Disclosure requirements and appropriate investigations before the USPTO may include communications with the FDA and other government agencies | Panda Anku

Spurred on by President Biden’s call to increase drug competition and a 2021 letter from Senators Leahy and Tillis to the United States Patent and Trademark Office (USPTO), urging the USPTO to “take action to… to require applicants to disclose relevant statements they have made to other agencies about inventions discussed in their patent applications or about the prior art used in the patent examination process,”1 the USPTO recently issued a notice2 clarifying disclosure and due investigation obligations that may relate to information submitted to the U.S. Food and Drug Administration (FDA) and other governmental agencies that is relevant to the patentability of a claimed invention.

duty of disclosure

The duty to inform3 applies to matters pending before the USPTO and extends broadly to any inventor or person materially interested in matters pending before the USPTO, including in connection with the preparation or prosecution of a patent application, reexamination, reissuance application, or a Proceedings before the Patent Trial and Appeal Board. The disclosure obligation does not only apply to information which, alone or in combination with other information, establishes a prima facie in the case of non-patentability of a claim, but also for information which refutes or is inconsistent with an applicant’s position on the claimed subject-matter.

Any person subject to disclosure requirements should review documents they receive in connection with communications with other government agencies, such as B. the FDA, received or discovered to determine whether the information should be submitted to the USPTO. For example, if a party to a USPTO proceeding determines that a prior position taken in a submission to the USPTO or other governmental agency was incorrect or inconsistent with other statements made by the party, the party must promptly correct the record. A patent application and patentee may provide the USPTO with material information, including erroneous or conflicting positions, through disclosure statements, supplemental examination, ex parte re-examination, re-issuance of applications or submissions after issuance in accordance with 37 CFR 1.501.

duty of due investigation

Any party that submits a paper to the USPTO (e.g., by signing, filing, filing, or later endorsement), whether a practitioner or non-practitioner, is required to conduct an investigation reasonable in the circumstances in order to For example, to ensure that: the paper is not presented for improper purposes, the allegations and other factual claims are supported by evidence, and the rejection of factual claims is justified by the evidence.4 The obligation to conduct an appropriate investigation may include reviewing documents submitted to or received from the FDA or other governmental agencies. If such examined documents contain information essential to the patentability of a matter pending with the USPTO, the party must file the relevant information with the USPTO. Isolating patent attorneys from those involved in FDA submissions to prevent patent attorneys from knowing material information is unreasonable.

Appropriate investigation may include:

  • Prior art filed with the FDA or other governmental agencies, including prior art identified in an Investigational Drug Application (IND), New Drug Application (NDA), Biologics Marketing Authorization Application (BLA), an application for an investigational medicinal product exemption (IDE), 510(k) premarket notification, de novo classification application, or application for premarket approval (PMA);
  • Claims to the FDA that a product is identical to a previously approved or marketed product in order to use the approval pathway under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act;5
  • Claims to the FDA that a particular diagnostic test would predictably indicate whether, for example, a drug would be effective;
  • Information and/or documents provided in a Section IV Certificate; and
  • Activities or documents related to market testing, marketing or commercialization by the patent applicant.

Possible consequences of failure to comply with disclosure and/or reasonable investigation requirements

A determination of “fraud,” “improper conduct,” or breach of disclosure through bad faith or willful misconduct with respect to any claim in an application or patent renders any claim unpatentable or unenforceable.6 When submitting a paper to the USPTO, failure to inquire when circumstances warrant may result in sanctions or other action by the USPTO under 37 CFR 11.18(c), including: (1) deletion of the offending paper; (2) Referring a practitioner’s conduct to the Director of Enrollment and Discipline for appropriate action; (3) barring any party or practitioner from filing a paper or presenting or contesting an issue; (4) affecting the weight attached to the paper in question; or (5) termination of proceedings before the USPTO.

Depending on the facts and circumstances, making false or misleading statements to the FDA or other governmental agencies may result in significant liability, fines, penalties, and other actions by the applicable authorities, including expulsion, debarment, or disqualification by the authority or the revocation of applicable approvals, Authorizations or authorizations granted by the FDA pursuant to, among other things, the False Claims Act and the FDA Policy on Fraud, Misrepresentation of Material Facts, Bribery and Illegal Benefits.

Practical Considerations

Patent applicants should exercise caution in downplaying the differences between an investigational product and a previously approved or marketed product to expedite regulatory review when seeking FDA approval (e.g., substantial equivalence to a marketed product), while the differences or unexpected results before the USPTO to obtain a patent. While what is essential to patentability is a fact-specific analysis and depends on the scope of the patent being applied for, applicants should carefully consider whether their positions or strategies before different agencies could be considered conflicting and essential to patentability by the USPTO.

This communication underscores the importance of a more holistic or interdisciplinary approach that considers the applicant’s therapeutic development strategies and positions with various governmental agencies, and that distinguishes and navigates (rather than obscures) the FDA’s regulatory standards for approval and the USPTO’s standards for patentability . Proper coordination and open communication between patent teams and regulatory specialists who handle communications with the FDA and other government agencies are important to ensure that statements made to the USPTO are consistent with those made to other government agencies and that patentability information is available is shared in a timely manner with persons who have such duties before the USPTO. Those with such USPTO duties should also give more thought to all channels through which patentability information material may be submitted or discussed with government agencies, including information related to research and discovery, preclinical and clinical development, regulatory review and approval, manufacturing, grant applications and marketing and, if necessary, will conduct an appropriate investigation.

For more informations

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’s FDA regulatory, healthcare and consumer products work out.

[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, Dutys of Disclosure and Reasonable Inquiry during Examination, Reexamination, and Reissue, and for Proceedings Before the Patent Trial and Appeal Board, 87 Fed. Registration number. 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 where at least some of the information required for approval comes from studies not conducted by or for the applicant including data from publications for which the applicant has not obtained reference rights. The 505(b)(2) trail is significantly shorter than a Section 505(b)(1) NDA that includes full reports of safety and efficacy studies.

[6] MPEP § 2016.


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