119th Congress · introduced in the Senate · Mar 24, 2025
Preserve Access to Affordable Generics and Biosimilars Act
Official title from Congress.gov
Latest action (Apr 10, 2025): Placed on Senate Legislative Calendar under General Orders. Calendar No. 46.
View on Congress.govPolicy area: Health
Congressional Research Service summary, version: Introduced in Senate (Mar 24, 2025)
Preserve Access to Affordable Generics and Biosimilars Act
This bill prohibits parties from entering into any agreement that resolves or settles a patent claim related to the sale of a drug or biological product and that has anticompetitive effects. Such an agreement is presumed to have anticompetitive effects if the filer of a generic drug or biosimilar application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biosimilar.
An agreement is exempt if the only consideration granted to the generic manufacturer is (1) the right to market and secure final approval for its product prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on any claim that the generic drug or biosimilar infringes a U.S. patent. An agreement is also exempt if the agreement's pro-competitive benefits outweigh the anticompetitive effects.
The bill provides for enforcement by the Federal Trade Commission (FTC). Violators are subject to penalties including the forfeiture of the 180-day marketing exclusivity period for a generic drug.
Additionally, when a generic or biosimilar drug manufacturer enters into an agreement with another drug manufacturer related to the manufacturing, marketing, or sale of a drug, the manufacturers must certify that the material they have given the FTC and the Department of Justice concerning the agreement contains the complete agreement and any related agreements, including descriptions of any oral agreements or representations.
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. 46.
Committee on the Judiciary. Reported by Senator Grassley with an amendment in the nature of a substitute. Without written report.
Committee on the Judiciary. Reported by Senator Grassley with an amendment in the nature of a substitute. Without written report.
Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
Read twice and referred to the Committee on the Judiciary.
Introduced in Senate
Actions from Congress.gov, newest first.
Administrative law and regulatory procedures · Civil actions and liability · Competition and antitrust · Contracts and agency · Federal Trade Commission (FTC) · Intellectual property · Judicial review and appeals · Licensing and registrations · Manufacturing · Marketing and advertising · 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 24, 2026.
182 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
…etition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the…
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
PUBLIC CITIZEN · lobbying firm or registrant: PUBLIC CITIZEN
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 21, 2026 · issue area: Pharmacy
$133,000
Spent on own lobbying
…care drug price negotiation delay periods and exemptions; H.R.3269 ETHIC Act; drug prices, S. 1040 Drug Competition Enhancement Act; S. 1095 Stop STALLING Act; S. 1096 Preserve Access to Affordable Generics and Biosimilars Act; S.2276, Affordable Pricing for Taxpayer Funded Drugs Act, Medicare Part D disenrollment, Affordable…
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
…Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1546/H.R.3152: Patent Eligibili…
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
…Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.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…
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: Medicare/Medicaid
$2,560,000
Spent on own lobbying
…Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions o…
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 FOR ACCESSIBLE MEDICINES · lobbying firm or registrant: TWINLOGIC STRATEGIES, LLP
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Copyright/Patent/Trademark
$40,000
Paid to lobbying firm
Issues related to patents and generic drugs Monitor S. 1096 - patent settlements Issues relating to review of pharmaceutical patents in inter partes reviews Issues relating to the Patent Trial and Appeal Board Patent th…
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
BLUE CROSS AND BLUE SHIELD OF KANSAS INC · lobbying firm or registrant: BLUE CROSS AND BLUE SHIELD OF KANSAS, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$10,000
Spent on own lobbying
…etition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the…
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
…S. 1041 - Affordable Prescriptions for Patients Act - Sen. Cornyn, John - Patent issues S. 1095 - Stop STALLING Act - Sen. Klobuchar, Amy - Drug patent reform S. 1096 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy - Drug patent reform S. 1414 - Expedited Access to Biosimilars Act - Sen. Pa…
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
FAMILIES USA FOUNDATION INC · lobbying firm or registrant: FAMILIES USA FOUNDATION, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$30,000
Spent on own lobbying
…to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. S.1096Preserve Access to Affordadable Generics and BiosimilarsTo prohibit brand name drug companies from compensating generic drug companies to delay the entry of a g…
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
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
S. 43: Skinny Labels, Big Savings Act S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Re…
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
S. 43: Skinny Labels, Big Savings Act S. 1040: Drug Competition Enhancement Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 1546: Patent Eligibility Re…
