Medication Affordability and Patent Integrity Act

General advocacy in support of pro-IP/innovation policies S. 2220, H.R. 4370 - Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act S. 2140, H.R. 9474 - Patent Eligibility Restoration Act (PERA) Opposition to misuse of March-in provisions under the Bayh-Dole Act ITC - IP-related issues Injunctive relief for patent rights holders S. 4840, H.R. 9221 - The RESTORE Patent Rights ACT of 2024 S.2780 - The Medication Affordability and Patent Integrity Act Proposed Changes to Standard Essential Patent (SEPs) Policies S. 527, Prescription Pricing for the People Act of 2025 S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes 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. 1097, Interagency Patent Coordination and Improvement Act of 2025 S.1367, H.R. 2794, No Fakes Act S. 1095. The Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act S. 2276/H.R. 3269 Eliminating Thickets to Increase Competition Act (Ethics Act)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 S. 1302: Increasing Transparency in Generic Drug Applications Act S. 1414: Expedited Acccess to Biosimilars Act S. 1784: MAPS Act S. 2780: Medication Affordability and Patent Integrity Act S. 1954: Biosimilar Red Tape Elimination Act H.R. 1: One Big Beautiful Bill Act H.R. 946: Orphan Cures Act H.R. 1262: Give Kids a Chance Act of 2025 H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R. 2214: DRUG Act H.R. 4132: Prescription Information Modernization Act of 2025 H.R. 8574: 340B ACCESS Act Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval policy issues FDA policy issues Competition policy issues Orphan Drug Act policy issues Compounding policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program rebate and policy issues 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: $7,580,000 · Firm income: Not reported

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), SENATE

General advocacy in support of pro-IP/innovation policies S. 2220, H.R. 4370 - Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act S. 2140, H.R. 9474 - Patent Eligibility Restoration Act (PERA) Opposition to misuse of March-in provisions under the Bayh-Dole Act ITC - IP-related issues Injunctive relief for patent rights holders S. 4840, H.R. 9221 - The RESTORE Patent Rights ACT of 2024 S.2780 - The Medication Affordability and Patent Integrity Act Proposed Changes to Standard Essential Patent (SEPs) Policies S. 527, Prescription Pricing for the People Act of 2025 S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes 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. 1097, Interagency Patent Coordination and Improvement Act of 2025 S.1367, H.R. 2794, No Fakes Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The DRUG Act, H.R.6283/S.1542 (generally, no specific provisions) The DOC Access Act, H.R.1385/S.1424 (generally, no specific provisions) The ACCESS Act, H.R.5608 (generally, no specific provisions) The ORPHAN Cures Act, H.R.5539/S.3131 (generally, no specific provisions) H.R. 3433, Give Kids a Chance Act of 2024 (generally, no specific provisions) H.R. 7623, Telehealth Modernization Act of 2024 (generally, no specific provisions) S. 2780, Medication Affordability and Patent Integrity Act (generally, no specific provisions) S. 4583, Creating Hope Reauthorization Act of 2024 (generally, no specific provisions)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General advocacy in support of pro-IP/innovation policies S. 2220, H.R. 4370 - Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act S. 2140 - Patent Eligibility Restoration Act (PERA) Opposition to misuse of March-in provisions under the Bayh-Dole Act ITC - IP-related issues S. 2934, H.R. 8684 - SHOP Safe Act Injunctive relief for patent rights holders S. 4840, H.R. 9221 - The RESTORE Patent Rights ACT of 2024 S.4713 - The IDEA Act S.2780 - The Medication Affordability and Patent Integrity Act Proposed Changes to Standard Essential Patent (SEPs) Policies H.R. 9474 Patent Restoration Act (PERA) of 2024 S. 527, Prescription Pricing for the People Act of 2025 S. 1040, A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes 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. 1097, Interagency Patent Coordination and Improvement Act of 2025

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 661, MIRACLE Medical Technology Act of 2025 H.R. 1650/S. 763, Telehealth Expansion Act of 2025 Potential legislation similar to H.R. 1843/S. 1001, Telehealth Expansion Act of 2023 Potential legislation similar to H.R. 2868, Association Health Plans Act Potential legislation similar to H.R. 3800, Chronic Disease Flexible Coverage Act Potential legislation similar to H.R. 4307/S. 2115, Medical Supply Chain Resiliency Act Potential legislation similar to H.R. 6363, Further Continuing Appropriations and Other Extensions Act of 2024, and issues pertaining to H.R. 1843/S. 1001, The Telehealth Expansion Act of 2023 Potential legislation similar to H.R. 6860, Restore Protections for Dialysis Patients Act Potential legislation similar to H.R. 9029, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025 Potential legislation similar to S. 142, Preserve Access to Affordable Generics and Biosimilars Act Potential legislation similar to S. 150, Affordable Prescriptions for Patients Act of 2023 Potential legislation similar to S. 1067, Ensuring Timely Access to Generics Act of 2023 Potential legislation similar to S. 1114, Expanding Access to Low-Cost Generics Act of 2023 Potential legislation similar to S. 2624, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024 Potential legislation similar to S. 2780, The Medication Affordability and Patent Integrity Act Final Rule, Mental Health Parity and Addiction Equity Act (89 Fed. Reg. 77,586-77,751, September 23, 2024) Various issues relating to the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, health savings account (HSAs), health reimbursement account (HRAs), employer mandate; implementation of the American Rescue Plan Act (P.L. 117-2); implementation of the Inflation Reduction Act (P.L. 117-169); balance or surprise billing and related issues; single-payer health care options; health reimbursement arrangements and other account-based group health plans; Health and Human Services international pricing index (IPI) model; mental health parity; drug pricing; COBRA subsidies; Federal Trade Commissions multilateral pharmaceutical merger taskforce; telehealth, including coverage of telehealth under High Deductible Health Plans (HDHPs) and expanding telehealth options for employees; impact of Pharmacy Benefit Managers Practices; FTC-2022-0015; petition to HHS to grant march-in rights for the patents on the drug Xtandi; legislative proposals to tax employer-provided health care coverage; artificial price caps on providing insulin; Reasonable Price Clause in reauthorization draft of the Pandemic and All Hazards Preparedness Act (PAHPA, P.L. 109-417); ERISA preemption protections including information on constructive changes/modifications to ERISA; efforts to reform the World Health Organizations (WHO) engagement with private sector; continued U.S. membership to the World Health Organization (WHO); support for necessary market conditions to incentivize health sector investment from private sector; support for private sector involvement in health systems strengthening; promote greater harmonization of standards and investment in digital health; health-related policy issues in the G20/G7 forums and other multilateral forums; support for improving access to health products and technologies globally, including via regulatory alignment, addressing trade barriers, strengthening the global supply chain, and raising awareness on potential pitfalls of local manufacturing; combatting anti-microbial resistance; support for continued and reformed U.S. foreign assistance, including in global health; Advance Notice of Methodological Changes for Calendar Year (CY) 2025 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies, U.S. Centers for Medicare & Medicaid Services, U.S. Department of Health and Human Services (2025 Advance Notice, January 31, 2024)

