Interagency Patent Coordination and Improvement Act of 2025

Generics access; Prescription Drug Cost; PBM Reform and Prescription Drug Policy S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S.3014 - Ensuring 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.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition 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 entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration 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.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] H.R.7895 - PBM Kickback Prohibition Act To amend section 408 of the Employee Retirement Income Security Act of 1974 to prohibit kickbacks to pharmacy benefit managers. Sponsor: Rep. Allen, Rick W. [R-GA-12] S.4189 - INSULIN Act of 2026 To reduce the price of insulin and provide for patient protections with respect to the cost of insulin. Sponsor: Sen. Shaheen, Jeanne [D-NH]

Client expense: $1,240,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Issues: Generics access; Prescription Drug Cost; PBM Reform and Prescription Drug Policy Bills: S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S.3014 - Ensuring 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.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition 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 entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration 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.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] H.R.7895 - PBM Kickback Prohibition Act To amend section 408 of the Employee Retirement Income Security Act of 1974 to prohibit kickbacks to pharmacy benefit managers. Sponsor: Rep. Allen, Rick W. [R-GA-12] S.4189 - INSULIN Act of 2026 To reduce the price of insulin and provide for patient protections with respect to the cost of insulin. Sponsor: Sen. Shaheen, Jeanne [D-NH]

Client expense: Not reported · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, White House Office

S.1637/H.R 7871; Medicaid VBPs for Patients Act S. 4323/ H.R. 8143; Ensuring Access to Lower-Cost Medicines for Seniors Act of 2026 S. 2355/H.R. 5582; Patients Deserve Price Tags Act S. 2426/H.R. 3164; Ensuring Community Access to Pharmacist Services Act S.4509/ H.R. 8779; Patients Before Monopolies Act S.2276/ H.R. 3269; Eliminating Thickets to Improve Competition Act S. 526; Pharmacy Benefit Manager Transparency Act S. 882; Patients Before Middlemen Act S. 927; Protecting Pharmacies in Medicaid Act S. 1041; Affordable Prescriptions for Patients Act S. 1095; Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act S. 1096; Preserve Access to Affordable Generics and Biosimilars Act S. 1097; Interagency Patent Coordination and Improvements Act of 2025 S. 1414; Expedited Access to Biosimilars Act S. 2617; Reducing Drug Prices for Seniors Act S. 2800; Pharmacy and Medically Underserved Areas Enhancement Act S. 3345; PBM Price Transparency and Accountability Act S. 3349; PBM Disclosure Act S. 3549; PBM Fiduciary, Accountability, Integrity, and Reform Act S. 3822; Break Up Big Medicine Act S. 4189; INSLUN Act of 2026 S. 5586; Ensuring Accurate Payments to Specialty Pharmacies Act H.R. 1244; Reducing Drug Prices for Seniors Act H.R. 2214; Delinking Revenue from Unfair Gouging Act H.R. 4317; PBM Reform Act H.R. 4409; Fair Pharmacies for Federal Employees Act H.R. 4570; Interagency Patent Coordination and Improvements Act of 2025 H.R. 6609; Pharmacists Fight Back Act in Medicare and Medicaid H.R. 6610; Pharmacists Fight Back Act in the Federal Employees Health Benefits Program H.R. 6837; To amend the Employee Retirement Income Security Act of 1974 to ensure that pharmacy benefit managers are considered fiduciaries, and for other purposes. H.R. 7148; Consolidated Appropriations Act of 2026 oSec. 6233- Any Willing Pharmacy oSec 6224- Medicare Delinking oSec. 6701- Oversight of PBM Services oSec. 6702- Full Rebate Pass Through to Plans H.R. 7895; PBM Kickback Prohibition Act H.R. 8324; Great American Healthcare Plan H.R. 9228; Health Data Access, Transparency, and Affordability Act of 2026 H.R. 9486; Health Data Access, Transparency and Affordability Act H.R. 9117; Clear Healthcare Expense Cost Knowledge Act H.R. 9393; Lower Cost, More Transparency Act of 2026 H.R. 9645; Health Care Price Certainty for All Americans Act H.R. 10369; Net Effective Cost Transparency and Prescription Drug Affordability Act of 2026 Implementation of the Inflation Reduction Act of 2022, P.L. 169- Provisions on Medicare Part D modernization and drug price negotiation, and the implementation of the Consolidated Appropriations Act of 2026 (P.L. 119-75)

Client expense: $3,203,049 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE, Small Business Administration (SBA)

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 - Skinny Labels, Big Savings Act. H.R. 3269/S. 2276 - Eliminating Thickets to Increase Competition (ETHIC) Act. H.R. 3160/S. 1533 - The Prevail Act. H.R. 3152/S. 1546 - Patient Eligibility Restoration Act.

Client expense: Not reported · Firm income: $90,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Pharmacy Benefit Managers Reform; Prescription Drug Cost; Delinking of Pharmacy; Generic Access; Direct to Consumer Marketing; Pay to Play; Patents S. 3014 - Ensuring Timely Access to Generics Act of 2025 To amend the Federal Food, Drug and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Jeanne Shaheen S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. John Cornyn S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition and 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 entry of o generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen Amy Klobuchar H.R. 4570 - Interagency Patent Coordination and Improvement Act of 2025 TO amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Rep Joe Neguse S1097 - Interagency Patent Coordination and Improvement Act of 2025 TO amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: S. Richard Durbin

Client expense: $420,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Patent abuse issues. S. 1041 Affordable Prescriptions for Patients Act of 2025. H.R. 4570/S. 1097 Interagency Patent Coordination Act. S. 2658, Medication Affordability and Patent Integrity Act. S. 1096 Preserve Access to Affordable Generics and Biosimilars Act. H.R. 3160 & S. 1533, the PREVAIL Act. S. 1546 & H.R. 3152, the Patent Eligibility Restoration Act of 2025. H.R. 6485 & S.43 Skinny Labels, Big Savings Act. S.1040 Drug Competition Enhancement Act. H.R. 3269 /S. 2276, Eliminating Thickets to Increase Competition (ETHIC) Act.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.1637/H.R 7871; Medicaid VBPs for Patients Act S. 4323/ H.R. 8143; Ensuring Access to Lower-Cost Medicines for Seniors Act of 2026 S. 2355/H.R. 5582; Patients Deserve Price Tags Act S. 2426/H.R. 3164; Ensuring Community Access to Pharmacist Services Act S.4509/ H.R. 8779; Patients Before Monopolies Act S. 526; Pharmacy Benefit Manager Transparency Act S. 882; Patients Before Middlemen Act S. 927; Protecting Pharmacies in Medicaid Act S. 1041; Affordable Prescriptions for Patients Act S. 1095; Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act S. 1096; Preserve Access to Affordable Generics and Biosimilars Act S. 1097; Interagency Patent Coordination and Improvements Act of 2025 S. 1414; Expedited Access to Biosimilars Act S. 2617; Reducing Drug Prices for Seniors Act S. 2800; Pharmacy and Medically Underserved Areas Enhancement Act S. 3345; PBM Price Transparency and Accountability Act S. 3349; PBM Disclosure Act S. 3549; PBM Fiduciary, Accountability, Integrity, and Reform Act S. 3822; Break Up Big Medicine Act S. 4189; INSLUN Act of 2026 H.R. 1244; Reducing Drug Prices for Seniors Act H.R. 2214; Delinking Revenue from Unfair Gouging Act H.R. 4317; PBM Reform Act H.R. 4409; Fair Pharmacies for Federal Employees Act H.R. 4570; Interagency Patent Coordination and Improvements Act of 2025 H.R. 6609; Pharmacists Fight Back Act in Medicare and Medicaid H.R. 6610; Pharmacists Fight Back Act in the Federal Employees Health Benefits Program H.R. 6837; To amend the Employee Retirement Income Security Act of 1974 to ensure that pharmacy benefit managers are considered fiduciaries, and for other purposes. H.R. 7148; Consolidated Appropriations Act of 2026 oSec. 6233- Any Willing Pharmacy oSec 6224- Medicare Delinking oSec. 6701- Oversight of PBM Services oSec. 6702- Full Rebate Pass Through to Plans H.R. 7895; PBM Kickback Prohibition Act H.R. 8324; Great American Healthcare Plan H.R. 9228; Health Data Access, Transparency, and Affordability Act of 2026 H.R. 9486; Health Data Access, Transparency and Affordability Act H.R. 9117; Clear Healthcare Expense Cost Knowledge Act H.R. 9393; Lower Cost, More Transparency Act of 2026 Implementation of the Inflation Reduction Act of 2022, P.L. 169- Provisions on Medicare Part D modernization and drug price negotiation, and the implementation of the Consolidated Appropriations Act of 2026 (P.L. 119-75)

Client expense: $3,282,990 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE, Small Business Administration (SBA)

Issues: Generics access; Prescription Drug Cost; PBM Reform and Prescription Drug Policy Bills: S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S.3014 - Ensuring 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.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition 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 entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration 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 submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] H.R.7895 - PBM Kickback Prohibition Act To amend section 408 of the Employee Retirement Income Security Act of 1974 to prohibit kickbacks to pharmacy benefit managers. Sponsor: Rep. Allen, Rick W. [R-GA-12] H.R. 6837 - PBM FAIR Act To amend the Employee Retirement Income Security Act of 1974 to ensure that pharmacy benefit managers are considered fiduciaries, and for other purposes. Sponsor: Rep. Auchincloss, Jake [D-MA-4] H.R.3164 - Ensuring Community Access to Pharmacist Services Act To amend title XVIII of the Social Security Act to provide pharmacy payment of certain services. Sponsor: Rep. Smith, Adrian [R-NE-3] S.43 - Skinny Labels, Big Savings Act To amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products. Sponsor: Sen. Hickenlooper, John W. [D-CO] H.R.6485 - Skinny Labels, Big Savings Act To amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products. Sponsor: Rep. Cline, Ben [R-VA-6] S.4189 - INSULIN Act of 2026 To reduce the price of insulin and provide for patient protections with respect to the cost of insulin. Sponsor: Sen. Shaheen, Jeanne [D-NH]

Client expense: $80,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, White House Office

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 Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting 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 S. 3452: Biological Intellectual Protection Act of 2025 H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act H.R. 6624: Biological Intellectual Property Protection Act of 2025 Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues

Client expense: $7,360,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE

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 - Skinny Labels, Big Savings Act. H.R. 3269/S. 2276 - Eliminating Thickets to Increase Competition (ETHIC) Act. H.R. 3160/S. 1533 - The Prevail Act. H.R. 3152/S. 1546 - Patient Eligibility Restoration Act.

Client expense: Not reported · Firm income: $90,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Generics access; Prescription Drug Cost; PBM Reform and Prescription Drug Policy S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S.3014 - Ensuring 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.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition 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 entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration 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 submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] H.R.7895 - PBM Kickback Prohibition Act To amend section 408 of the Employee Retirement Income Security Act of 1974 to prohibit kickbacks to pharmacy benefit managers. Sponsor: Rep. Allen, Rick W. [R-GA-12] H.R. 6837 - PBM FAIR Act To amend the Employee Retirement Income Security Act of 1974 to ensure that pharmacy benefit managers are considered fiduciaries, and for other purposes. Sponsor: Rep. Auchincloss, Jake [D-MA-4] H.R.3164 - Ensuring Community Access to Pharmacist Services Act To amend title XVIII of the Social Security Act to provide pharmacy payment of certain services. Sponsor: Rep. Smith, Adrian [R-NE-3] S.43 - Skinny Labels, Big Savings Act To amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products. Sponsor: Sen. Hickenlooper, John W. [D-CO] H.R.6485 - Skinny Labels, Big Savings Act To amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products. Sponsor: Rep. Cline, Ben [R-VA-6] S.4189 - INSULIN Act of 2026 To reduce the price of insulin and provide for patient protections with respect to the cost of insulin. Sponsor: Sen. Shaheen, Jeanne [D-NH]

Client expense: $990,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Issues: Generics access; Prescription Drug Cost; PBM Reform and Prescription Drug Policy Bills: S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S.3014 - Ensuring 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.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition 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 entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration 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 submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] H.R.7895 - PBM Kickback Prohibition Act To amend section 408 of the Employee Retirement Income Security Act of 1974 to prohibit kickbacks to pharmacy benefit managers. Sponsor: Rep. Allen, Rick W. [R-GA-12] H.R. 6837 - PBM FAIR Act To amend the Employee Retirement Income Security Act of 1974 to ensure that pharmacy benefit managers are considered fiduciaries, and for other purposes. Sponsor: Rep. Auchincloss, Jake [D-MA-4] H.R.3164 - Ensuring Community Access to Pharmacist Services Act To amend title XVIII of the Social Security Act to provide pharmacy payment of certain services. Sponsor: Rep. Smith, Adrian [R-NE-3] S.43 - Skinny Labels, Big Savings Act To amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products. Sponsor: Sen. Hickenlooper, John W. [D-CO] H.R.6485 - Skinny Labels, Big Savings Act To amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products. Sponsor: Rep. Cline, Ben [R-VA-6] S.4189 - INSULIN Act of 2026 To reduce the price of insulin and provide for patient protections with respect to the cost of insulin. Sponsor: Sen. Shaheen, Jeanne [D-NH]

Client expense: $20,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, White House Office

Pharmacy Benefit Managers Reform; Prescription Drug Cost; Delinking of Pharmacy; Generic Access; Direct to Consumer Marketing; Pay to Play; Patents S. 3014 - Ensuring Timely Access to Generics Act of 2025 To amend the Federal Food, Drug and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Jeanne Shaheen S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. John Cornyn S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition and 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 entry of o generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen Amy Klobuchar H.R. 4570 - Interagency Patent Coordination and Improvement Act of 2025 TO amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Rep Joe Neguse S1097 - Interagency Patent Coordination and Improvement Act of 2025 TO amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: S. Richard Durbin

Client expense: $140,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues: Generics access; Prescription Drug Cost; Step Therapy Bills: S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S.3014 - Ensuring 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.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition 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 entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration 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 submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] S.1040 - Drug Competition 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 entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration 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 submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2]

Client expense: $28,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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 Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting 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 S. 3452: Biological Intellectual Protection Act of 2025 H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act H.R. 6624: Biological Intellectual Property Protection Act of 2025 Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues

Client expense: $890,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE

Educating and raising awareness on conventional weapons destruction in Vietnam, lobbying for global funding for conventional weapons destruction funding under SFOPS/NSRP appropriations, lobbying for reintroduction of Legacies of War bill (HR4570, Congress 118).

Client expense: Not reported · Firm income: Not reported

Educating and raising awareness on conventional weapons destruction in Vietnam, lobbying for global funding for conventional weapons destruction funding under SFOPS/NSRP appropriations, lobbying for reintroduction of Legacies of War bill (HR4570, Congress 118).

Client expense: Not reported · Firm income: Not reported

S.1637/H.R 7871; Medicaid VBPs for Patients Act S. 2355/H.R. 5582; Patients Deserve Price Tags Act S. 2426/H.R. 3164; Ensuring Community Access to Pharmacist Services Act S. 526; Pharmacy Benefit Manager Transparency Act S. 882; Patients Before Middlemen Act S. 927; Protecting Pharmacies in Medicaid Act S. 1041; Affordable Prescriptions for Patients Act S. 1095; Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act S. 1096; Preserve Access to Affordable Generics and Biosimilars Act S. 1097; Interagency Patent Coordination and Improvements Act of 2025 S. 1414; Expedited Access to Biosimilars Act S. 2617; Reducing Drug Prices for Seniors Act S. 2800; Pharmacy and Medically Underserved Areas Enhancement Act S. 3345; PBM Price Transparency and Accountability Act S. 3349; PBM Disclosure Act S. 3549; PBM Fiduciary, Accountability, Integrity, and Reform Act S. 3822; Break Up Big Medicine Act H.R. 1244; Reducing Drug Prices for Seniors Act H.R. 2214; Delinking Revenue from Unfair Gouging Act H.R. 3164; Ensuring Community Access to Pharmacist Service Act H.R. 4317; PBM Reform Act H.R. 4409; Fair Pharmacies for Federal Employees Act H.R. 4570; Interagency Patent Coordination and Improvements Act of 2025 H.R. 6609; Pharmacists Fight Back Act in Medicare and Medicaid H.R. 6610; Pharmacists Fight Back Act in the Federal Employees Health Benefits Program H.R. 6837; To amend the Employee Retirement Income Security Act of 1974 to ensure that pharmacy benefit managers are considered fiduciaries, and for other purposes. H.R. 7148; Consolidated Appropriations Act of 2026 oSec. 6233- Any Willing Pharmacy oSec 6224- Medicare Delinking oSec. 6701- Oversight of PBM Services oSec. 6702- Full Rebate Pass Through to Plans H.R. 7895; PBM Kickback Prohibition Act H.R. 8143; Ensuring Access to Lower-Cost Medicines for Seniors Act of 2026 Implementation of the Inflation Reduction Act of 2022, P.L. 169- Provisions on Medicare Part D modernization and drug price negotiation, and the implementation of the Consolidated Appropriations Act of 2026 (P.L. 119-75)

Client expense: $2,996,995 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE, Small Business Administration (SBA)

Patent abuse issues. S. 1041 Affordable Prescriptions for Patients Act of 2025. H.R. 4570/S. 1097 Interagency Patent Coordination Act. S. 2658, Medication Affordability and Patent Integrity Act. S. 1096 Preserve Access to Affordable Generics and Biosimilars Act. H.R. 3160 & S. 1533, the PREVAIL Act. S. 1546 & H.R. 3152, the Patent Eligibility Restoration Act of 2025. H.R. 6485 & S.43 Skinny Labels, Big Savings Act. S.1040 Drug Competition Enhancement Act. H.R. 3269 /S. 2276, Eliminating Thickets to Increase Competition (ETHIC) Act.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 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. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting 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. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues

Client expense: $1,640,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE

H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating 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. H.R.4570/S.1097: Interagency Patent Coordination and Improvement Act of 2025. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act).

Client expense: $840,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Patent & Trademark Office (PTO), SENATE, White House Office

Issues: Generics access; Prescription Drug Cost; Step Therapy Bills: S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S.3014 - Ensuring 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.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition 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 entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration 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 submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2]

Client expense: $10,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, White House Office

Issues: Generics access; Prescription Drug Cost; Step Therapy Bills: S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S.3014 - Ensuring 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.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition 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 entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration 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 submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2]

Client expense: $130,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, White House Office

Issues: Generics access; Prescription Drug Cost; Step Therapy Bills: S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S.3014 - Ensuring 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.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition 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 entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration 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 submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] S.1040 - Drug Competition 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 entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration 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 submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2]

Client expense: $30,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.1637/H.R 7871; Medicaid VBPs for Patients Act S. 2355/H.R. 5582; Patients Deserve Price Tags Act S. 2426/H.R. 3164; Ensuring Community Access to Pharmacist Services Act S. 526; Pharmacy Benefit Manager Transparency Act S. 882; Patients Before Middlemen Act S. 927; Protecting Pharmacies in Medicaid Act S. 1041; Affordable Prescriptions for Patients Act S. 1095; Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act S. 1096; Preserve Access to Affordable Generics and Biosimilars Act S. 1097; Interagency Patent Coordination and Improvements Act of 2025 S. 1414; Expedited Access to Biosimilars Act S. 2617; Reducing Drug Prices for Seniors Act S. 2800; Pharmacy and Medically Underserved Areas Enhancement Act S. 3345; PBM Price Transparency and Accountability Act S. 3349; PBM Disclosure Act S. 3549; PBM Fiduciary, Accountability, Integrity, and Reform Act S. 3822; Break Up Big Medicine Act H.R. 1244; Reducing Drug Prices for Seniors Act H.R. 2214; Delinking Revenue from Unfair Gouging Act H.R. 3164; Ensuring Community Access to Pharmacist Service Act H.R. 4317; PBM Reform Act H.R. 4409; Fair Pharmacies for Federal Employees Act H.R. 4570; Interagency Patent Coordination and Improvements Act of 2025 H.R. 6609; Pharmacists Fight Back Act in Medicare and Medicaid H.R. 6610; Pharmacists Fight Back Act in the Federal Employees Health Benefits Program H.R. 6837; To amend the Employee Retirement Income Security Act of 1974 to ensure that pharmacy benefit managers are considered fiduciaries, and for other purposes. H.R. 7148; Consolidated Appropriations Act of 2026 oSec. 6233- Any Willing Pharmacy oSec 6224- Medicare Delinking oSec. 6701- Oversight of PBM Services oSec. 6702- Full Rebate Pass Through to Plans H.R. 7895; PBM Kickback Prohibition Act H.R. 8143; Ensuring Access to Lower-Cost Medicines for Seniors Act of 2026 Implementation of the Inflation Reduction Act of 2022, P.L. 169- Provisions on Medicare Part D modernization and drug price negotiation, and the implementation of the Consolidated Appropriations Act of 2026 (P.L. 119-75)

Client expense: $299,699 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE, Small Business Administration (SBA)

S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 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 Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting 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. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues

Client expense: $12,210,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE

Generics access; Prescription Drug Cost; Step Therapy S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S.3014 - Ensuring 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.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition 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 entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration 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 submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2]

Client expense: $1,520,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Pharmacy Benefit Managers; Prescription Drug Cost; Delinking of Pharmacy; Generic Access; Direct to Consumer Marketing; Pay to Play; Patents S. 3014 - Ensuring Timely Access to Generics Act of 2025 To amend the Federal Food, Drug and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Jeanne Shaheen S.1040 - Drug Competition Enhancement Act A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. John Cornyn S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition and 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 entry of o generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen Amy Klobuchar H.R. 4570 - Interagency Patent Coordination and Improvement Act of 2025 TO amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Rep Joe Neguse S1097 - Interagency Patent Coordination and Improvement Act of 2025 TO amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: S. Richard Durbin

Client expense: $220,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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 - Skinny Labels, Big Savings Act. H.R. 3269/S. 2276 - Eliminating Thickets to Increase Competition (ETHIC) Act. H.R. 3160/s. 1533 - the Prevail Act. H.R. 3152/S. 1546 - Patient Eligibility Restoration Act.

Client expense: Not reported · Firm income: $90,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Patent abuse issues. S. 1041 Affordable Prescriptions for Patients Act of 2025. H.R. 4570/S. 1097 Interagency Patent Coordination Act. S. 2658, Medication Affordability and Patent Integrity Act. S. 1096 Preserve Access to Affordable Generics and Biosimilars Act. H.R. 3160 & S. 1533, the PREVAIL Act. S. 1546 & H.R. 3152, the Patent Eligibility Restoration Act of 2025. H.R. 6485 & S.43 Skinny Labels, Big Savings Act. S.1040 Drug Competition Enhancement Act. H.R. 3269 /S. 2276, Eliminating Thickets to Increase Competition (ETHIC) Act.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 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. 1302: Increasing Transparency in Generic Drug Application Act S. 1546: Patent Eligibility Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 1784 MAPS 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. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues

Client expense: $810,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE

Issues: 340B Program/Transparency; generics access; Pharmacy Benefit Managers; Prescription Drug Cost; Step Therapy Bills: S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 775, Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] S. 1067, Ensuring Timely Access to Generics Act (118th) To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition 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 entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration 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 submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] H.R.1262 - Mikaela Naylon Give Kids a Chance Act To amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes. Sponsor: Rep. McCaul, Michael T. [R-TX-10] S.932 - Give Kids a Chance Act of 2025 A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes. Sponsor: Sen. Mullin, Markwayne [R-OK] H.R.6609 - Pharmacists Fight Back in Medicare and Medicaid Act To amend titles XI, XVIII, and XIX of the Social Security Act to establish certain requirements under Medicare and Medicaid with respect to prescription drug benefits and pharmacy benefit managers. Sponsor: Rep. Auchincloss, Jake [D-MA-4] H.R.6610 - Pharmacists Fight Back [in Federal Employee Health Benefit Plans Act] To amend chapter 89 of title 5, United States Code, to limit the costs of pharmacy benefit managers with respect to Federal employee health benefit plans, and for other purposes. Sponsor: Rep. Auchincloss, Jake [D-MA-4]

Client expense: $90,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, White House Office

S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 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 Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting 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. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 H.R. 6485: Skinny Labels, Big Savings Act Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues Patent fee policy issues

Client expense: $8,410,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Federal Trade Commission (FTC), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE

Issues: 340B Program/Transparency; generics access; Pharmacy Benefit Managers; Prescription Drug Cost; Step Therapy Bills: S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 775, Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] S. 1067, Ensuring Timely Access to Generics Act (118th) To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition 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 entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration 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 submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] H.R.1262 - Mikaela Naylon Give Kids a Chance Act To amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes. Sponsor: Rep. McCaul, Michael T. [R-TX-10] S.932 - Give Kids a Chance Act of 2025 A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes. Sponsor: Sen. Mullin, Markwayne [R-OK] H.R.6609 - Pharmacists Fight Back in Medicare and Medicaid Act To amend titles XI, XVIII, and XIX of the Social Security Act to establish certain requirements under Medicare and Medicaid with respect to prescription drug benefits and pharmacy benefit managers. Sponsor: Rep. Auchincloss, Jake [D-MA-4] H.R.6610 - Pharmacists Fight Back [in Federal Employee Health Benefit Plans Act] To amend chapter 89 of title 5, United States Code, to limit the costs of pharmacy benefit managers with respect to Federal employee health benefit plans, and for other purposes. Sponsor: Rep. Auchincloss, Jake [D-MA-4]

Client expense: Not reported · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, White House Office

340B Program/Transparency; generics access; Pharmacy Benefit Managers; Prescription Drug Cost; Step Therapy S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 775, Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] S. 1067, Ensuring Timely Access to Generics Act (118th) To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition 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 entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration 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 submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] H.R.1262 - Mikaela Naylon Give Kids a Chance Act To amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes. Sponsor: Rep. McCaul, Michael T. [R-TX-10] S.932 - Give Kids a Chance Act of 2025 A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes. Sponsor: Sen. Mullin, Markwayne [R-OK] H.R.6609 - Pharmacists Fight Back in Medicare and Medicaid Act To amend titles XI, XVIII, and XIX of the Social Security Act to establish certain requirements under Medicare and Medicaid with respect to prescription drug benefits and pharmacy benefit managers. Sponsor: Rep. Auchincloss, Jake [D-MA-4] H.R.6610 - Pharmacists Fight Back [in Federal Employee Health Benefit Plans Act] To amend chapter 89 of title 5, United States Code, to limit the costs of pharmacy benefit managers with respect to Federal employee health benefit plans, and for other purposes. Sponsor: Rep. Auchincloss, Jake [D-MA-4]

Client expense: $1,440,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Issues: 340B Program/Transparency; generics access; Pharmacy Benefit Managers; Prescription Drug Cost; Step Therapy Bills: S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 775, Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] S. 1067, Ensuring Timely Access to Generics Act (118th) To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition 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 entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration 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 submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2]

Client expense: $28,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act S. 2305: Biosimilar Red Tape Elimination Act S. 2658: Medication Affordability and Patient Integrity Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing

Client expense: $340,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, White House Office

S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 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 Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting 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. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent use codes policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues

Client expense: $1,700,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE

Patent abuse issues. S. 1041 Affordable Prescriptions for Patients Act of 2025. H.R. 4570/S. 1097 Interagency Patent Coordination Act. S. 2658, Medication Affordability and Patent Integrity Act. S. 1096 Preserve Access to Affordable Generics and Biosimilars Act. H.R. 3160 & S. 1533, the PREVAIL Act. S. 1546 & H.R. 3152, the Patent Eligibility Restoration Act of 2025. S.43 Skinny Labels, Big Savings Act. H.R. 5526/S. 1954, the Biosimilar Red Tape Elimination Act. S. 1785 & H.R. 3010, the No Handouts for Drug Advertisements Act. S.1040 Drug Competition Enhancement Act. H.R. 3269 /S. 2276, Eliminating Thickets to Increase Competition (ETHIC) Act.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. S.43: Skinny Labels, Big Savings Act. S.1040: Drug Competition Enhancement Act. H.R.4570/S.1097: Interagency Patent Coordination and Improvement Act of 2025.

Client expense: $640,000 · Firm income: Not reported

Government targets: Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), SENATE

Issues: 340B Program/Transparency; generics access; Pharmacy Benefit Managers; Prescription Drug Cost; Step Therapy Bills: S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 775, Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] S. 1067, Ensuring Timely Access to Generics Act (118th) To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition 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 entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration 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 submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2]

Client expense: $80,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, White House Office

340B Program/Transparency; generics access; Pharmacy Benefit Managers; Prescription Drug Cost; Step Therapy S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 775, Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] S. 1067, Ensuring Timely Access to Generics Act (118th) To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition 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 entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration 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 submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2]

Client expense: $1,150,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 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 Restoration Act of 2025 (PERA) S. 1553: Promoting and Respecting 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. 1574: RESTORE Patent Rights Act of 2025 H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) H.R. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent use codes policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues

Client expense: $9,030,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE

Issues: 340B Program/Transparency; generics access; Pharmacy Benefit Managers; Prescription Drug Cost; Step Therapy Bills: S.1954 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 775, Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] S. 1067, Ensuring Timely Access to Generics Act (118th) To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S.1041 - Affordable Prescriptions for Patients Act A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1040 - Drug Competition 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 entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1095 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Klobuchar, Amy [D-MN] S.1097 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Sponsor: Sen. Durbin, Richard J. [D-IL] H.R.4570 - Interagency Patent Coordination and Improvement Act of 2025 To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration 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 submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S.1302 - Increasing Transparency in Generic Drug Applications Act To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.1843 - Increasing Transparency in Generic Drug Applications Act To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2]

Client expense: Not reported · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, White House Office

S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act S. 1414/H.R._: Expedited Access to Biosimilars Act S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 1041: Affordable Prescriptions for Patients Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 43: Skinny Labels, Big Savings Act S. 1097/H.R. 4570: Interagency Patent Coordination and Improvement Act of 2025 HR 4317: PBM Reform Act of 2025 HR 2214: DRUG Act S. 1553/H.R. 3160: PREVAIL Act ERISA Fiduciary Duty PTAB Discretionary Denials IRA Reform Human Factor Studies Interchangeability Biosimilar User Fee Act (BsUFA) Drug Shortages Domestic Manufacturing

Client expense: $320,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, White House Office