Spurred by President Biden's call for action to increase drug competition and a 2021 letter addressed to the U.S. Patent and Trademark Office (USPTO) by Senators Leahy and Tillis requesting the USPTO "to take action to require applicants to disclose relevant statements they have made to other agencies relating to inventions discussed in their patent applications or about prior art that is being applied in the patent examination process,"1 the USPTO recently issued a Notice2 that clarifies the duties of disclosure and reasonable inquiry, which can concern information submitted to the U.S. Food and Drug Administration (FDA) and other government agencies that are material to the patentability of a claimed invention.
Duty of Disclosure
The duty to disclose3 applies to matters pending before the USPTO and extends broadly to each inventor and any individual who is substantively involved with matters pending before the USPTO, including in connection with the preparation or prosecution of a patent application, a reexamination proceeding, a reissue application, or a proceeding before the Patent Trial and Appeal Board. The duty to disclose not only applies to information that establishes, by itself or in combination with other information, a prima facie case of unpatentability of a claim, but also to information that refutes or is inconsistent with a position the applicant takes involving the claimed subject matter.
Each individual with a duty to disclose should review documents it receives or discovers related to communications with other government agencies, such as the FDA, to determine whether the information should be submitted to the USPTO. For example, if a party to a USPTO proceeding discovers that an earlier position taken in a submission to the USPTO or another government agency was incorrect or inconsistent with other statements made by the party, the party must promptly correct the record. Patent application and patent owners may bring material information, including incorrect or inconsistent positions, to the attention of the USPTO through information disclosure statements, supplemental examination, ex parte reexamination, reissue applications, or post-issuance submissions under 37 CFR 1.501.
Duty of Reasonable Inquiry
Any party presenting a paper to the USPTO (e.g., by signing, filing, submitting, or later advocating), whether a practitioner or non-practitioner, has a duty to perform an inquiry that is reasonable under the circumstances to ensure, for example, that the paper is not being presented for any improper purpose, the allegations and other factual contentions have evidentiary support, and the denials of factual contentions are warranted on the evidence.4 The duty of reasonable inquiry may include reviewing documents that are submitted to or received from the FDA or other government agencies. If such documents reviewed include information that is material to the patentability of a pending matter before the USPTO, the party must submit the relevant information to the USPTO. Walling off the patent practitioners from those involved in FDA regulatory submissions as a way to prevent patent practitioners from obtaining knowledge of material information is inappropriate.
The reasonable inquiry may comprise reviewing:
- prior art submitted to the FDA or other government agencies, including prior art that may be included in an investigational new drug (IND) application, new drug application (NDA), biologics license application (BLA), application for an investigational device exemption (IDE), 510(k) premarket notification, De Novo classification request, or a premarket approval application (PMA);
- assertions made to the FDA that a product is the same as a previously approved or marketed product to take advantage of the approval pathway under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act;5
- assertions made to the FDA that a particular diagnostic test would predictably indicate if, for example, a drug would be effective;
- information and/or documents provided in a Paragraph IV certification; and
- activities or documents associated with market testing, marketing, or commercialization by the patent applicant.
Potential Outcomes of Failure to Satisfy the Duties of Disclosure and/or Reasonably Inquire
A finding of "fraud," "inequitable conduct," or violation of duty of disclosure through bad faith or intentional misconduct with respect to any claim in an application or patent renders all the claims unpatentable or unenforceable.6 When presenting a paper to the USPTO, failing to inquire when the circumstances warrant it could result in sanctions or other action by the USPTO under 37 CFR 11.18(c), including: (1) striking the offending paper; (2) referring a practitioner's conduct to the Director of Enrollment and Discipline for appropriate action; (3) precluding a party or practitioner from submitting a paper, or presenting or contesting an issue; (4) affecting the weight given to the offending paper; or (5) termination of proceedings before the USPTO.
Depending on the facts and circumstances, making false or misleading statements to the FDA or other government agencies can result in significant liabilities, fines, penalties, and other actions by applicable agencies, including debarment, exclusion or disqualification by the agency, or revocation of any applicable approval, clearance, or authorization granted by the FDA, under the False Claims Act and the FDA's policy on Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities, among others.
Practical Considerations
Patent applicants should use caution when they downplay the differences between an investigational product and a previously approved or marketed product in order to expedite regulatory review when seeking FDA approval (e.g., when making arguments before the FDA regarding same or substantially similar safety or efficacy profile or substantial equivalence to a marketed product), while emphasizing the differences or unexpected results before the USPTO to obtain a patent. While what is material to patentability is a fact-specific analysis and depends on the scope of the patent sought, applicants should carefully consider whether their positions or strategies before different agencies could be viewed as inconsistent and material to the patentability by the USPTO.
This Notice highlights the importance of taking a more holistic or interdisciplinary approach that considers the applicant's therapeutic development strategies and positions with different government agencies, and that distinguishes and navigates (rather than obfuscates) the FDA's regulatory standards for approval and the USPTO's standards for patentability. Having proper coordination and open communication between patent teams and regulatory specialists who handle communications with the FDA and other government agencies are important for ensuring that statements made to the USPTO are consistent with those made to other government agencies and that information material to patentability are shared timely with individuals who have such duties before the USPTO. Those with such duties before the USPTO should also consider more broadly about all channels through which information material to patentability may be submitted or discussed with government agencies, including information associated with research and discovery, preclinical and clinical development, regulatory review and approval, manufacturing, grant applications, and marketing, and conduct a reasonable inquiry as appropriate.
For More Information
For questions regarding patent or FDA regulatory matters, disclosures, and strategy, please contact any member of Wilson Sonsini's patents and innovations practice and/or Wilson Sonsini's FDA regulatory, healthcare, and consumer products practice.
[1] Letter from Senator P. Leahy and Senator T. Tillis to Andrew Hirshfeld, USPTO Performing the Functions and Duties of Director (September 9, 2021), available at https://www.leahy.senate.gov/imo/media/doc/20210909%20Letter%20to%20PTO%20on%20FDA%20submissions.pdf.
[2] USPTO, Notice, Duties of Disclosure and Reasonable Inquiry During Examination, Reexamination, and Reissue, and for Proceedings Before the Patent Trial and Appeal Board, 87 Fed. Reg. 45764 (July 29, 2022), available at https://www.govinfo.gov/content/pkg/FR-2022-07-29/pdf/2022-16299.pdf.
[5] FDA approval process under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act refers to an NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant, including data from publications, and for which the applicant has not obtained a right of reference. The 505(b)(2) pathway is significantly shorter than an NDA submitted under section 505(b)(1), which contains full reports of investigations of safety and effectiveness.