Client expense: $19,340,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade & Development Agency (USTDA), U.S. Trade Representative (USTR)

Inflation Reduction Act (IRA) HR 7174 - Ensuring Pathways to Innovative Cures (EPIC) Act Medicare Price Setting Drug Shortages Global Access to Medicines Trade-Related Aspects of Intellectual Property Rights (IPR) March-in Framework Guidance and Policies S 79/ HR 1717 - Interagency Patent Coordination and Improvement Act of 2023 S 142 - Preserve Access to Affordable Generics and Biosimilars Act HR 6986 - To address patent thickets S 150 - Affordable Prescriptions for Patients Act of 2023 S 2780/ HR 5429 - Medication Affordability and Patent Integrity Act Antimicrobial Resistance PBM Transparency and Reform S 1542 - Delinking Revenue from Unfair Gouging (DRUG) Act S 3430 - Better Mental Health Care, Lower-Cost Drugs and Extenders Act S 2973 - Modernizing and Ensuring PMB Accountability Act 340B Reform HR 8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act

Client expense: $1,600,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office

Inflation Reduction Act (IRA) HR 7174 - Ensuring Pathways to Innovative Cures (EPIC) Act Medicare Price Setting Drug Shortages Global Access to Medicines Trade-Related Aspects of Intellectual Property Rights (IPR) March-in Framework Guidance and Policies S 79/ HR 1717 - Interagency Patent Coordination and Improvement Act of 2023 S 142 - Preserve Access to Affordable Generics and Biosimilars Act HR 6986 - To address patent thickets S 150 - Affordable Prescriptions for Patients Act of 2023 S 2780/ HR 5429 - Medication Affordability and Patent Integrity Act Antimicrobial Resistance PBM Transparency and Reform S 1542 - Delinking Revenue from Unfair Gouging (DRUG) Act S 3430 - Better Mental Health Care, Lower-Cost Drugs and Extenders Act S 2973 - Modernizing and Ensuring PMB Accountability Act 340B Reform HR 8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act

Client expense: $2,390,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office

Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patent Eligibility Restoration Act. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.4878: The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act. H.R.8134: Restoring Americas Leadership In Innovation Act of 2024. H.R.9221/S.4840: Realizing Engineering, Science, and Technology Opportunities by Restoring Exclusive (RESTORE) Patent Rights Act of 2024.

Client expense: $530,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. S.1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. S.2362 - Drug Shortage Prevention Act. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act.

Client expense: $530,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, SENATE

Inflation Reduction Act (IRA) HR 7174 - Ensuring Pathways to Innovative Cures (EPIC) Act Medicare Price Setting Drug Shortages Global Access to Medicines Trade-Related Aspects of Intellectual Property Rights (IPR) March-in Framework Guidance and Policies S 79/ HR 1717 - Interagency Patent Coordination and Improvement Act of 2023 S 142 - Preserve Access to Affordable Generics and Biosimilars Act HR 6986 - To address patent thickets S 150 - Affordable Prescriptions for Patients Act of 2023 S 2780/ HR 5429 - Medication Affordability and Patent Integrity Act Antimicrobial Resistance PBM Transparency and Reform S 1542 - Delinking Revenue from Unfair Gouging (DRUG) Act S 3430 - Better Mental Health Care, Lower-Cost Drugs and Extenders Act S 2973 - Modernizing and Ensuring PMB Accountability Act 340B Reform HR 8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act

Client expense: $2,830,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office

Patent abuse issues. S. 150 Affordable Prescriptions for Patients Act of 2023. S. 79 Interagency Patent Coordination Act. S. 2780 Medication Affordability and Patent Integrity Act S. 142 Preserve Access to Affordable Generics and Biosimilars Act Joint USPTO-FDA Collaboration Initiatives. S. 2140/H.R.9474 Patent Eligibility Restoration Act of 2023 S. 2220/H.R.4370 PREVAIL Act S. 3583 A bill to address patent thickets. H.R. 6986 To address patent thickets. S.5573 A bill 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.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 H.R. 4370: PREVAIL Act - Provisions related to the PTAB H.R. 4692: Increasing Prescription Drug Competition Act - Patent-related policy issues H.R. 5429: Medication Affordability and Patent Integrity Act H.R. 5475: Prohibiting Adversarial Patents Act of 2023 H.R. 6275: Protecting Consumer Access to Generic Drugs Act of 2023 - Patent-related policy issues H.R. 6436: Stopping Pharmas Ripoffs and Drug Savings For All Act - Patent-related policy issues H.R. 6986: To address patent thickets. - Provisions related to patents S. 79: Interagency Patent Coordination and Improvement Act of 2023 S. 142: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 150: Affordable Prescriptions for Patients Act of 2023 - Provisions related to intellectual property and patents S. 574: Increasing Prescription Drug Competition Act - Patent-related policy issues S. 2140: Patent Eligibility Restoration Act of 2023 - Provisions related to patents S. 2220: PREVAIL Act - Provisions related to the PTAB S. 2780: Medication Affordability and Patent Integrity Act S. 3583: A bill to address patent thickets. - Provisions related to patents S. 4878: REMEDY Act S. 5573: A bill 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 Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues Request for Information Regarding the Draft Interagency Guidance Framework for considering the Exercise of March-In Rights (Docket No.: 230831-0207) Patent thicket policy issues Patent use codes policy issues AI patent policy issues

