The bill amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to require sponsors of new drug and biological product applications — and holders of approved NDAs/BLAs — to certify that material information submitted to the Food and Drug Administration (FDA) is consistent with what they provided to the United States Patent and Trademark Office (USPTO). It also requires sponsors to submit to the USPTO any information material to patentability that they submit to FDA and to certify that those USPTO submissions include all material information and reflect communications with the FDA.
The measure directs the USPTO to update procedures to preserve trade secret and confidential protections for information received from sponsors that otherwise would only be held by FDA. It amends enforcement law to make failures in the new certification pathway enforceable under the FD&C Act and adds a statutory defense in patent‑infringement suits where a patent owner negligently or intentionally failed to disclose required information to the USPTO.
At a Glance
What It Does
The bill requires drug and biologic applicants and post‑approval holders to: (1) certify to FDA that material patentability‑related information they submitted there matches what they provided to USPTO; and (2) forward to USPTO any information material to patentability that they submitted to FDA, plus FDA responses. It limits the scope to information ‘material to patentability’ as defined by USPTO regulations and creates obligations for pre‑ and post‑enactment applications.
Who It Affects
Innovator drug and biologic manufacturers (NDA and BLA sponsors), patent counsel and patent prosecutors, USPTO and FDA examiners, and generic/biosimilar challengers who rely on patent records. It also implicates in‑house CMC, regulatory affairs, and litigation teams responsible for synchronizing disclosures and certifications.
Why It Matters
The bill routes regulatory‑grade analytical and CMC disclosures into patent prosecution, which could change how patent examiners evaluate novelty and obviousness, increase the information available to patent challengers, and create a new basis for defenses in infringement litigation — all while raising questions about protecting confidential commercial data.
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What This Bill Actually Does
This law ties together two previously parallel streams of information: what sponsors tell FDA to get their drug approved and what they tell USPTO to get patents allowed. For each patent that an applicant or holder controls, the sponsor must certify to FDA that the information they submitted (or will submit) to FDA that is material to patentability is consistent with what they provided to USPTO and with any communications they had with USPTO.
Separately, sponsors must actually send USPTO the material‑to‑patentability information they have given FDA and any FDA responses to those submissions, and certify to USPTO that the file is complete ‘‘to the best of their knowledge.’nThe bill defines the relevant information narrowly by cross‑reference to USPTO rulemaking: examples the text calls out include statements or characterizations of analytical data in the chemistry, manufacturing, and controls (CMC) portion of an NDA or BLA and statements regarding prior art or other patentability assertions. The statute makes these duties apply to new submissions filed after enactment and, for previously filed applications, it phases in obligations for patents issued after enactment or for submissions made after enactment.
To prevent routine public exposure of proprietary technical and financial data, the bill requires USPTO to update its regulations or create procedures so material submitted under this requirement remains subject to the same confidentiality and trade‑secret protections it would have had at FDA. The bill also adds the new certification items to the list of statements included in an NDA/BLA application form, and it amends the FD&C Act so that failure to comply with the certification duty becomes an enforcement lever for FDA.Finally, the bill inserts a narrow statutory defense into patent litigation: a defendant may invoke a non‑disclosure defense in infringement suits if the patent owner (or predecessor) negligently or intentionally failed to disclose the information the statute requires to USPTO.
That creates a direct litigation consequence for disclosure failures that is separate from existing inequitable conduct doctrine.
The Five Things You Need to Know
The bill requires sponsors or holders of NDAs and BLAs to certify to FDA that patentability‑material information submitted to FDA is consistent with information provided to USPTO and with communications with USPTO.
Sponsors must submit to USPTO any information material to patentability that they submit to FDA, including CMC analytical data characterizations and patent/prior‑art statements, and certify completeness ‘to the best of their knowledge.’, The obligation applies to new applications filed on or after enactment and to amendments; for pre‑enactment applications it applies only to patents issued after enactment or to submissions made after enactment.
USPTO must update regulations or procedures so that information transmitted under this requirement remains subject to trade‑secret/confidential protections comparable to those at FDA.
The bill amends enforcement law so FDA can act on failures to provide the required certification and creates a statutory defense under 35 U.S.C. allowing defendants to raise non‑disclosure by the patent owner as a defense in infringement cases.
Section-by-Section Breakdown
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Short title — Medication Affordability and Patent Integrity Act
Provides the act’s short title. This is a formal element; the title signals the bill’s dual policy aims — affordability and patent integrity — but does not itself create obligations.
Certification and cross‑filing obligations for NDAs and patents
Adds a new paragraph (7) to 21 U.S.C. 355(b) requiring sponsors and holders to certify to FDA that patentability‑material information they submitted to FDA is consistent with what they provided to USPTO and to forward those materials and FDA responses to USPTO. The provision enumerates sample categories — CMC analytical data characterizations, patent/prior‑art statements — and leaves the exact scope to USPTO rulemaking, shifting the definitional work to the patent office. The provision also amends the list of required statements in an application so applicants must include the new certifications on their NDA forms, which integrates the duty into application intake and creates an administrative checkpoint for FDA reviewers.
Parallel duties for BLAs and biologics
Mirrors the NDA requirements for biological product license applications (BLAs): sponsors and license holders must certify consistency, submit material‑to‑patentability info and FDA responses to USPTO, and certify completeness. The text treats biologics the same way as small‑molecule drugs, but it separately references ‘‘chemistry, manufacturing, and controls’’ material specific to biologics manufacturing to make clear the CMC data categories are relevant across product types.
Limited retroactivity and phased application
Sets a clear temporal rule: obligations apply to original applications filed on or after enactment and to subsequent amendments; for applications filed before enactment, the duties apply only to patents issued on or after enactment and to submissions/communications made after enactment. That carve reduces immediate retroactive effects on legacy patents but still brings future‑issued patents and post‑enactment filings under the new regime.
Confidentiality and trade‑secret protection at USPTO
Directs USPTO to update regulations or establish procedures so that material submitted to USPTO under the new requirement remains covered by trade‑secret/confidential/financial protections ‘‘as if’’ held by FDA. Practically, USPTO must reconcile public‑filed patent prosecution documents with the statute’s confidentiality protections — a procedural and regulatory task that affects how examiners and third parties can access prosecution files.
FD&C Act enforcement amendment and new patent defense
Amends FD&C Act section 301(q)(1) to include the new certification requirement among enforceable items, giving FDA an express enforcement pathway for failures to submit the certifications. Separately, adds a new section to 35 U.S.C. (section 274) creating a statutory defense in infringement suits if a patent owner violated the disclosure requirement by negligently or intentionally failing to disclose required information to USPTO. That links administrative noncompliance to litigation consequences and changes the risk calculus in patent enforcement.
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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
- Generic and biosimilar developers — they gain access to additional material in USPTO records that could improve patent examination or support challenges to weak patents by exposing technical characterizations that bear on obviousness or novelty.
- USPTO examiners — they receive regulatory‑grade analytical and CMC characterizations that can improve the quality of patent examination and reduce information asymmetries between patent filings and regulatory submissions.
- Patients, payers, and purchasers — to the extent that better patent vetting and stronger bases for challenges lead to earlier generic/biosimilar entry, prescription costs and payer expenditures could decline.
Who Bears the Cost
- Innovator drug and biologic sponsors — must identify, package, certify, and transmit FDA‑grade CMC and patentability material to USPTO and absorb added regulatory, legal, and prosecution costs; disclosure risks may also increase patent invalidation exposure.
- In‑house and outside patent counsel — increased coordination costs and heightened risk exposure in prosecution and litigation, with new certification language creating potential compliance and liability issues.
- USPTO and FDA operations — both agencies must invest staff time and rulemaking bandwidth to implement new procedures, coordinate confidentiality regimes, and handle increased information flows; USPTO must create procedures to treat certain submissions as confidential despite its public file regime, which is operationally complex.
Key Issues
The Core Tension
The bill forces a trade‑off between increased transparency for patent examination (which can improve patent quality and speed generic/biosimilar entry) and the need to protect proprietary, often commercially sensitive regulatory data and maintain predictable patent prosecution and commercial incentives for innovation.
The bill front‑loads two difficult implementation questions to agency rulemaking: (1) what counts as ‘‘information material to patentability’’ for purposes of cross‑filing, and (2) how USPTO will protect information that traditionally sits in FDA’s confidential administrative files. Delegating the materiality definition to USPTO is sensible in principle but risks mismatch with how FDA treats technical CMC statements; alignment will require careful interagency standards and likely litigation over boundaries.
The confidentiality instruction requires USPTO to reconcile its largely public prosecution record with statutory confidentiality protections — practical outcomes could range from gating access to particular exhibits to redesigning how prosecution histories are docketed.
The statutory defense in 35 U.S.C. links procedural failures to substantive litigation outcomes, but it raises a proof and scope problem. The defense applies where a patent owner ‘‘negligently or intentionally’’ failed to disclose required information; courts will need to decide what showing suffices and how that interacts with existing doctrines like inequitable conduct and duty of candor to the USPTO.
There is also a timing tension: FDA approvals and patent prosecution often proceed on different schedules, and sponsors could face demands to re‑open prosecution files or make post‑approval submissions to USPTO that complicate patent strategy and commercial confidentiality. Lastly, the ‘to the best knowledge’ certification standard reduces absolute strict liability but creates evidentiary disputes about what the sponsor knew and when — an uncertainty likely to generate pre‑litigation discovery fights and cautious behavior by small firms.
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