Hatch-Waxman Integrity Act of 2019

Issues related Inter Partes Review (IPR) process for biosimilars and generic drugs S.344, H.R. 990 - Hatch-Waxman Integrity Act of 2019 Patent Settlements Patent Reform

Client expense: $550,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

H.R. 3, Lower Drug Costs Now Act of 2019 H.R. 19/S. 3129, Lower Costs, More Cures Act of 2019 H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 H.R. 448/S. 99, Medicare Drug Price Negotiation Act H.R. 748/ S. 3548, Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R. 1346, Medicare Buy-In and Health Care Stabilization Act of 2019 H.R. 1384, Medicare for All Act of 2019 H.R. 1398/S. 172, Health Insurance Tax Relief Act of 2019 H.R. 1425, Patient Protection and Affordable Care Enhancement Act H.R. 1865, Further Consolidated Appropriations Act, 2020 H.R. 1922/S. 1089, Restoring Access to Medication Act of 2019 H.R. 1985, Family Savings for Kids and Seniors Act H.R. 2207, Protect Medical Innovation Act of 2019 H.R. 3030, Patient-Centered Outcomes Research Extension Act of 2019 H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201, Families First Coronavirus Response Act H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act H.R. 7617, Defense, Commerce, Justice, Science, Energy and Water Development, Financial Services and General Government, Labor, Health and Human Services, Education, Transportation, Housing, and Urban Development Appropriations Act, 2021 S. 12, Health Savings Act of 2019 S. 61, Safe and Affordable Drugs from Canada Act of 2019 S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 S. 64, Preserve Access to Affordable Generics and Biosimilars Act S. 80, Jobs and Premium Protection Act, including provisions relating to repeal of the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act S. 178, UIGHUR Act of 2019, including provisions relating to substitute amendment regarding COVID-19 relief package S. 340, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 S. 344, Hatch-Waxman Integrity Act of 2019 S. 470, Medicare at 50 Act S. 684, Middle Class Health Benefits Tax Repeal Act of 2019 S. 692, Protect Medical Innovation Act of 2019 S. 1416, Affordable Prescriptions for Patients Act of 2019 S. 1541, Tobacco-Free Youth Act S. 1895, Lower Health Care Costs Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 S. 2897, Patient-Centered Outcomes Research Institute Reauthorization Act S. 3200, Chronic Disease Management Act of 2020 S. 3548, Coronavirus Aid, Relief, and Economic Security (CARES) Act S. 4317, Safeguarding Americas Frontline Employees To Offer Work Opportunities Required to Kickstart the Economy (SAFE TO WORK) Act Potential legislation similar to H.R. 2911/S. 1697, Small Business Healthcare Relief Act (114th Cong.) Proposed regulation on the Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2020 (84 Fed. Reg. 227-321, January 24, 2019) Proposed regulations on Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; interoperability and patient access for Medicare advantage organization and Medicaid managed care plans, state Medicaid agencies, CHIP agencies and CHIP managed care entities, issuers of qualified health plans in the federally-facilitated exchanges and health care providers; supplement and extension of comment period (84 Fed, Reg. 16,834, April 23, 2019) Proposed regulation on Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2021; notice requirement for non-federal governmental plans (85 Fed. Reg. 7,088-7,159, February 6, 2020) Various issues relating to Patient Protection and Affordable Care Act (P.L. 111-148) and the Health Care and Education Affordability Reconciliation Act of 2010 (P.L. 111-152), including the employer-sponsored health care system, implementation of regulatory process, delivery system reform, health savings account (HSAs), health reimbursement account (HRAs), and flexible spending account (FSAs) changes, medical malpractice reform, the impact on small business, section 1557 on nondiscrimination, incompleteness or inaccuracy of cost impact analysis, lack of quantified benefit analysis, and need for empirical data sources on which to base costs and benefits, protect Medicare Part Ds Non-Interference Clause from repeal, proposed rule regarding section 1557; Public Health Services Act (P.L.78-410), Internal Revenue Code and the Employee Retirement Income Security Act (ERISA) (P.L. 93-406), regarding regulatory process and legislative corrections to ERISA preemption, changes to Medicare Advantage and Parts B, C, and D, including rebates and non-interference with prescription drug prices, entitlement reform, health information technology, telemedicine services in Medicare, and coordination and disease management programs; association health plans; importation of foreign pharmaceuticals into the United States and preemptive authority of federal food and drug regulations; balance or surprise billing and related issues; single-payer health care options; health reimbursement arrangements and other account-based group health plans; Health and Human Services international pricing index (IPI) model; legislation addressing mental health parity; inclusion of prescription drug pricing on 2019 congressional agenda; reauthorization of the Patient Centered Outcomes Research Institute (PCORI); potential premium reduction/reinsurance program to reduce health insurance premiums; proposals to expand Medicare including Medicare Buy-In and the development of a public option; Medicare hospital outpatient prospective payment system for CY 2020; drug pricing including most-favored nations proposals, international pricing index, importation and mandatory rebates; potential healthcare pricing proposals, including a medicaid rebate cap, spread pricing, and inflation penalty; comments on Medicare and State Healthcare Programs: fraud and abuse; revisions to safe harbors under the anti-kickback statute, and civil monetary penalty rules regarding beneficiary inducements; comments on Medicare Program; modernizing and clarifying the physician self-referral regulations; comments on CMS proposed Medicaid fiscal accountability regulation; comments on CMS proposed transparency in coverage rule; comments to the U.S. Department of Health and Human Services on the declaration under the Public Readiness and Emergency Preparedness (PREP) Act for medical countermeasures against COVID-19, as amended on April 10, 2020 and June 8, 2020 (Declaration), Section 319F-3 of the Public Health Service (PHS) Act (42 U.S.C. 247d-6d); comments to the U.S. Department of Health and Human Services on CMS-2393-P: Medicaid Program; Medicaid fiscal accountability regulation; comments to the U.S. Department of Health and Human Services on the Administrations proposed rule to eliminate drug manufacturer rebates in Part D; transparency in coverage; issues relating to the coronavirus pandemic, including testing, liability protection, and temporary COBRA subsidies; Public Health and Social Services Emergency Fund (PHSSEF); health insurance coverage during the coronavirus pandemic; health legislative priorities for the potential Phase 4 coronavirus relief package; provisions relating to Health Savings Accounts (HSA) and Flexible Spending Arrangements (FSA) in the Coronavirus, Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136); FCCs COVID-19 Telehealth Program; Federal Emergency Management Agencys (FEMA) temporary rule regarding Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use; distribution of COVID-19 vaccines; comments on notice of proposed rulemaking: securing updated and necessary statutory evaluations timely (SUNSET); reform of the World Health Organization (WHO); continued U.S. membership in the World Health Organization; COVID-19 liability issues; Phase IV COVID-19 relief legislation and civil liability issues affecting the business community

Client expense: $22,290,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Bureau of Citizenship & Immigration Services (BCIS), Bureau of Industry and Security (BIS), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Financial Protection Bureau (CFPB), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Emergency Management Agency (FEMA), Federal Energy Regulatory Commission (FERC), Federal Reserve System, Federal Trade Commission (FTC), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Natl Telecommunications & Information Administration (NTIA), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

Legislation and proposals related to the COVID-19 crisis; HR 3199-Terminating the Extension of Rights Misappropriated Act of 2019; S.64-Preserve Access to Affordable Generic & Biosimilars Act; HR 1499-Protecting Consumer Access to Generic Drugs Act; HR 1344-Competitive Drugs Act of 2019; HR 938-Bringing Low Cost Options & Competition While Keeping Incentives for New Generics Act ("BLOCKING Act"); HR 1506-Fair & Immediate Release of Generic Drugs Act; HR 1520-Purple Book Continuity Act; HR 1503-Orange Book Transparency Act; S.344/HR 990-Hatch-Waxman Integrity Act; Stronger Patents Act; S.1895-Lower Health Care Costs Act; S. 2543-Prescription Drug Pricing Reduction Act; HR 3-Elijah E Cummings Lower Drug Costs Now Act; Administration review of drug pricing policies; Proposals to improve pharmaceutical supply-chain vlunterabilities; HR 4597-Acting to Cancel Copays & Ensure Substantial Savings for Biosimilars (ACCESS) Act; HR 4455-Bolstering Innovative Options to Save Immediately on Medicines (BIOSIMS) Act; HR 6179-Lowering Costs for Taxpayers & Medicare Seniors with Biosimilars; HR 4629-Star Ratings for Biosimilars Act.

Client expense: $610,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), SENATE, White House Office

S. 3952, the Protecting American Intellectual Property Act of 2020 H.R. 6058, the SHOP SAFE Act H.R. 6196/ S. 3449, the Trademark Modernization Act H.R. 8037, the Advancing America's Interests Act S. 4473/H.R. 7956, Critical Medical Infrastructure Right-to-Repair Act of 2020 S. 4138/H.R. 7448, Telework for U.S. Innovation Act S. 2987, the Counterfeit Goods Seizure Act of 2019 H.R. 5478, the Inventor Rights Act S. 2082/H.R. 3666, the STRONGER Patents Act of 2019 H.R. 4164/S. 2439, the Trademark Licensing Protection Act of 2019 S. 4394/H.R. 7890, the Inventor Diversity for Economic Advancement (IDEA) Act of 2020 S. 2281/H.R. 4075, the Inventor Diversity for Economic Advancement (IDEA) Act of 2019 H.R. 3954. Including the exclusive economic zone as part of the United States for patent infringement H.R. 3991, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 H.R. 3199, Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 S. 1416, Affordable Prescriptions for Patients Act of 2019 H.R. 2426/S. 1272, the CASE Act H.R. 1999/S. 963, the Fair Licensing Access for Governments (FLAG) Act of 2019 (entire bill) S. 376 /H.R. 1683, No Stolen Trademarks Honored in America Act (entire bill) S. 659, A bill to provide for certain additional requirements with respect to patent disclosures. (entire bill) S. 440, Preserving Access to Cost Effective Drugs Act (PACED) Act (entire bill) S. 344/H.R. 990, Hatch-Waxman Integrity Act of 2019 (entire bill) H.R. 108, Targeting Rogue and Opaque Letters Act of 2019 (entire bill) S. 64, Preserve Access to Affordable Generics and Biosimilars Act (entire bill) H.R.902, Protect American IPR Act (entire bill) Issues related to USPTO operations Legislative proposal on patent subject matter eligibility Issues related to Covered Business Method Patent Pilot Program Issues related to Copyright Office Modernization Issues related to sovereign immunity Issues related to the review of the Digital Millennium Copyright Act (DMCA)

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)

H.R. 990 and S. 344, the Hatch-Waxman Integrity Act; S. 1416, Affordable Prescriptions for Patients Act of 2019: H.R. 3991, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; H.R. 4398, Affordable Prescriptions for Patients Through Promoting Competition Act of 2019; Senate amendment to H.R. 2486

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

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

H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 985, Fair Access for Safe and Timely (FAST) Generics Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 986, Protecting American with Preexisting Conditions Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 987, Marketing and Outreach Restoration to Empower Health Education Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1010, Short-Term, Limited Duration Insurance (STLDI), regarding all bio-pharmaceutical related provisions. H.R. 1323, Rural Hospital Frontier Fairness Act, regarding all bio-pharmaceutical related provisions. H.R. 1385, State Allowance for a Variety of Exchanges (SAVE) Act, regarding all bio-pharmaceutical related provisions. H.R. 1386, Expanded Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act, regarding all bio-pharmaceutical related provisions. H.R. 1409, Transparency in All Health Care Pricing Act, regarding all bio-pharmaceutical related provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions. H.R. 1478, Insulin importation, regarding all bio-pharmaceutical related provisions. H.R. 1503, Orange Book Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1506, Fair and Immediate Release (FAIR) of Generics Act, regarding all bio-pharmaceutical related provisions. H.R. 1520, Purple Book Continuity Act, regarding all bio-pharmaceutical related provisions. H.R. 2011, Protecting Access to Biosimilars Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2038, State-based , Market-Oriented, Prescription Drug Negotiations Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2064, Product Sample reporting, regarding all bio-pharmaceutical related provisions. S. 61, Safe and Affordable Drugs from Canada Act, regarding all bio-pharmaceutical related provisions. S. 97, Affordable and Safe Drug Importation Act, regarding all bio-pharmaceutical related provisions. S. 102, Prescription Drug Price Relief Act, regarding all bio-pharmaceutical related provisions. S. 344/H.R. 990, Hatch-Waxman Integrity Act, regarding all bio-pharmaceutical related provisions. S. 366/H.R. 1188, FLAT Prices Act- Reduced exclusivity period for certain price hikes, regarding all bio-pharmaceutical related provisions. S. 418, FDA Accountability for Public Safety Act, regarding all bio-pharmaceutical related provisions. S. 419, Protecting Americans from Dangerous Opioids Act, regarding all bio-pharmaceutical related provisions. S. 637, CURE High Drug Prices Act, regarding all bio-pharmaceutical related provisions. S. 657, Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. S. 658, Accelerated Drug Approval for Prescription Therapies Act, regarding all bio-pharmaceutical related provisions. S. 659, Biologic Patent Transparency Act, regarding all bio-pharmaceutical related provisions. S. 660, Transparency in Petitions Act, regarding all bio-pharmaceutical related provisions. S. 709, Establishes public dashboard for price and utilization of drugs purchased by federal programs, regarding all bio-pharmaceutical related provisions. S. 741 /H.R. 1730, Cancer Drug Parity Act, regarding all bio-pharmaceutical related provisions. S. 844, Short Competition Act, regarding all bio-pharmaceutical related provisions. S. 977, Transparent Drug Pricing Act of 2019, regarding all bio-pharmaceutical related provisions. S. 989, STEER Act, regarding all bio-pharmaceutical related provisions. S. 1140, A bill to amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009, regarding all bio-pharmaceutical related provisions. S.1169, FDA citizen petition, regarding all bio-pharmaceutical related provisions. S. 1209, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications, regarding all bio-pharmaceutical related provisions. H.R. 2115, Public Disclosure of Drug Discounts Act, regarding all bio-pharmaceutical related provisions H.R.2296/S.1391, FAIR Drug Pricing Act, regarding all bio-pharmaceutical related provisions H.R.2700, Lowering Prescription Drug Costs and Extending Community Health Centers and other Health Priorities Act, regarding all bio-pharmaceutical related provisions H.R. 3223, Pharmacy Benefit Manager Accountability Study Act, regarding all bio-pharmaceutical related provisions S. 1361/H.R.2584, Preventive Health Savings Act, regarding all bio-pharmaceutical related provisions S. 1437, DTC Act, regarding all bio-pharmaceutical related provisions S.1532, Pharmacy Benefit Managers Accountability Study Act, regarding all bio-pharmaceutical related provisions S.1636, Ensuring Innovation Act, regarding all bio-pharmaceutical related provisions S. 1664, Prescription Drug Price Reporting Act, regarding all bio-pharmaceutical related provisions S. 1801, Affordable Medications Act, regarding all bio-pharmaceutical related provisions S. 1895, Lowering Health Costs Act, regarding all bio-pharmaceutical related provisions S. 1897, a bill to establish a process for updating the labeling of certain drugs with outdated labeling, regarding all bio-pharmaceutical related provisions S. 1897/H.R. 3523, End Price Gouging for Medications Act, regarding all bio-pharmaceutical related provisions S. 2004, Emergency Access to Insulin Act, regarding all bio-pharmaceutical related provisions H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions H.R 748/S. 3548, Coronavirus Aid, Relief and Economic Security Act (CARES Act), regarding all bio-pharmaceutical provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, regarding all bio-pharmaceutical related provisions

Client expense: $1,090,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

H.R. 3, Lower Drug Costs Now Act of 2019 H.R. 19/S. 3129, Lower Costs, More Cures Act of 2019 H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 H.R. 448/S. 99, Medicare Drug Price Negotiation Act H.R. 748/ S. 3548, Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R. 1346, Medicare Buy-In and Health Care Stabilization Act of 2019 H.R. 1384, Medicare for All Act of 2019 H.R. 1398/S. 172, Health Insurance Tax Relief Act of 2019 H.R. 1425, Patient Protection and Affordable Care Enhancement Act H.R. 1865, Further Consolidated Appropriations Act, 2020 H.R. 1922/S. 1089, Restoring Access to Medication Act of 2019 H.R. 1985, Family Savings for Kids and Seniors Act H.R. 2207, Protect Medical Innovation Act of 2019 H.R. 3030, Patient-Centered Outcomes Research Extension Act of 2019 H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201, Families First Coronavirus Response Act H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act H.R. 7617, Defense, Commerce, Justice, Science, Energy and Water Development, Financial Services and General Government, Labor, Health and Human Services, Education, Transportation, Housing, and Urban Development Appropriations Act, 2021 S. 12, Health Savings Act of 2019 S. 61, Safe and Affordable Drugs from Canada Act of 2019 S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 S. 64, Preserve Access to Affordable Generics and Biosimilars Act S. 80, Jobs and Premium Protection Act, including provisions relating to repeal of the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act S. 178, UIGHUR Act of 2019, including provisions relating to substitute amendment regarding COVID-19 relief package S. 340, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 S. 344, Hatch-Waxman Integrity Act of 2019 S. 470, Medicare at 50 Act S. 684, Middle Class Health Benefits Tax Repeal Act of 2019 S. 692, Protect Medical Innovation Act of 2019 S. 1416, Affordable Prescriptions for Patients Act of 2019 S. 1541, Tobacco-Free Youth Act S. 1895, Lower Health Care Costs Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 S. 2897, Patient-Centered Outcomes Research Institute Reauthorization Act S. 3200, Chronic Disease Management Act of 2020 S. 4317, Safeguarding Americas Frontline Employees To Offer Work Opportunities Required to Kickstart the Economy (SAFE TO WORK) Act Potential legislation similar to H.R. 2911/S. 1697, Small Business Healthcare Relief Act (114th Cong.) Proposed regulation on the Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2020 (84 Fed. Reg. 227-321, January 24, 2019) Proposed regulations on Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; interoperability and patient access for Medicare advantage organization and Medicaid managed care plans, state Medicaid agencies, CHIP agencies and CHIP managed care entities, issuers of qualified health plans in the federally-facilitated exchanges and health care providers; supplement and extension of comment period (84 Fed, Reg. 16,834, April 23, 2019) Proposed regulation on Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2021; notice requirement for non-federal governmental plans (85 Fed. Reg. 7,088-7,159, February 6, 2020) Various issues relating to Patient Protection and Affordable Care Act (P.L. 111-148) and the Health Care and Education Affordability Reconciliation Act of 2010 (P.L. 111-152), including the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, delivery system reform, health savings account (HSAs), health reimbursement account (HRAs), and flexible spending account (FSAs) changes, IPAB, employer mandate, reporting requirements for issuers and applicable large employers, premium stabilization programs, medical loss ratio, medical malpractice reform, exchanges, the impact on small business, the Small Business Tax Credit, section 1332 waivers, section 1557 on nondiscrimination, caps on compensation deductibility required under section 9014, incompleteness or inaccuracy of cost impact analysis, lack of quantified benefit analysis, and need for empirical data sources on which to base costs and benefits, the Cost Sharing Reduction (CSR) program, the section 9010 Health Insurance Providers Fee or Health Insurance Tax (HIT), 40% excise tax on high-cost employer-sponsored health coverage (Cadillac tax); medical device tax; protect Medicare Part Ds Non-Interference Clause from repeal, proposed rule regarding section 1557; Public Health Services Act (P.L.78-410), Internal Revenue Code and the Employee Retirement Income Security Act (ERISA) (P.L. 93-406), regarding regulatory process and legislative corrections to ERISA preemption, changes to Medicare Advantage and Parts B, C, and D, including rebates and non-interference with prescription drug prices, entitlement reform, health information technology, telemedicine services in Medicare, and coordination and disease management programs; association health plans; importation of foreign pharmaceuticals into the United States and preemptive authority of federal food and drug regulations; balance or surprise billing and related issues; single-payer health care options; health reimbursement arrangements and other account-based group health plans; Health and Human Services international pricing index (IPI) model; legislation addressing mental health parity; inclusion of prescription drug pricing on 2019 congressional agenda; reauthorization of the Patient Centered Outcomes Research Institute; (PCORI); potential premium reduction/reinsurance program to reduce health insurance premiums; proposals to expand Medicare including Medicare Buy-In and the development of a public option; medical hospital outpatient prospective payment system for CY 2020; drug pricing including most-favored nations proposals, international pricing index, importation and mandatory rebates; potential healthcare pricing proposals, including a medicaid rebate cap, spread pricing, and inflation penalty; comments on Medicare and State Healthcare Programs: fraud and abuse; revisions to safe harbors under the anti-kickback statute, and civil monetary penalty rules regarding beneficiary inducements; comments on Medicare Program; modernizing and clarifying the physician self-referral regulations; comments on CMS proposed Medicaid fiscal accountability regulation; comments on CMS proposed transparency in coverage rule; comments to the U.S. Department of Health and Human Services on the declaration under the Public Readiness and Emergency Preparedness (PREP) Act for medical countermeasures against COVID-19, as amended on April 10, 2020 and June 8, 2020 (Declaration), Section 319F-3 of the Public Health Service (PHS) Act (42 U.S.C. 247d-6d); comments to the U.S. Department of Health and Human Services on CMS-2393-P: Medicaid Program; Medicaid fiscal accountability regulation; comments to the U.S. Department of Health and Human Services on the Administrations proposed rule to eliminate drug manufacturer rebates in Part D; transparency in coverage; issues relating to the coronavirus pandemic, including testing, liability protection, and temporary COBRA subsidies; Public Health and Social Services Emergency Fund (PHSSEF); health insurance coverage during the coronavirus pandemic; health legislative priorities for the potential Phase 4 coronavirus relief package; provisions relating to Health Savings Accounts (HSA) and Flexible Spending Arrangements (FSA) in the Coronavirus, Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136); FCCs COVID-19 Telehealth Program; Federal Emergency Management Agencys (FEMA) temporary rule regarding Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use; reform of the World Health Organization (WHO); continued U.S. membership in the World Health Organization Public Readiness and Emergency Preparedness Act (P.L. 109-148, Division C), and COVID -19; potential legislation dealing with COVID-19 liability issues

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

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Bureau of Citizenship & Immigration Services (BCIS), Bureau of Industry and Security (BIS), Bureau of Reclamation, Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Financial Protection Bureau (CFPB), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Emergency Management Agency (FEMA), Federal Energy Regulatory Commission (FERC), Federal Motor Carrier Safety Administration, Federal Reserve System, Federal Trade Commission (FTC), General Services Administration (GSA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Natl Telecommunications & Information Administration (NTIA), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

Promoting awareness of the biopharmaceutical and medical technology sectors. Opposing the imposition of price controls in the Medicare Part D program. Generally supporting intellectual property rights. Supporting changes to Medicare Part D's coverage gap liability assignment and out-of-pocket cliff. Supporting changes to the America Invents Act to prevent double jeopardy of patent challenges under the inter partes review process. Supporting the Hatch Waxman Integrity Act (HR 990, S344). Opposing the Medicare Negotiations and Competitive Pricing Act (HR 1046). Generally supporting the proposed CMS Safe Harbor rule. Opposing H.R. 3 legislation regarding health care costs Opposing the FDA's Proposed Rule regarding the importation of prescription drugs (Docket No. FDA-2019-N-5711) Supporting H.R. 5741, the "Strengthening Innovation in Medicare and Medicaid Act Supporting the CMS Notice of Benefit and Payment Parameters (NBPP) Proposed Rule (CMS-9944-P) Opposing a proposed White House Executive Order concerning the Buy America Act Opposing various legislative efforts to relocate supply and logistics chains Opposing various legislative and executive efforts to impose an international price index Supporting the SMART Act (S. 3752 and H.R. 6954) Supporting the DISARM Act (S. 1712 and H.R. 4100)

Client expense: $40,847 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 2082/H.R. 3666 (STRONGER Patents Act) Trade-related intellectual property policy/practices/encroachment by foreign countries/companies against U.S. competitiveness interests - China, Committee on Foreign Investment in the United States review of Chinese acquisitions and joint ventures, United States-Mexico-Canada Agreement IP chapter, International Trade Commission exclusion of U.S. patent-infringing imports, ITC baseband chip set patent infringement remedy, intellectual property exclusivity and protections in trade agreements Piracy of online and streaming copyrighted content Compulsory licensing - S. 377/H.R. 1046 (Medicare Negotiation and Competitive Licensing Act), S. 102/H.R. 465 (Prescription Drug Price Relief Act), S. 977 (Transparent Drug Pricing Act) NIST Return on Investment Initiative for Unleashing American Innovation S. 344/H.R. 990 (Hatch-Waxman Integrity Act) FTC/patent licensing as exclusive property right Bayh-Dole Act/technology transfer, misuse of march-in rights Procedural and evidentiary standards used at Patent Trial and Appeal Board PTO patentable subject matter eligibility guidance Section 101 patentable subject matter reform Injunctive relief from willful infringement DOJ-DOC withdrawal of 2013 Policy Statement on Remedies for Standards-Essential Patents Subject to Voluntary F/RAND Commitments S. 1273/H.R. 2426 (Copyright Alternative in Small-Claims Enforcement (CASE) Act) S. 1416 (Affordable Prescriptions for Patients Act) Obviousness/No Combination Drug Patents Act H.R. 4398/H.R. 5133 (Affordable Prescriptions for Patients Through Promoting Competition Act) H.R. 3991 (Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act) H.R. 5478 (Inventor Rights Act) Patent licensing/standards-essential patents/U.S. technological leadership in 5G and other technologies/economic and national security implications DOJ-PTO-NIST 2019 revised Joint Statement on Remedies for Standards-Essential Patents Subject to Voluntary F/RAND Commitments Efficient infringement Digital Millennium Copyright Act modernization Patent Trial & Appeal Board Covered Business Methods program PTAB Rules of Practice for Instituting on All Challenged Patent Claims and All Grounds and Eliminating the Presumption at Institution Favoring Petitioner as to Testimonial Evidence (Docket No. PTO-P-2019-0024) S. 3630 (Facilitating Innovation to Fight Coronavirus Act) Denial of rights of exclusivity for COVID-19-related innovations H.R. 7366 (Restoring Americas Leadership in Innovation Act) S. 3835 (SCRIPT Act) Proposed policy requiring privately produced, privately funded, copyrighted, peer-reviewed journal articles be given away free upon publication if they discuss any underlying research supported by a government grant Patent Trial and Appeal Board Covered Business Methods program statutory expiration Appointments Clause and the constitutionality of AdministrativePatent Judges invalidation of patents Amendments to the Rules of Practice for Trials Before the Patent Trial and Appeal Board (RIN:0651-AD47) Discretion to Institute Trials Before the Patent Trial and Appeal Board (Docket No. PTO-C-2020-0055) H.R. 133 (Consolidated Appropriations Act FY 2021 provisions related to Patent & Trademark Office, CASE Act, and copyright infringement via streaming loophole reform)

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE

H.R. 3, Lower Drug Costs Now Act of 2019 H.R. 19/S. 3129, Lower Costs, More Cures Act of 2019 H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 H.R. 448/S. 99, Medicare Drug Price Negotiation Act H.R. 748/ S. 3548, Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R. 1346, Medicare Buy-In and Health Care Stabilization Act of 2019 H.R. 1384, Medicare for All Act of 2019 H.R. 1398/S. 172, Health Insurance Tax Relief Act of 2019 H.R. 1425, Patient Protection and Affordable Care Enhancement Act H.R. 1865, Further Consolidated Appropriations Act, 2020 H.R. 1922/S. 1089, Restoring Access to Medication Act of 2019 H.R. 1985, Family Savings for Kids and Seniors Act H.R. 2207, Protect Medical Innovation Act of 2019 H.R. 3030, Patient-Centered Outcomes Research Extension Act of 2019 H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201, Families First Coronavirus Response Act H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act H.R. 7617, Defense, Commerce, Justice, Science, Energy and Water Development, Financial Services and General Government, Labor, Health and Human Services, Education, Transportation, Housing, and Urban Development Appropriations Act, 2021 S. 12, Health Savings Act of 2019 S. 61, Safe and Affordable Drugs from Canada Act of 2019 S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 S. 64, Preserve Access to Affordable Generics and Biosimilars Act S. 80, Jobs and Premium Protection Act, including provisions relating to repeal of the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act S. 178, UIGHUR Act of 2019, including provisions relating to substitute amendment regarding COVID-19 relief package S. 340, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 S. 344, Hatch-Waxman Integrity Act of 2019 S. 470, Medicare at 50 Act S. 684, Middle Class Health Benefits Tax Repeal Act of 2019 S. 692, Protect Medical Innovation Act of 2019 S. 1416, Affordable Prescriptions for Patients Act of 2019 S. 1541, Tobacco-Free Youth Act S. 1895, Lower Health Care Costs Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 S. 2897, Patient-Centered Outcomes Research Institute Reauthorization Act S. 3200, Chronic Disease Management Act of 2020 S. 4317, Safeguarding Americas Frontline Employees To Offer Work Opportunities Required to Kickstart the Economy (SAFE TO WORK) Act Potential legislation similar to H.R. 2911/S. 1697, Small Business Healthcare Relief Act (114th Cong.) Proposed regulation on the Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2020 (84 Fed. Reg. 227-321, January 24, 2019) Proposed regulations on Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; interoperability and patient access for Medicare advantage organization and Medicaid managed care plans, state Medicaid agencies, CHIP agencies and CHIP managed care entities, issuers of qualified health plans in the federally-facilitated exchanges and health care providers; supplement and extension of comment period (84 Fed, Reg. 16,834, April 23, 2019) Proposed regulation on Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2021; notice requirement for non-federal governmental plans (85 Fed. Reg. 7,088-7,159, February 6, 2020) Various issues relating to Patient Protection and Affordable Care Act (P.L. 111-148) and the Health Care and Education Affordability Reconciliation Act of 2010 (P.L. 111-152), including the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, delivery system reform, health savings account (HSAs), health reimbursement account (HRAs), and flexible spending account (FSAs) changes, IPAB, employer mandate, reporting requirements for issuers and applicable large employers, premium stabilization programs, medical loss ratio, medical malpractice reform, exchanges, the impact on small business, the Small Business Tax Credit, section 1332 waivers, section 1557 on nondiscrimination, caps on compensation deductibility required under section 9014, incompleteness or inaccuracy of cost impact analysis, lack of quantified benefit analysis, and need for empirical data sources on which to base costs and benefits, the Cost Sharing Reduction (CSR) program, the section 9010 Health Insurance Providers Fee or Health Insurance Tax (HIT), 40% excise tax on high-cost employer-sponsored health coverage (Cadillac tax); medical device tax; protect Medicare Part Ds Non-Interference Clause from repeal, proposed rule regarding section 1557; Public Health Services Act (P.L.78-410), Internal Revenue Code and the Employee Retirement Income Security Act (ERISA) (P.L. 93-406), regarding regulatory process and legislative corrections to ERISA preemption, changes to Medicare Advantage and Parts B, C, and D, including rebates and non-interference with prescription drug prices, entitlement reform, health information technology, telemedicine services in Medicare, and coordination and disease management programs; association health plans; importation of foreign pharmaceuticals into the United States and preemptive authority of federal food and drug regulations; balance or surprise billing and related issues; single-payer health care options; health reimbursement arrangements and other account-based group health plans; Health and Human Services international pricing index (IPI) model; legislation addressing mental health parity; inclusion of prescription drug pricing on 2019 congressional agenda; reauthorization of the Patient Centered Outcomes Research Institute; (PCORI); potential premium reduction/reinsurance program to reduce health insurance premiums; proposals to expand Medicare including Medicare Buy-In and the development of a public option; medical hospital outpatient prospective payment system for CY 2020; drug pricing including most-favored nations proposals, international pricing index, importation and mandatory rebates; potential healthcare pricing proposals, including a medicaid rebate cap, spread pricing, and inflation penalty; comments on Medicare and State Healthcare Programs: fraud and abuse; revisions to safe harbors under the anti-kickback statute, and civil monetary penalty rules regarding beneficiary inducements; comments on Medicare Program; modernizing and clarifying the physician self-referral regulations; comments on CMS proposed Medicaid fiscal accountability regulation; comments on CMS proposed transparency in coverage rule; comments to the U.S. Department of Health and Human Services on the declaration under the Public Readiness and Emergency Preparedness (PREP) Act for medical countermeasures against COVID-19, as amended on April 10, 2020 and June 8, 2020 (Declaration), Section 319F-3 of the Public Health Service (PHS) Act (42 U.S.C. 247d-6d); comments to the U.S. Department of Health and Human Services on CMS-2393-P: Medicaid Program; Medicaid fiscal accountability regulation; comments to the U.S. Department of Health and Human Services on the Administrations proposed rule to eliminate drug manufacturer rebates in Part D; transparency in coverage; issues relating to the coronavirus pandemic, including testing, liability protection, and temporary COBRA subsidies; Public Health and Social Services Emergency Fund (PHSSEF); health insurance coverage during the coronavirus pandemic; health legislative priorities for the potential Phase 4 coronavirus relief package; provisions relating to Health Savings Accounts (HSA) and Flexible Spending Arrangements (FSA) in the Coronavirus, Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136); FCCs COVID-19 Telehealth Program; Federal Emergency Management Agencys (FEMA) temporary rule regarding Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use; reform of the World Health Organization (WHO); continued U.S. membership in the World Health Organization Public Readiness and Emergency Preparedness Act (P.L. 109-148, Division C), and COVID -19; potential legislation dealing with COVID-19 liability issues

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

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Bureau of Citizenship & Immigration Services (BCIS), Bureau of Industry and Security (BIS), Bureau of Reclamation, Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Financial Protection Bureau (CFPB), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Emergency Management Agency (FEMA), Federal Energy Regulatory Commission (FERC), Federal Motor Carrier Safety Administration, Federal Reserve System, Federal Trade Commission (FTC), General Services Administration (GSA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Natl Telecommunications & Information Administration (NTIA), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

Issues related Inter Partes Review (IPR) process for biosimilars and generic drugs S.344, H.R. 990 - Hatch-Waxman Integrity Act of 2019 Patent Settlements

Client expense: $590,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

H.R. 990 and S. 344, the Hatch-Waxman Integrity Act; S. 1416, Affordable Prescriptions for Patients Act of 2019: H.R. 3991, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; H.R. 4398, Affordable Prescriptions for Patients Through Promoting Competition Act of 2019; Senate amendment to H.R. 2486

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

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

Issues related to drug pricing; S. 64, Preserve Access to Affordable Generics and Biosimilars Act; H.R. 938, BLOCKING Act of 2019 and HR 1506, FAIR Generics Act; Hatch-Waxman Integrity Act of 2019, H.R. 990 and S. 344; S. 1416, Affordable Prescriptions for Patients Act of 2019; issues related to the pharmaceutical supply chain; and issues related to FDA Abbreviated New Drug Application reviews of complex generics.

Client expense: Not reported · Firm income: $70,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6058, the SHOP SAFE Act H.R. 6196/ S. 3449, the Trademark Modernization Act H.R. 8037, the Advancing America's Interests Act S. 4473/H.R. 7956, Critical Medical Infrastructure Right-to-Repair Act of 2020 S. 4138/H.R. 7448, Telework for U.S. Innovation Act S. 2987, the Counterfeit Goods Seizure Act of 2019 H.R. 5478, the Inventor Rights Act S. 2082/H.R. 3666, the STRONGER Patents Act of 2019 H.R. 4164/S. 2439, the Trademark Licensing Protection Act of 2019 S. 4394/H.R. 7890, the Inventor Diversity for Economic Advancement (IDEA) Act of 2020 S. 2281/H.R. 4075, the Inventor Diversity for Economic Advancement (IDEA) Act of 2019 H.R. 3954. Including the exclusive economic zone as part of the United States for patent infringement H.R. 3991, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 H.R. 3199, Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 S. 1416, Affordable Prescriptions for Patients Act of 2019 H.R. 2426/S. 1272, the CASE Act H.R. 1999/S. 963, the Fair Licensing Access for Governments (FLAG) Act of 2019 (entire bill) S. 376 /H.R. 1683, No Stolen Trademarks Honored in America Act (entire bill) S. 659, A bill to provide for certain additional requirements with respect to patent disclosures. (entire bill) S. 440, Preserving Access to Cost Effective Drugs Act (PACED) Act (entire bill) S. 344/H.R. 990, Hatch-Waxman Integrity Act of 2019 (entire bill) H.R. 108, Targeting Rogue and Opaque Letters Act of 2019 (entire bill) S. 64, Preserve Access to Affordable Generics and Biosimilars Act (entire bill) H.R.902, Protect American IPR Act (entire bill) Issues related to USPTO operations Legislative proposal on patent subject matter eligibility Issues related to Covered Business Method Patent Pilot Program Issues related to Copyright Office Modernization Issues related to sovereign immunity Issues related to the review of the Digital Millennium Copyright Act (DMCA)

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)

H.R. 3, Lower Drug Costs Now Act of 2019 H.R. 19/S. 3129, Lower Costs, More Cures Act of 2019 H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 H.R. 448/S. 99, Medicare Drug Price Negotiation Act H.R. 748/ S. 3548, Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R. 1346, Medicare Buy-In and Health Care Stabilization Act of 2019 H.R. 1384, Medicare for All Act of 2019 H.R. 1398/S. 172, Health Insurance Tax Relief Act of 2019 H.R. 1425, Patient Protection and Affordable Care Enhancement Act H.R. 1865, Further Consolidated Appropriations Act, 2020 H.R. 1922/S. 1089, Restoring Access to Medication Act of 2019 H.R. 1985, Family Savings for Kids and Seniors Act H.R. 2207, Protect Medical Innovation Act of 2019 H.R. 3030, Patient-Centered Outcomes Research Extension Act of 2019 H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201, Families First Coronavirus Response Act H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act H.R. 7617, Defense, Commerce, Justice, Science, Energy and Water Development, Financial Services and General Government, Labor, Health and Human Services, Education, Transportation, Housing, and Urban Development Appropriations Act, 2021 S. 12, Health Savings Act of 2019 S. 61, Safe and Affordable Drugs from Canada Act of 2019 S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 S. 64, Preserve Access to Affordable Generics and Biosimilars Act S. 80, Jobs and Premium Protection Act, including provisions relating to repeal of the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act S. 178, UIGHUR Act of 2019, including provisions relating to substitute amendment regarding COVID-19 relief package S. 340, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 S. 344, Hatch-Waxman Integrity Act of 2019 S. 470, Medicare at 50 Act S. 684, Middle Class Health Benefits Tax Repeal Act of 2019 S. 692, Protect Medical Innovation Act of 2019 S. 1416, Affordable Prescriptions for Patients Act of 2019 S. 1541, Tobacco-Free Youth Act S. 1895, Lower Health Care Costs Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 S. 2897, Patient-Centered Outcomes Research Institute Reauthorization Act S. 3200, Chronic Disease Management Act of 2020 S. 4317, Safeguarding Americas Frontline Employees To Offer Work Opportunities Required to Kickstart the Economy (SAFE TO WORK) Act Potential legislation similar to H.R. 2911/S. 1697, Small Business Healthcare Relief Act (114th Cong.) Proposed regulation on the Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2020 (84 Fed. Reg. 227-321, January 24, 2019) Proposed regulations on Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; interoperability and patient access for Medicare advantage organization and Medicaid managed care plans, state Medicaid agencies, CHIP agencies and CHIP managed care entities, issuers of qualified health plans in the federally-facilitated exchanges and health care providers; supplement and extension of comment period (84 Fed, Reg. 16,834, April 23, 2019) Proposed regulation on Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2021; notice requirement for non-federal governmental plans (85 Fed. Reg. 7,088-7,159, February 6, 2020) Various issues relating to Patient Protection and Affordable Care Act (P.L. 111-148) and the Health Care and Education Affordability Reconciliation Act of 2010 (P.L. 111-152), including the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, delivery system reform, health savings account (HSAs), health reimbursement account (HRAs), and flexible spending account (FSAs) changes, IPAB, employer mandate, reporting requirements for issuers and applicable large employers, premium stabilization programs, medical loss ratio, medical malpractice reform, exchanges, the impact on small business, the Small Business Tax Credit, section 1332 waivers, section 1557 on nondiscrimination, caps on compensation deductibility required under section 9014, incompleteness or inaccuracy of cost impact analysis, lack of quantified benefit analysis, and need for empirical data sources on which to base costs and benefits, the Cost Sharing Reduction (CSR) program, the section 9010 Health Insurance Providers Fee or Health Insurance Tax (HIT), 40% excise tax on high-cost employer-sponsored health coverage (Cadillac tax); medical device tax; protect Medicare Part Ds Non-Interference Clause from repeal, proposed rule regarding section 1557; Public Health Services Act (P.L.78-410), Internal Revenue Code and the Employee Retirement Income Security Act (ERISA) (P.L. 93-406), regarding regulatory process and legislative corrections to ERISA preemption, changes to Medicare Advantage and Parts B, C, and D, including rebates and non-interference with prescription drug prices, entitlement reform, health information technology, telemedicine services in Medicare, and coordination and disease management programs; association health plans; importation of foreign pharmaceuticals into the United States and preemptive authority of federal food and drug regulations; balance or surprise billing and related issues; single-payer health care options; health reimbursement arrangements and other account-based group health plans; Health and Human Services international pricing index (IPI) model; legislation addressing mental health parity; inclusion of prescription drug pricing on 2019 congressional agenda; reauthorization of the Patient Centered Outcomes Research Institute; (PCORI); potential premium reduction/reinsurance program to reduce health insurance premiums; proposals to expand Medicare including Medicare Buy-In and the development of a public option; medical hospital outpatient prospective payment system for CY 2020; drug pricing including most-favored nations proposals, international pricing index, importation and mandatory rebates; potential healthcare pricing proposals, including a medicaid rebate cap, spread pricing, and inflation penalty; comments on Medicare and State Healthcare Programs: fraud and abuse; revisions to safe harbors under the anti-kickback statute, and civil monetary penalty rules regarding beneficiary inducements; comments on Medicare Program; modernizing and clarifying the physician self-referral regulations; comments on CMS proposed Medicaid fiscal accountability regulation; comments on CMS proposed transparency in coverage rule; comments to the U.S. Department of Health and Human Services on the declaration under the Public Readiness and Emergency Preparedness (PREP) Act for medical countermeasures against COVID-19, as amended on April 10, 2020 and June 8, 2020 (Declaration), Section 319F-3 of the Public Health Service (PHS) Act (42 U.S.C. 247d-6d); comments to the U.S. Department of Health and Human Services on CMS-2393-P: Medicaid Program; Medicaid fiscal accountability regulation; comments to the U.S. Department of Health and Human Services on the Administrations proposed rule to eliminate drug manufacturer rebates in Part D; transparency in coverage; issues relating to the coronavirus pandemic, including testing, liability protection, and temporary COBRA subsidies; Public Health and Social Services Emergency Fund (PHSSEF); health insurance coverage during the coronavirus pandemic; health legislative priorities for the potential Phase 4 coronavirus relief package; provisions relating to Health Savings Accounts (HSA) and Flexible Spending Arrangements (FSA) in the Coronavirus, Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136); FCCs COVID-19 Telehealth Program; Federal Emergency Management Agencys (FEMA) temporary rule regarding Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use; reform of the World Health Organization (WHO); continued U.S. membership in the World Health Organization Public Readiness and Emergency Preparedness Act (P.L. 109-148, Division C), and COVID -19; potential legislation dealing with COVID-19 liability issues

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

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Bureau of Citizenship & Immigration Services (BCIS), Bureau of Industry and Security (BIS), Bureau of Reclamation, Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Financial Protection Bureau (CFPB), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Emergency Management Agency (FEMA), Federal Energy Regulatory Commission (FERC), Federal Motor Carrier Safety Administration, Federal Reserve System, Federal Trade Commission (FTC), General Services Administration (GSA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Natl Telecommunications & Information Administration (NTIA), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 985, Fair Access for Safe and Timely (FAST) Generics Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 986, Protecting American with Preexisting Conditions Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 987, Marketing and Outreach Restoration to Empower Health Education Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1010, Short-Term, Limited Duration Insurance (STLDI), regarding all bio-pharmaceutical related provisions. H.R. 1323, Rural Hospital Frontier Fairness Act, regarding all bio-pharmaceutical related provisions. H.R. 1385, State Allowance for a Variety of Exchanges (SAVE) Act, regarding all bio-pharmaceutical related provisions. H.R. 1386, Expanded Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act, regarding all bio-pharmaceutical related provisions. H.R. 1409, Transparency in All Health Care Pricing Act, regarding all bio-pharmaceutical related provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions. H.R. 1478, Insulin importation, regarding all bio-pharmaceutical related provisions. H.R. 1503, Orange Book Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1506, Fair and Immediate Release (FAIR) of Generics Act, regarding all bio-pharmaceutical related provisions. H.R. 1520, Purple Book Continuity Act, regarding all bio-pharmaceutical related provisions. H.R. 2011, Protecting Access to Biosimilars Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2038, State-based , Market-Oriented, Prescription Drug Negotiations Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2064, Product Sample reporting, regarding all bio-pharmaceutical related provisions. S. 61, Safe and Affordable Drugs from Canada Act, regarding all bio-pharmaceutical related provisions. S. 97, Affordable and Safe Drug Importation Act, regarding all bio-pharmaceutical related provisions. S. 102, Prescription Drug Price Relief Act, regarding all bio-pharmaceutical related provisions. S. 344/H.R. 990, Hatch-Waxman Integrity Act, regarding all bio-pharmaceutical related provisions. S. 366/H.R. 1188, FLAT Prices Act- Reduced exclusivity period for certain price hikes, regarding all bio-pharmaceutical related provisions. S. 418, FDA Accountability for Public Safety Act, regarding all bio-pharmaceutical related provisions. S. 419, Protecting Americans from Dangerous Opioids Act, regarding all bio-pharmaceutical related provisions. S. 637, CURE High Drug Prices Act, regarding all bio-pharmaceutical related provisions. S. 657, Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. S. 658, Accelerated Drug Approval for Prescription Therapies Act, regarding all bio-pharmaceutical related provisions. S. 659, Biologic Patent Transparency Act, regarding all bio-pharmaceutical related provisions. S. 660, Transparency in Petitions Act, regarding all bio-pharmaceutical related provisions. S. 709, Establishes public dashboard for price and utilization of drugs purchased by federal programs, regarding all bio-pharmaceutical related provisions. S. 741 /H.R. 1730, Cancer Drug Parity Act, regarding all bio-pharmaceutical related provisions. S. 844, Short Competition Act, regarding all bio-pharmaceutical related provisions. S. 977, Transparent Drug Pricing Act of 2019, regarding all bio-pharmaceutical related provisions. S. 989, STEER Act, regarding all bio-pharmaceutical related provisions. S. 1140, A bill to amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009, regarding all bio-pharmaceutical related provisions. S.1169, FDA citizen petition, regarding all bio-pharmaceutical related provisions. S. 1209, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications, regarding all bio-pharmaceutical related provisions. H.R. 2115, Public Disclosure of Drug Discounts Act, regarding all bio-pharmaceutical related provisions H.R.2296/S.1391, FAIR Drug Pricing Act, regarding all bio-pharmaceutical related provisions H.R.2700, Lowering Prescription Drug Costs and Extending Community Health Centers and other Health Priorities Act, regarding all bio-pharmaceutical related provisions H.R. 3223, Pharmacy Benefit Manager Accountability Study Act, regarding all bio-pharmaceutical related provisions S. 1361/H.R.2584, Preventive Health Savings Act, regarding all bio-pharmaceutical related provisions S. 1437, DTC Act, regarding all bio-pharmaceutical related provisions S.1532, Pharmacy Benefit Managers Accountability Study Act, regarding all bio-pharmaceutical related provisions S.1636, Ensuring Innovation Act, regarding all bio-pharmaceutical related provisions S. 1664, Prescription Drug Price Reporting Act, regarding all bio-pharmaceutical related provisions S. 1801, Affordable Medications Act, regarding all bio-pharmaceutical related provisions S. 1895, Lowering Health Costs Act, regarding all bio-pharmaceutical related provisions S. 1897, a bill to establish a process for updating the labeling of certain drugs with outdated labeling, regarding all bio-pharmaceutical related provisions S. 1897/H.R. 3523, End Price Gouging for Medications Act, regarding all bio-pharmaceutical related provisions S. 2004, Emergency Access to Insulin Act, regarding all bio-pharmaceutical related provisions H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions H.R 748/S. 3548, Coronavirus Aid, Relief and Economic Security Act (CARES Act), regarding all bio-pharmaceutical provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, regarding all bio-pharmaceutical related provisions

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

Legislation and proposals related to the COVID-19 crisis; HR 3199-Terminating the Extension of Rights Misappropriated Act of 2019; S.64-Preserve Access to Affordable Generic & Biosimilars Act; HR 1499-Protecting Consumer Access to Generic Drugs Act; HR 1344-Competitive Drugs Act of 2019; HR 938-Bringing Low Cost Options & Competition While Keeping Incentives for New Generics Act ("BLOCKING Act"); HR 1506-Fair & Immediate Release of Generic Drugs Act; HR 1520-Purple Book Continuity Act; HR 1503-Orange Book Transparency Act; S.344/HR 990-Hatch-Waxman Integrity Act; Stronger Patents Act; S.1895-Lower Health Care Costs Act; S. 2543-Prescription Drug Pricing Reduction Act; HR 3-Elijah E Cummings Lower Drug Costs Now Act; Administration review of drug pricing policies; Proposals to improve pharmaceutical supply-chain vlunterabilities; HR 4597-Acting to Cancel Copays & Ensure Substantial Savings for Biosimilars (ACCESS) Act; HR 4455-Bolstering Innovative Options to Save Immediately on Medicines (BIOSIMS) Act; HR 6179-Lowering Costs for Taxpayers & Medicare Seniors with Biosimilars; HR 4629-Star Ratings for Biosimilars Act.

Client expense: $500,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), SENATE, White House Office

Promoting awareness of the biopharmaceutical and medical technology sectors. Opposing the imposition of price controls in the Medicare Part D program. Generally supporting intellectual property rights. Supporting changes to Medicare Part D's coverage gap liability assignment and out-of-pocket cliff. Supporting changes to the America Invents Act to prevent double jeopardy of patent challenges under the inter partes review process. Supporting the Hatch Waxman Integrity Act (HR 990, S344). Opposing the Medicare Negotiations and Competitive Pricing Act (HR 1046). Generally supporting the proposed CMS Safe Harbor rule. Opposing H.R. 3 legislation regarding health care costs Opposing the FDA's Proposed Rule regarding the importation of prescription drugs (Docket No. FDA-2019-N-5711) Supporting H.R. 5741, the "Strengthening Innovation in Medicare and Medicaid Act Supporting the CMS Notice of Benefit and Payment Parameters (NBPP) Proposed Rule (CMS-9944-P) Opposing a proposed White House Executive Order concerning the Buy America Act Opposing various legislative efforts to relocate supply and logistics chains Opposing various legislative and executive efforts to impose an international price index Supporting the SMART Act (S. 3752 and H.R. 6954)

Client expense: $39,779 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 2082/H.R. 3666 (STRONGER Patents Act) Trade-related intellectual property policy/practices/encroachment by foreign countries/companies against U.S. competitiveness interests - China, Committee on Foreign Investment in the United States review of Chinese acquisitions and joint ventures, United States-Mexico-Canada Agreement IP chapter, International Trade Commission exclusion of U.S. patent-infringing imports, ITC baseband chip set patent infringement remedy, intellectual property exclusivity and protections in trade agreements Piracy of online and streaming copyrighted content Compulsory licensing - S. 377/H.R. 1046 (Medicare Negotiation and Competitive Licensing Act), S. 102/H.R. 465 (Prescription Drug Price Relief Act), S. 977 (Transparent Drug Pricing Act) NIST Return on Investment Initiative for Unleashing American Innovation S. 344/H.R. 990 (Hatch-Waxman Integrity Act) FTC/patent licensing as exclusive property right Bayh-Dole Act/technology transfer, march-in rights Procedural and evidentiary standards used at Patent Trial and Appeal Board PTO patentable subject matter eligibility guidance Section 101 patentable subject matter reform Injunctive relief from willful infringement DOJ-DOC withdrawal of 2013 Policy Statement on Remedies for Standards-Essential Patents Subject to Voluntary F/RAND Commitments S. 1273/H.R. 2426 (Copyright Alternative in Small-Claims Enforcement (CASE) Act) S. 1416 (Affordable Prescriptions for Patients Act) Obviousness/No Combination Drug Patents Act H.R. 4398/H.R. 5133 (Affordable Prescriptions for Patients Through Promoting Competition Act) H.R. 3991 (Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act) H.R. 5478 (Inventor Rights Act) Patent licensing/standards-essential patents/U.S. technological leadership in 5G and other technologies/economic and national security implications DOJ-PTO-NIST 2019 revised Joint Statement on Remedies for Standards-Essential Patents Subject to Voluntary F/RAND Commitments Efficient infringement Digital Millennium Copyright Act modernization Patent Trial & Appeal Board Covered Business Methods program PTAB Rules of Practice for Instituting on All Challenged Patent Claims and All Grounds and Eliminating the Presumption at Institution Favoring Petitioner as to Testimonial Evidence (Docket No. PTO-P-2019-0024) S. 3630 (Facilitating Innovation to Fight Coronavirus Act) Denial of rights of exclusivity for COVID-19-related innovations H.R. 7366 (Restoring Americas Leadership in Innovation Act) S. 3835 (SCRIPT Act) Proposed policy requiring privately produced, privately funded, copyrighted, peer-reviewed journal articles be given away free upon publication if they discuss any underlying research supported by a government grant Patent Trial and Appeal Board Covered Business Methods program statutory expiration Amendments to the Rules of Practice for Trials Before the Patent Trial and Appeal Board (RIN:0651-AD47)

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Council on Environmental Quality (CEQ), Environmental Protection Agency (EPA), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE

H.R. 3, Lower Drug Costs Now Act of 2019 H.R. 19/S. 3129, Lower Costs, More Cures Act of 2019 H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 H.R. 448/S. 99, Medicare Drug Price Negotiation Act H.R. 748/ S. 3548, Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R. 1346, Medicare Buy-In and Health Care Stabilization Act of 2019 H.R. 1384, Medicare for All Act of 2019 H.R. 1398/S. 172, Health Insurance Tax Relief Act of 2019 H.R. 1425, Patient Protection and Affordable Care Enhancement Act H.R. 1865, Further Consolidated Appropriations Act, 2020 H.R. 1922/S. 1089, Restoring Access to Medication Act of 2019 H.R. 1985, Family Savings for Kids and Seniors Act H.R. 2207, Protect Medical Innovation Act of 2019 H.R. 3030, Patient-Centered Outcomes Research Extension Act of 2019 H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201, Families First Coronavirus Response Act H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act S. 12, Health Savings Act of 2019 S. 61, Safe and Affordable Drugs from Canada Act of 2019 S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 S. 64, Preserve Access to Affordable Generics and Biosimilars Act S. 80, Jobs and Premium Protection Act, including provisions relating to repeal of the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act S. 340, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 S. 344, Hatch-Waxman Integrity Act of 2019 S. 470, Medicare at 50 Act S. 684, Middle Class Health Benefits Tax Repeal Act of 2019 S. 692, Protect Medical Innovation Act of 2019 S. 1416, Affordable Prescriptions for Patients Act of 2019 S. 1541, Tobacco-Free Youth Act S. 1895, Lower Health Care Costs Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 S. 2897, Patient-Centered Outcomes Research Institute Reauthorization Act S. 3200, Chronic Disease Management Act of 2020 Potential legislation similar to H.R. 2911/S. 1697, Small Business Healthcare Relief Act (114th Cong.) Proposed regulation on the Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2020 (84 Fed. Reg. 227-321, January 24, 2019) Proposed regulations on Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; interoperability and patient access for Medicare advantage organization and Medicaid managed care plans, state Medicaid agencies, CHIP agencies and CHIP managed care entities, issuers of qualified health plans in the federally-facilitated exchanges and health care providers; supplement and extension of comment period (84 Federal Register 16,834, April 23, 2019) Proposed regulations on Medicare modernizing and clarifying physician self-referral regulations (84 Fed. Reg. 55,766-55,847, October 17, 2019) Proposed regulation on Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2021; notice requirement for non-federal governmental plans (85 Fed. Reg. 7,088-7,159, February 6, 2020) Various issues relating to Patient Protection and Affordable Care Act (P.L. 111-148) and the Health Care and Education Affordability Reconciliation Act of 2010 (P.L. 111-152), including the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, delivery system reform, health savings account (HSAs), health reimbursement account (HRAs), and flexible spending account (FSAs) changes, IPAB, employer mandate, reporting requirements for issuers and applicable large employers, premium stabilization programs, medical loss ratio, medical malpractice reform, exchanges, the impact on small business, the Small Business Tax Credit, section 1332 waivers, section 1557 on nondiscrimination, caps on compensation deductibility required under section 9014, incompleteness or inaccuracy of cost impact analysis, lack of quantified benefit analysis, and need for empirical data sources on which to base costs and benefits, the Cost Sharing Reduction (CSR) program, the section 9010 Health Insurance Providers Fee or Health Insurance Tax (HIT), 40% excise tax on high-cost employer-sponsored health coverage (Cadillac tax); medical device tax; protect Medicare Part Ds Non-Interference Clause from repeal, proposed rule regarding section 1557; Public Health Services Act (P.L.78-410), Internal Revenue Code and the Employee Retirement Income Security Act (ERISA) (P.L. 93-406), regarding regulatory process and legislative corrections to ERISA preemption, changes to Medicare Advantage and Parts B, C, and D, including rebates and non-interference with prescription drug prices, entitlement reform, health information technology, telemedicine services in Medicare, and coordination and disease management programs; association health plans; importation of foreign pharmaceuticals into the United States and preemptive authority of federal food and drug regulations; balance or surprise billing and related issues; single-payer health care options; health reimbursement arrangements and other account-based group health plans; Health and Human Services international pricing index (IPI) model; legislation addressing mental health parity; inclusion of prescription drug pricing on 2019 congressional agenda; reauthorization of the Patient Centered Outcomes Research Institute; (PCORI); potential premium reduction/reinsurance program to reduce health insurance premiums; medical hospital outpatient prospective payment system for CY 2020; drug pricing; potential healthcare pricing proposals, including a medicaid rebate cap, spread pricing, and inflation penalty; comments on Medicare and State Healthcare Programs: fraud and abuse; revisions to safe harbors under the anti-kickback statute, and civil monetary penalty rules regarding beneficiary inducements; comments on Medicare Program; modernizing and clarifying the physician self-referral regulations; comments on CMS proposed Medicaid fiscal accountability regulation; comments on CMS proposed transparency in coverage rule; comments on HHS notice of benefit and payment parameters for 2021; transparency in coverage; Medicaid fiscal accountability regulations; issues relating to the coronavirus pandemic, including testing, liability protection, and temporary COBRA subsidies; Public Health and Social Services Emergency Fund (PHSSEF); health insurance coverage during the coronavirus pandemic; health legislative priorities for the potential Phase 4 coronavirus relief package; provisions relating to Health Savings Accounts (HSA) and Flexible Spending Arrangements (FSA) in the Coronavirus, Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136); FCCs COVID-19 Telehealth Program; Federal Emergency Management Agencys (FEMA) temporary rule regarding Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use

Client expense: $12,300,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Bureau of Citizenship & Immigration Services (BCIS), Bureau of Industry and Security (BIS), Bureau of Labor Statistics (BLS), Bureau of Reclamation, Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Financial Protection Bureau (CFPB), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Emergency Management Agency (FEMA), Federal Energy Regulatory Commission (FERC), Federal Motor Carrier Safety Administration, Federal Reserve System, Federal Trade Commission (FTC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Natl Telecommunications & Information Administration (NTIA), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

Issues related Inter Partes Review (IPR) process for biosimilars and generic drugs S.344, H.R. 990 - Hatch-Waxman Integrity Act of 2019 Patent Settlements

Client expense: $550,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE, Transportation, Dept of (DOT), U.S. Trade Representative (USTR), White House Office

Issues related to drug pricing; S. 64, Preserve Access to Affordable Generics and Biosimilars Act; H.R. 938, BLOCKING Act of 2019 and HR 1506, FAIR Generics Act; Hatch-Waxman Integrity Act of 2019, H.R. 990 and S. 344; S. 1416, Affordable Prescriptions for Patients Act of 2019; issues related to the pharmaceutical supply chain; and issues related to FDA Abbreviated New Drug Application reviews of complex generics.

Client expense: Not reported · Firm income: $70,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 985, Fair Access for Safe and Timely (FAST) Generics Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 986, Protecting American with Preexisting Conditions Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 987, Marketing and Outreach Restoration to Empower Health Education Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1010, Short-Term, Limited Duration Insurance (STLDI), regarding all bio-pharmaceutical related provisions. H.R. 1323, Rural Hospital Frontier Fairness Act, regarding all bio-pharmaceutical related provisions. H.R. 1385, State Allowance for a Variety of Exchanges (SAVE) Act, regarding all bio-pharmaceutical related provisions. H.R. 1386, Expanded Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act, regarding all bio-pharmaceutical related provisions. H.R. 1409, Transparency in All Health Care Pricing Act, regarding all bio-pharmaceutical related provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions. H.R. 1478, Insulin importation, regarding all bio-pharmaceutical related provisions. H.R. 1503, Orange Book Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1506, Fair and Immediate Release (FAIR) of Generics Act, regarding all bio-pharmaceutical related provisions. H.R. 1520, Purple Book Continuity Act, regarding all bio-pharmaceutical related provisions. H.R. 2011, Protecting Access to Biosimilars Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2038, State-based , Market-Oriented, Prescription Drug Negotiations Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2064, Product Sample reporting, regarding all bio-pharmaceutical related provisions. S. 61, Safe and Affordable Drugs from Canada Act, regarding all bio-pharmaceutical related provisions. S. 97, Affordable and Safe Drug Importation Act, regarding all bio-pharmaceutical related provisions. S. 102, Prescription Drug Price Relief Act, regarding all bio-pharmaceutical related provisions. S. 344/H.R. 990, Hatch-Waxman Integrity Act, regarding all bio-pharmaceutical related provisions. S. 366/H.R. 1188, FLAT Prices Act- Reduced exclusivity period for certain price hikes, regarding all bio-pharmaceutical related provisions. S. 418, FDA Accountability for Public Safety Act, regarding all bio-pharmaceutical related provisions. S. 419, Protecting Americans from Dangerous Opioids Act, regarding all bio-pharmaceutical related provisions. S. 637, CURE High Drug Prices Act, regarding all bio-pharmaceutical related provisions. S. 657, Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. S. 658, Accelerated Drug Approval for Prescription Therapies Act, regarding all bio-pharmaceutical related provisions. S. 659, Biologic Patent Transparency Act, regarding all bio-pharmaceutical related provisions. S. 660, Transparency in Petitions Act, regarding all bio-pharmaceutical related provisions. S. 709, Establishes public dashboard for price and utilization of drugs purchased by federal programs, regarding all bio-pharmaceutical related provisions. S. 741 /H.R. 1730, Cancer Drug Parity Act, regarding all bio-pharmaceutical related provisions. S. 844, Short Competition Act, regarding all bio-pharmaceutical related provisions. S. 977, Transparent Drug Pricing Act of 2019, regarding all bio-pharmaceutical related provisions. S. 989, STEER Act, regarding all bio-pharmaceutical related provisions. S. 1140, A bill to amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009, regarding all bio-pharmaceutical related provisions. S.1169, FDA citizen petition, regarding all bio-pharmaceutical related provisions. S. 1209, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications, regarding all bio-pharmaceutical related provisions. H.R. 2115, Public Disclosure of Drug Discounts Act, regarding all bio-pharmaceutical related provisions H.R.2296/S.1391, FAIR Drug Pricing Act, regarding all bio-pharmaceutical related provisions H.R.2700, Lowering Prescription Drug Costs and Extending Community Health Centers and other Health Priorities Act, regarding all bio-pharmaceutical related provisions H.R. 3223, Pharmacy Benefit Manager Accountability Study Act, regarding all bio-pharmaceutical related provisions S. 1361/H.R.2584, Preventive Health Savings Act, regarding all bio-pharmaceutical related provisions S. 1437, DTC Act, regarding all bio-pharmaceutical related provisions S.1532, Pharmacy Benefit Managers Accountability Study Act, regarding all bio-pharmaceutical related provisions S.1636, Ensuring Innovation Act, regarding all bio-pharmaceutical related provisions S. 1664, Prescription Drug Price Reporting Act, regarding all bio-pharmaceutical related provisions S. 1801, Affordable Medications Act, regarding all bio-pharmaceutical related provisions S. 1895, Lowering Health Costs Act, regarding all bio-pharmaceutical related provisions S. 1897, a bill to establish a process for updating the labeling of certain drugs with outdated labeling, regarding all bio-pharmaceutical related provisions S. 1897/H.R. 3523, End Price Gouging for Medications Act, regarding all bio-pharmaceutical related provisions S. 2004, Emergency Access to Insulin Act, regarding all bio-pharmaceutical related provisions H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions H.R 748/S. 3548, Coronavirus Aid, Relief and Economic Security Act (CARES Act), regarding all bio-pharmaceutical provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, regarding all bio-pharmaceutical related provisions

Client expense: $2,160,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

Promote inter partes reform proposals -- specifically, including the Hatch Waxman Integrity Act (S. 344 and H.R. 990). Also, monitor patent reform proposals such as S. 1416, The Affordable Prescriptions for Patients Act of 2019; and S. 440, The PACED Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 990 and S. 344, the Hatch-Waxman Integrity Act; S. 1416, Affordable Prescriptions for Patients Act of 2019: H.R. 3991, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; H.R. 4398, Affordable Prescriptions for Patients Through Promoting Competition Act of 2019; Senate amendment to H.R. 2486

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

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

Legislation and proposals related to the COVID-19 crisis; HR 3199-Terminating the Extension of Rights Misappropriated Act of 2019; S.64-Preserve Access to Affordable Generic & Biosimilars Act; HR 1499-Protecting Consumer Access to Generic Drugs Act; HR 1344-Competitive Drugs Act of 2019; HR 938-Bringing Low Cost Options & Competition While Keeping Incentives for New Generics Act ("BLOCKING Act"); HR 1506-Fair & Immediate Release of Generic Drugs Act; HR 1520-Purple Book Continuity Act; HR 1503-Orange Book Transparency Act; S.344/HR 990-Hatch-Waxman Integrity Act; Stronger Patents Act; S.1895-Lower Health Care Costs Act; S. 2543-Prescription Drug Pricing Reduction Act; HR 3-Elijah E Cummings Lower Drug Costs Now Act; Administration review of drug pricing policies; Proposals to improve pharmaceutical supply-chain vlunterabilities; HR 4597-Acting to Cancel Copays & Ensure Substantial Savings for Biosimilars (ACCESS) Act; HR 4455-Bolstering Innovative Options to Save Immediately on Medicines (BIOSIMS) Act; HR 6179-Lowering Costs for Taxpayers & Medicare Seniors with Biosimilars; HR 4629-Star Ratings for Biosimilars Act.

Client expense: $580,000 · Firm income: Not reported

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

H.R. 6058, the SHOP SAFE Act H.R. 6196/ S. 3449, the Trademark Modernization Act S. 2987, the Counterfeit Goods Seizure Act of 2019 H.R. 5478, the Inventor Rights Act S. 2082/H.R. 3666, the STRONGER Patents Act of 2019 H.R. 4164/S. 2439, the Trademark Licensing Protection Act of 2019 S. 2281/H.R. 4075, the Inventor Diversity for Economic Advancement (IDEA) Act of 2019 H.R. 3954. Including the exclusive economic zone as part of the United States for patent infringement H.R. 3991, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 H.R. 3199, Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 S. 1416, Affordable Prescriptions for Patients Act of 2019 H.R. 2426/S. 1272, the CASE Act H.R. 1999/S. 963, the Fair Licensing Access for Governments (FLAG) Act of 2019 (entire bill) S. 376 /H.R. 1683, No Stolen Trademarks Honored in America Act (entire bill) S. 659, A bill to provide for certain additional requirements with respect to patent disclosures. (entire bill) S. 440, Preserving Access to Cost Effective Drugs Act (PACED) Act (entire bill) S. 344/H.R. 990, Hatch-Waxman Integrity Act of 2019 (entire bill) H.R. 108, Targeting Rogue and Opaque Letters Act of 2019 (entire bill) S. 64, Preserve Access to Affordable Generics and Biosimilars Act (entire bill) H.R.902, Protect American IPR Act (entire bill) Issues related to USPTO operations Legislative proposal on patent subject matter eligibility Issues related to Copyright Office Modernization Issues related to sovereign immunity Issues related to the review of the Digital Millennium Copyright Act (DMCA)

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)

Promoting awareness of the biopharmaceutical and medical technology sectors. Opposing the imposition of price controls in the Medicare Part D program. Generally supporting intellectual property rights. Supporting changes to Medicare Part D's coverage gap liability assignment and out-of-pocket cliff. Supporting changes to the America Invents Act to prevent double jeopardy of patent challenges under the inter partes review process. Supporting the Hatch Waxman Integrity Act (HR 990, S344). Opposing the Medicare Negotiations and Competitive Pricing Act (HR 1046). Generally supporting the proposed CMS Safe Harbor rule. Generally supporting the proposed United States Mexico Canada (USMCA) Trade Agreement. Opposing H.R. 3 legislation regarding health care costs Opposing the FDA's Proposed Rule regarding the importation of prescription drugs (Docket No. FDA-2019-N-5711) Supporting H.R. 5741, the "Strengthening Innovation in Medicare and Medicaid Act Supporting the CMS Notice of Benefit and Payment Parameters (NBPP) Proposed Rule (CMS-9944-P) Opposing a proposed White House Executive Order concerning the Buy America Act Opposing various legislative efforts to relocate supply and logistics chains Opposing various legislative efforts to impose an international price index Supporting the SMART Act (S. 3752 and H.R. 6954)

Client expense: $35,228 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 2082/H.R. 3666 (STRONGER Patents Act) Trade-related intellectual property policy/practices/encroachment by foreign countries/companies against U.S. competitiveness interests - China, Committee on Foreign Investment in the United States review of Chinese acquisitions and joint ventures, United States-Mexico-Canada Agreement IP chapter, International Trade Commission exclusion of U.S. patent-infringing imports, ITC baseband chip set patent infringement remedy, intellectual property exclusivity and protections in trade agreements Piracy of online and streaming copyrighted content Compulsory licensing - S. 377/H.R. 1046 (Medicare Negotiation and Competitive Licensing Act), S. 102/H.R. 465 (Prescription Drug Price Relief Act), S. 977 (Transparent Drug Pricing Act) NIST Return on Investment Initiative for Unleashing American Innovation S. 344/H.R. 990 (Hatch-Waxman Integrity Act) FTC/patent licensing as exclusive property right Bayh-Dole Act/technology transfer, march-in rights Procedural and evidentiary standards used at Patent Trial and Appeal Board PTO patentable subject matter eligibility guidance Section 101 patentable subject matter reform Injunctive relief from willful infringement DOJ-DOC withdrawal of 2013 Policy Statement on Remedies for Standards-Essential Patents Subject to Voluntary F/RAND Commitments S. 1273/H.R. 2426 (Copyright Alternative in Small-Claims Enforcement (CASE) Act) S. 1416 (Affordable Prescriptions for Patients Act) Obviousness/No Combination Drug Patents Act H.R. 4398/H.R. 5133 (Affordable Prescriptions for Patients Through Promoting Competition Act) H.R. 3991 (Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act) H.R. 5478 (Inventor Rights Act) Patent licensing/standards-essential patents/U.S. technological leadership in 5G and other technologies/economic and national security implications DOJ-PTO-NIST 2019 revised Joint Statement on Remedies for Standards-Essential Patents Subject to Voluntary F/RAND Commitments Efficient infringement Digital Millennium Copyright Act modernization Patent Trial & Appeal Board Covered Business Methods program PTAB Rules of Practice for Instituting on All Challenged Patent Claims and All Grounds and Eliminating the Presumption at Institution Favoring Petitioner as to Testimonial Evidence (Docket No. PTO-P-2019-0024) S. 3630 (Facilitating Innovation to Fight Coronavirus Act) Denial of rights of exclusivity for COVID-19-related innovations H.R. 7366 (Restoring Americas Leadership in Innovation Act)

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

Government targets: Council on Environmental Quality (CEQ), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE

Issues related Inter Partes Review (IPR) process for biosimilars and generic drugs S.344, H.R. 990 - Hatch-Waxman Integrity Act of 2019 Patent Settlements

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, Transportation, Dept of (DOT), U.S. Trade Representative (USTR), White House Office

Issues related to drug pricing; Issues related to Risk Evaluation and Mitigation Strategies (REMS), including CREATES Act of 2019 - S. 340 and H.R. 965; S. 64, Preserve Access to Affordable Generics and Biosimilars Act; H.R. 938, BLOCKING Act of 2019 and HR 1506, FAIR Generics Act; Hatch-Waxman Integrity Act of 2019, H.R. 990 and S. 344; Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics, including Affordable Insulin Approvals Now Act, S. 2103; S. 1416, Affordable Prescriptions for Patients Act of 2019.

Client expense: Not reported · Firm income: $70,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 990 and S. 344, the Hatch-Waxman Integrity Act; S. 1416, Affordable Prescriptions for Patients Act of 2019: H.R. 3991, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; H.R. 4398, Affordable Prescriptions for Patients Through Promoting Competition Act of 2019; Senate amendment to H.R. 2486

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

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

Issues related to implementation of the FDA user fee reauthorization bill Issues related to the Inter Partes Review (IPR) process S. 344, H.R. 990, Hatch-Waxman Integrity Act of 2019 S. 340, H.R. 965, CREATES Act of 2019 Issues related to drug compounding and counterfeit drugs S. 440, PACED Act

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

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

H.R. 3, Lower Drug Costs Now Act of 2019 H.R. 19/S. 3129, Lower Costs, More Cures Act of 2019 H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 H.R. 448/S. 99, Medicare Drug Price Negotiation Act H.R. 748, Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R. 1346, Medicare Buy-In and Health Care Stabilization Act of 2019 H.R. 1384, Medicare for All Act of 2019 H.R. 1398/S. 172, Health Insurance Tax Relief Act of 2019 H.R. 1865, Further Consolidated Appropriations Act, 2020 H.R. 1922/S. 1089, Restoring Access to Medication Act of 2019 H.R. 1985, Family Savings for Kids and Seniors Act H.R. 2207, Protect Medical Innovation Act of 2019 H.R. 3030, Patient-Centered Outcomes Research Extension Act of 2019 H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201, Families First Coronavirus Response Act S. 12, Health Savings Act of 2019 S. 61, Safe and Affordable Drugs from Canada Act of 2019 S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 S. 64, Preserve Access to Affordable Generics and Biosimilars Act S. 80, Jobs and Premium Protection Act, including provisions relating to repeal of the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act S. 340, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 S. 344, Hatch-Waxman Integrity Act of 2019 S. 470, Medicare at 50 Act S. 684, Middle Class Health Benefits Tax Repeal Act of 2019 S. 692, Protect Medical Innovation Act of 2019 S. 1416, Affordable Prescriptions for Patients Act of 2019 S. 1541, Tobacco-Free Youth Act S. 1895, Lower Health Care Costs Act S. 1948, Chronic Disease Management Act of 2019 S. 2543, Prescription Drug Pricing Reduction Act of 2019 S. 2897, Patient-Centered Outcomes Research Institute Reauthorization Act S. 3200, Chronic Disease Management Act of 2020 S. 3548, Coronavirus Aid, Relief, and Economic Security Act or the CARES Act Potential legislation similar to H.R. 2911/S. 1697, Small Business Healthcare Relief Act (114th Cong.) Proposed regulation on the Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2020 (84 Fed. Reg. 227-321, January 24, 2019) Proposed regulations on Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; interoperability and patient access for Medicare advantage organization and Medicaid managed care plans, state Medicaid agencies, CHIP agencies and CHIP managed care entities, issuers of qualified health plans in the federally-facilitated exchanges and health care providers; supplement and extension of comment period (84 Federal Register 16,834, April 23, 2019) Proposed regulations on transparency in health insurance coverage (84 Fed. Reg. 65,464-65,523, November 27, 2019) Proposed regulations on Medicare modernizing and clarifying physician self-referral regulations (84 Fed. Reg. 55,766-55,847, October 17, 2019) Proposed regulation on Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2021; notice requirement for non-federal governmental plans (85 Fed. Reg. 7,088-7,159, February 6, 2020) Proposed regulation on Medicare and Medicaid Programs; Contract Year 2021 and 2022 Policy and technical changes to the Medicare Advantage Program, Medicare prescription drug benefit program, Medicaid program, Medicare cost plan program, and programs of all-inclusive care for the elderly (85 Fed. Reg. 9,002-9,260, February 18, 2020) Various issues relating to Patient Protection and Affordable Care Act (P.L. 111-148) and the Health Care and Education Affordability Reconciliation Act of 2010 (P.L. 111-152), including the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, delivery system reform, health savings account (HSAs), health reimbursement account (HRAs), and flexible spending account (FSAs) changes, IPAB, employer mandate, reporting requirements for issuers and applicable large employers, premium stabilization programs, medical loss ratio, medical malpractice reform, exchanges, the impact on small business, the Small Business Tax Credit, section 1332 waivers, section 1557 on nondiscrimination, caps on compensation deductibility required under section 9014, incompleteness or inaccuracy of cost impact analysis, lack of quantified benefit analysis, and need for empirical data sources on which to base costs and benefits, the Cost Sharing Reduction (CSR) program, the section 9010 Health Insurance Providers Fee or Health Insurance Tax (HIT), 40% excise tax on high-cost employer-sponsored health coverage (Cadillac tax); medical device tax; protect Medicare Part Ds Non-Interference Clause from repeal, proposed rule regarding section 1557; Public Health Services Act (P.L.78-410), Internal Revenue Code and the Employee Retirement Income Security Act (ERISA) (P.L. 93-406), regarding regulatory process and legislative corrections to ERISA preemption, changes to Medicare Advantage and Parts B, C, and D, including rebates and non-interference with prescription drug prices, entitlement reform, health information technology, telemedicine services in Medicare, and coordination and disease management programs; association health plans; importation of foreign pharmaceuticals into the United States and preemptive authority of federal food and drug regulations; balance or surprise billing and related issues; single-payer health care options; health reimbursement arrangements and other account-based group health plans; Health and Human Services international pricing index (IPI) model; legislation addressing mental health parity; inclusion of prescription drug pricing on 2019 congressional agenda; reauthorization of the Patient Centered Outcomes Research Institute; potential premium reduction/reinsurance program to reduce health insurance premiums; medical hospital outpatient prospective payment system for CY 2020; drug pricing; potential healthcare pricing proposals, including a medicaid rebate cap, spread pricing, and inflation penalty; comments on Medicare and State Healthcare Programs: fraud and abuse; revisions to safe harbors under the anti-kickback statute, and civil monetary penalty rules regarding beneficiary inducements; comments on Medicare Program; modernizing and clarifying the physician self-referral regulations; comments on CMS proposed Medicaid fiscal accountability regulation; comments on CMS proposed transparency in coverage rule; comments on HHS notice of benefit and payment parameters for 2021; Medicaid fiscal accountability regulations; transparency on coverage; issues relating to the coronavirus pandemic

Client expense: $15,770,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Bureau of Citizenship & Immigration Services (BCIS), Bureau of Industry and Security (BIS), Bureau of Labor Statistics (BLS), Bureau of Reclamation, Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Financial Protection Bureau (CFPB), Council of Economic Advisers (CEA), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Emergency Management Agency (FEMA), Federal Energy Regulatory Commission (FERC), Federal Motor Carrier Safety Administration, Federal Reserve System, Federal Trade Commission (FTC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Natl Telecommunications & Information Administration (NTIA), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

H.R. 6058, the SHOP SAFE Act H.R. 6196/ S. 3449, the Trademark Modernization Act S. 2987, the Counterfeit Goods Seizure Act of 2019 H.R. 5478, the Inventor Rights Act S. 2082/H.R. 3666, the STRONGER Patents Act of 2019 H.R. 4164/S. 2439, the Trademark Licensing Protection Act of 2019 S. 2281/H.R. 4075, the Inventor Diversity for Economic Advancement (IDEA) Act of 2019 H.R. 3954. Including the exclusive economic zone as part of the United States for patent infringement H.R. 3991, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 H.R. 3199, Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 S. 1416, Affordable Prescriptions for Patients Act of 2019 H.R. 2426/S. 1272, the CASE Act H.R. 1999/S. 963, the Fair Licensing Access for Governments (FLAG) Act of 2019 (entire bill) S. 376 /H.R. 1683, No Stolen Trademarks Honored in America Act (entire bill) S. 659, A bill to provide for certain additional requirements with respect to patent disclosures. (entire bill) S. 440, Preserving Access to Cost Effective Drugs Act (PACED) Act (entire bill) S. 344/H.R. 990, Hatch-Waxman Integrity Act of 2019 (entire bill) H.R. 108, Targeting Rogue and Opaque Letters Act of 2019 (entire bill) S. 64, Preserve Access to Affordable Generics and Biosimilars Act (entire bill) H.R.902, Protect American IPR Act (entire bill) Issues related to USPTO operations Legislative proposal on patent subject matter eligibility Issues related to Copyright Office Modernization

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)

Coronavirus Aid, Relief & Economic Stability Act (CARES Act) and other legislative proposals related to the COVID-19 crisis; HR 3199-Terminating the Extension of Rights Misappropriated Act of 2019; S.64-Preserve Access to Affordable Generic & Biosimilars Act; HR 1499-Protecting Consumer Access to Generic Drugs Act; HR 1344-Competitive Drugs Act of 2019; HR 938-Bringing Low Cost Options & Competition While Keeping Incentives for New Generics Act ("BLOCKING Act"); HR 1506-Fair & Immediate Release of Generic Drugs Act; HR 1520-Purple Book Continuity Act; HR 1503-Orange Book Transparency Act; S.344/HR 990-Hatch-Waxman Integrity Act; Stronger Patents Act; S.1895-Lower Health Care Costs Act; S. 2543-Prescription Drug Pricing Reduction Act; HR 3-Elijah E Cummings Lower Drug Costs Now Act; and Administration review of drug pricing policies.

Client expense: $430,000 · Firm income: Not reported

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

H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 985, Fair Access for Safe and Timely (FAST) Generics Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 986, Protecting American with Preexisting Conditions Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 987, Marketing and Outreach Restoration to Empower Health Education Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1010, Short-Term, Limited Duration Insurance (STLDI), regarding all bio-pharmaceutical related provisions. H.R. 1323, Rural Hospital Frontier Fairness Act, regarding all bio-pharmaceutical related provisions. H.R. 1385, State Allowance for a Variety of Exchanges (SAVE) Act, regarding all bio-pharmaceutical related provisions. H.R. 1386, Expanded Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act, regarding all bio-pharmaceutical related provisions. H.R. 1409, Transparency in All Health Care Pricing Act, regarding all bio-pharmaceutical related provisions. H.R. 1425, State Health Care Premium Reduction Act, regarding all bio-pharmaceutical related provisions. H.R. 1478, Insulin importation, regarding all bio-pharmaceutical related provisions. H.R. 1503, Orange Book Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1506, Fair and Immediate Release (FAIR) of Generics Act, regarding all bio-pharmaceutical related provisions. H.R. 1520, Purple Book Continuity Act, regarding all bio-pharmaceutical related provisions. H.R. 2011, Protecting Access to Biosimilars Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2038, State-based , Market-Oriented, Prescription Drug Negotiations Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 2064, Product Sample reporting, regarding all bio-pharmaceutical related provisions. S. 61, Safe and Affordable Drugs from Canada Act, regarding all bio-pharmaceutical related provisions. S. 97, Affordable and Safe Drug Importation Act, regarding all bio-pharmaceutical related provisions. S. 102, Prescription Drug Price Relief Act, regarding all bio-pharmaceutical related provisions. S. 344/H.R. 990, Hatch-Waxman Integrity Act, regarding all bio-pharmaceutical related provisions. S. 366/H.R. 1188, FLAT Prices Act- Reduced exclusivity period for certain price hikes, regarding all bio-pharmaceutical related provisions. S. 418, FDA Accountability for Public Safety Act, regarding all bio-pharmaceutical related provisions. S. 419, Protecting Americans from Dangerous Opioids Act, regarding all bio-pharmaceutical related provisions. S. 637, CURE High Drug Prices Act, regarding all bio-pharmaceutical related provisions. S. 657, Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. S. 658, Accelerated Drug Approval for Prescription Therapies Act, regarding all bio-pharmaceutical related provisions. S. 659, Biologic Patent Transparency Act, regarding all bio-pharmaceutical related provisions. S. 660, Transparency in Petitions Act, regarding all bio-pharmaceutical related provisions. S. 709, Establishes public dashboard for price and utilization of drugs purchased by federal programs, regarding all bio-pharmaceutical related provisions. S. 741 /H.R. 1730, Cancer Drug Parity Act, regarding all bio-pharmaceutical related provisions. S. 844, Short Competition Act, regarding all bio-pharmaceutical related provisions. S. 977, Transparent Drug Pricing Act of 2019, regarding all bio-pharmaceutical related provisions. S. 989, STEER Act, regarding all bio-pharmaceutical related provisions. S. 1140, A bill to amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009, regarding all bio-pharmaceutical related provisions. S.1169, FDA citizen petition, regarding all bio-pharmaceutical related provisions. S. 1209, A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications, regarding all bio-pharmaceutical related provisions. H.R. 2115, Public Disclosure of Drug Discounts Act, regarding all bio-pharmaceutical related provisions H.R.2296/S.1391, FAIR Drug Pricing Act, regarding all bio-pharmaceutical related provisions H.R.2700, Lowering Prescription Drug Costs and Extending Community Health Centers and other Health Priorities Act, regarding all bio-pharmaceutical related provisions H.R. 3223, Pharmacy Benefit Manager Accountability Study Act, regarding all bio-pharmaceutical related provisions S. 1361/H.R.2584, Preventive Health Savings Act, regarding all bio-pharmaceutical related provisions S. 1437, DTC Act, regarding all bio-pharmaceutical related provisions S.1532, Pharmacy Benefit Managers Accountability Study Act, regarding all bio-pharmaceutical related provisions S.1636, Ensuring Innovation Act, regarding all bio-pharmaceutical related provisions S. 1664, Prescription Drug Price Reporting Act, regarding all bio-pharmaceutical related provisions S. 1801, Affordable Medications Act, regarding all bio-pharmaceutical related provisions S. 1895, Lowering Health Costs Act, regarding all bio-pharmaceutical related provisions S. 1897, a bill to establish a process for updating the labeling of certain drugs with outdated labeling, regarding all bio-pharmaceutical related provisions S. 1897/H.R. 3523, End Price Gouging for Medications Act, regarding all bio-pharmaceutical related provisions S. 2004, Emergency Access to Insulin Act, regarding all bio-pharmaceutical related provisions H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions H.R 748/S. 3548, Coronavirus Aid, Relief and Economic Security Act (CARES Act), regarding all bio-pharmaceutical related provisions

Client expense: $540,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

Promote inter partes reform proposals -- specifically, including the Hatch Waxman Integrity Act (S. 344 and H.R. 990). Also, monitor patent reform proposals such as S. 1416, The Affordable Prescriptions for Patients Act of 2019; and S. 440, The PACED Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 2082/H.R. 3666 (STRONGER Patents Act) Trade-related intellectual property policy/practices/encroachment by foreign countries/companies against U.S. competitiveness interests - China, Committee on Foreign Investment in the United States review of Chinese acquisitions and joint ventures, United States-Mexico-Canada Agreement IP chapter, International Trade Commission exclusion of U.S. patent-infringing imports, ITC baseband chip set patent infringement remedy, intellectual property exclusivity and protections in trade agreements Piracy of online and streaming copyrighted content Compulsory licensing - S. 377/H.R. 1046 (Medicare Negotiation and Competitive Licensing Act), S. 102/H.R. 465 (Prescription Drug Price Relief Act), S. 977 (Transparent Drug Pricing Act) NIST Return on Investment Initiative for Unleashing American Innovation S. 344/H.R. 990 (Hatch-Waxman Integrity Act) FTC/patent licensing as exclusive property right Bayh-Dole Act/technology transfer, march-in rights Procedural and evidentiary standards used at Patent Trial and Appeal Board PTO patentable subject matter eligibility guidance Section 101 patentable subject matter reform Injunctive relief from willful infringement DOJ-DOC withdrawal of 2013 Policy Statement on Remedies for Standards-Essential Patents Subject to Voluntary F/RAND Commitments S. 1273/H.R. 2426 (Copyright Alternative in Small-Claims Enforcement (CASE) Act) S. 1416 (Affordable Prescriptions for Patients Act) Obviousness/No Combination Drug Patents Act H.R. 4398/H.R. 5133 (Affordable Prescriptions for Patients Through Promoting Competition Act) H.R. 3991 (Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act) H.R. 5478 (Inventor Rights Act) Patent licensing/standards-essential patents/U.S. technological leadership in 5G and other technologies/economic and national security implications DOJ-PTO-NIST 2019 revised Joint Statement on Remedies for Standards-Essential Patents Subject to Voluntary F/RAND Commitments Efficient infringement Digital Millennium Copyright Act modernization

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

Government targets: Council on Environmental Quality (CEQ), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

Promoting awareness of the biopharmaceutical and medical technology sectors. Opposing the imposition of price controls in the Medicare Part D program. Generally supporting intellectual property rights. Supporting changes to Medicare Part D's coverage gap liability assignment and out-of-pocket cliff. Supporting changes to the America Invents Act to prevent double jeopardy of patent challenges under the inter partes review process. Supporting the Hatch Waxman Integrity Act (HR 990, S344). Opposing the Medicare Negotiations and Competitive Pricing Act (HR 1046). Generally supporting the proposed CMS Safe Harbor rule. Generally supporting the proposed United States Mexico Canada (USMCA) Trade Agreement. Opposing H.R. 3 legislation regarding health care costs Opposing the FDA's Proposed Rule regarding the importation of prescription drugs (Docket No. FDA-2019-N-5711) Supporting H.R. 5741, the "Strengthening Innovation in Medicare and Medicaid Act Supporting the CMS Notice of Benefit and Payment Parameters (NBPP) Proposed Rule (CMS-9944-P) Opposing a proposed White House Executive Order concerning the Buy America Act

Client expense: $75,897 · 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, SENATE, White House Office

21st Century Cures: Health Care Pricing Transparency RFI ACA Implementation Association Health Plans Blueprint to Lower Drug Prices and Reduce Out of Pocket Costs Cadillac Tax Delay/Repeal Compulsory Licensing Health Care pricing transparency Health Care Reform Health Insurance Tax Health Reimbursement Arrangements (HRAs) Health Savings Accounts International Pricing Index Model for Medicare Part B Drugs ANPRM Medical Device Tax Medicare for All/Single Payer Medicare Part D Rebates Opioid Crisis Pharmaceutical Drug Importation Pharmaceutical Pricing Transparency S. 1895 Lower Health Care Cost Act S. 344, H.R. 990 Hatch Waxman Integrity Act of 2019 Surprise Billing Tax Treatment of Employer-Sponsored Health Care Wellness Plans

Client expense: $1,900,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Product Safety Commission (CPSC), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Export-Import Bank of the United States (EXIM Bank), Federal Communications Commission (FCC), Federal Energy Regulatory Commission (FERC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Internal Revenue Service (IRS), Intl Trade Administration (ITA), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), President of the U.S., SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), Vice President of the U.S., White House Office

H.R. 465: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 990: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms H.R. 1188: FLAT Prices Act - Provisions related to prescription drug patents, exclusivity periods and pricing H.R. 1344: Competitive Deals Resulting in Unleased Generics and Savings Act of 2019 - Provisions related to patent settlements H.R. 1499: Protecting Consumer Access to Generic Drugs Act of 2019 - Provisions related to patent settlements H.R. 1503: Orange Book Transparency Act - Provisions related to prescription drug and device patent listings H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to prescription drug patent listings H.R. 2374: Stop STALLING Act - Provisions related to citizen petitions H.R. 2375: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 2387: STOP GAMES Act of 2019 - Provisions related to citizen petitions H.R. 2455: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions H.R. 2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act - Provisions related to patent settlements, generic exclusivity, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 3666: STRONGER Patents Act of 2019 - Provisions related to prescription drug patents H.R. 3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 - Provisions related to patent litigation H.R. 4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug patents H.R. 4712: Fairness in Orphan Drug Exclusivity Act - Provisions related to prescription drug exclusivity periods H.R. 4850: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures H.R. 4955: Protecting Access to Safe and Effective Medicines Act of 2019 - Provisions related to new chemical exclusivity H.R. 5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug exclusivity periods and manufacturer behavior H.R. 5444: To amend the Biologics Price Competition and Innovation Act of 2009 to streamline the transition of certain products from approval as a drug to licensure as a biological product, and for other purposes. - Provisions related to BPCIA and biological products S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights S. 344: Hatch-Waxman Integrity Act of 2019 - Provisions related to PTAB proceedings and other patent system reforms S. 366: FLAT Prices Act - Provisions related to prescription drug patents, exclusivity periods and pricing S. 440: PACED Act - Provisions related to use of sovereign immunity in patent disputes S. 659: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures S. 1169: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions S. 1209: Reforming Evergreening and Manipulation that Extends Drug Years Act - Provisions related to prescription drug patents S. 1224: Stop STALLING Act - Provisions related to citizen petitions S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents S. 1617: Second Look at Drug Patents Act of 2019 - Provisions related to prescription drug patents S. 1636: Ensuring Innovation Act - Provisions related to new chemical exclusivity S. 2082: STRONGER Patents Act of 2019 - Provisions related to prescription drug patents Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Trademark legislative proposals Bayh-Dole march-in rights policy issues

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

Issues related Inter Partes Review (IPR) process for biosimilars and generic drugs S.344, H.R. 990 - Hatch-Waxman Integrity Act of 2019 Patent Settlements

Client expense: $630,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR), White House Office

Issues related to implementation of the FDA user fee reauthorization bill Issues related to the Inter Partes Review (IPR) process S. 344, H.R. 990, Hatch-Waxman Integrity Act of 2019 S. 340, H.R. 965, CREATES Act of 2019 Issues related to drug compounding and counterfeit drugs S. 440, PACED Act

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

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

S. 61, Safe and Affordable Drugs from Canada Act (Grassley) - drug importation S. 64, Preserve Access to Affordable Generics and Biosimilars Act (Grassley-Klobuchar) - prohibiting pay-for-delay settlements S. 73, End Taxpayer Subsidies for Drug Ads Act (Shaheen) - prohibiting tax deduction for DTC advertising expenses S. 102, Prescription Drug Price Relief Act (Sanders) - reforms linked to international pricing S. 340, CREATES Act (Leahy) - removing barriers to generic drugs S. 344, Hatch-Waxman Integrity Act (Tillis) - inter partes review process S. 366, FLAT Prices Act (Durbin) - reforms for drugs with sudden price spikes S. 378, Stop Price Gouging Act (Durbin) - excise tax for drugs that have price spikes S. 440, Preserving Access to Cost-Effective Drugs Act (Cotton) - sovereign immunity and Inter Partes Review process S. 474, SPIKE Act (Wyden) - justification for drug price increases S. 476, Creating Transparency to Have Drug Rebates Unlocked Act (Wyden) - drug price transparency S. 637, CURE High Drug Prices Act (Blumenthal) - remedies for price gouging S. 657, Point of Sale Rebates (Braun) S. 659, Biologic Patent Transparency Act (Collins) - patent disclosure requirements S. 660, Efficiency and Transparency in Petitions Act (Braun) - FDA citizen petition process S. 844, Short on Competition Act (Klobuchar) - remedies for marginally competitive drug markets S. 977, Transparency Drug Pricing Act (Scott) - transparency and drug pricing reforms S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years Act (Cassidy) - preventing evergreening of patent protections S. 1224, Stop STALLING Act (Klobuchar) - citizen petition process S. 1227, Prescription Pricing for the People Act (Grassley) - FTC report on role of PBMs and allegations of anticompetitive conduct by manufacturers of sole-source drugs S. 1384, Prescription Drug Rebate Reform Act (Romney-Braun) - prescription drug cost sharing S. 1416, Affordable Prescriptions for Patients Act (Cornyn) - product hopping, patent thickets S. 1664, Prescription Drug Price Reporting Act (Scott) - prescription drug price reporting S. 2247, Phair Relief Act of 2019 (Kennedy)-transparency around price concessions for drugs S. 2387, We Protect American Investment in Drugs Act (Van Hollen)-drug pricing S. 2543, Prescription Drug Pricing Reduction Act of 2019 (Grassley)-Drug pricing S. 2740, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 (Isakson) - regulations re nonprescription drugs that are marketed without an approved new drug application S. 3052, United States-Mexico-Canada Agreement Implementation Act (Grassley) - drug pricing S. 3067, Non-Opioids Prevent Addiction In the Nation Act (Capito) - non-opioid treatments S. 3092, Expanding Access to Low-Cost Generics Act of 2019 (Smith) - exclusivity period H.R. 3, Lower Drug Costs Now Act of 2019 (Pallone)-drug pricing H.R. 465, Prescription Drug Price Relief Act (Khanna) - reforms linked to international pricing H.R. 478, Safe and Affordable Drugs from Canada Act (Pingree) - drug importation H.R. 938, BLOCKING Act (Schrader) - changes to 180-day period of market exclusivity for first generic applicant H.R. 965, CREATES Act (Cicilline) - removing barriers to generic drugs H.R. 985, FAST Generics Act (Welch) - removing barriers to generic drugs H.R. 990, Hatch-Waxman Integrity Act (Flores) - inter partes review process H.R. 1093, Stop Price Gouging Act (Pocan) - excise tax for drugs that have price spikes H.R. 1188, FLAT Prices Act (Golden) - reforms for drugs with sudden price spikes H.R. 1344, Competitive DRUGS Act (Doggett) - prohibiting pay-for-delay agreements H.R. 1419, Public Option Deficit Reduction Act (DeFazio) - public option H.R. 1499, Protecting Consumer Access to Generic Drugs Act (Rush) - prohibiting pay-for-delay agreements H.R. 1503, Orange Book Transparency Act (Kelly) - removal of invalidated patents from Orange Book H.R. 1506, FAIR Generics Act (Barragan) - changes to 180-day period of market exclusivity for first generic applicant H.R. 1520, Purple Book Continuity Act (Eshoo) - access to updated information on biologics and biosimilars H.R. 2038, State-Based, Market-Oriented Prescription Drug Negotiations Act (Meadows) - drug price negotiations H.R. 2064, Sunshine for Samples Act (Chu) - reporting requirements on drug samples H.R. 2069, SPIKE Act (Horsford) -justification for drug price increases H.R. 2087, Drug Price Transparency Act (Doggett) - reporting of drug pricing data under Medicare Part B H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting Act (Neal) - transparency in drug pricing H.R. 2115, Public Disclosure of Drug Discounts Act (Spanberger) - disclosure of negotiated Rx discounts H.R. 2279, Safe Step Act (Ruiz) - exceptions process for medication step therapy H.R. 2296, FAIR Drug Pricing Act (Schakowsky) - transparency requirements and justification for high list prices and drug price increases H.R. 2374, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Jeffries) - citizen petition process H.R. 2375, Preserve Access to Affordable Generics and Biosimilars Act (Nadler) - prohibiting pay-for-delay agreements H.R. 2376, Prescription Pricing for the People Act (Collins) - FTC study on role of PBMs and competition and transparency in pharmaceutical supply chain H.R. 3379, Price Relief, Innovation, and Competition for Essential Drugs Act (Schakowsky) - exclusivity period for biological products H.R. 3805, Prescription Drug Rebate Reform Act of 2019 (Gallagher)- drug rebates H.R. 3927, PDMPs Help Patients Act of 2019 (McKinley)-integrating SUDs and behavioral health into PDMPs H.R. 3947, Competition Prescription Act of 2019 (Meadows)- drug pricing H.R. 4010, Emergency Access to Insulin Act of 2019 (Craig)- drug pricing H.R. 4106, Responsibility in Drug Advertising Act of 2019 (DeLauro)-transparency in drug pricing H.R. 4244, MAGIC Act (Kelly)-pathways for insulin approval H.R. 4398, Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (Cicilline)-drug pricing H.R. 4455, BIOSIM Act (Schrader)-access to biosimilars H.R. 4460, Turn the Tide Act (Kuster)-Opioids H.R. 4538, Closing Loopholes for Orphan Drugs Act (Welch)-Access to drugs H.R. 4640, Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2019 (DeFazio) - direct negotiation H.R. 4712, Fairness in Orphan Drug Exclusivity Act (Dean) - limitations on exclusive approval of orphan drugs H.R. 4810, Opioid Prescription Verification Act of 2019 (David) - dispensing of controlled substances H.R. 4906, Insulin Price Reduction Act (Diana DeGette) - insulin costs H.R. 5304, PBM Transparency in Prescription Drug Costs Act (Schrader) - PBMs H.R. 5364, End Price Gouging for Insulin Act (Beatty) - annual reference price for insulin products H.R. 5430, United States-Mexico-Canada Agreement Implementation Act (Hoyer) - drug pricing H.R. 5442, Lowest Price for Patients Act (Porter) - pharmacies to disclose any differential between the cost of a prescription drug H.R. 5444, Lower Insulin Costs Now Act (Underwood) - lowering insulin costs H.Con.Res. 55, Expressing the sense of Congress on the need to inform American consumers with more balanced purchasing information for prescription drugs through the disclosure of price information in direct-to-consumer (DTC) advertisements. (Burgess)-drug pricing Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

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

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