Is the Interagency Patent Coordination and Improvement Act (S. 1097) Really Needed?
A Closer Look
The U.S. Senate is considering a bill that would formalize a task force between the United States Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) to share information and provide technical assistance regarding patents for human drugs and biologics. The bill, entitled, “Interagency Patent Coordination and Improvement Act” (S. 1097) was introduced in March 24, 2025 by Senators Richard Durbin (D-IL), Thom Tillis (R-NC), Chuck Grassley (R-IA), Christopher Coons (D-DE) and Peter Welch (D-VT), and reflects ongoing concerns about patent quality and the perceived need for greater agency coordination. But is this legislation necessary, or is it a solution in search of a problem? Let’s break down what the bill proposes and why we believe it’s both unnecessary and potentially counterproductive.
What would S. 1097 do?
At its core, S. 1097 would:
Establish a formal “Interagency Task Force on Patents” between the USPTO and FDA, focusing on sharing information, decisions, and actions related to patents for human drugs and biologics. A Memorandum of Understanding between the agencies would be required to facilitate this collaboration.
Promote reciprocal access to information, including sharing information on new approvals of patents, human drugs, and biological products, new technologies and prior art, and scientific trends and developments.
Set up processes that allow (1) the USPTO to request from FDA information for use by patent examiners regarding when information relating to a human drug or biological product approval, including updates to a label or newly approved indication, is made publicly available, including when it is posted online; (2) patent examiners to have access to relevant sources of a drug or biologic application, approval, patent, and labeling information or communications between the FDA and the human drug or biological product sponsor that may not currently be publicly available, provided that access to this information is only to permitted to the “extent necessary” for the USPTO to ensure that “accurate representations and access to information on whether the claimed invention that would be the subject of the patent was on sale before the effective filing date of the claimed invention, as described in section 102(a)(1)”; (3) the USPTO to assist FDA in its role listing patents; and (4) FDA, at the request of the USPTO, to provide “specific, available information” to the USPTO with respect to “certain applications, responses, or affidavits after rejections” to assist patent examiners in carrying out their examination.
Establish protocols for handling confidential information and preventing inappropriate disclosure of information between the agencies. The protocols to be established would require: (1) FDA, before sharing any information with the USPTO, to provide 30 days’ notice to the human drug or biological product sponsor to allow the sponsor to “consult with the agency”; and (2) the USPTO to maintain and keep any information shared by FDA separate from pending patent applications and establish procedures for identifying confidential information to protect against inadvertent disclosure. Appropriate remedies are to be provided for any injury suffered when confidential information is made available, including any made inadvertently, by the sharing of information between the agencies.
Mandate periodic reporting to Congress on the frequency of information sharing, its utility, and whether other agencies should be included in future coordination efforts.
The bill’s stated goal is to improve the quality and consistency of patent examination by giving USPTO examiners access to information that might otherwise be siloed at the FDA. It also seeks to ensure that representations made to the USPTO and FDA are accurate and consistent.
S. 1097 is unnecessary
There are several reasons why S. 1097 is unnecessary and misses the mark.
1. The Current System Works
Existing USPTO rules require applicants to submit all information material to patentability, including relevant FDA documentation, during prosecution, as required by the duty of candor and good faith under 37 CFR §1.56. Moreover, the Manual of Patent Examining Procedure § 2001.06(e) makes it clear that if documentation submitted to a regulatory body, such as the FDA, is material to a pending patent application, it must also be submitted to the USPTO.
There is no evidence of widespread abuse or inconsistent statements between agencies. Innovators are incentivized to maintain consistency in their USPTO and FDA filings, knowing that any discrepancies can (and do) surface in litigation. In the rare instances where inconsistencies arise, adversarial court proceedings have proven effective in addressing them, such as in Belcher Pharms., LLC v. Hospira, Inc., 11 F.4th 1345, 1353-54 (Fed. Cir. 2021).
2. Practical and Logistical Nightmares
FDA filings are massive. New Drug Applications (NDAs) and Biologics License Applications (BLAs) typically span tens or hundreds of thousands of pages. Most of this material is irrelevant to patentability. Expecting patent examiners, already under time pressure and facing a $ 1.2 million application backlog, to sift through these documents is unrealistic and would further slow the process.
Confidentiality concerns abound. While the bill calls for protocols to protect sensitive information, USPTO’s obligation to make material information public creates a real risk of inadvertent disclosure of trade secrets or proprietary data.
3. Resource Constraints
Both the USPTO and FDA are already stretched thin. Both agencies are dealing with layoffs, retirements, hiring freezes, and increased workloads. The bill would add significant new responsibilities without any apparent benefit, undermining the agencies’ ability to fulfill their core missions.
The bottom line: no evidence, no need
The current USPTO rules and everyday law work. This bill would solve no systemic problem of inconsistent statements or hidden prior art. The rare issues that do arise are already addressed through existing legal mechanisms. Instead, S. 1097 would impose new risks, inefficiencies, and burdens on already overtaxed agencies, all without any demonstrable improvement in patent quality or public benefit.
Lessons learned from Brazil and ANVISA
Perhaps the U.S. should consider what has happened in other countries that have included roles for regulatory agencies in the patent application review process. After almost two decades, Brazil ended the participation of the Brazilian FDA, known as ANVISA, in examining patent applications to reduce the excessive patent backlog and eliminate inconsistent interpretations (both associated with ANVISA’s role in the patent examination process).
In December 1999, the Brazilian IP Statute was amended to include Article 229-C, establishing ANVISA’s participation in the examination workflow for patent applications related to pharmaceutical products and processes. Article 229-C read, “[t]he granting of patents for pharmaceutical products and processes shall be subject to the ANVISA’s prior approval.”
The participation of ANVISA in the prior approval of pharmaceutical patents has raised concerns in the local community, as it has been the subject of several court decisions limiting its role and is also considered one of the reasons for the growing patent examination backlog in Brazil over the last few decades. ANVISA and Article 229-C generated concerns in the Office of the United States Trade Representative (USTR). According to the USTR, ANVISA’s duplicative review lacked transparency and resulted in additional delays in patent prosecution (USTR 2016 report).
The mandatory participation of ANVISA under Article 229-C was revoked in August 2021, following nearly 20 years of legal debates regarding its role and potential impact on patent examination.
Final Thoughts
The Interagency Patent Coordination and Improvement Act (S. 1097) may be well-intentioned, but our analysis leads us to conclude that it is both unnecessary and likely to be counterproductive. The current U.S. patent system already imposes a robust duty of candor, requiring applicants to disclose all information material to patentability, including relevant FDA documentation, under established rules and procedures. There is no compelling evidence of systemic abuse or widespread inconsistencies between USPTO and FDA filings that would justify the creation of a new interagency task force.
Experience in other jurisdictions, such as Brazil’s now-repealed requirement for ANVISA’s prior approval of pharmaceutical patents, demonstrates that involving regulatory agencies in patent examination can result in significant delays, increased backlogs, and inconsistent outcomes, without yielding clear benefits for patent quality or public health. The proposed legislation risks introducing similar inefficiencies into the U.S. system, while also raising serious concerns about the protection of confidential business information and further straining the limited resources of both the USPTO and FDA.
Rather than layering on additional bureaucracy, the focus should be on equipping patent examiners with the time, resources, and targeted training necessary to maintain and enhance patent quality. Strengthening the agencies’ core missions is a more effective path forward than imposing new mandates to address hypothetical problems. In our view, the best way to support innovation and the public interest is to trust in the established mechanisms that already serve the U.S. patent system well.
This post was written by Lisa Mueller and Rob Rodrigues of RNA Law.