Client expense: $920,000 · Firm income: Not reported

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

S. 79/HR 1717 Interagency Patent Coordination and Improvement Act of 2023 S. 113 Prescription Pricing for the People Act of 2023 . S. 1250 Drug-price Transparency for Consumers Act S.127 Pharmacy Benefit Transparency Act S. 150 Affordable Prescriptions for Patients Act of 2023 S. 148 Stop STALLING Act S. 142 Preserve Access to Affordable Generics and Biosimilars Federal Trade Commission related issues, no specific bill Issues related to the Patent Act, no specific bill Issues related to March-In/Bayh Dole, WTO/TRIPS waiver, no specific bill Issues related to patent thickets/product hopping Issues related to obviousness/ double patenting S.2140 Patent Eligibility Restoration Act of 2023 S.2220/HR 4370 Promoting and Respecting Economically Vital American Innovation Leadership Act S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents H.R. 3858/S.1834: A bill to prohibit the President from negotiating or concluding any withdrawal, suspension, waiver, or modification to the Agreement on Trade-Related Aspects of Intellectual Property Rights without explicit authorization from Congress. H.R. 3535 Advancing Americas Interests Act H.R. 5475 Prohibiting Adversarial Patents Act of 2023 S.3385/HR 8333-- BIOSECURE Act BIOCOMPETE (no bill number)- Issues related to prohibiting the export of biotechnology to certain foreign entities Issues related to FDA/PTO coordination S.2780 Medication Affordability and Patent Integrity Act Issues related to skinny labeling S. 3583/HR 6986 To Address Patent Thickets S. 1956 Invent It Here, Make It Here Act S 5573 Skinny Labels, Big Savings Act

Client expense: $2,780,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The DRUG Act, H.R.6283/S.1542 (generally, no specific provisions) The DOC Access Act, H.R.1385/S.1424 (generally, no specific provisions) The ACCESS Act, H.R.5608 (generally, no specific provisions) The ORPHAN Cures Act, H.R.5539/S.3131 (generally, no specific provisions) H.R. 3433, Give Kids a Chance Act of 2024 (generally, no specific provisions) H.R. 7623, Telehealth Modernization Act of 2024 (generally, no specific provisions) S. 2780, Medication Affordability and Patent Integrity Act (generally, no specific provisions) S. 4583, Creating Hope Reauthorization Act of 2024 (generally, no specific provisions)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 142, Preserve Access to Affordable Generics and Biosimilars Act S. 2780, Medication Affordability and Patent Integrity Act Patent litigation reform issues and issues related to post-grant proceedings at the USPTO Value of intellectual property

Client expense: $1,080,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 H.R. 4370: PREVAIL Act - Provisions related to the PTAB H.R. 4692: Increasing Prescription Drug Competition Act - Patent-related policy issues H.R. 5429: Medication Affordability and Patent Integrity Act H.R. 5475: Prohibiting Adversarial Patents Act of 2023 H.R. 6275: Protecting Consumer Access to Generic Drugs Act of 2023 - Patent-related policy issues H.R. 6436: Stopping Pharmas Ripoffs and Drug Savings For All Act - Patent-related policy issues H.R. 6986: To address patent thickets. - Provisions related to patents S. 79: Interagency Patent Coordination and Improvement Act of 2023 S. 142: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 150: Affordable Prescriptions for Patients Act of 2023 - Provisions related to intellectual property and patents S. 574: Increasing Prescription Drug Competition Act - Patent-related policy issues S. 2140: Patent Eligibility Restoration Act of 2023 - Provisions related to patents S. 2220: PREVAIL Act - Provisions related to the PTAB S. 2780: Medication Affordability and Patent Integrity Act S. 3583: A bill to address patent thickets. - Provisions related to patents S. 4878: REMEDY Act S. 5573: A bill 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 Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues Request for Information Regarding the Draft Interagency Guidance Framework for considering the Exercise of March-In Rights (Docket No.: 230831-0207) Patent thicket policy issues Patent use codes policy issues AI patent policy issues

Client expense: $7,560,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilar Red Tape Elimination Act (S.2305); Give Kids a Chance Act of 2023 (H.R. 3433/S.2897); Affordable Prescriptions for Patients Act of 2023 (S. 150); S.3583/H.R. 6986, A bill to address patent thickets; Medication Affordability and Patent Integrity Act (S.2780); Stop STALLING Act (S. 148); S.5573 - A bill 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; H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications; Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025 (H.R. 10445); FDA Modernization Act 3.0 (H.R. 7248); Promising Pathway Act (H.R. 3761/S. 1644); BIOSECURE Act (H.R. 7085); Section 851 (Prohibition on Contracting with Covered Entities that Contract with Lobbyists for Chinese Military Companies) of the Fiscal Year 2024 National Defense Authorization bill ((H.R. 5009/S. 4638); Biotechnological Innovation and Opportunity for Competitive Economic Transformation Act of 2024 (BioCompete) ; clinical trial diversity; rare diseases; patent listing; rare pediatric disease priority review vouchers.

Client expense: Not reported · Firm income: $200,000

Government targets: SENATE

Inflation Reduction Act (IRA) HR 7174 - Ensuring Pathways to Innovative Cures (EPIC) Act Medicare Price Setting Drug Shortages Global Access to Medicines Trade-Related Aspects of Intellectual Property Rights (IPR) March-in Framework Guidance and Policies S 79/ HR 1717 - Interagency Patent Coordination and Improvement Act of 2023 S 142 - Preserve Access to Affordable Generics and Biosimilars Act HR 6986 - To address patent thickets S 150 - Affordable Prescriptions for Patients Act of 2023 S 2780/ HR 5429 - Medication Affordability and Patent Integrity Act Antimicrobial Resistance PBM Transparency and Reform S 1542 - Delinking Revenue from Unfair Gouging (DRUG) Act S 3430 - Better Mental Health Care, Lower-Cost Drugs and Extenders Act S 2973 - Modernizing and Ensuring PMB Accountability Act 340B Reform HR 8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act

Client expense: $2,760,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office

Addressing drug shortages and enhancing domestic production of critical medicines Issues related to biosimilars Promoting long-term sustainability of access for patients to generic and biosimilar medicines H.R.1503/S.2916: Prescription Information Modernization Act of 2023 H.R.2880: Protecting Patients Against PBM Abuses Act H.R.5429/S.2780: Medication Affordability and Patent Integrity Act 117 - S.2082 - Manufacturing API, Drugs, and Excipients (MADE) in America Act S.3311 - American Made Pharmaceuticals Act of 2023 Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024 Lower Costs, More Transparency Act (H.R. 5378) H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act S.2305: Biosimilar Red Tape Elimination Act Appropriations pertaining to American Made preference for generic products Issues related to Medicaid Generics Penalty Issues related to the IRA Issues related to drug supply chain Senate Finance Committee drug shortage legislation Proposals related to drug shortages Issues related to Levothyroxine.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Addressing drug shortages and enhancing domestic production of critical medicines Issues related to biosimilars Promoting long-term sustainability of access for patients to generic and biosimilar medicines H.R.1503/S.2916: Prescription Information Modernization Act of 2023 H.R.2880: Protecting Patients Against PBM Abuses Act H.R.5429/S.2780: Medication Affordability and Patent Integrity Act 117 - S.2082 - Manufacturing API, Drugs, and Excipients (MADE) in America Act S.3311 - American Made Pharmaceuticals Act of 2023 Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024 Lower Costs, More Transparency Act (H.R. 5378) H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act S.2305: Biosimilar Red Tape Elimination Act Appropriations pertaining to American Made preference for generic products Issues related to Medicaid Generics Penalty Issues related to the IRA Issues related to drug supply chain Senate Finance Committee drug shortage legislation Proposals related to drug shortages

Client expense: $230,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.652 - Safe Step Act (Murkowski/Hassan), support passage H.R. 830 - HELP Copays Act, support passage S.935- Fair Accountability and Innovative Research Drug Pricing Act of 2023, support passage H.R. 485, Protecting Health Care For All Patients Act, oppose passage as currently written S.127, the Pharmacy Benefit Manager Transparency Act, support passage Urged HELP and House Energy and Commerce Committee to hold roundtables and advance proposals that address workforce issues within the healthcare community. S. 2333 - Pandemic and All-Hazards Preparedness and Response Act, support passage H.R. 824, Telehealth Benefit Expansion for Workers Act of 2023, oppose passage H.R. 4421, Preparing for All Hazards and Pathogens Reauthorization Act, monitor legislation H.R. 4420, Preparedness and Response Reauthorization Act, monitor legislation Committee Draft -The Primary Care and Health Workforce Expansion Act, support passage S. 1339, the Pharmacy Benefit Manager Reform Act, support passage S.127, the PBM Transparency Act of 2023, support passage S.113, The Prescription Pricing for the People Act of 2023, support passage S.2052, Protect Patient Access to Pharmacies Act H.R. 1692, Health Care Affordability Act of 2023 H.R. 3561, the PATIENT Act of 2023, support passage H.R. 3284, Providers and Payers Compete Act, support passage H.R. 4507, Transparency in Coverage Act, support passage H.R. 4508, Hidden Fee Disclosure Act, support passage H.R. 2816, PBM Sunshine and Accountability Act, support passage S.79- Interagency Patent Coordination and Improvement Act of 2023, support passage S. 142- Preserve Access to Affordable Generics and Biosimilars Act, support passage S.148- Stop STALLING Act, support passage S.150- Affordable Prescriptions for Patients Act of 2023, support passage S.775-Increasing Transparency in Generic Drug Applications Act, monitoring S.1067-Ensuring Timely Access to Generics Act of 2023, support passage S. 2780 Medication Affordability and Patent Integrity Ac H.R. 4189, the CONNECT for Health Act, support passage H.R. 1843, the Telehealth Expansion Act, support passage H.R. 8018, the Alleviating Barriers for Caregivers Act, support passage S. 3109, the Alleviating Barriers for Caregivers Act, support passage H.R.6302, the Health Share Transparency Act of 2023 H.R.7623, the Telehealth Modernization Act of 2024

Client expense: $51,247 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

General advocacy in support of pro-IP/innovation policies S. 2220, H.R. 4370 - Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act S. 2140 - Patent Eligibility Restoration Act (PERA) Opposition to misuse of March-in provisions under the Bayh-Dole Act Opposition to FTC proposal to limit non-compete agreements ITC - IP-related issues S. 2934, H.R. 8684 - SHOP Safe Act Injunctive relief for patent rights holders S. 4840, H.R. 9221 - The RESTORE Patent Rights ACT of 2024 S.4713 - The IDEA Act S.2780 - The Medication Affordability and Patent Integrity Act Proposed Changes to Standard Essential Patent (SEPs) Policies H.R. 9474 Patent Restoration Act (PERA) of 2024

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.485, Protecting Health Care for All Patients Act H.R.5378, Lowering Costs, More Transparency Act H.R.6283/S.1542, DRUG Act H.R.1385/S.1424, DOC Access Act H.R.5608, ACCESS Act H.R.5539/S.3131, ORPHAN Cures Act H.R. 3433, Give Kids a Chance Act of 2024 H.R. 7623, Telehealth Modernization Act of 2024 S. 2780, Medication Affordability and Patent Integrity Act S. 4583, Creating Hope Reauthorization Act of 2024

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Antitrust Legislation Artificial Intelligence patent policy issues (AI) Bayh-Dole Act March-In Rights S.2780/H.R. 5429: Interagency Patent Coordination and Improvement Act Restrictions on Intellectual Property Rights Patent Litigation Reform S. 3583/HR. 6986 - to address patent thickets - Provisions related to patents

Client expense: $720,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) ---Patent eligibility for inventions created using AI tools Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights ---NIST RFI Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March in Rights ---Reasonable Pricing Clause Compulsory Licensing Data Privacy Issues ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---H.R.8818: American Privacy Rights Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diversity in Patenting ---S.2566: Inventor Diversity for Economic Advancement (IDEA) Act Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.2780: Medication Affordability and Patient Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---S.5573: A bill 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. ---H.R.5475: Prohibiting Adversarial Patents Act of 2023 (Fitzgerald - WI) ---H.R.6275: Protecting Consumer Access to Generic Drugs Act ---FTC Orange Book Delisting Initiative ---Orange Book Listing ---PTO Proposed Rules on Terminal Disclaimer Practice ---Restrictions on Intellectual Property Rights Foreign Drug Data Protection Law ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Intellectual Property Enforcement ---China ---TRIPS Waiver Patent Reform ---H.R.4575: Prohibiting Adversarial Patents Act (PAPA) ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.2140: Patent Eligibility Restoration Act (PERA) ---S.2220/H.R.4370: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act ---Patent Litigation Reform ---The USPTO Request for Comments: Experimental Use Defense 89 Fed.Reg 53963 Patenting of Biological Inventions ---S.2140: Patent Eligibility Restoration Act (PERA) ---Section 101 Modernization World Health Organization (WHO) ---WHO Pandemic Preparedness Accord World Intellectual Property Office (WIPO) ---Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge World Trade Organization (WTO) ---TRIPS Waiver

Client expense: $1,460,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

340B Drug Discount Program ---H.R.8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S.1133: 340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---S.4667: Risky Research Review Act ---Bio COMPETES (Draft) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---House GOP RFI on Supply Chain ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---American Pandemic Preparedness Plan (AP3) ---Gain of function (Viral Gain of Function Research Moratorium Act, Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Bio COMPETES (Draft) ---Biosimilar Copay ---House GOP RFI on Supply Chain ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy Climate Change Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---H.R.8818: American Privacy Rights Act of 2025 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.2780: Medication Affordability & Patient Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---S.5573: A bill 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. ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547/S.476: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.2305: Biosimilar Red Tape Elimination Act ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---H.R.2408: Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---Patients Before Monopolies (PBM) Act ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Efforts to expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---MCM PRV ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---VICP Funding for FDA ---FY 2025 Appropriations ---Creating Hope Reauthorization Act ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) ---Funding for Womens Health Research Generic Drug Entry ---H.R.6973: Generic Drug Application Review Reforms ---S.148: Stop STALLING Act ---S.4351: Enhanced Access to Affordable Medicines Act Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4758: Accelerating Kids Access to Care Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/S.2933: Support for Patients and Communities Reauthorization Act ---Non-Opioid Analgesics ---Coverage and Reimbursement Orphan Drug Issues ---H.R.3433: Give Kids a Chance Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Implementation of the Prepare for and Respond to Existing Viruses ---Emerging New Threats and (PREVENT) Pandemics Act ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---H.R.5796/S424: Protect our Seniors Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---H.R.5260: Reduced Costs and Continued Cures Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Client expense: $1,460,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), SENATE, State, Dept of (DOS), White House Office

Patent abuse issues. S. 150/H.R. 9070 - Affordable Prescriptions for Patients Act of 2023. S. 79 - Interagency Patent Coordination Act. S. 2780 - Medication Affordability and Patent Integrity Act. S. 142 - Preserve Access to Affordable Generics and Biosimilars Act. Joint USPTO-FDA Collaboration Initiatives. H.R. 9474/S. 2140 - Patent Eligibility Restoration Act of 2023. H.R. 4370/S. 2220 - PREVAIL Act. S. 3583 - A bill to address patent thickets. H.R. 6986 - A bill to address patent thickets. H.R. 10545 - American Relief Act

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

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

H.R. 1264, Commonsense Reporting Act of 2023 H.R. 2813, Self-Insurance Protection Act H.R. 2868, Association Health Plans Act H.R. 3800, Chronic Disease Flexible Coverage Act H.R. 4307/S. 2115, Medical Supply Chain Resiliency Act H.R. 6363, Further Continuing Appropriations and Other Extensions Act of 2024, and issues pertaining to H.R. 1843/S. 1001, The Telehealth Expansion Act of 2023 H.R. 6860, Restore Protections for Dialysis Patients Act H.R. 9029, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025 S. 127, Pharmacy Benefit Manager Transparency Act of 2023 S. 142, Preserve Access to Affordable Generics and Biosimilars Act S. 148, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act S. 150, Affordable Prescriptions for Patients Act of 2023 S. 1067, Ensuring Timely Access to Generics Act of 2023 S. 1114, Expanding Access to Low-Cost Generics Act of 2023 S. 1214, Retaining Access and Restoring Exclusivity (RARE) Act S. 1339, Pharmacy Benefit Manager Reform Act S. 2624, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024 S. 2780, The Medication Affordability and Patent Integrity Act Proposed Rule, Internal Revenue Service, the Employee Benefits Security Administration, and the Health and Human Services Department; Requirements Related to the Mental Health Parity and Addiction Equity Act (88 Fed. Reg. 51,552-51,669, August 3, 2023) Proposed Rule, Employee Benefits Security Administration, Department of Labor; Definition of Employer-Association Health Plans (88 Fed. Reg. 87,968-87,981, December 20, 2023) Various issues relating to the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, health savings account (HSAs), health reimbursement account (HRAs), employer mandate; Medicare Drug Price Negotiation Program: Initial Memorandum, Implementation of Sections 1191 - 1198 of the Social Security Act for Initial Price Applicability Year 2026, and Solicitation of Comments; implementation of the American Rescue Plan Act (P.L. 117-2); implementation of the Inflation Reduction Act (P.L. 117-169); balance or surprise billing and related issues; single-payer health care options; health reimbursement arrangements and other account-based group health plans; Health and Human Services international pricing index (IPI) model; mental health parity; drug pricing; COBRA subsidies; Federal Trade Commissions multilateral pharmaceutical merger taskforce; telehealth, including coverage of telehealth under High Deductible Health Plans (HDHPs) and expanding telehealth options for employees; impact of Pharmacy Benefit Managers Practices; FTC-2022-0015; petition to HHS to grant march-in rights for the patents on the drug Xtandi; legislative proposals to tax employer-provided health care coverage; artificial price caps on providing insulin; Reasonable Price Clause in reauthorization draft of the Pandemic and All Hazards Preparedness Act (PAHPA, P.L. 109-417); over-the-counter preventive services; ERISA preemption protections including information on constructive changes/modifications to ERISA; efforts to reform the World Health Organizations (WHO) engagement with private sector; support for necessary market conditions to incentivize health sector investment from private sector; support for private sector involvement in health systems strengthening; promote greater harmonization of standards and investment in digital health; health-related policy issues in the G20/G7 forums and other multilateral forums; support for improving access to health products and technologies globally, including via regulatory alignment, addressing trade barriers, strengthening the global supply chain, and raising awareness on potential pitfalls of local manufacturing; combatting anti-microbial resistance; Advance Notice of Methodological Changes for Calendar Year (CY) 2025 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies, U.S. Centers for Medicare & Medicaid Services, U.S. Department of Health and Human Services (2025 Advance Notice, January 31, 2024)

Client expense: $22,410,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade & Development Agency (USTDA), U.S. Trade Representative (USTR)

H.R. 5475, Prohibiting Adversarial Patents Act of 2023 H.R. 8070, National Defense Authorization Act for Fiscal Year 2025 S. 79, Interagency Patent Coordination and Improvement Act of 2023 S. 142, Preserve Access to Affordable Generics and Biosimilars Act S. 150, Affordable Prescriptions for Patients Act of 2023 S. 315, Taxpayer Research and Contributions Knowledge (TRACK) Act of 2023, including provisions related to university tech transfer S. 1264, Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act S. 2140, Patent Eligibility Restoration Act of 2023 S. 2220, Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act S. 2780, Medication Affordability and Patent Integrity Act S.5160, A bill to expand the sharing of information with respect to suspected violations of intellectual property rights in trade Potential legislation similar to H.R. 5376, Inflation Reduction Act of 2022 Potential legislation similar to S. 1416, Affordable Prescriptions for Patients Act of 2019 Potential legislation regarding revisions to the tech transfer framework established under the Bayh-Dole Act (P.L. 96-517) 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 artificial intelligence and intellectual property rights Potential legislation related to patent eligibility reform Potential legislation related to changes in Patent Trial and Appeal Board Proceedings Potential legislation related to digital copyright piracy Potential legislation making omnibus year-end appropriations, with a focus on appropriations for USPTO and the United States Copyright Office Potential legislation related to the NIST Draft Framework on the use of march-in rights for federally funded research. Proposed rulemaking regarding changes to Patent Trial and Appeal Board Proceedings (Fed. Reg. 28,693-28,706, April 19, 2024) Various issues relating to implementation of Trade Facilitation and Trade Enforcement Act of 2015 (P.L. 114-125); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; modernization of the U.S. Copyright Office; patent examination practices and patent quality; patent filing fees; U.S. Patent and Trademark Office and Food and Drug Administration collaboration efforts; State Departments Office of Authentication; IP issues related to counterfeiting; patent linkage and regulatory data protection; 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); implementation of the Bayh-Dole Act (P.L. 96-517), including march-in rights; implementation of the NIST draft interagency guidance for the use of march-in rights on federally funded inventions; emerging issues surrounding artificial intelligence, intellectual property, and data protection; IP issues related to digital piracy; increase utilization of federal criminal penalties resulting from the passage of the Protect Lawful Streaming Act (PSLA) (P.L. 116-260, Div. Q, Title II), for certain types of copyright infringement via illicit streaming of copyrighted works; intellectual property enforcement priorities at the U.S.-Mexico border; licensing negotiations and remedies for standard-essential patents subject to voluntary F/RAND Commitments; funding for the Intellectual Property Enforcement Program in FY25 Appropriations Legislation; the "Reasonable Price Clause" in reauthorization draft of the Pandemic and All Hazards Preparedness Act (PAHPA, P.L. 109-417); WHOIS policy for .us web domains; March-In rights under the Bayh-Dole Act (P.L. 96-517); inventorship guidance for AI-assisted inventions

Client expense: $22,410,000 · 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), White House Office

Issues related to Inter Partes Review and patent policy generally; Preserve Access to Affordable Generics and Biosimilars Act, S.142; Affordable Prescriptions for Patients Act, S. 150 Issues related to FDA and PTO coordination, including, Interagency Patent Coordination and Improvement Act of 2023, S. 79 and HR 1717, and Medication Affordability and Patent Integrity Act, S.2780 and HR 5429; PREVAIL Act, S.2220 and HR 4370; Patent Eligibility Restoration Act of 2023, S.2140.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to patent policy and reform, including to address patent thickets (HR 6986, S. 3583) and Promoting and Respecting Economically Vital American Innovation Leadership Act (S. 2220, HR 4370), and Patent Eligibility Restoration Act of 2023 (S. 2140) FDA/PTO Coordination, including Interagency Patent Coordination and Improvement Act of 2023 (S.79) and Medication Affordability and Patent Integrity Act (S. 2780, HR 5429) Prescription Pricing for the People Act of 2023 (S.113); Preserve Access to Affordable Generics and Biosimilars Act (S.142); Affordable Prescriptions for Patients Act of 2023 (S.150).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to pharmaceutical patents. S. 150/H.R. 9070 - Affordable Prescriptions for Patients Act of 2023. S. 79 - Interagency Patent Coordination Act. S. 2780 - Medication Affordability and Patent Integrity Act. S. 142 - Preserve Access to Affordable Generics and Biosimilars Act. Joint USPTO-FDA Collaboration Initiatives. S. 2140 - Patent Eligibility Restoration Act of 2023. S. 2220 - PREVAIL Act. S. 3583/ H.R. 6986 - A bill to address patent thickets. H.R. 10545 - American Relief Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. S.1114 - Expanding Access to Low-Cost Generics Act of 2023. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. H.R.10239/S.5368: End Drug Shortages Act. H.R. 3008/S.2362: Drug Shortage Prevention Act of 2023. S.2305: Biosimilar Red Tape Elimination Act. H.R.2880: Protecting Patients Against PBM Abuses Act. H.R.10545: American Relief Act, 2025 as it relates to Patent Thickets and Q1/Q2.

Client expense: $800,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.4370/S.2220: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. S.2140/H.R.9474: Patient Eligibility Restoration Act of 2023. H.R.6986/S.3583: To address patent thickets. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. H.R.9070/S.150: Affordable Prescriptions for Patients Act of 2024. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.5573: A bill 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.

Client expense: $800,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B drug discount program; drug pricing; importation of biopharmaceuticals; direct-to-consumer (DTC) advertising; transparency; international pharmaceutical supply chain; antimicrobial resistance legislation; insulin price cap; DoD TRICARE Pharmacy Benefits Program, H.R.8070/S.4638, National Defense Authorization Act for Fiscal Year 2025; H.R.5376, Inflation Reduction Act of 2022 (P.L.117-169) implementation; Pandemic and All-Hazards Preparedness Act (PAHPA) reauthorization; H.R.830, HELP Copays Act; S.127, Pharmacy Benefit Manager Transparency Act of 2023; H.R.3285, Fairness for Patient Medications Act; S.1339, Pharmacy Benefit Manager Reform Act; S.1067, Ensuring Timely Access to Generics Act of 2023; S.1114, Expanding Access to Low-Cost Generics Act of 2023; S.1214, RARE Act; H.R.5378, Lower Costs, More Transparency Act; S.2840, Bipartisan Primary Care and Health Workforce Act; S.3430, Better Mental Health Care Lower-Cost Drugs and Health Extenders Act; S.2973, Modernizing and Ensuring PBM Accountability Act; H.R.6283, DRUG Act; S.2305, Biosimilar Red Tape Elimination Act; S.2780, Medication Affordability and Patent Integrity Act.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Inflation Reduction Act (IRA) HR 7174 - Ensuring Pathways to Innovative Cures (EPIC) Act Medicare Price Setting Drug Shortages Global Access to Medicines Trade-Related Aspects of Intellectual Property Rights (IPR) March-in Framework Guidance and Policies S 79/ HR 1717 - Interagency Patent Coordination and Improvement Act of 2023 S 142 - Preserve Access to Affordable Generics and Biosimilars Act HR 6986 - To address patent thickets S 150 - Affordable Prescriptions for Patients Act of 2023 S 2780/ HR 5429 - Medication Affordability and Patent Integrity Act Antimicrobial Resistance PBM Transparency and Reform S 1542 - Delinking Revenue from Unfair Gouging (DRUG) Act S 3430 - Better Mental Health Care, Lower-Cost Drugs and Extenders Act S 2973 - Modernizing and Ensuring PMB Accountability Act 340B Reform HR 8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act

Client expense: $2,710,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office

Legislation and regulation regarding pharmaceutical pricing, coverage and care; retail and inpatient pharmacy operations and the role of pharmacy benefit managers. S.2140 - Patent Eligibility Restoration Act of 2023 H.R. 2679, the PBM Accountability Act H.R.3285 - To establish patient protections with respect to highly rebated drugs S. 1067, the Ensuring Timely Access to Generics Act of 2023 S. 1114, the Expanding Access to Low-Cost Generics Act of 2023 S.1269 - INSULIN Act of 2023 S. 1909 Pharmacy DIR Reform to Reduce Senior Drug Costs Act S. 1967 The Patients Before Middlemen Act (the PBM Act) S. 1339 The Pharmacy Benefit Managers Reform Act S. 127, the Pharmacy Benefit Manager Transparency Act of 2023 H.R. 485, the Protecting Health Care for All Patients Act of 2023 S. 2780 & H.R. 5429 - Medication Affordability and Patent Integrity Act S. 2305 - Biosimilar Red Tape Elimination Act S.150 & H.R. 9070 - Affordable Prescriptions for Patients Act of 2023 S. 5503 and H.R. 10362 - The Patients Before Monopolies Act

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Intellectual property issues including patent, copyright, and trademark issues. Patent March-In Rights. Method of Use Patents (Legislation Net Yet Introduced). S.2140 - Patent Eligibility Restoration Act of 2023. S.2780 - Medication Affordability and Patent Integrity Act. H.R.4370/S.2220 - PREVAIL Act. H.R.4499 - IDEA Act of 2023. H.R.3479/S.1753 - RESTORE Act of 2023.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.4875/H.R. 9551, the NO FAKES Act of 2023 S. 2780, the Medication Affordability and Patent Integrity Act H.R. 9455/ S. the IDEA Act H.R. 9211/S. 4840, the RESTORE Patent Rights Act of 2024 S. 5160, Sharing of information with respect to suspected violations of intellectual property rights. H.R. 8134, the Restoring America's Leadership in Innovation Act of 2024 (RALIA) H.R. 8132, Balancing Incentives Act of 2024 H.R. 7913, Generative AI Copyright Disclosure Act of 2024 H.R. 6684/S. 3569, Improving Efficiency to Increase Competition Act H.R. 5475, Prohibiting Adversarial Patents Act of 2023 H.R. 6436, Stopping Pharmas Ripoffs and Drug Savings For All Act S, 2934, the SHOP SAFE Act of 2023 H.R. 5475, Prohibiting Adversarial Patents Act of 2023 S. 2566, the American IP Defense and Enforcement Advancement Act H.R. 9474/S. 2140, Patent Eligibility Restoration Act of 2023 S. 2220/H.R. 4370, Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act H.R. 1707, the SMART Act S. 1128, Ensuring Access to Generic Medications Act S.835/H.R.1631, the Pro Codes Act S. 746/H.R. 1505, the No Stolen Trademarks Honored in America Act S. 574, Increasing Prescription Drug Competition Act S. 253/H.R. 791, the American Music Fairness Act of 2023 S. 153, the Fair Trade with China Enforcement Act S. 150, the Affordable Prescriptions for Patients Act S. 113 Pricing for the People Act S. 79/H.R. 1717, the Interagency Patent Coordination and Improvement Act of 2023. S. 42, Prescription Preserve Access to Affordable Generics and Biosimilars Act H.R.2594 - To control the export to the People's Republic of China of certain technology and intellectual property important to the national interest of the United States, and for other purposes. H.R. 2070 - To provide for a limitation on availability of funds for Executive Office of the President, Intellectual Property Enforcement Coordinator for fiscal year 2024 H.R. 1016, the Stop Chinas IP Theft Act H.R. 906 , the REPAIR Act H.R. 576, the Copyright Clause Restoration Act of 2023 Issues related to USPTO operations Issues related to international patent harmonization Issues related to patent subject matter eligibility Issues related to Copyright Office Modernization Issues related to the WTO TRIPs Waiver Request

Client expense: Not reported · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Library of Congress (LOC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office

S. 2780, Medication Affordability and Patent Integrity Act S. 2220, Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) S. 4875, Nurture Originals, Foster Art, and Keep Entertainment Safe Act of 2024 (NO FAKES Act) S.4713, Inventor Diversity for Economic Advancement Act of 2024 (IDEA Act) S. 3583, Bill to Address Patent Thickets Patent Act Section 101, S. S.2140, Patent Eligibility Restoration Act Preventing Abuse of Digital Replicas Act (PADRA) Patent Terminal Disclaimers

Client expense: $40,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Copyright Office, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)

Patent Trial and Appeal Board, including institution of proceedings, Fintiv/NHK and related procedures Patent-eligible subject matter Injunctive relief against patent infringers Standard Essential Royalty Act, to establish a patent licensing royalty rate-setting judicial panel disadvantageous to patent owners and favorable to patent infringers H.R. 3535 (Advancing Americas Interest Act) to disadvantageously change U.S. firms access to and treatment before the U.S. International Trade Commission when seeking Section 337 remedies blocking importation of U.S. patent-infringing goods S. 2321/H.R. 5893 (Commerce-Justice-Science Appropriations, FY24) report language to erect barriers to Sec. 337 USITC remedies to block importation of U.S. patent-infringing goods Proposals to misuse Bayh-Dole Acts march-in against patent ownership rights based on product price Unilateral changes to Dept. of Energy funding agreements requiring headquarters review of any licensing agreement, undermining the Bayh-Dole Act Comments on Initiatives to Ensure the Robustness and Reliability of Patent Rights (Docket No. PTO-P-2022-0025) Request for Comments Regarding Joint USPTO-FDA Collaboration Initiatives (Docket No. PTO-P-2022-0037) Federal position on proposal at World Trade Organization to waive intellectual property protections due under Trade-Related Aspects of Intellectual Property Rights Agreement with regard to COVID-19-related inventions Comments on U.S. International Trade Commission Investigation No. 332-596, COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities Comments on advance notice of proposed rulemaking, Changes Under Consideration to Discretionary Institution Practices, Petition Word-Count Limits, and Settlement Practices for America Invents Act Trial Proceedings Before the Patent Trial and Appeal Board (Docket No. PTO-P-2020-0022) S. 2220/H.R. 4370 (Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act) Comments related to National Institutes of Health, Workshop on Transforming Discoveries into Products: Maximizing NIHs Levers to Catalyze Technology Transfer S. 2140 (Patent Eligibility Restoration Act (PERA)) Mandatory customer stay that deprives patent owners of the ability to enforce their patent rights against all parties such as through injunctive relief and that would unfairly protect direct and contributory patent infringers, including large retail corporations Defending American Patents Act, which would punish U.S. patent owners with the loss of six years of patent protection for asserting their patent in a foreign court against an American patent infringer H.R. 5475 (Preventing Adversarial Patents Act), which would radically change from the hallmark of merit-based U.S. patent issuance, by adding denial or unenforceability of patents based on certain characteristics of the patentee Comments on U.S. Patent & Trademark Office, Joint Collaboration Initiative Regarding Standards (Docket No. PTO-C-2023-0034) Digital copyright piracy, site-blocking injunction National Institute of Standards and Technology, Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights (Docket No. NIST-2023-0008) Comments to U.S. Patent & Trademark Office, regarding WIPO IGC Negotiations on Genetic Resources and Associated Traditional Knowledge (Docket No.: PTO-C-2023-0019) H.R. 7476 (Countering Communist China Act) intellectual property provisions H.R. 8134 (Restoring Americas Leadership in Innovation Act) Comments to USPTO on Unlocking the Full Potential of Intellectual Property by Translating More Innovation to the Marketplace (Docket No. PTO-C-2024-0004) Comments to USPTO on Patent Trial and Appeal Board Rules of Practice for Briefing Discretionary Denial Issues, and Rules for 325(d) Considerations, Instituting Parallel and Serial Petitions, and Termination Due to Settlement Agreement (Docket No. PTO- P-2023-0048) Leadership in Critical and Emerging Technologies (CET) Act to expedite CET patent examination S. 1956 (Invent Here, Make Here Act) S. 4840/H.R. 9221 (RESTORE Patent Rights Act) Comments to USPTO on Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting (Docket No. PTO- P-2024-0003) S. 4875 (Nurture Originals, Foster Art, and Keep Entertainment Safe (NO FAKES) Act) S. 2780 (Medication Affordability and Patent Integrity Act) Ensure free-market-based licensing terms and royalty rate settings of standard-essential patents (SEPs) Codification of 2019 Joint Policy Statement on Remedies for Standards-Essential Patents

Client expense: Not reported · Firm income: $7,600

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Price controls proposals regarding pharmaceuticals or other medical goods or services, including direct government price-setting, reduced reimbursement rates, and restrictions on beneficiary choice and plan or provider competition in government health programs or private insurance plans H.R. 485 (Protecting Health Care for All Patients Act) S. 1246/S. 1264 (Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act) Senate HELP Committees 2023 Reauthorization of the Pandemic and All-Hazards Preparedness Act, Sec. 601, BARDA reasonable pricing requirements, and Sec. 602, CDC reasonable pricing requirements, other contemplated "reasonable pricing price controls and patent prize schemes Repeal of Inflation Reduction Act (IRA), Sec. 5000D, drug price controls product price negotiation and 95% inflation penalty and IRA implementation S. 2305 (Biosimilar Red Tape Elimination Act) S. 2780 (Medication Affordability and Patent Integrity Act) S. 2973 (Modernizing and Ensuring PBM Accountability Act) S. 3430 (Mental Health, Lower-Cost Drug and Extenders Package)

Client expense: Not reported · Firm income: $7,600

Government targets: HOUSE OF REPRESENTATIVES, SENATE

VICP Reform and Excise Tax Inflation Reduction Act (IRA) HR7174 - Ensuring Pathways to Innovative Cures (EPIC) Act Medicare Price Setting Part D Payer Utilization Management Drug Shortages S2916 - Prescription Information Modernization Act of 2023 Vaccines, Clinical Trials and Coverage S2305 - Biosimilar Red Tape Elimination Act Biosimilar Access and Interchangeability HR 2666 - Medicaid Value Based Payments for Patients (MVP) Act HR 4758 - Accelerating Kids Access to Care Act HR 7384 - Rare Pediatric Disease Priority Review (PRV) Voucher Trade-Related Aspects of Intellectual Property Rights March-in Framework Guidance and Policies S.79 - Interagency Patent Coordination and Improvement Act of 2023 S.142 - Preserve Access to Affordable Generics and Biosimilars Act S.150 - Affordable Prescriptions for Patients Act of 2023 S.2780 - Medication Affordability and Patent Integrity Act Digital: Data Flows and Digital Trade

Client expense: $1,070,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE

Addressing drug shortages and enhancing domestic production of critical medicines Issues related to biosimilars Promoting long-term sustainability of access for patients to generic and biosimilar medicines H.R.1503/S.2916: Prescription Information Modernization Act of 2023 H.R.2880: Protecting Patients Against PBM Abuses Act H.R.5429/S.2780: Medication Affordability and Patent Integrity Act 117 - S.2082 - Manufacturing API, Drugs, and Excipients (MADE) in America Act S.3311 - American Made Pharmaceuticals Act of 2023 Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024 Lower Costs, More Transparency Act (H.R. 5378) H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act S.2305: Biosimilar Red Tape Elimination Act Appropriations pertaining to American Made preference for generic products Issues related to Medicaid Generics Penalty Issues related to the IRA Issues related to drug supply chain Senate Finance Committee drug shortage legislation Proposals related to drug shortages

Client expense: $170,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE