On July 29, 2022, the United States Patent and Trademark Office (USPTO) published a notice titled "Duties of Disclosure and Reasonable Inquiry During Examination, Reexamination, and Reissue, and for Proceedings Before the Patent Trial and Appeal Board." The notice was issued in relation to a 2021 Executive Order on Promoting Competition in the American Economy, which aimed to help ensure that the patent system, while incentivizing innovation, does not also unjustifiably delay generic drug and biosimilar competition. The notice specifically addresses the duties of candor and good faith, and by extension the duty of disclosure, in dealing with the USPTO in the pharmaceutical space, and the applicability of these duties to materials or statements presented to the USPTO relating to patentability, including those which are inconsistent with submissions to the Food and Drug Administration (FDA) and other governmental agencies.
In the notice, the USPTO specified that the duty of disclosure extends broadly to named inventors, assignees, attorneys, and agents associated with the filing and prosecution of a patent application or in a reexamination proceeding. The duty also extends to parties and individuals involved in Patent Trial and Appeal Board (PTAB) proceedings.
The notice explains that the information subject to mandatory disclosure includes that which is material to patentability and has not been made of record in the application. This includes information that contributes to establishing a prima facie case of unpatentability of a claim. It also includes information that refutes or presents an inconsistency with an applicant's position opposing an argument of unpatentability relied on by the Office or asserting an argument of patentability. The USPTO emphasized that it will hold individuals who are subject to this duty "to the highest standards." Failure to timely correct an incorrect or inconsistent statement may amount to a finding of "fraud," "inequitable conduct," or violation through bad faith or intentional misconduct, and could render all involved patent claims invalid.
Moreover, the notice empowers patent examiners to request and require submission of information which may not be directly material to patentability itself, but may be necessary to obtain a complete record for the determination of patentability. The examiner can make such a request when they have a "reasonable basis" To conclude there is information that would aid in the examination of the application. As one example provided in the notice, during the examination of a claim directed to a process of manufacturing a drug which was effectively filed more than one year after FDA approval, the USPTO may request that the applicant produce information submitted to the FDA (e.g., in a New Drug Application or Biologics License Application) relating to the drug's manufacturing.
In addition to the duty of disclosure, the notice indicates that parties who present documents to the USPTO must also abide by the additional duty to perform an inquiry that is reasonable under the circumstances. For pharmaceutical patents, the reasonable inquiry may comprise reviewing documents submitted to or received from the FDA which are related to patent applications, reexamination proceedings, or pending issues before the PTAB. Failure to inquire under reasonable circumstances may result in disciplinary sanctions, striking of the offending documents from the Office's consideration, or termination of the proceedings.
Both the duty of disclosure and duty of reasonable inquiry come into play when a generic drug company seeks FDA approval through an Abbreviated New Drug Application (ANDA). For instance, each ANDA must contain a "paragraph IV certification" that the brand-name drug patents listed in the FDA's Orange Book are unenforceable, are invalid, or will not be infringed by the generic counterpart. As part of the duty of reasonable inquiry, the notice suggests that the party receiving the paragraph IV certification or other information relevant to the ANDA process should determine if it would be material to patentability in a pending USPTO matter. Upon making a determination that the information is material to patentability in a pending USPTO matter, the party should then submit the full paragraph IV certification (i.e., not merely its listing on the FDA website) and other material information to the USPTO during the pendency of the matter to fulfill the duties of candor, good faith, and disclosure.
Finally, the notice cautions against "deliberate schemes or established practices" which are designed to prevent individuals from obtaining knowledge of material information, such as "walling off" the patent prosecution practitioners from the attorneys seeking FDA approval to block the exchange of information. Such deliberate steps to suppress material information may lead to denial of patent enforceability by the courts.
Readers are encouraged to read the notice, also available on the Federal Register's website.
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