Alert August 18, 2022

The USPTO’s Increasing Focus on FDA Submissions and the Duty of Disclosure

The United States Patent and Trademark Office (USPTO) imposes a Duty of Disclosure, Candor and Good Faith (Duty of Disclosure) on all individuals associated with the filing and prosecution of a patent application before the USPTO. This Duty requires that these individuals disclose to the USPTO any information known to them that is material to the prosecution of a patent application. The USPTO has recently clarified that the Duty of Disclosure includes disclosure of statements made to other governmental agencies (e.g., the FDA) that are inconsistent with disclosures made to the USPTO. Further, Congress is currently considering a bill that that will enable USPTO examiners to access relevant public and non-public information submitted to the Food and Drug Administration (FDA). 

Duty of Disclosure, Candor and Good Faith

Commonly, the Duty of Disclosure is understood to apply to third party references published prior to the earliest filing date of an application (“prior art”). The Duty of Disclosure also includes a duty to disclose any known public disclosures (e.g., talks, poster presentations, offer to sell, etc.) of the claimed inventions, when such disclosures are made prior to the earliest filing date of an application.

However, the Duty of Disclosure applies more broadly. The Duty requires disclosure of information that “establishes, by itself or in combination with other information, a prima facie case of unpatentability of a claim; or … refutes, or is inconsistent with, a position the applicant takes in: (i) opposing an argument of unpatentability relied on by the Office, or (ii) asserting an argument of patentability.”1

On September 9, 2021, Senators Leahy and Tillis wrote to the Director of the PTO expressing concern that applicants were not fully complying with the Duty of Disclosure.2 “Unfortunately, it has come to our attention that some patent applicants may, in certain circumstances, make significantly different statements in submissions to other federal agencies that conflict directly with those made at the U.S. Patent and Trademark Office (PTO).” Specifically, the letter was concerned that statements to the FDA in support of drug approval (e.g., asserting that a drug product is the same as a prior product already approved) can directly contradict statement made to the USPTO is support of patentability (e.g., asserting that a claimed molecule or formulation or use is innovative). Disclosure to the FDA are often made in confidential submissions or can be difficult to identify. Without the patent applicant disclosing these statements, Senators Leahy and Tillis were concerned that patent examiners might not be aware of any contradictory statements made to the FDA, though such statements would material to patentability because they relate to positions an applicant has taken with respect to patentability.  

USPTO Guidance of July 29, 2022

On July 29, 2022, the USPTO responded to the concerns of Senators Leahy and Tillis by issuing new guidance on the Duty of Disclosure - Duties of Disclosure and Reasonable Inquiry During Examination, Reexamination, and Reissue, and for Proceedings Before the Patent Trial and Appeal Board (the “Notice”).3 As stated by the Notice, “providing material information to other Government agencies, including the FDA, while simultaneously withholding the same information from the USPTO undermines both the intent and spirit of the duty of disclosure and violates those duties.”

The Notice makes it explicit that “if a party to a USPTO proceeding discovers that an earlier position taken in a submission to … another Government agency was incorrect or inconsistent with other statements made by the party, the party must promptly correct the record. . . . In the context of prosecution, an applicant must disclose to the USPTO any information that refutes, or is inconsistent with, a position the applicant takes in: (i) opposing an argument of unpatentability relied on by the Office, or (ii) asserting an argument of patentability.” The Notice specifies that this duty to correct the record applies during active prosecution of a patent application and after a patent has issued. In the latter situation, a patent owner has the option of using supplemental examination, ex parte reexamination, reissue applications, or submissions under 37 CFR 1.501.

With respect to applicants prosecuting patent claims that cover a paragraph IV certified drug product, the Notice states that “to assist USPTO staff in evaluating patentability effectively and efficiently, the party receiving a paragraph IV certification should review such documents to determine whether they are material to the patentability of any pending matters before the USPTO, such as pending patent applications, reexamination proceedings, or issues in proceedings pending before the PTAB.”

As part of patent life cycle management, companies will often file patent applications around the method of manufacturing a therapeutic agent. Specifically with respect to such claims, the Notice specifies that “[W]hen examining a claim directed to a process of manufacturing a particular drug product that was effectively filed more than one year after FDA approval of the drug product, an examiner may appropriately require an applicant to submit to the USPTO information submitted to the FDA (e.g., in a New Drug Application or Biologics License Application) on how the drug product was manufactured.”

The Notice also emphasizes that anyone involved in the filing or prosecution of a patent application has a “duty of inquiry.” The Notice specifies that ‘[e]ach party presenting a paper to the USPTO… has a duty to perform an inquiry that is reasonable under the circumstances. This reasonable inquiry may comprise reviewing documents that are submitted to or received from other Government agencies, including the FDA.” The duty of inquiry requires that the relevant parties “ensure that the statements made to the USPTO and other Government agencies, or any statements made on their behalf to other Government agencies regarding the claimed subject matter, are consistent.” Thus, it seems that the duty of inquiry could potentially arise for a patent application or patent that corresponds to a product under government regulatory review. 

The Interagency Patent Coordination and Improvement Act of 2022

Shortly before the USPTO Guidance of July 29, 2022 was issued, Senator Richard Durbin (on behalf of himself and Senators Tillis, Grassley, Leahy, Coons, and Cornyn) introduced the Interagency Patent Coordination and Improvement Act of 2022.4 This bill is likewise targeted to ensuring that USPTO examiners receive information submitted to the FDA which is material to patentability. 

The Bill requires the establishment of an interagency task force “to coordinate efforts between the Director [of the USPTO] and the Commissioner of [the FDA] … regarding communication about, evaluation of, and effective implementation of the activities of the [USPTO] and the [FDA] with respect to patents, and decisions or actions involving patents …for human drugs and biological products.” 

The interagency task force will proactively “share information on new approvals of patents, human drugs and biological products, new technologies and prior art (as appropriate on a case-by-case basis), and scientific trends and developments.” Further, the interagency task force will establish a process to enable USPTO examiners to access potentially material information (public and non-public) related to patent applications they are examining (including, updates to a label or newly approved indications). 

Recommendations 

We recommend that companies consider establishing internal processes that will proactively connect relevant individuals with material submitted to the FDA. Further, companies with programs currently before the FDA might consider reviewing their submissions for consistency with positions taken with the USPTO in “(i) opposing an argument of unpatentability relied on by the Office, or (ii) asserting an argument of patentability.”


[1]MPEP 2100.05
[2]www.leahy.senate.gov/imo/media/doc/20210909%20Letter%20to%20PTO%20on%20FDA%20submissions.pdf
[3]https://www.federalregister.gov/documents/2022/07/29/2022-16299/duties-of-disclosure-and-reasonable-inquiry-during-examination-reexamination-and-reissue-and-for
[4]https://www.congress.gov/bill/117th-congress/senate-bill/4430/text