SB1097 amends Title 35 to create an Interagency Task Force on Patents that formalizes ongoing coordination between the United States Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) for human drugs and biological products. The bill requires a memorandum of understanding, identifies who sits on the task force, defines a set of information‑sharing activities (including access to certain nonpublic FDA materials), and imposes confidentiality safeguards and notice procedures for sponsors.
The statute also directs the USPTO Director to report to the House and Senate Judiciary Committees within four years about how often FDA materials were shared and used in examination, which methods were useful, recommended changes, and other agencies that might warrant similar coordination. For professionals, the bill shifts the evidentiary terrain of drug/biologic patent prosecution by widening the universe of agency-held materials examiners may consult while preserving specific ministerial boundaries for the FDA’s patent‑listing role.
At a Glance
What It Does
Establishes the Interagency Task Force on Patents to coordinate USPTO–FDA exchanges about patents for human drugs and biological products, requires a memorandum of understanding, and sets procedures for requests, information access, and confidentiality. It directs the USPTO Director to report to congressional judiciary committees within four years on frequency, utility, and recommendations related to these exchanges.
Who It Affects
Patent examiners handling drug and biologic applications, FDA reviewers and listing staff, sponsors of NDAs/BLAs (and related applicants), USPTO and FDA officials who will serve on the task force, and patent prosecutors and litigators who rely on agency records. It also implicates in-house IP teams and outside counsel managing confidentiality-sensitive submissions to FDA.
Why It Matters
The bill can materially change what agency-held evidence is available to examiners assessing novelty and prior art, potentially affecting allowance decisions and the quality of patents on drugs and biologics. It also creates a statutory framework for sharing nonpublic regulatory materials while imposing notice and segregation rules that will drive new operational processes at both agencies.
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What This Bill Actually Does
SB1097 inserts a new statutory provision into chapter 1 of Title 35 creating an Interagency Task Force on Patents focused on patents for human drugs and biological products. The task force is a standing vehicle for coordination between the USPTO Director and the FDA Commissioner; members are appointed from each agency and must have relevant operational, scientific, and decision‑making expertise.
The bill requires the agencies to document their cooperation via a memorandum of understanding or by updating an existing one.
The task force’s duties include routine exchanges about how each agency evaluates applications, workshops and trainings, and sharing information about approvals, new technologies, prior art, and scientific trends. Critically, the statute instructs the USPTO Director to request—and the FDA to provide—information that may not currently be publicly available if it is necessary for patent examination, including access to product application, approval, patent, and labeling materials and communications between FDA and sponsors, subject to limits tied to the Office’s responsibilities.To protect confidential material, the bill requires protocols: sponsors must receive notice and have 30 days to consult before confidential FDA information is shared with the USPTO; the Director must keep information received from FDA separate from pending patent applications; and the task force must identify remedies for any injuries caused by inadvertent disclosures.
The statute also includes rules of construction clarifying that nothing here alters the FDA’s ministerial patent‑listing role or the legal standing of patents in litigation.Finally, the USPTO must report to the House and Senate Judiciary Committees not later than four years after enactment. The report must describe how often FDA provided information to the USPTO through the task force or its processes, how that information was used in examinations, which sharing methods and types of information were most useful, recommendations for congressional action on the task force’s mandate or funding, and other federal agencies that might merit similar coordination.
The Five Things You Need to Know
The bill creates an Interagency Task Force on Patents (new 35 U.S.C. § 15 14) to coordinate USPTO and FDA activities concerning patents for human drugs and biological products.
The Director of the USPTO may request, and the FDA must provide upon request, appropriate information to support patent examiners’ review, including access to product applications, approvals, labeling updates, and certain nonpublic communications with sponsors, to the extent necessary for examination.
Before any confidential FDA information is shared, the sponsor of the related drug or biologic must receive notice and is given a 30‑day period to consult with the agency sharing that information.
The USPTO must keep information received from the FDA separate from pending patent applications and the task force must adopt protocols and identify remedies for inadvertent disclosure of confidential information.
The USPTO Director must submit a report to the House and Senate Judiciary Committees within four years documenting frequency and use of FDA‑provided information, which sharing methods worked best, recommended changes, and other agencies for potential coordination.
Section-by-Section Breakdown
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Short title
Designates the bill as the 'Interagency Patent Coordination and Improvement Act of 2025.' This is purely nominative but signals the bill’s purpose: to improve interagency coordination rather than to rewrite substantive patent law doctrines.
Findings
Lists congressional findings that patents decisions implicate information held by other agencies, that applicants often supply information across agencies, and that examiners may benefit from additional agency data. The findings create a legislative rationale for mandatory interagency mechanisms but have no independent legal force beyond framing intent.
Four‑year USPTO report to Judiciary Committees
Directs the USPTO Director to submit a report within four years describing how often FDA provided information to the USPTO through the task force or its processes and how examiners used that information; which methods and types of information were most useful; recommendations for Congress about the task force’s mandate, funding, or operations; and identification of other agencies for possible coordination. Practically, this creates a congressionally mandated evaluation checkpoint and potential sourcing for future legislative changes.
Statutory consultation requirement for drug/biologic patents
Adds a statutory hook in USPTO’s general authorities requiring the Director, when acting on patents for human drugs and biological products, to consult with the FDA Commissioner 'in the manner described' by the new task force provision. This ties the task force’s activities to the Director’s exercise of patent powers and makes consultation an explicit component of the Director’s duties for this subject area.
Establishment, MOU, membership, and core activities
Creates the task force, requires the USPTO and FDA to enter or update a memorandum of understanding, and sets membership criteria: employees appointed by each agency with appropriate technical, medical, or decision‑making expertise. The provision lists concrete activities: routine information exchanges, trainings, sharing of approvals and scientific trends, processes for the Director to request FDA information (including nonpublic materials where appropriate), assistance from the USPTO for FDA’s patent‑listing ministerial function, and procedures for the Commissioner to provide specific information to assist examiners after rejections. Operationally, agencies must implement new workflows and designate staff.
Rules of construction and confidentiality protocols
Contains three rules of construction clarifying that nothing authorizes the USPTO to interfere with or change FDA’s ministerial patent‑listing role, or alters patent enforceability in litigation. It also permits sharing of confidential records between agencies while preserving FDA protections and directs the task force to establish protocols to safeguard confidentiality. The protocols must include sponsor notice with a 30‑day consultation window, USPTO segregation of FDA‑provided materials from pending patent files, and identification of remedies for inadvertent disclosures. This section creates the principal privacy and operational constraints on information exchange.
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Explore Healthcare in Codify Search →Who Benefits and Who Bears the Cost
Every bill creates winners and losers. Here's who stands to gain and who bears the cost.
Who Benefits
- USPTO patent examiners — Gain access to FDA application, approval, labeling, and certain nonpublic communications that may fill evidentiary gaps about prior art, on‑sale issues, or the state of science when assessing drug and biologic patent claims.
- Generic and biosimilar developers — Benefit indirectly because better‑informed examination can expose weak or improperly-prosecuted patents earlier, potentially lowering barriers to entry if examiners find stronger prior art.
- FDA listing and review staff — Obtain a formal mechanism and USPTO assistance for the ministerial patent‑listing process and clearer lines for communicating how regulatory decisions relate to patent issues.
- In‑house IP and outside counsel for sponsors — Gain clearer procedures and statutory predictability about when and how FDA information may be shared with the USPTO, enabling more targeted risk management for confidential submissions.
Who Bears the Cost
- USPTO — Must allocate staff time and systems to receive, segregate, and manage confidential FDA materials, change examination workflows, and prepare the mandated four‑year report.
- FDA — Faces resource demands to respond to USPTO requests, to produce nonpublic materials where appropriate, and to implement sponsor‑notice and consultation processes under tight confidentiality constraints.
- Drug and biologics sponsors — May face disclosure risk, additional consultation burdens, and potential strategic harm if nonpublic regulatory communications become available to examiners; they also must engage in 30‑day consultations when notified.
- Small biotech companies — Likely to have fewer legal and compliance resources to manage consultations and potential remediation if confidential information is shared or inadvertently disclosed.
Key Issues
The Core Tension
The central dilemma is between raising patent quality by giving examiners broader, often nonpublic, FDA information that improves prior art and validity assessments, and preserving sponsors’ confidential regulatory communications and the FDA’s independent regulatory processes—protecting commercial secrets and efficient regulatory review while avoiding delays or legal exposure from interagency disclosures.
The bill trades improved examiner access to agency-held scientific and regulatory materials against the practical and legal complexity of sharing confidential regulatory records across agencies. 'Appropriate access' to nonpublic communications is not precisely defined; implementing rules will need to reconcile FOIA exemptions, trade secret protections, and statutory confidentiality authorities that apply to FDA files. Agencies must build secure segregation systems and clear chains of custody so that FDA‑provided materials do not improperly bleed into prosecution histories or public file wrappers.
The 30‑day sponsor notice window is a procedural protection, but it also creates a potential timing issue: if examiners wait for sponsor consultations or redactions, examinations could slow; if examiners proceed without waiting, sponsors may argue inadequate opportunity to protect trade secrets. Remedies for inadvertent disclosures are to be 'identified' by the task force, but the bill does not specify liability standards, damages, or administrative consequences, leaving ambiguity about effective deterrence and recovery.
Finally, although the statute insists it does not alter FDA’s ministerial listing or change patent enforceability, making confidential regulatory material available during examination could generate new kinds of evidence and admissions that reshape claim scope and litigation strategies in ways not contemplated by the bill’s text.
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