On July 29, 2022, the United States Patent and Trademark Office (USPTO) issued a Notice by Director Kathy Vidal that may be relevant to those seeking or holding patents on medical devices that require Food and Drug Administration (FDA) approval. The Notice relates to certain duties owed to the USPTO with regard to statements and documents submitted to the FDA and other government agencies. The duties include a duty to disclose certain information and a duty of reasonable inquiry.
The Notice states “[t]he duty of candor and good faith in dealing with the USPTO includes the duty to disclose to the USPTO information material to the patentability of a claimed invention.” Further, “[e]ach party submitting a paper to the USPTO has an additional duty to perform an inquiry that is reasonable under the circumstances, including reviewing documents to identify information that is material to the patentability of a claimed invention.” The Notice states it “is intended to clarify the duties, including as to materials or statements material to patentability or statements made to the USPTO that are inconsistent with statements submitted to the FDA and other governmental agencies.”
The Notice was issued against the backdrop of an Executive Order by President Biden regarding competition in the economy, specifically in the pharmaceutical industry. Additionally, U.S. Senators sent a letter to the USPTO requesting “that the Office ‘take steps to reduce patent applicants’ making inappropriate conflicting statements in submissions to the [USPTO] and other federal agencies.'” Regarding the letter, the Notice further states:
The letter provided a specific example in which “inconsistent statements submitted to the Food and Drug Administration (FDA) to secure approval of a product—asserting that the product is the same as a prior product that is already on the market— can then be directly contradicted by statements made to the [USPTO] to secure a patent on the product.” The Letter noted that such inconsistent statements “should be cause for rejecting the application and, when made knowingly and with bad intent, potentially other sanctions.”
Against this background, the Notice states it “is part of the USPTO’s efforts to put into effect the Administration’s goals and address the Senators’ concerns.”
The Notice thus discusses which parties have a duty to disclose information to the USPTO in various patent examinations and proceedings, and what material information must be disclosed. For example, the duty to disclose “applies to positions taken by applicants or parties involving the claimed subject matter. For instance, in PTAB proceedings, parties should not take a position about the patentability of challenged claims that is inconsistent with positions taken in submissions to other Government agencies regarding the same subject matter.” An example PTAB proceeding is cited which resulted in “suspending a practitioner for four years for failure to correct the written record after learning of inaccuracies in a declaration the practitioner had filed.” The Notice discusses similar duties in the context of patent examination and prosecution.
In addition to the duty to disclose, the Notice discusses the duty of reasonable inquiry and when these two duties arise in dealings with other government agencies besides the USPTO. For example, the Notice cites a Federal Circuit decision “affirming a district court’s determination of inequitable conduct because the patent owner’s Chief Science Officer failed to provide to the USPTO submissions he made to the FDA about the prior art that were inconsistent with positions taken before the USPTO during the prosecution of a pending patent application.” In another case, the Federal Circuit “inferred intent to deceive and found inequitable conduct occurred when an official involved in both the FDA and the USPTO submissions chose to disclose material prior art to the FDA but not to the USPTO.”
The Notice provides further detail on these and other relevant issues, and the full text may be found here.
