Disclosure and reasonable investigative duties before the USPTO may include communications with the FDA and other government agencies


Spurred by President Biden’s call to action to increase drug competition and a 2021 letter to the United States Patent and Trademark Office (USPTO) from Senators Leahy and Tillis asking the USPTO “to take steps to require applicants to disclose relevant statements they have made to other bodies regarding inventions discussed in their patent applications or prior art that is applied in the examination process patents, “1 the USPTO recently published a notice2 which clarifies the duties of disclosure and reasonable inquiry, which may relate to information submitted to the United States Food and Drug Administration (FDA) and other government agencies that is material to the patentability of a claimed invention.

Disclosure requirement

The duty to disclose3 applies to matters pending before the USPTO and extends broadly to each inventor and anyone substantially involved in matters pending before the USPTO, including in connection with the preparation or prosecution of a patent application, a re-examination proceeding, an application for reissue or a before the Patent Trial and Appeal Board. The duty to disclose does not apply only to information that establishes, by itself or in combination with other information, a At first glance case of non-patentability of a claim, but also to information that refutes or is inconsistent with a position taken by the applicant concerning the claimed subject matter.

Each person with a duty to disclose should review documents they receive or discover 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 a prior position taken in a communication to the USPTO or another government agency was incorrect or inconsistent with other statements made by the party, the party must quickly correct the file. The patent application and patentees may bring important information, including incorrect or inconsistent positions, to the attention of the USPTO through information disclosure statements, additional review, ex parte re-examination, reissue requests, or post-grant submissions under 37 CFR 1.501.

Reasonable investigation duty

Any party presenting a document to the USPTO (for example, by signing, filing, submitting, or later defending), whether a practitioner or non-practitioner, has a duty to to make a reasonable inquiry in the circumstances to ensure, for example, that the document is not presented for an improper purpose, that the allegations and other factual assertions are supported by evidence and that denials of factual assertions are justified by the evidence.4 The reasonable investigative duty may include reviewing documents that are submitted or received from the FDA or other government agencies. If these documents under review include information material to the patentability of a matter pending before the USPTO, the party must submit the relevant information to the USPTO. Separating patent practitioners from those involved in FDA regulatory submissions as a means of preventing patent practitioners from obtaining material information is inappropriate.

Reasonable inquiry may include examining:

  • prior art submitted to the FDA or other government agencies, including prior art that may be included in an investigational new drug application (IND), new drug application (NDA), license application (BLA), Investigational Device Exemption (IDE) Request, 510(k) Premarket Notification, De Novo Classification Request, or Premarket Approval (PMA) Request;
  • claims made to the FDA that a product is identical to a product previously approved or marketed to take advantage of the Federal Food, Drug, and Cosmetic Section 505(b)(2) approval pathway Act;5
  • claims made to the FDA that a particular diagnostic test would predict in a predictable way whether, for example, a drug would be effective;
  • the information and/or documents provided in a Paragraph IV certificate; and
  • activities or documents associated with market testing, marketing or commercialization by the patent applicant.

Potential Consequences of Failure to Comply with Disclosure and/or Reasonable Inquiry Obligations

A finding of “fraud”, “unfair conduct”, or breach of duty of disclosure in bad faith or willful misconduct with respect to any claim in an application or patent renders all claims unpatentable or unenforceable.6 When submitting a document to the USPTO, failure to ask when circumstances warrant could result in sanctions or other action by the USPTO under 37 CFR 11.18(c), including: (1) deleting the offending document; (2) refer a practitioner’s conduct to the Director of Registration and Discipline for appropriate action; (3) prevent a party or practitioner from submitting an article, or presenting or challenging a question; (4) affecting the weight given to the offending paper; or (5) termination of the proceeding before the USPTO.

Depending on the facts and circumstances, making false or misleading statements to the FDA or other government agencies may result in significant liabilities, fines, penalties, and other actions by the relevant agencies, including debarment, exclusion or disqualification by the agency, or revocation of any applicable approval, clearance, or clearance granted by the FDA, under the False Claims Act and the FDA Fraud Policy , misrepresentation of material facts, bribery and illegal tipping, among others.

Practical Considerations

Patent applicants should exercise caution when minimizing differences between an investigational product and a previously approved or marketed product in order to expedite regulatory review when seeking FDA approval (for example, when they present arguments to the FDA concerning an identical or substantially similar safety or efficacy profile or substantial equivalence to a marketed product), while insisting on differences or unexpected results before the USPTO to obtain a patent. Although what matters for patentability is a factual analysis and depends on the scope of the patent sought, applicants should carefully consider whether their positions or strategies before different agencies might be considered inconsistent and material to patentability by the USPTO.

This review highlights the importance of adopting a more holistic or interdisciplinary approach that takes into account the applicant’s therapeutic development strategies and positions with different government agencies, and that distinguishes and navigates (rather than obscures) regulatory standards of FDA approval and USPTO patentability standards. It is important to have good coordination and open communication between patent teams and regulatory specialists who handle communications with the FDA and other government agencies to ensure that statements made to the USPTO are consistent with those made to other government agencies and that patentability information is shared in a timely manner. with people who have such functions before the USPTO. Those in such positions before the USPTO should also consider more broadly all channels through which patentability information may be submitted or discussed with government agencies, including information associated with research and discovery, development preclinical and clinical, regulatory review and approval, manufacturing, grant applications and marketing, and conduct reasonable investigation as appropriate.

For more information

For questions regarding patent or FDA regulatory matters, disclosures and strategy, please contact a member of Wilson Sonsini’s patents and innovations practice and/or Wilson Sonsini FDA Regulatory, Health, and Consumer Products practice.

[1] Letter from Senator P. Leahy and Senator T. Tillis to Andrew Hirshfeld, USPTO Performing Duties 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.

[3] 37 CFR § 1.56.

[4] 37 CFR § 11.18.

[5] The FDA approval process under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act refers to an NDA in which at least some of the information required for the approval come from studies not carried out by or for the applicant, including data from publications, and for which the applicant has not obtained the right to reference. The 505(b)(2) track is significantly shorter than an NDA submitted under section 505(b)(1), which contains comprehensive safety and efficacy investigation reports.

[6] MPEP § 2016.


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