent owners presenting substitute claims in an inter partes review or post grant review proceeding" before the PTAB.

According to the Notice, "each party presenting a paper to the USPTO, whether a practitioner or non-practitioner, has a duty to perform an inquiry that is reasonable under the circumstances." The "reasonable inquiry' may comprise reviewing documents that are submitted to or received from other Government agencies, including the FDA." If, upon review, "any reviewed document is material to the patentability of a pending matter before the Office . . . the party has a duty to submit the information to the USPTO."

The duty to perform an inquiry that is reasonable under the circumstance is applicable to all patents, and may be particularly significant for patents related to technology that involves submissions to the FDA, including, for example, patents related to:

• Compositions of matter (including formulations, crystalline forms, and others)
• Methods of treatment or conditions of use
• Methods of manufacturing
• Risk evaluation and mitigation systems (REMS)
• Medical devices and drug/device combinations
• Diagnostic methods
• Digital health
• Others (e.g., technology related to clinical studies and batch testing)

Information subject to the duty includes:

• Prior art
• Incorrect or inconsistent positions taken or submitted by the patent owner or its licensee during FDA regulatory review or other governmental proceedings
• FDA submissions or disclosures to patent owners during regulatory review
• Third-party submissions to patent owners (e.g., Paragraph IV certifications or Orange Book challenges)
• Third-party party submissions to the PTO during or after prosecution or in connection with reexamination or PTAB proceedings
• Examiner requests for information submitted to FDA that may bear on patentability (e.g., materials indicative of an on-sale bar).

However, the Notice leaves unanswered several questions on issues including, for example:

• Understanding the breadth and timing of a "reasonable inquiry"
• Determining what is "reasonable" under your particular circumstances
• Implementing internal and/or external procedures for conducting a "reasonable inquiry" and possible document review and disclosure
• Resolving disclosure issues identified during a "reasonable inquiry"
• Striking the right balance between navigating ethical walls between teams and avoiding "walling off" between the teams
• Developing patent prosecution strategies to facilitate compliance with the Notice
• Reviewing your patent prosecution files for cases of strategic importance to your company
• Replying to USPTO requests for information
• Preserving confidentiality and privilege
• Responding to challenges based on a failure to comply (e.g., alleged failures to conduct a reasonable inquiry or to submit communications to or from another government agency such as the FDA)

What This Means for Life Sciences Patent Applicants

The clarified duties are expected to increase the risk of invalidity or unenforceability challenges for possibly inconsistent statements made in regulatory filings with other governmental regulatory agencies, including the FDA. Life sciences companies may benefit from paying even closer attention to the many FDA submissions made during the regulatory review process that could implicate patents related to drugs, biologics, or medical devices. To meet the PTO-clarified duties and to minimize the risk of increased challenges in court, before the ITC, or in connection with various PTAB proceedings, life sciences companies may consider reviewing existing procedures and possibly adopting additional procedures.

Such additional procedures could include both pre- and post-submission reviews. Companies may consider identifying relevant patent claims and linking them to the formal or informal information submissions required during each stage of the FDA regulatory review process. For drugs and biologics, this could include, for example, IND and NDA/BLA submissions, risk evaluation and mitigation strategies (REMS), post-market studies, and field reports. For devices, it could include, for example, IDE and PMA/510(k) submissions, post-marketing studies, and field reports.

Such procedures may require a closer cooperation of patent, regulatory, and even marketing personnel to identify the type and timing of each relevant submission during each stage of the FDA review process — e.g., pre-clinical studies, in vitro testing, clinical studies, chemistry manufacturing and control (CMC) disclosures, scientific and statistical reviews, and label negotiations — that might reasonably involve an information overlap with relevant patent claims. In some cases, time for a thorough review by patent personnel may need to be built into and coordinated with the regulatory approval process.

While the procedures may differ for in-house versus outside patent counsel, especially if multiple law firms are involved, they may benefit from clearly setting forth standards for determining when an inquiry is reasonable under the circumstances and, if inconsistencies are discovered, whether any such inconsistencies are non-cumulative and material to patentability and, if so, what form of PTO disclosure (or other action) is required to meet the PTO duties.

In addition, the procedures should be flexible enough to cover different scenarios, for example, where the patent owner controls the FDA submissions (e.g., a large drug company), as compared to the scenario where the patent is owned by a third party (e.g., a university) but licensed to an entity to obtain FDA approval. In the latter case, the procedures may need to be enforceable via specific terms provided in a patent license or joint venture agreement.

Procedures may also be developed for inclusion on the company's "due diligence" checklist for patent, product, or company acquisitions and/or sales involving FDA-regulated products.

Further, in terms of enforcing the procedures, companies should anticipate the kinds of questions likely to be raised by litigation counsel during discovery or at trial that will probe whether the PTO duties were followed or patent validity or enforceability was put at risk by a failure to do so. For example: what specific procedures the company had in place to meet the PTO's duties; whether they were reasonable under the circumstances, consistently followed and properly documented by trained personnel; whether the standards for review were applied; and what disclosures/reporting decisions were made or not made.

Finally, the procedures may need to ensure the attorney/client privilege is not inadvertently waived during a review or disclosure process that may be in place to fulfill these PTO duties.

How Fish Can Help

Patent counsel can play a key role in reviewing FDA submissions for material inconsistencies with PTO filings, disclosing inconsistencies that have already been made, and screening against inconsistencies in ongoing FDA submissions.

Fish & Richardson offers a unique perspective on how to deal with the serious challenges raised by the PTO's newly clarified duties: what is a reasonable inquiry under particular circumstances, what to review if further review is warranted, what to disclose, and how to disclose it, along with a sober assessment of the legal implications of such disclosures.

Fish has an unparalleled reputation for patent prosecution and litigation in the life sciences space, as well as an FDA regulatory practice that focuses exclusively on IP-related drug and device issues. It is the integration of these specialized practice areas that gives Fish a unique advantage over other firms in advising life sciences clients on how to navigate the challenges and pitfalls brought on by the PTO's clarified duties of reasonable inquiry and disclosure. Here are just some of the ways that Fish attorneys are assisting their life sciences clients:

• Identifying the FDA regulatory milestones and submissions for which an inquiry could be reasonable under the particular circumstances,
• Reviewing PTO and FDA submissions for material inconsistencies,
• Advising on PTO or FDA submissions to resolve or minimize potential or discovered inconsistencies,
• Assisting in drug label and device IFU negotiations with FDA,
• Drafting client procedures for coordinating patent prosecution and regulatory functions to help meet the PTO's clarified duties,
• Assisting with due diligence reviews related to the PTO duties for acquisitions or sales of life sciences entities and products,
• Establishing internal client procedures to help minimize waiver of the privilege protecting attorney/client communications involving the foregoing, and
• Representing clients on inquiries or actions related to the PTO's clarified duties or their possible breach.

If you would like to discuss the Notice and how it might affect your business, please let us know. We will be happy to advise.

For more information, please contact Fish attorneys Gwilym Attwell or Terry Mahn.