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
BLUE CROSS AND BLUE SHIELD OF FLORIDA INC · lobbying firm or registrant: BLUE CROSS AND BLUE SHIELD OF FLORIDA, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$100,000
Spent on own lobbying
…etition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the…
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
BLUE CROSS AND BLUE SHIELD ASSOCIATION · lobbying firm or registrant: BLUE CROSS AND BLUE SHIELD ASSOCIATION
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$1,240,000
Spent on own lobbying
…etition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the…
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
BLUE CROSS BLUE SHIELD OF MICHIGAN · lobbying firm or registrant: BLUE CROSS BLUE SHIELD OF MICHIGAN
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$276,347
Spent on own lobbying
…Timely Access to Generics Act of 2025 To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the…
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
GUIDEWELL MUTUAL HOLDING CORPORATION · lobbying firm or registrant: GUIDEWELL MUTUAL HOLDING CORPORATION
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
Amount not reported
…etition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. View filing
NOVARTIS · lobbying firm or registrant: NOVARTIS
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Copyright/Patent/Trademark
$840,000
Spent on own lobbying
S. 43: Skinny Labels, Big Savings Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating…
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
…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, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical…
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
THE CAMPAIGN FOR SUSTAINABLE RX PRICING · lobbying firm or registrant: MEHLMAN CONSULTING, INC.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Copyright/Patent/Trademark
$90,000
Paid to lobbying firm
Patent abuse issues. S.1040 - Drug Competition Enhancement Act. S.1041 - Affordable Prescriptions for Patients Act. S.1096 - Preserve Access to Affordable Generics and Biosimilars Act. S. 1097/H.R. 4570 - Interagency Patent Coordination and Improvement Act of 2025. 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
TIBER CREEK HEALTH STRATEGIES, INC. (ON BEHALF OF ELI LILLY AND COMPANY) · lobbying firm or registrant: TIBER CREEK GROUP
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Copyright/Patent/Trademark
$80,000
Paid to lobbying firm
…s related to intellectual property; Issues related to S. 1041 - Affordable Prescriptions for Patients Act; Issues related to patent thickets; Issues related to S. 1096 - Preserve Access to Affordable Generics and Biosimilars Act; Issues related to 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
BLUECROSS BLUESHIELD OF TENNESSEE · lobbying firm or registrant: BLUECROSS BLUESHIELD OF TENNESSEE
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 19, 2026 · issue area: Pharmacy
$420,000
Spent on own lobbying
…facilitate the effective review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen Amy Klobuchar S. 1096 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the…
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 INTELLECTUAL PROPERTY LAW ASSOCIATION (AIPLA) · lobbying firm or registrant: AMERICAN INTELLECTUAL PROPERTY LAW ASSOCIATION (AIPLA)
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 19, 2026 · issue area: Copyright/Patent/Trademark
$10,000
Spent on own lobbying
…n Act of 2025 S. 1367/H.R. 5794, NO FAKES H.R 791, Foreign Anti-Digital Piracy Act (FADPA) S. 1097, Interagency Patent Coordination and Improvement Act of 2025 S. 1096, Preserve Access to Affordable Generics and Biosimilars Act S. 1041, Affordable Prescriptions for Patients Act S. 708/H.R. 1574, RESTORE Patent Rights Act of 2…
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: CROSSROADS STRATEGIES, LLC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 17, 2026 · issue area: Health Issues
$50,000
Paid to lobbying firm
…ncement Act; S.1041, Affordable Prescriptions for Patients Act; S.1097, Interagency Patent Coordination and Improvement Act of 2025; S.1095, Stop STALLING Act; S.1096, Preserve Access to Affordable Generics and Biosimilars Act; Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients; FY2027 Departments…
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 FOR ACCESSIBLE MEDICINES · lobbying firm or registrant: ASSOCIATION FOR ACCESSIBLE MEDICINES
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 17, 2026 · issue area: Copyright/Patent/Trademark
$770,000
Spent on own lobbying
…ing Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Re…
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 (MYLAN, INC) · lobbying firm or registrant: S-3 GROUP
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 16, 2026 · issue area: Copyright/Patent/Trademark
$60,000
Paid to lobbying firm
Issues related to patent policy and reform, including to address patent thickets and FDA/PTO Coordination; S.527 Prescription Pricing for the People Act; S.1096 Preserve Access to Affordable Generics and Biosimilars Act; S.1041 Affordable Prescriptions for Patients 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
CAMBIA HEALTH SOLUTIONS · lobbying firm or registrant: CAMBIA HEALTH SOLUTIONS
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 15, 2026 · issue area: Health Issues
$670,000
Spent on own lobbying
…R. 4710); Cybersecurity; Health IT, Health Care Innovation, Transparency & PBMs (S. 891, H.R. 6703), PBM Compensation (H.R. 7895), Prescription Drugs (S. 1954, S. 1096, S.1040), Price Transparency (S. 2355, H.R. 9393, H.R. 9397, H.R. 9645, H.R. 9390), Prior Authorization (H.R. 9396), 340B, Insulin (S. 4189), Corporate Practic…
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