Medication Affordability and Patent Integrity Act

Bill Number

S. 2658

Origin Chamber

Senate

Congress

119th Congress, Session 1

Policy Area

Commerce

Status

Introduced

Latest Action

2026-06-17: Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.

Last Updated

2026-03-20T11:03:18Z

AI-Generated Summary

Purpose

The Medication Affordability and Patent Integrity Act aims to promote transparency between the Food and Drug Administration (FDA) and the United States Patent and Trademark Office (USPTO) by requiring drug and biologic sponsors to share consistent, relevant information about patents. This is intended to ensure patent integrity, prevent misleading submissions that could extend drug monopolies unnecessarily, and ultimately support more affordable medications through fairer competition.

Key Provisions

• Disclosure and Certification Requirements for Drugs (New Drug Applications - NDAs):
• Sponsors of NDAs or holders of approved applications must certify to the FDA that information submitted to it about "applicable patents" (patents claiming the drug, its formulation, composition, method of use, or manufacturing, owned or licensed by the sponsor) is consistent with what they provided to the USPTO, including any communications.
• They must submit to the USPTO any information "material to patentability" (details that could affect whether a patent is valid, as defined by USPTO rules) shared with the FDA, along with FDA responses, and certify its completeness and consistency.
• "Material" information includes analytical data from the chemistry, manufacturing, and controls (CMC) section of applications, statements about prior art (existing inventions that might invalidate a patent), and other items required by regulation.
• These requirements apply to original NDAs submitted after enactment, and to amendments/supplements; for pre-enactment applications, they apply only to new patents or post-enactment submissions.

• Disclosure and Certification Requirements for Biologics (Biologic License Applications - BLAs):
• Similar rules apply to biologic products, with sponsors or holders certifying consistency between FDA and USPTO submissions for applicable patents (defined analogously for biologics).
• Includes CMC data, prior art statements, and regulatory additions; applicability follows the same timeline as for drugs.
• USPTO must protect submitted information as confidential (e.g., trade secrets) as if held by the FDA, and update regulations accordingly.

• Integration into Application Processes:
• Certifications must be included in NDA and BLA submissions for listed applicable patents.

• Enforcement:
• Failure to provide required certifications is prohibited under the Federal Food, Drug, and Cosmetic Act (FDCA), allowing FDA to take action (e.g., warnings, seizures, or injunctions).

• Patent Infringement Defense:
• Adds a new section to U.S. patent law (35 U.S.C. § 274) allowing a defense in infringement lawsuits if the patent owner negligently or intentionally failed to disclose required information to the USPTO. This applies specifically to applicable patents for drugs or biologics.

Significant Changes to Existing Law

• Amends Section 505(b) of the FDCA (governing NDAs) by adding a new paragraph (7) for disclosures and certifications, and updates application content requirements to include these certifications.
• Amends Section 351(a)(2) of the Public Health Service Act (governing BLAs) by adding a new subparagraph (F) with parallel requirements.
• Expands FDCA's prohibited acts (Section 301(q)) to include non-submission of certifications.
• Introduces a novel defense in Chapter 28 of Title 35, U.S. Code (patent defenses), which did not previously exist for non-disclosure in drug patent contexts, potentially weakening enforceability of non-compliant patents.

Potential Impacts

• Government Agencies: The FDA and USPTO will receive more synchronized information, reducing discrepancies that could lead to invalid patents. Both may need to promulgate new regulations for material information and confidentiality procedures, increasing administrative workload but improving oversight.
• Citizens: Could lower drug and biologic prices by facilitating challenges to questionable patents, enabling faster entry of generics or biosimilars (lower-cost alternatives), benefiting patients and healthcare payers.
• International Relations: Minimal direct impact, though it may influence global pharmaceutical innovation by aligning U.S. standards on patent-drug approvals, potentially affecting how foreign companies approach U.S. markets.

Main Stakeholders Affected

• Pharmaceutical and Biotech Companies: Sponsors and holders of drug/biologic approvals (e.g., brand-name manufacturers like Pfizer or Amgen) face new compliance burdens, including certifications and disclosures, with risks of enforcement or patent challenges.
• Generic and Biosimilar Manufacturers: Benefit from the new infringement defense, making it easier to contest patents and enter markets sooner.
• Patients and Consumers: Indirectly gain through potential affordability improvements.
• Healthcare Providers and Insurers: May see reduced costs for medications.
• FDA and USPTO: Gain tools for better coordination but must implement regulatory changes.

Notable Legal, Constitutional, or Political Implications

• Legal: Enhances patent validity scrutiny by mandating cross-agency transparency, potentially increasing litigation over non-disclosure (e.g., more invalidation challenges under the new defense). It builds on existing "Hatch-Waxman" framework for generics without altering core approval processes.
• Constitutional: No apparent issues; aligns with Congress's authority to regulate interstate commerce and patents (Article I, Section 8).
• Political: Bipartisan sponsorship (Sens. Hassan and Hawley) signals broad support for drug affordability amid concerns over "patent evergreening" (minor tweaks to extend monopolies). Could set precedent for future reforms balancing innovation incentives with access, though implementation may face industry pushback.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Sen. Hassan, Margaret Wood [D-NH]

Cosponsors (1)

Sen. Hawley, Josh [R-MO]

Recent Actions

• 2026-06-17: Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
• 2026-03-19: Committee on Health, Education, Labor, and Pensions. Hearings held.
• 2025-08-01: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
• 2025-08-01: Introduced in Senate

Bill Versions

• Medication Affordability and Patent Integrity Act — issued 2025-08-01 — PDF (12 pages)