Interagency Patent Coordination and Improvement Act of 2023

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

- S 150, "Affordable Prescriptions for Patients Act of 2023", regarding all provisions. - S 79/HR 1717, "Interagency Patent Coordination and Improvement Act of 2023", regarding all provisions. - Issues related to intellectual property.

Client expense: $1,520,000 · 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

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

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

S.79 - Interagency Patent Coordination and Improvement Act of 2023, support passage S.113, the Prescription Pricing for the People Act of 2023,support passage S.142, the Preserve Access to Affordable Generics and Biosimilars Act, support passage S.148, the Stop Stalling Act, support passage S.150, the Affordable Prescriptions for Patients Act of 2023, support passage H.R.1114- Long COVID Recovery Now Act S.801/H.S. 1616 CARE for Long COVID Act, support passage The Biosimilar Red Tape Elimination Act, monitor legislation U.S. HOUSE OF REPRESENTATIVES, U.S. Senate, Natl Institutes of Health (NIH), Defense - Dept of (DOD), Food & Drug Administration (FDA), Veterans Affairs - Dept of (VA)

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

Government targets: Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE, Veterans Affairs, Dept of (VA)

H.R. 2139/S. 908: Medicare Drug Price Negotiation Act H.R. 2148/S. 909: Prescription Drug Price Negotiation Act S. 476/H.R. 5547: Maintaining Investments in New Innovation Act H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act S. 79/H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 PBM Reform Medicaid H.R. 2666: The Medicaid VBPs for Patients (MVP) Act Coverage of Accelerated Approval Products Drug Benefit Design Medicaid Drug Rebate Program Rule Pricing and Rebates Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products 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. 2630/S. 652: SAFE STEP Act H.R. 4895: Lowering Drug Costs, More Transparency Act CMMI Authority Implementation of the Inflation Reduction Act (IRA) Lower Costs, More Cures Act Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Inflation Reduction Act of 2022 (P.L. 117-169) Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Value-based purchasing arrangements policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMS Guidance on the Medicare Drug Price Negotiation Program: Initial Memorandum CMS Medicare Drug Price Negotiation Revised Guidance S.1544/H.R. 1199: Facilitating Innovative Nuclear Diagnostics Act of 2023

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

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

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

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 Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---BSUFA Negotiations ---Implementation of BSUFA Agreement ---Interchangeability and Pharmacy Substitution ---Reimbursement 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 ---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 & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---FDA Hiring Flexibility 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.3583/H.R.6986: A bill to address patent thickets ---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.1790: Biologics Competition Act of 2023 ---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.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547: 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.1067: Ensuring Timely Access to Generics ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---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 Foreign Drug Data Protection Laws ---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 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 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry 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 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program ---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 ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---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 ---House GOP RFI on Supply Chain ---Implementation of the Prepare for and Respond to Existing Viruses ---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/S.4583: 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 ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---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 ---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 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---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 ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---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. 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

S. 79, Interagency Patent Coordination and Improvement Act of 2023. S. 150, Affordable Prescriptions for Patients Act of 2023. Issues concerning mergers and acquisitions.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to intellectual property and patent reform, including: S. 150, Affordable Prescriptions for Patients Act; S. 79, Interagency Patent Coordination and Improvement Act; S. 113, Prescription Pricing for the People Act; S. 142, Preserve Access to Affordable Generics and Biosimilars Act; and S. 148, Stop STALLING Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to intellectual property and patent reform, including: S. 150, Affordable Prescriptions for Patients Act; S. 79, Interagency Patent Coordination and Improvement Act; S. 113, Prescription Pricing for the People Act; S. 142, Preserve Access to Affordable Generics and Biosimilars Act; and S. 148, Stop STALLING Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to intellectual property and patent reform, including: S. 150, Affordable Prescriptions for Patients Act; S. 79, Interagency Patent Coordination and Improvement Act; S. 113, Prescription Pricing for the People Act; S. 142, Preserve Access to Affordable Generics and Biosimilars Act; and S. 148, Stop STALLING Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to intellectual property and patent reform, including: S. 150, Affordable Prescriptions for Patients Act; S. 79, Interagency Patent Coordination and Improvement Act; S. 113, Prescription Pricing for the People Act; S. 142, Preserve Access to Affordable Generics and Biosimilars Act; and S. 148, Stop STALLING Act. Issues related to the National Institute of Standards and Technology request for public comment on a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to intellectual property and patent reform, including: S. 150, Affordable Prescriptions for Patients Act; S. 79, Interagency Patent Coordination and Improvement Act; S. 113, Prescription Pricing for the People Act; S. 142, Preserve Access to Affordable Generics and Biosimilars Act; and S. 148, Stop STALLING Act. Issues related to the National Institute of Standards and Technology request for public comment on a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

S 652/HR 2630: Safe Step Act- implementing safe guards around step therapy (fail first) programs in ERISA regulated plan S 1375/HR 830: HELP Copays Act- copay accumulator programs Addressing Pharmacy Benefit Managers S 127: Pharmacy Benefit Manager Transparency Act of 2023- prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs S 79: Interagency Patent Coordination and Improvement Act of 2023- establishes an interagency taskforce between the United States Patent and Trademark Office and the FDA S 2243: Palliative Care and Hospice Education and Training Act (PCHETA)- promote education and research in palliative care and hospice Palliative care S 2213: Comprehensive Cancer Survivorship Act- cancer survivorship S 2039: Cancer Drug Parity Act of 2023- oral parity for cancer drugs HR 3633: PREVENT HPV Cancers Act of 2023 S 1624/HR 3391: Gabriella Miller Kids First Research Act 2.0- pediatric cancer research Addressing healthcare workforce shortages Increasing diversity in clinical trials Mitigating drug shortages and increasing supply chain resiliency and future pandemic preparedness, including bolstering the strategic national stockpile S 1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023- require an interagency risk assessment of the pharmaceutical supply chain to identify and mitigate health and national security risks HR 3810: Drug Origin Transparency Act of 2023 - Require drug manufacturers to report to the Food and Drug Administration (FDA) quarterly the supplier's location and drug ingredients HR 3793: Ensuring Access to Lifesaving Drugs Act of 2023 - require manufacturers of life-saving drugs to submit data and information to assess the stability of the drugs and determine their longest supported expiration date, and for other purposes. S 2364: MAPS ACT - A bill to map the United States pharmaceutical supply chain S 2510: RAPID Reserve Act - establish reserves of both Active Pharmaceutical Ingredients (APIs) and finished drug products to be held as vendor-managed inventory and used when needed to prevent supply disruptions HR 5526: Seniors' Access to Critical Medications Act of 2023 - make permanent a waiver issued by the Centers for Medicare and Medicaid Services (CMS) that allowed for Medicare patients to receive critical medications by mail or allow for caregivers and family members to obtain medications for them. HR 6301: Cancer Drug Parity Act of 2023 - To amend the Employee Retirement Income Security Act of 1974 to require a group health plan (or health insurance coverage offered in connection with such a plan) to provide for cost-sharing for oral anticancer drugs on terms no less favorable than the cost-sharing provided for anticancer medications administered by a health care provider. HR 6963: To direct the Secretary of Health and Human Services to enter into agreements with drug manufacturers to establish reserve supplies of covered pediatric cancer drugs, and for other purposes - establish reserve supplies of covered pediatric cancer drugs, and for other purposes. HR 6992: Mapping America's Pharmaceutical Supply Act- require the Department of Health and Human Services to update its essential medicines list and create a database to help predict vulnerabilities in the U.S. pharmaceutical supply chain. S 3458: Seniors' Access to Critical Medications Act of 2023 - clarify the application of the in-office ancillary services exception to the physician self-referral prohibition for drugs furnished under the Medicare program. HR 8404/S 4330: ROCR Value Based Program Act of 2024 - To amend title XVIII of the Social Security Act to create a Radiation Oncology Case Rate Value Based Payment Program exempt from budget neutrality adjustment requirements, and to amend section 1128A of title XI of the Social Security Act to create a new statutory exception for the provision of free or discounted transportation for radiation oncology patients to receive radiation therapy services. HR 3633: Prevent HPV Cancers ACt of 2023 - To amend the Public Health Service Act to provide for a public awareness campaign with respect to human papillomavirus, and for other purposes. HR 3008: Drug Shortage Prevention Act of 2023 - To amend the Federal Food, Drug, and Cosmetic Act to provide for notification by manufacturers of critical essential medicines of increased demand of such drugs, and for other purposes. S 5368/HR 10239: End Drug Shortages Act - To amend the Federal Food, Drug, and Cosmetic Act to expand drug shortage notification practices to include surges in demand for a drug, and for other purposes.

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

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

GLP-1 pricing and licensing, Medical Innovation Act, Medicare drug price negotiation implementation, Medicines for All Act, pharmaceutical manufacturer-sponsored telehealth platforms, S.2140 PERA, S.2220 PREVAIL Act, S.Res.684 supporting GAVI; PILLS Act, H.R.885, S.315 TRACK Act, Medicare drug price negotiation, international reference price negotiation price caps, number of drugs negotiated, out of pocket caps, inflation rebates, negotiation delay periods, S.2044 End Price Gouging for Medications Act, S.2140 PERA; S.2220 PREVAIL Act; S. 79, Interagency Patent Coordination and Improvement Act; S. 142, Preserve Access to Affordable Generics and Biosimilars Act; S. 148, Stop STALLING Act; S. 150, Affordable Prescriptions for Patients Act, We PAID Act; march-in rights, S.2140 PERA; S.2220 PREVAIL Act, intramural access plan and licensing policy, march-in rights guidance.

Client expense: $65,190 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, White House Office

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

H.R. 1613 - Drug Price Transparency in Medicaid Act of 2023 - Rep. Carter, Earl - spread-pricing by PBMs for Medicaid H.R. 2880 - Protecting Patients Against PBM Abuses Act - Rep. Carter, Earl - PBM transparency H.R. 4818 - Treat and Reduce Obesity Act - Rep. Wenstrup, Brad - weight loss coverage H.R. 5372 - Expanding Seniors Access to Lower Cost Medicines Act of 2023 - Rep. Joyce, John - generic drugs, biosimilars cost H.R. 5378 - Lower Costs, More Transparency Act - Rep. McMorris Rodgers, Cathy - PBM transparency H.R. 5385 - Medicare PBM Accountability Act - Rep. Landsman, Greg McMorris - PBM transparency H.R. 6283 - DRUG Act - Rep. Miller-Meeks, Mariannette - PBM contracts H.R. 6963 - Pediatric Cancer Drug Supply Act of 2024 - Rep. Eshoo, Anna - establishes agreements with drug manufacturers to establish reserve supplies of covered pediatric cancer drugs H.R. 7635 - The 340B PATIENTS Act of 2024- Rep. Matsui, Doris - ensures accessibility of drugs under 340B drug discount program S. 79 - Interagency Patent Coordination and Improvement Act of 2023 - Sen. Durbin, Richard - prescription drug patenting S. 113 - Prescription Pricing for the People Act of 2023 - Sen. Grassley, Chuck - PBM transparency S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 - Sen. Cantwell, Maria - PBM transparency S. 142 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy - pharmacy and biosimilar prescription drugs S. 148 - Stop STALLING Act - Sen. Klobuchar, Amy - pharmacy market approval processes S. 150 - Affordable Prescriptions for Patients Act of 2023 - Sen. Cornyn, John - pharmacy and prescription drug prices, prevent patent thickets S. 574 - Increasing Prescription Drug Competition Act - Sen. Hassan, Maggie - closure of pharmaceutical patent loophole S. 652 - Safe Step Act - Sen. Murkowski, Lisa - medication step therapy protocol S. 954 - Affordable Insulin Now Act of 2023 - Sen. Warnock, Raphael - insulin pricing and cost sharing S. 1038 - Drug Price Transparency in Medicaid Act of 2023 - Sen. Welch, Peter - drug pricing transparency S. 1269 - INSULIN Act of 2023 - Sen. Shaheen, Jeanne - insulin pricing S. 1339 - Pharmacy Benefit Manager Reform Act - Sen. Sanders, Bernie - PBM transparency S. 1542 - DRUG Act - Sen. Marshall, Roger - PBM regulation S. 2973 - Modernizing and Ensuring PBM Accountability Act - Sen. Wyden, Ron - Plan implementation S. 3934 - Increasing Access to Biosimilars Act of 2023- Sen. Cornyn, John - Medicare drug access Issues related to the implementation of Inflation Reduction Act - Medicare negotiation; coverage of weight loss drugs; high priced drugs; patent reforms; Pharmacy Benefit Managers; and copay coupons.

Client expense: $2,560,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), 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. 6684: Improving Efficiency to Increase Competition 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. 3569: Improving Efficiency to Increase Competition Act S. 3583: A bill to address patent thickets. - Provisions related to patents 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: $1,540,000 · Firm income: Not reported

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

S. 1133: 340B Accountability Act 340B Drug Discount Program - Program Implementation & Oversight H.R 2534 - PROTECT 340B Act 340B Drug Discount Program - RFI for SUSTAIN 340B Act H.R. 2408: Access to Innovative Treatments Act of 2023 HR. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) H.R. 2408: Access to Innovative Treatments Act of 2023 Accelerated Approval Alternative Funding Programs Drug Shortages 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 PBM Reform S. 2973: Modernizing and Ensuring PBM Accountability (MEPA) Act Alternative Payment Arrangements for Gene Therapies Coverage of Accelerated Approval Products Drug Benefit Design Value-Based Purchasing (VBP) Rule Orphan Drug Issues H.R. 5539/S. 3131: ORPHAN Cures Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 S. 1214: Retaining Access and Restoring Exclusivity (RARE) Act Implementation of the Inflation Reduction Act (IRA) of 2022 Reimbursement and Coverage of Innovative Products H.R. 830/S. 1375: HELP Copays Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2139/S. 909: Prescription Drug Price Relief Act H.R. 2630/S. 652: SAFE STEP Act H.R. 2666: Medicaid for VBPs for Patients (MVP) Act H.R. 4895: Lowering Drug Costs for American Families Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products National Coverage Determination Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications Value-Based Purchasing (VBP) Rule H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3285: Fairness for Patient Medications Act H.R. 3433: Give Kids a Chance Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 5376: Share the Savings with Seniors Act S. 476/H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 4953: Protect Drug Innovation Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval authority policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues

Client expense: $740,000 · Firm income: Not reported

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

H.R. 2139/S. 908: Medicare Drug Price Negotiation Act H.R. 2148/S. 909: Prescription Drug Price Negotiation Act S. 476/H.R. 5547: Maintaining Investments in New Innovation 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. 142: Preserve Access to Affordable Generics and Biosimilars Act PBM Reform Medicaid H.R. 2666: The Medicaid VBPs for Patients (MVP) Act Average Manufacturers Price Calculations Coverage of Accelerated Approval Products Drug Benefit Design Medicaid Drug Rebate Program Rule Pricing and Rebates Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products 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. 4895: Lowering Drug Costs, More Transparency Act CMMI Authority Implementation of the Inflation Reduction Act (IRA) In-Home Administration of Part B Drugs Lower Costs, More Cures Act National Coverage Determination Protected Classes Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-Based Purchasing (VBP) Rule H.R. 3421: Medicare for All Act Inflation Reduction Act of 2022 (P.L. 117-169) Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Value-based purchasing arrangements policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMS Guidance on the Medicare Drug Price Negotiation Program: Initial Memorandum CMS Medicare Drug Price Negotiation Revised Guidance S.1544/H.R. 1199: Facilitating Innovative Nuclear Diagnostics Act of 2023

Client expense: $740,000 · Firm income: Not reported

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

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

Client expense: $2,770,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

- S 150, "Affordable Prescriptions for Patients Act of 2023", regarding all provisions. - S 79/HR 1717, "Interagency Patent Coordination and Improvement Act of 2023", regarding all provisions. - Issues related to intellectual property.

Client expense: $2,340,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B Drug Discount Program ---H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S1133: 350B 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, SAFE 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 ---Reimbursement Cell & Gene Therapy Climate Change ---FY 2025 Appropriations 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 ---COVID-19 Lessons Learned ---FDA Hiring Flexibility 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 ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---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.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 Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---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 ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---S.4351: Enhanced Access to Affordable Medicines Act ---H.R 6973: Generic Drug Application Review Reforms ---Incentives for Generic Entry 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 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---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.4531/2933: SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---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 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) 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 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Client expense: $1,680,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), 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 ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---S1133: 350B Accountability Act ---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 ---American Pandemic Preparedness Plan (AP3) ---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 ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE 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 ---Biosimilar Copay ---BSUFA Negotiations ---Implementation of BSUFA Agreement ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change ---FY 2025 Appropriations 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. ---HR 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 & 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 ---COVID-19 Lessons Learned ---FDA Hiring Flexibility 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 and Patent Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---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.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547: 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.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---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 ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act 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 ---Regulatory Harmonization 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 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry 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 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/S.2933: SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---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 ---House GOP RFI on Supply Chain ---Implementation of the Prepare for and Respond to Existing Viruses ---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/S.4583: 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 ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---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 ---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 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---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 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Client expense: $1,680,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), 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

Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) Bayh-Dole Act/Tech Transfer ---S.1956 Invent Here, Make Here Act of 2023 (Baldwin) ---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 ---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: $1,680,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), 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

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, The 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. 7430, Protecting American Innovation Act 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 internet counterfeiting and piracy; 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; domain name system abuse; 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: $14,750,000 · 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

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. 6684: Improving Efficiency to Increase Competition 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. 3569: Improving Efficiency to Increase Competition Act S. 3583: A bill to address patent thickets. - Provisions related to patents 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: $6,880,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation and proposed amendments to the Inflation Reduction Act (P.L. 117-169); Innovation in Pediatric Drugs Act of 2023 (H.R. 6664); 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); Induced infringement and generic drug labeling; S.3583/H.R. 6986, A bill to address patent thickets; REMEDY Act (S. 1209); Medication Affordability and Patent Integrity Act (S.2780); rare pediatric disease priority review vouchers; Stop STALLING Act (S. 148); Interagency Patent Coordination and Improvement Act of 2023 (S. 79); Preserve Access to Affordable Generics and Biosimilars Act (S. 142); Bayh-Dole; Biosecure Act (H.R. 7085, H.R. 8333, S. 3385); and The Federal Acquisition Security Council Improvement Act (discussion draft).

Client expense: Not reported · Firm income: $290,000

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: $10,000 · 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

Issues related to intellectual property and patent reform, including: S. 150, Affordable Prescriptions for Patients Act; S. 79, Interagency Patent Coordination and Improvement Act; S. 113, Prescription Pricing for the People Act; S. 142, Preserve Access to Affordable Generics and Biosimilars Act; and S. 148, Stop STALLING Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to intellectual property and patent reform, including: S. 150, Affordable Prescriptions for Patients Act; S. 79, Interagency Patent Coordination and Improvement Act; S. 113, Prescription Pricing for the People Act; S. 142, Preserve Access to Affordable Generics and Biosimilars Act; and S. 148, Stop STALLING Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to intellectual property and patent reform, including: S. 150, Affordable Prescriptions for Patients Act; S. 79, Interagency Patent Coordination and Improvement Act; S. 113, Prescription Pricing for the People Act; S. 142, Preserve Access to Affordable Generics and Biosimilars Act; and S. 148, Stop STALLING Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to intellectual property and patent reform, including: S. 150, Affordable Prescriptions for Patients Act; S. 79, Interagency Patent Coordination and Improvement Act; S. 113, Prescription Pricing for the People Act; S. 142, Preserve Access to Affordable Generics and Biosimilars Act; and S. 148, Stop STALLING Act. Issues related to the National Institute of Standards and Technology request for public comment on a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to intellectual property and patent reform, including: S. 150, Affordable Prescriptions for Patients Act; S. 79, Interagency Patent Coordination and Improvement Act; S. 113, Prescription Pricing for the People Act; S. 142, Preserve Access to Affordable Generics and Biosimilars Act; and S. 148, Stop STALLING Act. Issues related to the National Institute of Standards and Technology request for public comment on a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE