119th Congress · introduced in the Senate · Aug 1, 2025
Medication Affordability and Patent Integrity Act
Official title from Congress.gov
Latest action (Jul 28, 2026): Placed on Senate Legislative Calendar under General Orders. Calendar No. 528.
View on Congress.govPolicy area: Health
Congressional Research Service summary, version: Reported to Senate (Jul 28, 2026)
Medication Affordability and Patent Integrity Act
This bill requires applicants seeking approval of a drug or licensure of a biological product to submit certain information about relevant patents to both the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO).
Specifically, the bill requires applicants to make certifications and disclosures related to each applicable patent on a proposed drug or biological product. An applicable patent is a patent or patent application held or sought by the applicant for the drug or biological product (including a formulation or composition, method of use, or method of manufacturing).
For each applicable patent, an applicant must submit to the USPTO any information material to patentability that the applicant submitted to the FDA and any information provided by the FDA in response. The applicant must certify that this submission is complete and consistent with the information the applicant provided to the FDA.
Further, for each applicable patent, an applicant must certify that certain information submitted to the FDA is consistent with information the applicant provided to the USPTO. This is specific to statements or characterizations that are material to patentability and related to (1) an applicable patent (including a statement or characterization of relevant publicly known information), or (2) analytical data included in a new drug or biological product application.
The bill establishes a defense to a patent infringement action if the owner of an applicable patent negligently or intentionally failed to make the disclosures required by these provisions.
Includes amendment, cloture, and procedural votes. Each is labeled with its exact question; only a passage question is a vote to pass the bill.
No recorded roll calls on this bill in coverage.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 528.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Committee on Health, Education, Labor, and Pensions. Hearings held.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Actions from Congress.gov, newest first.
Drug safety, medical device, and laboratory regulation · Inflation and prices · Intellectual property · Manufacturing · Prescription drugs
LD-2 reports whose issue descriptions explicitly cite this bill (bill type and number validated against Congress.gov records). A citation does not establish the client's position or any contact with a member.
Loading lobbying reportsCoverage: reports for 2025 onward, posted Jan 1, 2025 through Oct 23, 2026.
127 citations; showing the 25 most recently posted.
BCBSM INC · lobbying firm or registrant: BCBSM, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 21, 2026 · issue area: Pharmacy
$30,000
Spent on own lobbying
…tion for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Rep. Neguse, Joe [D-CO-2] S.2658 - Medication Affordability and Patent Integrity Act To require sponsors of drug applications and holders of approved applications to provide certain submission…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
AMGEN · lobbying firm or registrant: THE NICKLES GROUP, LLC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 21, 2026 · issue area: Health Issues
$60,000
Paid to lobbying firm
…ted to the drug supply chain. S. 3788, Clear Labels Act. S. 3014, Ensuring Timely Access to Generics Act of 2025; S. 1954, Biosimilar Red Tape Elimination Act; S. 2658, Medication Affordability and Patent Integrity Act.
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
VIATRIS INC · lobbying firm or registrant: VIATRIS INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 21, 2026 · issue area: Health Issues
$450,000
Spent on own lobbying
…ug Tiering HR 4132 / S.2027 - Prescription Information Modernization Act Medicaid Generics Penalty Implementation of the Inflation Reduction Act Drug Shortages S. 2658, The Medication Affordability and Patent Integrity Act
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS · lobbying firm or registrant: AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 21, 2026 · issue area: Health Issues
$250,000
Spent on own lobbying
…he Affordable Prescriptions for Patents Act (H.R. 1768), the Skinny Labels, Big Savings Act (H.R. 6485), the Medication Affordability and Patent Integrity Act (S. 2658), and the Ensuring Timely Access to Generics Act of 2025 (S. 3014), issues related to drug pricing, drug shortages, drug importation plans, and the drug supply…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
BIOTECHNOLOGY INNOVATION ORGANIZATION · lobbying firm or registrant: BIOTECHNOLOGY INNOVATION ORGANIZATION
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 21, 2026 · issue area: Copyright/Patent/Trademark
$2,560,000
Spent on own lobbying
…le Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---S.2658: Medication Affordability and Patient Integrity Act ---S.3014: Ensuring Timely Access to Generics Act ---Department of Commerce Patent Valuation Fee Proposal -…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
BIOTECHNOLOGY INNOVATION ORGANIZATION · lobbying firm or registrant: BIOTECHNOLOGY INNOVATION ORGANIZATION
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 21, 2026 · issue area: Health Issues
$2,560,000
Spent on own lobbying
…1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining I…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · lobbying firm or registrant: RADIUS ADVOCACY, LLC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$30,000
Paid to lobbying firm
…ated to competition pracitces in the pharmaceutical marketplace. S.1040 - Drug Competition Enhancement Act. S.1041 - Affordable Prescriptions for Patients Act. S.2658 - Medication Affordability and Patent Integrity Act (MAPIA). S.1095 - Stop STALLING Act. S.43 - Skinny Labels, Big Savings Act.
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
COUNCIL FOR INNOVATION PROMOTION (C4IP) · lobbying firm or registrant: RADIUS ADVOCACY, LLC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Copyright/Patent/Trademark
$50,000
Paid to lobbying firm
…ion and Improvement Act of 2025. H.R.3160/S.1553 - PREVAIL Act. H.R.1574/S.708 - RESTORE Patent Rights Act of 2025. S.2276 - A bill to address patent thickets. S.2658 - Medication Affordability and Patent Integrity Act (MAPIA). H.R.3269/S.2276 - Eliminating Thickets to Increase Competition Act (ETHIC Act). USPTO Fee-Setting…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
AMERICA'S HEALTH INSURANCE PLANS INC (AHIP) · lobbying firm or registrant: AMERICA'S HEALTH INSURANCE PLANS, INC. (AHIP)
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$3,010,000
Spent on own lobbying
…; Orphan drug inclusion in Medicare Drug Price Negotiation Program S. 2620 - REMEDY Act - Sen. Durbin, Richard - Expedited approvals for certain drug approvals S. 2658 - Medication Affordability and Patient Integrity Act - Sen. Hassan, Maggie - FDA and USPTO coordination S. 3014 - Ensuring Timely Access to Generics Act - Sen.…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · lobbying firm or registrant: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Copyright/Patent/Trademark
$7,040,000
Spent on own lobbying
…g Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 3152: Patent Eligibility Restoration Ac…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · lobbying firm or registrant: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$7,040,000
Spent on own lobbying
…Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3014: Ensuring Timely Access to Generics Act of 2025 S. 3345: PBM Price Transparency and Accountability A…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
GSK (FKA GLAXOSMITHKLINE INC.) · lobbying firm or registrant: GSK (FKA GLAXOSMITHKLINE INC.)
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Copyright/Patent/Trademark
$1,530,000
Spent on own lobbying
…g Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 2276: Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 2620: REMEDY Act S. 2658: Medication Affordability and Patent Integrity Act H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 3152: Patent Eligibility Restoration Ac…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
GSK (FKA GLAXOSMITHKLINE INC.) · lobbying firm or registrant: GSK (FKA GLAXOSMITHKLINE INC.)
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$1,530,000
Spent on own lobbying
…Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3014: Ensuring Timely Access to Generics Act of 2025 S. 3345: PBM Price Transparency and Accountability A…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · lobbying firm or registrant: COVINGTON & BURLING LLP
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Copyright/Patent/Trademark
$340,000
Paid to lobbying firm
Medication Affordability and Patent Integrity Act (S. 2658); Biopharmaceutical policy issues; Skinny Labels, Big Savings Act (S. 43/H.R. 6485).
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · lobbying firm or registrant: COVINGTON & BURLING LLP
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$340,000
Paid to lobbying firm
…egotiation Program and Medicare Prescription Drug Benefit Program Proposed Rule, 91 Fed. Reg. 36236; Medication Affordability and Patent Integrity (MAPIA) Act (S. 2658); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Expedited Access to Biosimilars Act (S. 1414/ H.R.9661); Biosimilar Red Tape Elimination Act (S. 1954/H.R.…
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
AMGEN INC · lobbying firm or registrant: AMGEN, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Copyright/Patent/Trademark
$3,150,000
Spent on own lobbying
…bility Restoration Act of 2025 (PERA) S 2276 / HR 3269 Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 43/HR 6485 Skinny Labels Big Savings Act S.2658 Medication Affordability and Patent Integrity Act S. 3452/HR 6624 Biological Intellectual Property Protection Act of 2025
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
JOHNSON & JOHNSON SERVICES INC · lobbying firm or registrant: JOHNSON & JOHNSON SERVICES, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Copyright/Patent/Trademark
$2,220,000
Spent on own lobbying
…and Improvement Act of 2025, regarding all provisions - H.R. 3269/S. 2276, Eliminating Thickets to Increase Competition (ETHIC) Act, regarding all provisions - S.2658, Medication Affordability and Patent Integrity Act, regarding all provisions Issues related to: - intellectual property, including amending the Federal Trade C…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
SUN PHARMACEUTICAL INDUSTRIES, INC. · lobbying firm or registrant: SUN PHARMACEUTICAL INDUSTRIES, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$140,000
Spent on own lobbying
H.R. 5526 - Biosimilar Red Tape Elimination Act; all provisions. S. 1414 - Expedited Access to Biosimilars Act; all provisions. S. 2658 - Medication Affordability and Patent Integrity Act; all provisions.
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
FRESENIUS KABI USA LLC · lobbying firm or registrant: FRESENIUS KABI USA LLC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Medicare/Medicaid
$630,000
Spent on own lobbying
S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) Domestic Manufacturing of Essential Medicines
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
FRESENIUS KABI USA LLC · lobbying firm or registrant: FRESENIUS KABI USA LLC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Copyright/Patent/Trademark
$630,000
Spent on own lobbying
S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) PTAB: Proposed Rule, Settled Expectations, Patent Thickets and Ancillary Product Patents, Discretion…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
FRESENIUS KABI USA LLC · lobbying firm or registrant: FRESENIUS KABI USA LLC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$630,000
Spent on own lobbying
…H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act H.R. 10369: Net Effective Cost Transparency and Prescription Drug Affordability Act of 2026 S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimil…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
CHAMBER OF COMMERCE OF THE U.S.A. · lobbying firm or registrant: CHAMBER OF COMMERCE OF THE U.S.A.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Copyright/Patent/Trademark
$16,480,000
Spent on own lobbying
H.R. 3269/S. 2276, Eliminating Thickets to Increase Competition (ETHIC) Act S. 2658, Medication Affordability and Patent Integrity Act Potential legislation amending the Inflation Reduction Act (P.L. 117-169) Potential legislation seeking to i…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
EISAI INC. · lobbying firm or registrant: EISAI INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Copyright/Patent/Trademark
$450,000
Spent on own lobbying
Issues related to pharmaceutical Intellectual Property (IP), including: S. 2658, Medication Affordability and Patent Integrity Act.
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
TAKEDA PHARMACEUTICALS AMERICA INC · lobbying firm or registrant: TAKEDA PHARMACEUTICALS AMERICA, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$1,450,000
Spent on own lobbying
…provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, a…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ASSOCIATION OF ACCESSIBLE MEDICINES (FORMERLY KNOWN AS GPHA) · lobbying firm or registrant: FIERCE GOVERNMENT RELATIONS
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$60,000
Paid to lobbying firm
Biosimilars; Generic drugs; Issues around country of origin labeling; Supply Chain; S.2658 - Medication Affordability and Patent Integrity Act; S.3014 - Ensuring Timely Access to Generics Act; S.1414 - Expedited Access to Biosimilars Act; S.1954 - Bi…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing