Loading…
Medication Affordability and Patent Integrity Act
Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
97pct
361d open
vs 5,674 other S bills in the 119th — cohort avg 32d
Medication Affordability and Patent Integrity Act This bill requires applicants seeking approval of a drug or licensure of a biological product to submit certain information about relevant patents to both the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO). Specifically, the bill requires applicants to make certifications and disclosures related to each applicable patent on a proposed drug or biological product. An applicable patent is a patent or patent application held or sought by the applicant for the drug or biological product (including a formulation or composition, method of use, or method of manufacturing). For each applicable patent, an applicant must submit to the USPTO any information material to patentability that the applicant submitted to the FDA and any information provided by the FDA in response. The applicant must certify that this submission is complete and consistent with the information the applicant provided to the FDA. Further, for each applicable patent, an applicant must certify that certain information submitted to the FDA is consistent with information the applicant provided to the USPTO. This is specific to statements or characterizations that are material to patentability and related to (1) an applicable patent (including a statement or characterization of relevant publicly known information), or (2) analytical data included in a new drug or biological product application. The bill establishes a defense to a patent infringement action if the owner of an applicable patent negligently or intentionally failed to make the disclosures required by these provisions.
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (39)
Placed on Senate Legislative Calendar under General Orders. Calendar No. 528.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Committee on Health, Education, Labor, and Pensions. Hearings held.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2026 · third_quarter · Pharmacy
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] 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
2026 · third_quarter · Health Issues
Issues related to pharmacy benefit management reforms. Issues related to cardiovascular care. Issues related to drug pricing. Issues related to the drug supply chain. S. 3788, Clear Labels Act. S. 3014, Ensuring Timely Access to Generics Act of 2025; S. 1954, Biosimilar Red Tape Elimination Act; S. 2658, Medication Affordability and Patent Integrity Act.
Client expense: Not reported · Firm income: $60,000
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
2026 · third_quarter · Health Issues
S. 891, the Bipartisan Health Care Act Part D Formulary Design and Generic Drug Tiering HR 4132 / S.2027 - Prescription Information Modernization Act Medicaid Generics Penalty Implementation of the Inflation Reduction Act Drug Shortages S. 2658, The Medication Affordability and Patent Integrity Act
Client expense: $450,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2026 · third_quarter · Health Issues
Issues related to vaccine access and evidence-based resources for patients and pharmacists (generally, no specific legislation). Tylers Law (H.R. 2004), the ALERT Communities Act (H.R. 1561), and the HERO Act (H.R. 7994), issues related to access to fentanyl test strips and medications for opioid use disorder (MOUD). The Eliminating Thickets to Increase Competition Act (ETHIC) Act (H.R. 3269), the Affordable Prescriptions for Patents Act (H.R. 1768), the Skinny Labels, Big Savings Act (H.R. 6485), the Medication Affordability and Patent Integrity Act (S. 2658), and the Ensuring Timely Access to Generics Act of 2025 (S. 3014), issues related to drug pricing, drug shortages, drug importation plans, and the drug supply chain. Issues related to telehealth and pharmacist provision of testing and vaccination (generally, no specific legislation). Patient access to pharmacist provided services for respiratory illnesses, initiation of oral antivirals, buprenorphine, and other pharmacist services authorized under state law (generally, no specific legislation). Issues related to healthcare workforce shortages (generally, no specific legislation). The Dr. Lorna Breen Health Care Provider Protection Reauthorization Act (H.R. 929/S. 266), provisions related to supporting health workers mental health and well-being. Issues related to implementation of the Inflation Reduction Act (generally, no specific legislation). The Drug-Price Transparency for Consumers (DTC) Act (H.R.3789), issues related to direct-to-consumer (DTC) prescription drug advertising. The Agriculture, Rural Development, Food and Drug Administration, and Related Agency Appropriations Act, 2027 (H.R. 8646), issues related to funding of FDA. Issues related to the Substance Abuse and Mental Health Services Administration (SAMHSA) decision to end the use of federal funds to purchase fentanyl test strips or other substance test kits, including xylazine and medetomidine test strips, that are distributed for individual use. Issues related to pharmacist deprescribing medications (generally, no specific legislation). The Medication Affordability and Patent Integrity Act, issues related to preventing manufacturers from filing inconsistent information with the Food and Drug Administration and the U.S. Patent and Trademark Office, with the intent to unfairly extend product exclusivity. The Improving Seniors Timely Access to Care Act of 2025 (H.R. 3514) and the Prior Authorization Accountability Act (H.R. 9396), issues related to prior authorization.
2026 · third_quarter · Health Issues
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
| Senate |
| Referred To |
| August 1, 2025 |
Client expense: $250,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
Client expense: $2,560,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), SENATE
2026 · third_quarter · Copyright/Patent/Trademark
Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) ---Patentability of AI Assisted Inventions Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act Compulsory Licensing ---28 U.S.C. 1498 - Patent and copyright cases Data Privacy ---H.R.8413: SECURE Data Act ---Implementation of BIOSECURE Act Drug Patenting ---H.R.3160/S.1553: PREVAIL Act ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.9142: Prohibiting Adversarial Patents Act of 2026 ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---S.2658: Medication Affordability and Patient Integrity Act ---S.3014: Ensuring Timely Access to Generics Act ---Department of Commerce Patent Valuation Fee Proposal ---PTAB Reform ---PTO Proposed Rules on Terminal Disclaimer Practice ---Restrictions on Intellectual Property Rights ---Section 101 Modernization Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Intellectual Property Enforcement ---China
Client expense: $2,560,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), Patent & Trademark Office (PTO), SENATE
2026 · third_quarter · Pharmacy
Issues related to competition pracitces in the pharmaceutical marketplace. S.1040 - Drug Competition Enhancement Act. S.1041 - Affordable Prescriptions for Patients Act. S.2658 - Medication Affordability and Patent Integrity Act (MAPIA). S.1095 - Stop STALLING Act. S.43 - Skinny Labels, Big Savings Act.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · third_quarter · Copyright/Patent/Trademark
Intellectual property issues including patent, copyright, and trademark issues. S.1040 - Drug Competition Enhancement Act. S.1041 - Affordable Prescriptions for Patients Act. S.1097 - Interagency Patent Coordination and Improvement Act of 2025. H.R.3160/S.1553 - PREVAIL Act. H.R.1574/S.708 - RESTORE Patent Rights Act of 2025. S.2276 - A bill to address patent thickets. S.2658 - Medication Affordability and Patent Integrity Act (MAPIA). H.R.3269/S.2276 - Eliminating Thickets to Increase Competition Act (ETHIC Act). USPTO Fee-Setting Authority.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · third_quarter · Pharmacy
H.R. 1 - One Big Beautiful Bill Act - Rep. Arrington, Jodey - Medicaid eligibility and state financing, Marketplace coverage and enrollment, Health Savings Account expansion, Pharmacy Benefit Manager financing and regulation H.R. 843 - Prompt Approval of Safe Generic Drugs Act - Rep. Barragan, Nanette Diaz - Generic drugs applications and approvals H.R. 946 - ORPHAN Cures Act - Rep. Joyce, John - Medicare Drug Negotiation Program H.R. 950 - Saving Seniors Money on Prescriptions Act - Rep. Landsman, Greg - PBM reporting requirements for MA/Part D plans. H.R. 1117 - Responsibility in Drug Advertising Act - Rep. DeLauro, Rosa - Direct-to-consumer ads H.R. 1244 - Reducing Drug Prices for Seniors Act - Rep. Davis, Donald - Coinsurance for Part D drugs H.R. 2214 - DRUG Act - Rep. Miller-Meeks, Mariannette - PBM contracts H.R. 2450 - Prescription Drug Transparency and Affordability Act - Rep. McDonald Rivet, Kristen - PBM transparency H.R. 3493 - Global Fairness in Drug Pricing Act - Rep. Khanna, Ro - Prescription drug international reference pricing H.R. 3546 - Prescription Drug Price Relief Act - Rep. Khanna, Ro - Prescription drug patent reform H.R. 3775 - Fair Prescription Drug Prices for Americans Act - Rep. Van Drew, Jefferson - Prescription drug and biological product international reference pricing H.R. 3789 - DTC Act - Rep. Taylor, David - Direct-to-consumer prescription advertising transparency H.R. 4139 - Cutting Copays Act - Rep. McGarvey, Morgan - Medicare cost-sharing for generic drugs H.R. 4231 - Treat and Reduce Obesity Act - Rep. Kelly, Mike - Medicare coverage of obesity drugs H.R. 4317 - PBM Reform Act - Rep. Carter, Earl L. "Buddy" - PBM contracting requirements and transparency H.R. 4605 - End Prescription Drug Ads Now Act - Rep. Nadler, Jerrold - Ban on DTC drug ads H.R. 4623 - Plain Prescription Prices Act - Rep. Williams, Nikema - Transparency requirements for DTC drug ads H.R. 5094 - Protect Patients from Costly Care Act - Rep. Pappas, Chris - Repeal of Medicaid cost sharing requirements for drugs; Orphan drug inclusion in Medicare Drug Price Negotiation Program H.R. 5197 - Protect Beneficiaries from Middlemen Act - Rep. Malliotakis, Nicole - Medicare cost-sharing limit for drugs H.R. 5526 - Biosimilar Red Tape Elimination Act - Rep. Pfluger, Austin - Biosimilars approval procedures H.R. 6255 - Affordable Insulin Now Act - Rep. Craig, Angie - require cost-sharing for certain insulin products H.R. 7837 - Most Favored Patient Act - Rep. Meuser, Daniel - MFN demonstration H.R. 8779 - PBM Act - Rep. Harshbarger, Diana - PBM ownership requirements H.R. 9661 - Expedited Access to Biosimilars Act - Rep. Langworthy, Nicholas - Biosimilar approval requirements H.R. 10227 - INSULIN Act - Rep. DeGette, Diana - Copay caps H.R. 10369 - Net Effective Cost Transparency and Prescription Drug Affordability Act - Rep. Mackenzie, Ryan - Requirements for PBMs S. 229 - DTC Act - Sen. Durbin, Richard - Drug advertising requirements S. 483 - Responsibility in Drug Advertising Act - Sen. King, Angus - Drug advertising requirements S. 526 - Pharmacy Benefit Manager Transparency Act of 2025 - Sen. Grassley, Chuck - PBM reporting requirements S. 529 - Capping Prescription Costs Act - Sen. Warnock, Raphael - Drug copay caps S. 652 - Protecting Patients from Deceptive Drugs Ads Act - Sen. Durbin, Richard - Drug advertising requirements S. 882 - Patients Before Middlemen Act - Sen. Blackburn, Marsha - PBM reforms S. 891 - Bipartisan Health Care Act - Sen. Wyden, Ron - PBM reforms and transparency S. 1040 - Drug Competition Enhanced Act - Sen. Cornyn, John - Drug patent reform S. 1041 - Affordable Prescriptions for Patients Act - Sen. Cornyn, John - Patent issues S. 1095 - Stop STALLING Act - Sen. Klobuchar, Amy - Drug patent reform S. 1096 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy - Drug patent reform S. 1414 - Expedited Access to Biosimilars Act - Sen. Paul, Rand - Biosimilars assessment and approval S. 1587 - Fair Prescription Drug Prices for Americans Act - Sen. Hawley, Josh - Prescription drug international reference pricing S. 1753 - End Price Gouging for Medications Act - Sen. Merkley, Jeff - Prescription drug international reference pricing S. 1818 - Prescription Drug Price Relief Act - Sen. Sanders, Bernard - Prescription drug patent reform S. 1954 - Biosimilar Red Tape Elimination Act - Sen. Lee, Mike - Biological product assessment and approval S. 1973 - Treat and Reduce Obesity Act - Sen. Cassidy, Bill - Medicare coverage for obesity drugs S. 2345 - Short on Competition Act - Sen. Klobuchar, Amy - Expedited approval for generic drugs S. 2447 - Repealing the Trump Sick Tax Act - Sen. Welch, Peter - Repeal of Medicaid cost sharing requirements for drugs; Orphan drug inclusion in Medicare Drug Price Negotiation Program S. 2620 - REMEDY Act - Sen. Durbin, Richard - Expedited approvals for certain drug approvals S. 2658 - Medication Affordability and Patient Integrity Act - Sen. Hassan, Maggie - FDA and USPTO coordination S. 3014 - Ensuring Timely Access to Generics Act - Sen. Shaheen, Jeanne - Generic drug approval S. 4332 - Medication Competition Act - Sen. Hassan, Maggie - Pharmaceutical exclusivity periods S. 4355 - Drug Deal Disclosure Act - Sen. Wyden, Ron - Federal MFN agreement transparency S. 4509 - PBM Act - Sen. Warren, Elizabeth - PBM ownership requirements S. 5059 - A bill to amend the Public Health Service Act to streamline the review of biosimilar biological products. - Sen. Moody, Ashley - Biosimilar and biological product review process Issues related to the implementation of Inflation Reduction Act - Medicare negotiation; cost-sharing and coverage of weight loss drugs/GLP-1s; high priced drugs; patent reforms; generic approval; 340B; Most Favored Nation; Pharmacy Benefit Managers; PBM-related issues; step therapy; copay caps; insulin costs; and copay coupons.
Client expense: $3,010,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · third_quarter · Copyright/Patent/Trademark
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 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 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: $7,040,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
2026 · third_quarter · Copyright/Patent/Trademark
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 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 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: $1,530,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE
2026 · third_quarter · Health Issues
S. 355: FDA Modernization Act 3.0 S. 652: Protecting Patients from Deceptive Drug Ads Act S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 864: HELP Copays Act S. 1387: National Biotechnology Initiative Act of 2025 S. 1414: Expedited Access to Biosimilars Act S. 1954: Biosimilar Red Tape Elimination Act S. 2296: BIOSECURE Act (S.Amdt. 3236 to National Defense Authorization Act for FY 2026) S. 2658: Medication Affordability and Patent Integrity Act S. 3014: Ensuring Timely Access to Generics Act of 2025 S. 3345: PBM Price Transparency and Accountability Act S. 3788: CLEAR LABELS Act S. 3794: SAFE Drugs Act of 2026 S. 4189: INSULIN Act of 2026 S. 5043: Secure Drug Supply Chain Act of 2026 S. 5244: SUSTAIN 340B Act H.R. 1: One Big Beautiful Bill Act (Public Law No. 119-21) H.R. 946: ORPHAN Cures Act H.R. 1492: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 3521: Clinical Trial Modernization Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 6509: SAFE Drugs Act of 2025 H.R. 6610: Pharmacists Fight Back [in Federal Employee Health Benefit Plans Act] H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR ACT H.R. 8269: CLEAR LABELS Act H.R. 9599: SECURE 340B Act H.R. 9661: Expedited Access to Biosimilars Act 340B Drug Pricing Integrity and Affordability for Patients Act (draft) SECURE Act of 2026 (draft) Biopharmaceutical innovation policy issues User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Most Favored Nation (MFN) policy issues Drug importation policy issues FDA policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance policy issues Compounding policy issues Supply chain policy issues Peptides/counterfeiting policy issues Controlled substances policy issues Generics/devices policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 340B Rebate Model Pilot Program Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Artificial intelligence policy issues Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First
Client expense: $1,530,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2026 · third_quarter · Health Issues
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program Proposed Rule, 91 Fed. Reg. 36236; Medication Affordability and Patent Integrity (MAPIA) Act (S. 2658); Skinny Labels, Big Savings Act (S. 43/H.R. 6485); Expedited Access to Biosimilars Act (S. 1414/ H.R.9661); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Clinical trial regulation; Community Health Center Clinical Trial Grant Program discussion draft; Alex and Jacis Law discussion draft; Untitled discussion draft on clinical trial regulation (no bill number); Untitled discussion draft on generic drugs intended for use with a device (no bill number); Food & Drug Administration Fiscal Year 2027 Legislative Proposals (no bill number); Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act, (S.3788 / H.R.8269); draft legislation relating to potential improvements the National Childhood Vaccine Injury Act and the Vaccine Injury Compensation Program; American Biotechnology Act, Senate Amendment 6334 to S. 4784, National Defense Authorization Act (NDAA) for Fiscal Year 2027; CARES Act (P.L. 116-136) reporting issues.
Client expense: Not reported · Firm income: $340,000
2026 · third_quarter · Copyright/Patent/Trademark
Medication Affordability and Patent Integrity Act (S. 2658); Biopharmaceutical policy issues; Skinny Labels, Big Savings Act (S. 43/H.R. 6485).
Client expense: Not reported · Firm income: $340,000
2026 · third_quarter · Copyright/Patent/Trademark
Federal Trade Commission related issues Issues related to the Patent Act, no specific bill Issues related to March-In/Bayh Dole, WTO/TRIPS Issues related to patent thickets Issues related to obviousness/ double patenting Issues related to FDA/PTO coordination Issues related to skinny labeling S.1041 A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes S.1040 -A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes S 708/ HR 1574 -- Realizing Engineering, Science and Technology Opportunities by Restoring Exclusive Patent Rights Act of 2025 (RESTORE) S.1553/HR3160-- Promoting and Respecting Economically Viable American Innovation Act (PREVAIL) S. 1546/ HR 3152-- Patent Eligibility Restoration Act of 2025 (PERA) S 2276 / HR 3269 Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 43/HR 6485 Skinny Labels Big Savings Act S.2658 Medication Affordability and Patent Integrity Act S. 3452/HR 6624 Biological Intellectual Property Protection Act of 2025
Client expense: $3,150,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · third_quarter · Copyright/Patent/Trademark
- S. 1040, Drug Competition Enhancement Act, regarding all provisions - S. 1041, Affordable Prescriptions for Patients Act of 2025, regarding all provisions - S. 1097, Interagency Patent Coordination and Improvement Act of 2025, regarding all provisions - H.R. 3269/S. 2276, Eliminating Thickets to Increase Competition (ETHIC) Act, regarding all provisions - S.2658, Medication Affordability and Patent Integrity Act, regarding all provisions Issues related to: - intellectual property, including amending the Federal Trade Commission Act to prohibit product hopping - patent thickets - patent fees
Client expense: $2,220,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE
2026 · third_quarter · Health Issues
H.R. 5526 - Biosimilar Red Tape Elimination Act; all provisions. S. 1414 - Expedited Access to Biosimilars Act; all provisions. S. 2658 - Medication Affordability and Patent Integrity Act; all provisions.
Client expense: $140,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · third_quarter · Health Issues
HJRes 197 / SJRes 197, CRA related to the 2027 NBPP; HR 247 / S 46, Health Care Affordability Act; HR 6867 / S 3562, the NIH Clinical Trial Integrity Act; HR 3521 / S 4440, the Clinical Trial Modernization Act; HR 4710 / S 2420, No Surprises Act Enforcement Act; HR 5526 / S 1954, Biosimilar Red Tape Elimination Act; HR 5582 / S 2355, the Patients Deserve Price Tags Act; HR 6248 / S 4027, Healthy Competition for Better Care Act HR 6485 / S 43, Skinny Labels, Big Savings Act; HR 6867 / S 3562, NIH Clinical Trial Integrity Act; HR 7895, the PBM Kickback Prohibition Act; HR 8879 / S 4509, Patients Before Monopolies Act; HR 8908, the STOP GAMES Act; HR 9393, Lower Costs, More Transparency Act; HR 9396, the Prior Authorization Accountability Act; HR 9397, the Premium Transparency Act; HR 9645, the Health Care Price Certainty for All Americans Act; HR 9661 / S 1414, the Expedited Access to Biosimilars Act; HR 10370, the AIM to Cure Kids with Cancer Act; HR 10788, the Lower Premiums, Faster Payments Act; S 976, the Insurance Fraud Accountability Act; S 1041, Affordable Prescriptions for Patients Act; S 1095, Stop STALLING Act; S 1096, Preserve Access to Affordable Generics & Biosimilars Act S 1097, Interagency Patent Coordination & Improvements Act; S 2658, Medication Affordability & Patent Integrity Act; S 3014, Ensuring Timely Access to Generics Act; S 3822, the Break Up Big Medicine Act Policies to address the expiration of the enhanced Advanced Premium Tax Credits; Policies to improve transparency in hospital and insurer costs and finances; Policies to streamline pediatric patient access to subspecialist care via telemedicine; Policies to protect patients and consumers from junk insurance, including short-term limited duration insurance; Policies related to modernization of clinical trials; Policies related to the 2027 FDA user fee agreements; Implementation of the No Surprises Act; Policies related to oversight of insurance agents and brokers; Oversight and patient impact of the 340B program; Policies related to consolidation within the healthcare sector;
Client expense: $120,000 · Firm income: Not reported
Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE
2026 · third_quarter · Health Issues
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act H.R. 10369: Net Effective Cost Transparency and Prescription Drug Affordability Act of 2026 S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act S. 43/H.R. 26485: Skinny Labels, Big Savings Act S. 3549/H.R. 6837: PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act Toxic-Free Medical Devices Drug Enforcement Administration Quotas Department of Labor Proposed and Final PBM Transparency Rule 340b Contract Pharmacies
Client expense: $630,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, White House Office
2026 · third_quarter · Medicare/Medicaid
S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) Domestic Manufacturing of Essential Medicines
Client expense: $630,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, White House Office
2026 · third_quarter · Copyright/Patent/Trademark
S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) PTAB: Proposed Rule, Settled Expectations, Patent Thickets and Ancillary Product Patents, Discretionary Denials
Client expense: $630,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), SENATE
2026 · third_quarter · Copyright/Patent/Trademark
H.R. 3269/S. 2276, Eliminating Thickets to Increase Competition (ETHIC) Act S. 2658, Medication Affordability and Patent Integrity Act Potential legislation amending the Inflation Reduction Act (P.L. 117-169) Potential legislation seeking to impose pharmaceutical price controls to private sector payers Potential legislation related to digital piracy Potential legislation relating to U.S. Copyright Office leadership Potential legislation related to changes in Patent Trial and Appeal Board Proceedings Potential legislation related to implementing most favored nation style reference pricing Potential legislation related to detection of counterfeit imports Potential legislation related to protecting consumers from counterfeit goods online Potential legislation related to the administration of federal grants and funding Various issues relating to patent examination practices and patent quality; patent filing fees and potential patent valuation fees; IP issues related to counterfeiting; pharmaceutical price controls; IP issues related to prescription drug pricing and labeling; implementation of the Inflation Reduction Act of 2022, Drug Price Negotiation Program (P.L. 117-169, subtitle B); ongoing practice of discretionary denials at the Patent Trial and Appeal Board; MFN style pricing; intellectual property and artificial intelligence; digital commercial piracy
Client expense: $16,480,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Natl Institute of Standards & Technology (NIST), Natl Telecommunications & Information Administration (NTIA), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR)
2026 · third_quarter · Copyright/Patent/Trademark
Issues related to pharmaceutical Intellectual Property (IP), including: S. 2658, Medication Affordability and Patent Integrity Act.
Client expense: $450,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · third_quarter · Health Issues
H.R. 9599 SECURE 340B Act, all pharmaceutical related provisions H.R. 5256 340B ACCESS Act, all pharmaceutical related provisions S. 2372 H.R. 4581 340B Patients Act of 2025, all pharmaceutical related provisions H.R. 8269 CLEAR LABELS Act, all pharmaceutical related provisions S. 2658 Medication Affordability and Patient Integrity Act, all pharmaceutical related provisions S. 1096 Preserve Access to Affordable Generics and Biosimilars Act, all pharmaceutical related provisions S. 1040 Drug Competition Enhancement Act, all pharmaceutical related provisions S.1095 Stop STALLING Act, all pharmaceutical related provisions S. 1954 Biosimilar Red Tape Elimination Act, all pharmaceutical related provisions Drug Pricing: Policies pertaining to drug pricing not yet introduced Plasma: Policies or advocacy in the promotion of protecting access PBM Reform: Policies related to PBM not yet introduced (e.g., coverage, transparency, accumulators, etc) (Note: RFIs do not count) 340B: Policies related to 340B not specific to a piece of legislation PDUFA: Perscription Drug User Fee Act Global pharmaceutical supply chain operations and manufacturing locations Bayh-Dole march in rights policy issues
Client expense: $1,450,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · third_quarter · Pharmacy
Biosimilars; Generic drugs; Issues around country of origin labeling; Supply Chain; S.2658 - Medication Affordability and Patent Integrity Act; S.3014 - Ensuring Timely Access to Generics Act; S.1414 - Expedited Access to Biosimilars Act; S.1954 - Biosimilar Red Tape Reduction Act; S.3788 - Clear Labels Act; S.43 - Skinny Labels, Big Savings Act; Tariffs; General Business Issues.
Client expense: Not reported · Firm income: $60,000
Government targets: SENATE
2026 · third_quarter · Copyright/Patent/Trademark
Issues related to intellectual property; Issues related to S. 1041 - Affordable Prescriptions for Patients Act; Issues related to patent thickets; Issues related to S. 1096 - Preserve Access to Affordable Generics and Biosimilars Act; Issues related to S.2658 - Medication Affordability and Patent Integrity Act.
Client expense: Not reported · Firm income: $80,000
Government targets: SENATE
2026 · third_quarter · Copyright/Patent/Trademark
S.1040, to prohibit product hopping and for other purposes; proposals regarding patent thickets. S. 2658, Medication Affordability and Patent Integrity Act
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · third_quarter · Trade (domestic/foreign)
Issues related to intellectual property protections; Issues related to S.2658 - Medication Affordability and Patent Integrity Act.
Client expense: Not reported · Firm income: $110,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · third_quarter · Health Issues
Issues related to implementation of drug pricing and reimbursement for prescription drugs related to the Inflation Reduction Act of 2022 (PL 117-169); Issues related to the implementation of the American Relief Act of 2025 (PL 118-158); Issues related to the One Big Beautiful Bill Act (PL 119-21); Issues related to drug pricing; Issues related to S. 2658 - Medication Affordability and Patent Integrity Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · third_quarter · Health Issues
340B drug discount program; drug pricing; importation of biopharmaceuticals; direct-to-consumer (DTC) advertising; transparency; international pharmaceutical supply chain; PBM reform; TRICARE Pharmacy Program (FY2027 National Defense Authorization Act, H.R.8800/S.4784); Pandemic and All-Hazards Preparedness Act (PAHPA) reauthorization; S.891, Bipartisan Health Care Act; S.527, Prescription Pricing for the People Act of 2025; S.1040, Drug Competition Enhancement Act; S.1041, Affordable Prescriptions for Patients Act; S.1097, Interagency Patent Coordination and Improvement Act of 2025; S.1095, Stop STALLING Act; S.1096, Preserve Access to Affordable Generics and Biosimilars Act; Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients; FY2027 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act (H.R.9260); FY2027 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (H.R.8646); S.2658, Medication Affordability and Patent Integrity Act; S.3014, Ensuring Timely Access to Generics Act of 2025.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · third_quarter · Copyright/Patent/Trademark
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. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.
Client expense: $770,000 · Firm income: Not reported
Government targets: Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2026 · third_quarter · Health Issues
Eliminating Thickets to Improve Competition (S. 2276 and HR 3269); Medication Affordability and Patent Integrity Act (S. 2658)
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · third_quarter · Copyright/Patent/Trademark
Eliminating Thickets to Improve Competition (S. 2276 and HR 3269); Medication Affordability and Patent Integrity Act (S. 2658)
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · third_quarter · Pharmacy
Prescription drug industry issues relating to domestic construction and maintenance, prescription drug pricing and price controls, supply chain issues, pharmacy benefit managers transparency issues, intellectual property, trade, and employment issues, 340B program, generally; S. 1040, Drug Competition Enhancement Act; H.R. 1492, To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; H.R. 4317, PBM Reform Act of 2025; H.R. 5256, 340B ACCESS Act"; S. 3345, "PBM Price Transparency and Accountability Act"; S. 2658, Medication Affordability and Patent Integrity Act; S. 1414, Expedited Access to Biosimilars Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · second_quarter · Copyright/Patent/Trademark
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
2026 · second_quarter · Health Issues
S. 891, the Bipartisan Health Care Act Part D Formulary Design and Generic Drug Tiering HR 4132 / S.2027 - Prescription Information Modernization Act Medicaid Generics Penalty Implementation of the Inflation Reduction Act Drug Shortages S. 2658, The Medication Affordability and Patent Integrity Act
Client expense: $360,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2026 · second_quarter · Copyright/Patent/Trademark
Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights Compulsory Licensing ---28 U.S.C. 1498 - Patent and copyright cases Data Privacy ---H.R.8413: SECURE Data Act ---Implementation of BIOSECURE Act Drug Patenting ---H.R.3160/S.1553: PREVAIL Act ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.9142: Prohibiting Adversarial Patents Act of 2026 ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act of 2025 ---S.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---S.2658: Medication Affordability and Patient Integrity Act ---S.3014: Ensuring Timely Access to Generics Act of 2025 ---Department of Commerce Patent Valuation Fee Proposal ---Patent Litigation Reform ---Patent Tax/fees ---PTAB Reform ---Restrictions on Intellectual Property Rights ---Section 101 Modernization Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Intellectual Property Enforcement ---China
Client expense: $2,360,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE, Treasury, Dept of
2026 · second_quarter · Health Issues
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---Program Implementation & Oversight ---Rebate Models ---SECURE 340B Act ---SUSTAIN 340B Act Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---S.1414: Expedited Access to Biosimilars Act ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Senate Finance Committee Minority RFI on Drug Pricing ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---S.1816: Improving Seniors Timely Access to Care Act of 2025 ---Access to Innovative Treatments ---Administrative Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prescription Drug Price Relief Act ---Prior Authorization Reform ---SAFE STEP Act ---Step Therapy Vaccines and Infectious Diseases ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---PASTEUR ACT ---SAFE STEP Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Client expense: $2,360,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, White House Office
2026 · second_quarter · Health Issues
Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Fast-tracking Approval for Innovative Rare disease therapies (FAIR) Act (H.R. 7953); Ensuring Timely Access to Generics Act of 2025 (S. 3014); Stop STALLING Act (S. 1095); Food & Drug Administration Fiscal Year 2027 Legislative Proposals; Agriculture, Rural Development, Food and Drug Administration, and Related Agency Appropriations Act, 2027 (H.R. 8646); Medication Affordability and Patent Integrity Act (S. 2658); Biosimilar Red Tape Elimination Act (S. 1954/H.R. 5526); Expedited Access to Biosimilars Act (S. 1414); Clinical trial regulation; Securing Essential Components for U.S. Readiness in Essential Pharmaceuticals (SECURE Rx) Act of 2026 (discussion draft); Securing Innovation and Research from Adversaries (discussion draft); amendments to the National Childhood Vaccine Injury Act of 1986 and the Vaccine Injury Compensation Program; Destruction of Hazardous Imports Act (H.R. 2715); potential amendments to drug country of origin labeling requirements (discussion draft).
Client expense: Not reported · Firm income: $220,000
2026 · second_quarter · Copyright/Patent/Trademark
Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Medication Affordability and Patent Integrity Act (S. 2658); Biopharmaceutical policy issues.
Client expense: Not reported · Firm income: $220,000
2026 · second_quarter · Pharmacy
Draft, the Expedited Access to Biosimilars Act (no bill number) - Rep. Langworthy, Nick - Biosimilar approval requirements H.R. 1 - One Big Beautiful Bill Act - Rep. Arrington, Jodey - Medicaid eligibility and state financing, Marketplace coverage and enrollment, Health Savings Account expansion, Pharmacy Benefit Manager financing and regulation H.R. 843 - Prompt Approval of Safe Generic Drugs Act - Rep. Barragan, Nanette Diaz - Generic drugs applications and approvals H.R. 946 - ORPHAN Cures Act - Rep. Joyce, John - Medicare Drug Negotiation Program H.R. 950 - Saving Seniors Money on Prescriptions Act - Rep. Landsman, Greg - PBM reporting requirements for MA/Part D plans. H.R. 1117 - Responsibility in Drug Advertising Act - Rep. DeLauro, Rosa - Direct-to-consumer ads H.R. 1244 - Reducing Drug Prices for Seniors Act - Rep. Davis, Donald - Coinsurance for Part D drugs H.R. 2214 - DRUG Act - Rep. Miller-Meeks, Mariannette - PBM contracts H.R. 2450 - Prescription Drug Transparency and Affordability Act - Rep. McDonald Rivet, Kristen - PBM transparency H.R. 3493 - Global Fairness in Drug Pricing Act - Rep. Khanna, Ro - Prescription drug international reference pricing H.R. 3546 - Prescription Drug Price Relief Act - Rep. Khanna, Ro - Prescription drug patent reform H.R. 3775 - Fair Prescription Drug Prices for Americans Act - Rep. Van Drew, Jefferson - Prescription drug and biological product international reference pricing H.R. 3789 - DTC Act - Rep. Taylor, David - Direct-to-consumer prescription advertising transparency H.R. 4139 - Cutting Copays Act - Rep. McGarvey, Morgan - Medicare cost-sharing for generic drugs H.R. 4231 - Treat and Reduce Obesity Act - Rep. Kelly, Mike - Medicare coverage of obesity drugs H.R. 4317 - PBM Reform Act - Rep. Carter, Earl L. Buddy - PBM contracting requirements and transparency H.R. 4605 - End Prescription Drug Ads Now Act - Rep. Nadler, Jerrold - Ban on DTC drug ads H.R. 4623 - Plain Prescription Prices Act - Rep. Williams, Nikema - Transparency requirements for DTC drug ads H.R. 5094 - Protect Patients from Costly Care Act - Rep. Pappas, Chris - Repeal of Medicaid cost sharing requirements for drugs; Orphan drug inclusion in Medicare Drug Price Negotiation Program H.R. 5197 - Protect Beneficiaries from Middlemen Act - Rep. Malliotakis, Nicole - Medicare cost-sharing limit for drugs H.R. 5526 - Biosimilar Red Tape Elimination Act - Rep. Pfluger, Austin - Biosimilars approval procedures H.R. 6255 - Affordable Insulin Now Act - Rep. Craig, Angie - require cost-sharing for certain insulin products H.R. 7837 - Most Favored Patient Act - Rep. Meuser, Daniel - MFN demonstration H.R. 8779 - PBM Act - Rep. Harshbarger, Diana - PBM ownership requirements S. 229 - DTC Act - Sen. Durbin, Richard - Drug advertising requirements S. 483 - Responsibility in Drug Advertising Act - Sen. King, Angus - Drug advertising requirements S. 526 - Pharmacy Benefit Manager Transparency Act of 2025 - Sen. Grassley, Chuck - PBM reporting requirements S. 529 - Capping Prescription Costs Act - Sen. Warnock, Raphael - Drug copay caps S. 652 - Protecting Patients from Deceptive Drugs Ads Act - Sen. Durbin, Richard - Drug advertising requirements S. 882 - Patients Before Middlemen Act - Sen. Blackburn, Marsha - PBM reforms S. 891 - Bipartisan Health Care Act - Sen. Wyden, Ron - PBM reforms and transparency S. 1040 - Drug Competition Enhanced Act - Sen. Cornyn, John - Drug patent reform S. 1041 - Affordable Prescriptions for Patients Act - Sen. Cornyn, John - Patent issues S. 1095 - Stop STALLING Act - Sen. Klobuchar, Amy - Drug patent reform S. 1096 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy - Drug patent reform S. 1414 - Expedited Access to Biosimilars Act - Sen. Paul, Rand - Biosimilars assessment and approval S. 1587 - Fair Prescription Drug Prices for Americans Act - Sen. Hawley, Josh - Prescription drug international reference pricing S. 1753 - End Price Gouging for Medications Act - Sen. Merkley, Jeff - Prescription drug international reference pricing S. 1818 - Prescription Drug Price Relief Act - Sen. Sanders, Bernard - Prescription drug patent reform S. 1954 - Biosimilar Red Tape Elimination Act - Sen. Lee, Mike - Biological product assessment and approval S. 1973 - Treat and Reduce Obesity Act - Sen. Cassidy, Bill - Medicare coverage for obesity drugs S. 2345 - Short on Competition Act - Sen. Klobuchar, Amy - Expedited approval for generic drugs S. 2447 - Repealing the Trump Sick Tax Act - Sen. Welch, Peter - Repeal of Medicaid cost sharing requirements for drugs; Orphan drug inclusion in Medicare Drug Price Negotiation Program S. 2620 - REMEDY Act - Sen. Durbin, Richard - Expedited approvals for certain drug approvals S. 2658 - Medication Affordability and Patient Integrity Act - Sen. Hassan, Margaret - FDA and USPTO coordination S. 3014 - Ensuring Timely Access to Generics Act - Sen. Shaheen, Jeanne - Generic drug approval S. 4332 - Medication Competition Act - Sen. Hassan, Maggie - Pharmaceutical exclusivity periods S. 4355 - Drug Deal Disclosure Act - Sen. Wyden, Ron - Federal MFN agreement transparency S. 4509 - PBM Act - Sen. Warren, Elizabeth - PBM ownership requirements Issues related to the implementation of Inflation Reduction Act - Medicare negotiation; cost-sharing and coverage of weight loss drugs/GLP-1s; high priced drugs; patent reforms; generic approval; Pharmacy Benefit Managers; PBM-related issues; step therapy; copay caps; insulin costs; and copay coupons.
Client expense: $3,010,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · second_quarter · Copyright/Patent/Trademark
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. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.
Client expense: $870,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2026 · second_quarter · Health Issues
Issues related to pharmacy benefit management. Issues related to cardiovascular care. Issues related to drug pricing. Issues related to the drug supply chain. S. 3788, Clear Labels Act. S. 3014, Ensuring Timely Access to Generics Act of 2025; S. 1954, Biosimilar Red Tape Elimination Act; S. 2658, Medication Affordability and Patent Integrity Act.
Client expense: Not reported · Firm income: $60,000
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
2026 · second_quarter · Pharmacy
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
2026 · second_quarter · Copyright/Patent/Trademark
H.R. 3269/S. 2276, Eliminating Thickets to Increase Competition (ETHIC) Act S. 2658, Medication Affordability and Patent Integrity Act S. 3822, Break Up Big Medicine Act S. 4007, Family Grocery and Farmer Relief Act Potential legislation amending the Inflation Reduction Act (P.L. 117-169) Potential legislation seeking to impose pharmaceutical price controls to private sector payers Potential legislation related to digital piracy Potential legislation related to changes in Patent Trial and Appeal Board Proceedings Potential legislation related to implementing most favored nation style reference pricing Potential legislation related to detection of counterfeit imports Potential legislation related to protecting consumers from counterfeit goods online Various issues relating to patent examination practices and patent quality; patent filing fees and potential patent valuation fees; IP issues related to counterfeiting; pharmaceutical price controls; IP issues related to prescription drug pricing and labeling; implementation of the Inflation Reduction Act of 2022, Drug Price Negotiation Program (P.L. 117-169, subtitle B); ongoing practice of discretionary denials at the Patent Trial and Appeal Board
Client expense: $16,950,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Natl Institute of Standards & Technology (NIST), Natl Telecommunications & Information Administration (NTIA), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR)
2026 · second_quarter · Copyright/Patent/Trademark
S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) PTAB Proposed Rule - Discretionary Denials and One and Done Ancillary Product Patent Reform
Client expense: $580,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), Patent & Trademark Office (PTO), SENATE
2026 · second_quarter · Medicare/Medicaid
S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) CMS Advance Notice of Proposed Rulemaking (ANPRM) on Domestic Manufacturing of Essential Medicines Drug Shortages and Supply Chain Resilience PBM Transparency: Implementation of Consolidated Appropriations Act (CAA) Inflation Reduction Act (IRA) redesigned Medicare Part D: Manufacturer Discount Program and Biosimilars Net Elective Cost Policy: PBM Reform Through Bid Transparency
Client expense: $580,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE, White House Office
2026 · second_quarter · Health Issues
S. 2276/H.R. 3269: Eliminating Thickets to Increase Competition (ETHIC) Act S. 2658: Medication Affordability and Patent Integrity Act (MAPIA) S. 1954/H.R. 5526: Biosimilar Red Tape Elimination Act (BRTEA) S. 1414: Expedited Access to Biosimilars Act PTAB Proposed Rule - Discretionary Denials and One and Done Domestic Production of Essential Medicines Federal Procurement Preferences for Domestic Medicines Ancillary Product Patent Reform CMS Advance Notice of Proposed Rulemaking (ANPRM) on Domestic Manufacturing of Essential Medicines Use of Industrial Chemicals in Medical Devices Drug Shortages and Supply Chain Resilience Employee Benefits Security Administration (EBSA) Proposed Rule Re: Broker/Consultant Transparency to Employer Plans Section 301 Investigation re: Germany Issues PBM Transparency: Implementation of Consolidated Appropriations Act (CAA) Section 232 of the Trade Expansion Act: Patents as a Barrier to US Manufacturing of Biosimilars Inflation Reduction Act (IRA) redesigned Medicare Part D: Manufacturer Discount Program and Biosimilars Net Elective Cost Policy: PBM Reform Through Bid Transparency
Client expense: $580,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Economic Council (NEC), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
2026 · second_quarter · Health Issues
HR 247 / S 46, Health Care Affordability Act; S 2420, No Surprises Act Enforcement Act; HR 3521, the Clinical Trial Modernization Act; HR 5526, Biosimilar Red Tape Elimination Act; HR 5582, S 2355, the Patients Deserve Price Tags Act; HR 6248 / S 4027, Healthy Competition for Better Care Act HR 6485 / S 43, Skinny Labels, Big Savings Act; HR 6867 / S 3562, NIH Clinical Trial Integrity Act; HR 7895, the PBM Kickback Prohibition Act; HR 8908, the STOP GAMES Act; HR 9393, Lower Costs, More Transparency Act; HR 9396, the Prior Authorization Accountability Act; HR 9397, the Premium Transparency Act; HR 9661, Expedited Access to Biosimilars Act; S 1041, Affordable Prescriptions for Patients Act; S 1095, Stop STALLING Act; S 1096, Preserve Access to Affordable Generics & Biosimilars Act S 1097, Interagency Patent Coordination & Improvements Act; S 2658, Medication Affordability & Patent Integrity Act; S 3014, Ensuring Timely Access to Generics Act; S 4509, Patients Before Monopolies Act; Policies to address the expiration of the enhanced Advanced Premium Tax Credits; Policies to improve transparency in hospital and insurer costs and finances; Policies to streamline pediatric patient access to subspecialist care via telemedicine; Policies to protect patients and consumers from junk insurance, including short-term limited duration insurance; Policies related to the modernization of clinical trials; Policies related to the 2027 FDA user fee agreements; Implementation of the No Surprises Act; Policies related to oversight of insurance agents and brokers; Oversight and patient impact of the 340B program;
Client expense: $590,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · second_quarter · Copyright/Patent/Trademark
Federal Trade Commission related issues Issues related to the Patent Act, no specific bill Issues related to March-In/Bayh Dole, WTO/TRIPS Issues related to patent thickets Issues related to obviousness/ double patenting Issues related to FDA/PTO coordination Issues related to skinny labeling S.1041 A bill to amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes S.1040 -A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes S 708/ HR 1574 -- Realizing Engineering, Science and Technology Opportunities by Restoring Exclusive Patent Rights Act of 2025 (RESTORE) S.1553/HR3160-- Promoting and Respecting Economically Viable American Innovation Act (PREVAIL) S. 1546/ HR 3152-- Patent Eligibility Restoration Act of 2025 (PERA) S 2276 / HR 3269 Eliminating Thickets to Increase Competition Act (ETHIC Act) S. 43/HR 6485 Skinny Labels Big Savings Act S.2658 Medication Affordability and Patent Integrity Act S. 3452/HR 6624 Biological Intellectual Property Protection Act of 2025
Client expense: $2,440,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE