On July 29, 2022, the U.S. Patent and Trademark Office (USPTO) issued a Notice in the Federal Register clarifying the duty of disclosure that may keep patent practitioners up at night. The Notice reminds applicants of the duties of disclosure and “reasonable inquiry” for proceedings before the USPTO or Patent Trial and Appeal Board (PTAB). It is an outgrowth of President Biden’s 2021 Executive Order on Promoting Competition in the American Economy, in which the acting U.S. Food and Drug Administration (FDA) Commissioner wrote to the acting USPTO Director highlighting numerous areas in which the USPTO and FDA could work together to reduce drug costs.
In particular, the Notice emphasized the duty to disclose material information and statements from communications with the FDA. Companies that make submissions to both the USPTO and the FDA, such as pharmaceutical companies and medical device manufacturers, should pay special attention to the Notice.
Disclosing Information Received from the FDA
As part of an abbreviated new drug application (ANDA), generics can provide arguments that patents covering the innovator drug are invalid in a Paragraph IV certification. The Paragraph IV certifications are then communicated to the patent owners by the FDA.
The duty of “reasonable inquiry” under 37 C.F.R 11.18(b)(2) requires that each party submitting a paper to the USPTO perform an inquiry that is reasonable under the circumstances to confirm the accuracy and consistency of statements made therein, but does not detail what is involved in a reasonable inquiry.
The Notice now expressly clarifies that the duty of reasonable inquiry includes reviewing paragraph IV certifications received by patent owners to determine their materiality to patentability of any pending matters before the USPTO. “If the content of the detailed statement, or other information that is part of the ANDA process, is deemed material to patentability in a pending USPTO matter, then such information must be submitted to the USPTO during the pendency of the matter, to meet the duties of candor and good faith and disclosure under 37 CFR 1.56, 1.555, 42.11(a) or (c), or 11.18(b)(2),” the Notice states.
Additionally, the Notice warns that merely submitting the FDA’s listing of paragraph IV certifications to the USPTO does not satisfy the duty of disclosure, since these lists “do not include patent numbers, relevant claims, or an explanation of the basis for the certification.”
Importance of Consistency in Statements Before the USPTO and FDA
The Notice underscores the importance of consistency in statements made before the USPTO and the FDA. Specifically, the Notice states that “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.”
A recent Federal Circuit decision, Belcher Pharmaceuticals v. Hospira (Fed. Cir. Sept. 1, 2021), was cited as an 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.”
In Belcher, the Federal Circuit affirmed a district court’s ruling that a patent covering a formulation of the drug epinephrine is unenforceable due to inequitable conduct. In a new drug application (NDA) filed with the FDA, Belcher’s Chief Scientific Officer had submitted several prior art references disclosing an “old” pH range for the epinephrine formulation. During prosecution before the USPTO, however, Belcher failed to disclose the references submitted to the FDA, and argued that the claims were patentable because the same pH range was “was unexpectedly found to be critical by the Applicant to reduce the racemization of l-epinephrine.”
Belcher illustrates the key tension between relying on existing information for regulatory approval and establishing novelty and non-obviousness for patentability purposes. Parties involved in proceedings before the USPTO or PTAB that are seeking FDA approval should take special care to ensure consistency and coordination of strategies.
As part of the duty of reasonable inquiry, parties should ensure that information and statements received from or submitted to the FDA are reviewed by both FDA regulatory counsel and patent counsel for potential materiality to patentability and disclosure to the USPTO or PTAB. This duty cannot be avoided by deliberate schemes to prevent individuals with the duty of disclosure from obtaining knowledge of material information, which the Notice indicates is “inappropriate.”
Finally, parties should err on the side of disclosure to avoid allegations of inequitable conduct. As stated in the Manual of Patent Examining Procedure and reiterated in the Notice, “[in] close cases where the materiality or consistency of the information is in question, the applicant should consider submitting this information to the USPTO.” Given the significant leadership attention this topic has received at both the FDA and the USPTO, and the political pressure on both agencies to assist in the Biden administration’s efforts to reduce drug costs, the FDA and USPTO are likely both considering enforcement tools that may be employed to ensure appropriate disclosures.