v2 introduces substantive changes to the disclosure requirements for drug and biological product applications, primarily by clarifying the scope of trade secret protections for information shared with the USPTO and adding a new restriction on who can assert a non-disclosure defense in patent infringement actions. The bill also corrects an erroneous cross-reference and renumbers a key paragraph with corresponding updates.
Medication Affordability and Patent Integrity Act
- Sponsor
- Sen. Hassan, Margaret Wood [D-NH]
- Committees
- Health, Education, Labor, and Pensions Committee (primary)
- Last action
- Jul 28, 2026
Bottom line
The bill aims to enhance transparency and consistency in patent information submitted by drug manufacturers to reduce 'patent thickets' and facilitate earlier market entry for generic and biosimilar drugs, potentially lowering drug costs, while balancing trade secret protections.
What it actually does
This bill mandates that pharmaceutical companies applying for new drug or biological product approval must submit all information material to patentability, including communications with the Food and Drug Administration (FDA), to the U.S. Patent and Trademark Office (USPTO). They are also required to certify that information provided to both agencies is consistent. The bill establishes FDA enforcement authority for non-compliance and creates a new legal defense against patent infringement for generic and biosimilar manufacturers if the original patent owner negligently or intentionally failed to disclose required information.
Proponents argue
Proponents argue this bill will curb abusive patenting practices by pharmaceutical companies, which often create 'patent thickets' to extend monopolies and delay generic competition. By requiring consistent disclosure to both FDA and USPTO, it will improve patent quality, reduce frivolous litigation, and ultimately lower drug prices for consumers by speeding up the entry of more affordable generic and biosimilar alternatives.
Opponents contend
Opponents, likely from the pharmaceutical industry, might argue that the bill adds unnecessary regulatory burdens and costs to drug development, potentially stifling innovation. They may contend that existing processes are sufficient and that forcing disclosure of sensitive R&D information could compromise trade secrets, weaken intellectual property rights, and deter investment in new drug discovery, ultimately harming patient access to novel treatments.
The bill is moderately complex due to its legal and technical nature, requiring careful reading to understand its implications for FDA and patent law. An informed reader would need adequate time to fully digest its provisions.
Section 2(a)(1), amending Federal Food, Drug, and Cosmetic Act, Section 505(b) by adding new paragraph (8).
Disclosure Requirements for New Drug Applications (NDAs)
This provision requires sponsors of new drug applications (NDAs) or holders of approved NDAs to certify to the FDA that patent-related information submitted to the Secretary is consistent with what was provided to the USPTO. It also mandates submitting to the USPTO any information material to patentability given to the FDA, along with FDA's responses, and certifying its completeness and consistency. This applies to new applications and certain aspects of existing ones.
Supporters argue
This provision is crucial for preventing manufacturers from strategically misrepresenting patent information across agencies, which can lead to unjustified patent extensions and delays in generic drug availability. It promotes fair competition and lowers drug costs.
Critics contend
The pharmaceutical industry may argue that these requirements create an undue administrative burden and risk disclosing proprietary information, potentially hindering innovation and the ability to protect valuable intellectual property.
Tradeoffs
Balances the need for patent transparency and generic competition against concerns about administrative burden and protection of proprietary information.
Section 2(b), amending Public Health Service Act, Section 351(a)(2) by adding new subparagraph (F).
Disclosure Requirements for Biological Product Applications (BLAs)
This provision extends the same disclosure and certification requirements as for NDAs to sponsors of biological product applications (BLAs) or holders of biological product licenses. This includes certifying consistency of patent information between FDA and USPTO submissions and providing material patentability information from FDA interactions to the USPTO. This aims to address similar issues in the biologics market.
Section 2(c)(1), amending Federal Food, Drug, and Cosmetic Act, Section 301(q)(1) by adding new clause (D).
FDA Enforcement for Non-Disclosure
This provision amends the Federal Food, Drug, and Cosmetic Act to classify the failure to submit the required certifications to the FDA (related to consistent patent information) as a prohibited act. This grants the FDA explicit enforcement authority over these new disclosure requirements, allowing them to take action against non-compliant companies.
Section 2(c)(2), amending Chapter 28 of title 35, United States Code, by adding new Section 274.
Non-Disclosure Defense to Patent Infringement
This provision establishes a new legal defense against patent infringement actions. A person accused of infringement can use this defense if the patent owner negligently or intentionally failed to disclose information required under the new FDA/USPTO consistency provisions. However, this defense is not available to 'covered foreign persons' as defined in the Defense Production Act of 1950.
These clauses state that information submitted to the USPTO to fulfill the new requirements, which would not otherwise be submitted, remains subject to trade secret or confidential information protections 'as if the information were held by the Food and Drug Administration, except that such protections shall not apply to information that the United States Patent and Trademark Office determines necessary for the public to understand the scope of patent claims granted.'
Section 2(a)(1), new 505(b)(8)(E)(i) and Section 2(b), new 351(a)(2)(F)(v)(I).
Why it matters:This is a critical carve-out that balances industry concerns about trade secrets with the public interest in patent transparency. Its placement might be a result of negotiation to ensure both aspects are addressed without drawing excessive attention to the potential for disclosure.
Case for: Proponents of transparency would argue this exception is vital to ensure the public and potential generic competitors can truly understand the scope of a patent, preventing companies from hiding critical information under the guise of trade secrets, which could otherwise undermine the bill's intent.
Case against: Pharmaceutical companies might argue that this exception creates uncertainty regarding the protection of proprietary information, potentially leading to the involuntary disclosure of sensitive R&D or manufacturing data that could be exploited by competitors, thereby disincentivizing innovation.
Estimated impact: Could significantly impact the level of transparency around drug patents, potentially facilitating more robust challenges to questionable patents and accelerating generic/biosimilar market entry.
The non-disclosure defense to patent infringement 'shall not be available if the person asserting such a defense is a covered foreign person (as defined in section 809 of the Defense Production Act of 1950 (50 U.S.C. 4589)).'
Section 2(c)(2)(A), new 35 U.S.C. 274.
Why it matters:This exclusion likely reflects national security or economic protectionist concerns, aiming to prevent foreign entities from benefiting from this specific defense, especially those from adversarial nations. It's a common legislative technique to use cross-references for established definitions.
Case for: Supporters would argue this protects U.S. national interests and prevents foreign adversaries or competitors from exploiting a domestic legal mechanism designed to benefit U.S. consumers and companies.
Case against: Critics might argue it introduces complexity and potential for discrimination, possibly hindering global competition or creating diplomatic issues, especially if the definition of 'covered foreign person' is broad or subject to political interpretation.
Estimated impact: Limits the applicability of the new patent defense for certain foreign entities, potentially affecting the global landscape of generic/biosimilar competition involving U.S. patents.