Consider a familiar device-company scenario. A regulatory team prepares a 510(k) and tells FDA that a design feature tracks a predicate device, is supported by familiar engineering literature, and does not raise new questions of safety or effectiveness. Around the same time, the patent team argues to the USPTO that the same feature, or a particular implementation of it, is central to novelty or nonobviousness. Each position may be defensible. The risk begins when no one has put the two records next to each other and asked whether the factual premise behind both can be reconciled.

That operational gap is the focus of this post. Medical device companies routinely pursue FDA clearance or approval while building patent protection. The two systems serve different purposes, but they often draw from the same technical record, the same subject matter experts, and the same internal document universe. When those inputs are handled in silos, the company may create a side-by-side record that is difficult to defend later, even if no one set out to mislead either agency.

USPTO risk: Rule 56 and inequitable conduct

On the patent side, the starting point is the duty of candor and good faith. Patent applicants, and individuals substantively involved in prosecution, must disclose to the USPTO information known to be material to patentability. (37 C.F.R. § 1.56(a).) A breach can support inequitable conduct if the record establishes both materiality and a specific intent to deceive the USPTO. (Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276, 1287 (Fed. Cir. 2011) (en banc).) The fact pattern can include nondisclosure of material information, affirmative misrepresentations, or submission of false information, coupled with an intent to mislead the examiner. (Purdue Pharma L.P. v. Endo Pharms., Inc., 438 F.3d 1123, 1133-35 (Fed. Cir. 2006).)

FDA submissions often become natural inputs to that Rule 56 review. A regulatory file may collect comparative literature, predicate-device descriptions, testing summaries, and statements about what is already known, conventional, comparable, or supported by prior work. Those materials are not automatically material to patentability. But they are exactly the kind of materials patent counsel should see before arguing that a technical feature is novel, nonobvious, unexpected, or claim-defining. The risk increases when the same engineers, regulatory personnel, or executives contribute to both tracks. In later litigation, the FDA record can become evidence of knowledge, relevance, and access.

Inequitable conduct remains a demanding doctrine, not a strict-liability trap. The accuser bears the burden to prove both materiality and deceptive intent by clear and convincing evidence. (Therasense, 649 F.3d at 1287.) Courts also emphasize that intent cannot be inferred solely from nondisclosure. There must be a factual basis supporting a deliberate decision to deceive. (M. Eagles Tool Warehouse, Inc. v. Fisher Tooling Co., 439 F.3d 1335, 1340-41 (Fed. Cir. 2006); Purdue Pharma, 438 F.3d at 1134-35.) That is why process matters. A company that can show it captured FDA-facing materials, routed them through a contemporaneous materiality assessment, and recorded the outcome is in a much better position than a company forced to reconstruct its thinking years later. (M. Eagles, 439 F.3d at 1340-41.)

Why courts treat FDA-to-USPTO omissions as a red flag: Bruno

Bruno Independent Living Aids remains the classic device example, and the facts are more useful than the shorthand. Bruno sought FDA authorization to sell the SRE-1500 stairlift while it was prosecuting the patent application that became the ’405 patent. In the FDA submission, Bruno characterized the SRE-1500 as similar in design and function to existing stairlift units and enclosed product information on the Wecolator/Weckalator stairlift. The

Wecolator information did not make its way to the USPTO.

That omission mattered because Bruno was also trying to distinguish its claims over the prior art. The later-issued claim 15 included a front-offset swivel-seat limitation, and Bruno argued to the examiner that the feature supplied advantages not taught or suggested by the cited references. The undisclosed Wecolator information cut directly across that point: the record showed an optional seat assembly with an off-center swivel that provided similar advantages. The Federal Circuit also emphasized that Bruno’s Director of Engineering, William Belson, was involved in the FDA submission and in the patent work, including prior-art-search efforts. (Bruno Independent Living Aids, Inc. v. Acorn Mobility Services, Ltd., 394 F.3d 1348 (Fed. Cir. 2005).)

The lesson is not that every FDA enclosure must be dumped into an IDS. That reflexive approach produces noise and can obscure the genuinely important material. The practical lesson is narrower and more uncomfortable: if a company gives FDA a document showing that the allegedly inventive feature already existed in a comparable product, and the patent team never evaluates that document, the company has created exactly the exhibit a later accused infringer wants. In Bruno, the absence of a credible good-faith explanation for treating the FDA and USPTO records differently was central to the inequitable-conduct and exceptional-case findings. (277 F. Supp. 2d 965 (W.D. Wis. 2003); 394 F.3d 1348 (Fed. Cir. 2005).)

Practical mitigation: a regulatory-to-patent disclosure pipeline

The best mitigation is a controlled disclosure pipeline, not indiscriminate over-disclosure. Companies usually get this wrong by treating Rule 56 review as an end-of-prosecution housekeeping task, after the regulatory story has already been written and the patent story has already hardened. By then, the useful question - what did we tell FDA about this feature, and does it matter to patentability? - may be asked too late.

A workable pipeline has three parts. First, FDA submissions and their supporting literature, predicate comparisons, test reports, and technical summaries should reliably reach patent counsel. Second, those materials should be reviewed under Rule 56 with attention to the actual patentability positions being advanced. Third, when disclosure is appropriate, the company should make a timely IDS submission; when disclosure is not required, the company should preserve a contemporaneous note explaining the reason. (37 C.F.R. § 1.56(a).) This is not mere administrative hygiene. Because intent is a separate element, a real-time record of good-faith decision-making can be the best answer to a later inequitable-conduct narrative.

The reverse direction: USPTO-to-FDA risks (truthfulness, false statements, and FDCA penalties)

Cross-agency consistency cuts both ways. Information developed or emphasized in USPTO patent prosecution can also matter in FDA submissions, particularly where the FDA requires truthful and complete disclosure of data and relevant information. For 510(k) submissions, for example, the regulations require a statement that the submitter believes, to the best of their knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted. (21 C.F.R. § 807.87(l).)

Knowingly and willfully false statements or concealments of material facts in communications with a federal agency can create exposure under the federal false-statements statute, 18 U.S.C. § 1001. Materiality generally turns on whether the statement or concealment has a natural tendency to influence, or is capable of influencing, agency decision-making. See, e.g., United States v. Cooper, 482 F.2d 1393 (5th Cir. 1973); Christopher Village, L.P. v. United States, 360 F.3d 1319 (Fed. Cir. 2004). The Federal Food, Drug, and Cosmetic Act separately authorizes enforcement for prohibited acts and provides penalty provisions that can apply to false or misleading submissions, including device-specific liability pathways. (21 U.S.C. §§ 331, 333.)

FDA integrity tools: Application Integrity Policy

FDA also has integrity tools for more serious submission problems. The Application Integrity Policy (AIP) should be understood as the outer edge of the risk spectrum, not as the consequence of every mismatch between patent and regulatory wording. It becomes relevant where FDA has reason to question the reliability of data or information submitted in support of an application, including because of fraud, untrue statements of material fact, bribery, illegal gratuities, or related integrity concerns. In those circumstances, FDA may defer substantive scientific review while it assesses the reliability of affected data and information and may require corrective measures before review proceeds. See Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities; Final Policy, 56 Fed. Reg. 46,191 (Sept. 10, 1991).

Belcher v. Hospira: unreconciled narratives and unenforceability risk

Belcher Pharmaceuticals, LLC v. Hospira, Inc. arose in the drug context, not the device context, but it is a useful warning because the evidentiary pattern is familiar. Belcher sought FDA approval for injectable l-epinephrine. During the FDA process, the company dealt with the relationship between pH, racemization, and impurity levels, including information about prior products and literature. The later patent story centered on a pH range of 2.8 to 3.3 and the assertion that the range was critical and produced unexpected results.

The factual details made the side-by-side comparison especially damaging. Belcher’s Chief Science Officer, Darren Rubin, was involved in regulatory approval, product development, and intellectual-property matters. The FDA-facing record included information about prior products and literature, including Sintetica’s formulation, JHP’s product, and Stepensky. The record also showed that Belcher treated the 2.8 to 3.3 pH range as known or “old” in the FDA context and reverted to that range at least in part because it corresponded to the reference product and could help expedite FDA approval. Before the USPTO, however, the same range was presented as a critical innovation that unexpectedly reduced racemization. (Belcher Pharmaceuticals, LLC v. Hospira, Inc., 11 F.4th 1345 (Fed. Cir. 2021).)

That contrast drove the Federal Circuit’s materiality and intent analysis. The examiner allowed the claims after accepting the criticality argument, while the withheld information showed that the alleged improvement was already within the public domain, just not before the examiner. The court also treated Rubin’s overlapping role in FDA approval and patent prosecution as important circumstantial evidence. For device companies, the translation is straightforward: if a 510(k) file treats a technological characteristic as predicate-supported or previously used, patent counsel should see that file before telling the USPTO that the same characteristic supplies the inventive advance.

This is where many compliance programs are too polite. They assume that regulatory and patent teams will notice the inconsistency because everyone is working from the same project documents. In practice, no one owns the comparison unless the company assigns it. Regulatory counsel may be focused on substantial equivalence, patent counsel on claim scope, and the engineers on getting the product through design controls. The side-by-side review has to be built into the workflow.

For medical-device companies, the pressure points are predictable: predicate-device comparisons, substantial-equivalence narratives, testing summaries, known technological characteristics, literature reviews, and explanations of why a design change does or does not affect safety or effectiveness. Those materials may be entirely appropriate in an FDA submission. But if they bear on novelty, obviousness, written description, enablement, or prosecution arguments, they should be visible to patent counsel before the USPTO record hardens.

USPTO 2022 notice: reasonable inquiry and cross-agency consistency

The USPTO has also emphasized duties of disclosure and reasonable inquiry in connection with inconsistent statements made to the USPTO and other government agencies such as FDA. In its 2022 notice, the Office stated that a reasonable inquiry may include reviewing documents submitted to or received from other government agencies, including FDA, and that parties should ensure consistency between statements made to the USPTO and statements made to other government agencies regarding the claimed subject matter. The notice specifically cites Belcher and Bruno as examples of why FDA-facing materials and statements can matter to patent prosecution. See Duties of Disclosure and Reasonable Inquiry During Examination, Reexamination, and Reissue, and for Proceedings Before the Patent Trial and Appeal Board, 87 Fed. Reg. 45,764 (July 29, 2022).

Bottom line

A strong regulatory strategy and a strong patent strategy can coexist. What they cannot do safely is proceed as if the other record will never be read. FDA submissions should be treated as a predictable source of information that may be material to patentability, and patent-prosecution narratives should be treated as part of the company’s broader government-facing record. For device innovators, the practical answer is a disciplined pipeline: capture FDA-facing materials, assess them under Rule 56, document the outcome, and make sure FDA submissions remain truthful and complete. That process is often the difference between a patent portfolio that remains enforceable and one that becomes vulnerable precisely when enforcement matters most.