PACED Act

Tribal Sovereignty, S. 440, S. 4079, H.R. 7565

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

Government targets: HOUSE OF REPRESENTATIVES, Interior, Dept of (DOI), SENATE, Treasury, Dept of

H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents Act, regarding all bio-pharmaceutical related provisions H.R. 133, the Consolidated Appropriations Act of 2021, 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)

Issues related to drug pricing; issues related to the IPI CMMI demonstration; monitored issues related to the RFI, the Blueprint to Lower Drug Prices and Reduce Out of Pocket Costs. H.R. 3 - The Lower Drug Costs Now Act H.R. 965/ S. 340, CREATES Act of 2019 S. 1895 - Lower Health Care Costs Act S. 1416 - Affordable Prescriptions for Patients Act S. 440 - Preserving Access to Cost Effective Drugs Act S. 1391 & H.R. 2296 - Fair Accountability and Innovative Research Drug Pricing Act H.R. 1520 - Purple Book Continuity Act H.R. 1503 - Orange Book Continuity Act S. 659 - Biologic Patent Transparency Act S. 1209 - Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act

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

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

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. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents 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)

Tribal Sovereignty, S. 440, S. 4079, H.R. 7565

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

Government targets: HOUSE OF REPRESENTATIVES, Interior, Dept of (DOI), SENATE, Treasury, Dept of

Issues related to drug pricing; issues related to the IPI CMMI demonstration; monitored issues related to the RFI, the Blueprint to Lower Drug Prices and Reduce Out of Pocket Costs. H.R. 3 - The Lower Drug Costs Now Act H.R. 965/ S. 340, CREATES Act of 2019 S. 1895 - Lower Health Care Costs Act S. 1416 - Affordable Prescriptions for Patients Act S. 440 - Preserving Access to Cost Effective Drugs Act S. 1391 & H.R. 2296 - Fair Accountability and Innovative Research Drug Pricing Act H.R. 1520 - Purple Book Continuity Act H.R. 1503 - Orange Book Continuity Act S. 659 - Biologic Patent Transparency Act S. 1209 - Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act

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

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

Tribal Sovereignty, S. 440, S. 4079, H.R. 7565

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

Government targets: HOUSE OF REPRESENTATIVES, Interior, Dept of (DOI), SENATE, Treasury, Dept of

H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents 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. 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)

Issues related to drug pricing; issues related to the IPI CMMI demonstration; monitored issues related to the RFI, the Blueprint to Lower Drug Prices and Reduce Out of Pocket Costs. H.R. 3 - The Lower Drug Costs Now Act H.R. 965/ S. 340, CREATES Act of 2019 S. 1895 - Lower Health Care Costs Act S. 1416 - Affordable Prescriptions for Patients Act S. 440 - Preserving Access to Cost Effective Drugs Act S. 1391 & H.R. 2296 - Fair Accountability and Innovative Research Drug Pricing Act H.R. 1520 - Purple Book Continuity Act H.R. 1503 - Orange Book Continuity Act S. 659 - Biologic Patent Transparency Act S. 1209 - Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act

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

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

Bayh-Dole Act/Tech Transfer ---Bayh-Dole 40th Anniversary ---March-In Rights Compulsory Licensing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 Drug Patenting ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous prices (FLAT) prices Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.3199: Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 Intellectual Property International Enforcement ---China ---India Inter Partes Review ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.3666/S.2082: Support Technology and Research for Our Nation's Growth and Economic Resilience (STRONGER) Patents Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.440 PACED Act of 2019 ---Implementation of the America Invents Act of 2011 Patent Reform ---H.R.3199: Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---Patent Litigation Reforms Patenting of Biological Inventions ---Section 101 Modernization The United States-Mexico-Canada Agreement ---IP Provisions US-China Trade Negotiations ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions

Client expense: $2,890,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Council of Economic Advisers (CEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), Treasury, Dept of, 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: $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

Tribal Sovereignty, S. 440, H.R. 6201, H.R. 748, S. 3548

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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)

H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents 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

Medicaid and Medicare drug pricing. Prescription drug pricing. H.R. 965 - CREATES Act of 2019. H.R. 985 - FAST Generics Act of 2019. S.1895 - Lower Health Care Costs Act. S. 440 - PACED Act H.R. 938 - BLOCKING Act of 2019 H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act S. 2543 - Prescription Drug Pricing Reduction Act of 2019

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

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

Bayh-Dole Act/Tech Transfer ---Domestic Manufacturing Requirement ---March-In Rights Compulsory Licensing ---H.R.465/S.102: Prescription Drug Price Relief Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 Drug Patenting ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous (FLAT) Prices Act ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.3199 Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---H.R.4398/S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 Intellectual Property International Enforcement ---China ---Colombia ---India ---Malaysia ---Saudi Arabia Inter Partes Review ---H.R.3666/S.2082: Support Technology and Research for Our Nation's Growth and Economic Resilience (STRONGER) Patents Act of 2019 ---S.440: Preserving Access to Cost Effective Drugs Act (PACED) Act of 2019 Patent Reform ---H.R.3666/S.2082: Support Technology and Research for Our Nation's Growth and Economic Resilience (STRONGER) Patents Act of 2019 Patenting of Biological Inventions ---Argentina Biotech Patentability Guidelines ---DNA Patenting and Licensing ---PTO Examination Guidelines ---Section 101 Modernization The United States-Mexico-Canada Agreement ---IP Provisions US-China Trade Negotiations ---IP Provisions US-Japan Trade Agreement ---IP Provisions

Client expense: $3,120,000 · Firm income: Not reported

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

Issues related to drug pricing; issues related to the IPI CMMI demonstration; monitored issues related to the RFI, the Blueprint to Lower Drug Prices and Reduce Out of Pocket Costs. H.R. 3 - The Lower Drug Costs Now Act H.R. 965/ S. 340, CREATES Act of 2019 S. 1895 - Lower Health Care Costs Act S. 1416 - Affordable Prescriptions for Patients Act S. 440 - Preserving Access to Cost Effective Drugs Act S. 1391 & H.R. 2296 - Fair Accountability and Innovative Research Drug Pricing Act H.R. 1520 - Purple Book Continuity Act H.R. 1503 - Orange Book Continuity Act S. 659 - Biologic Patent Transparency Act S. 1209 - Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act

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

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

Issue: Educate Congress and the administration on academic medicines missions, including education, research, patient care, GME, workforce, and physician shortages in rural and urban communities. H.R. 2781, Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness for Health Act of 2019 S. 2997, Title VII Health Care Workforce Reauthorization Act of 2019 Issue: Support the reauthorization of Health Resources and Services Administrations Title VII health professions workforce programs. P.L 116-94, Further Consolidated Appropriations Act, 2020, Division N P.L. 116-59, Continuing Appropriations Act 2020, and Health Extenders Act of 2019 P.L. 116-69, Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019 S.1895, Lower Health Care Costs Act S. 106, H.R. 1983, H.R.2328, Community Health Investment, Modernization, and Excellence Act of 2019 S. 192, Community and Public Health Programs Extension Act S. 692, H.R. 1943, Community Health Center and Primary Care Workforce Expansion Act of 2019 Issue: Support the reauthorization of the National Health Service Corps, Community Health Centers, and Teaching Health Centers mandatory appropriation funds. Issue: Support initiatives of hospitals to promote affordable housing in local communities and eliminate other social determinants of health to improve health equity. Issues: Educate Congress and the administration about academic medicines response to the opioid epidemic. Support funding for training on substance use disorders, pain management, and safe prescribing practices. P.L. 116-94, The Further Consolidated Appropriations Act, 2020, Division N P.L. 116-69, Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019 H.R. 3030, Patient-Centered Outcomes Research Extension Act of 2019 H.R. 3439, Protecting Access to Information for Effective and Necessary Treatment Act H.R. 2328, Reauthorizing and Extending Americas Community Health (REACH) Act S. 2897, Patient-Centered Outcomes Research Institute Reauthorization Act Draft Senate Finance Committee Health Extenders Legislation Issue: Support long-term reauthorization of the Patient Centered Outcomes Research Institute (PCORI) and the Patient Centered Outcomes Research Trust Fund Issue: Oppose restrictions on fetal tissue research. Urge changes to HHS and NIH policy on fetal tissue research. P.L. 116-22, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 Issues: Support the Hospital Preparedness Program and the reauthorization of the Pandemic and All-Hazards Preparedness Act. Support increased funding authorization levels. Issues: Support high-quality affordable health insurance. Support programs and funds for safety-net providers. Issue: Support measures to preserve and strengthen the 340B Drug Pricing Program and oppose efforts to reduce the scope of the program, including instituting a moratorium, increasing reporting requirements on covered entities, and imposing user fees Draft, Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2018 Draft, Diagnostic Accuracy and Innovation Act (DAIA) Issue: Oppose burdensome regulation of Laboratory Developed Tests S. 1895, Lower Health Care Costs Act H.R. 3630, No Surprises Act S. 1531, Stopping The Outrageous Practice of Surprise Medical Bills Act of 2019 H.R. 3502, Protecting People From Surprise Medical Bills Act Issues: Educate Congress on surprise medical bills and price transparency. Support general principles for surprise medical bills draft legislation. Oppose statutory benchmark rate setting. Oppose Senate hospital/insurer contracting provisions and onerous reporting burden. S. 1895, Lower Health Care Costs Act, Title IV Issues: Prescription drug pricing, public health, and health information technology. P.L. 116-94, the Further Consolidated Appropriations Act, 2020, Division N H.R. 2328, Community Health Investment, Modernization, and Excellence Act of 2019 Issue: Support legislation providing stable and predictable funding for quality measurement activities carried out by the National Quality Forum Issue: Development of Enhanced Primary Care Pilot Act proposal Issue: Educate Congress about medical education on nutrition, consent, implicit bias, and maternal health. Issue: Support efforts to address maternal health S. 1416, Affordable Prescriptions for Patients Act S. 1224, H.R. 2374, Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act S. 440, Preserving Access to Cost Effective Drugs Act H.R. 2296 / S.1391, The Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2019 S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act H.R. 2113, Prescription Drug STAR Act US-Mexico-Canada Agreement Issue: Support measures to lower prescription drug cost H.R. 4004, S.2986, Social Determinants Accelerator Act of 2019 Issue: Support grants to address social determinants of health Issue: Support aligning 42 CFR Part 2 regulations with the Health Insurance Portability and Accountability Act (HIPAA) for the purposes of treatment, payment, and healthcare operations. Draft, firearm safety legislation Issue: Support universal background checks, violence prevention programs, extreme risks protection orders, child access safety laws, and reinstating assault weapons ban. H.R. 8, Bipartisan Background Checks Act of 2019 Issue: Support universal background checks Issue: Support nomination of Stephen Hahn, MD, as FDA commissioner. H.R. 1888, Expanding Nutritions Role in Curricula and Healthcare (ENRICH Act) Issue: Support legislation to create or expand nutrition and physical activity curricula. Draft Cures 2.0 Legislation Issue: Support efforts to modernize health care coverage and ensure access to scientific break-throughs through electronic health records, addressing health disparities, harnessing data, and supporting the physician workforce. Issue: Addressing preparedness for influenza. S. 2723, Mitigating Emergency Drug Shortages Act Issue: Support efforts to mitigate drug shortages and develop market-based incentives to help ensure a stable supply of medications critical for patient care Draft Health Equity and Accountability Act Issue: Support programs to improve health equity and address social determinants of health

Client expense: $1,137,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Bureau of Citizenship & Immigration Services (BCIS), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Director of National Intelligence (ODNI), Education, Dept of, Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Internal Revenue Service (IRS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Natl Science Foundation (NSF), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Science & Technology Policy (OSTP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Treasury, Dept of, Veterans Affairs, Dept of (VA), White House Office

Issue: Educate Congress regarding technology transfer and the importance of the Bayh-Dole Act to the US patent system. Issue: Oppose draft legislation to make changes to patent eligibility as written in Section 101 of the Patent Act. S. 440, PACED Act H.R. 2375, Preserve Access to Affordable Generics and Biosimilars Act H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019 Issue: Support legislation to address patent abuse in prescription drug pricing

Client expense: $1,137,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Bureau of Citizenship & Immigration Services (BCIS), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Director of National Intelligence (ODNI), Education, Dept of, Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Internal Revenue Service (IRS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Natl Science Foundation (NSF), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Science & Technology Policy (OSTP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Treasury, Dept of, Veterans Affairs, Dept of (VA), White House Office

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

Bayh-Dole Act/Tech Transfer ---Domestic Manufacturing Requirement ---March-In Rights Compulsory Licensing ---H.R.465/S.102: Prescription Drug Price Relief Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 Drug Patenting ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous (FLAT) Prices Act ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.3199 Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---H.R.4398/S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 Intellectual Property International Enforcement ---China ---Colombia ---India ---Malaysia ---Saudi Arabia Inter Partes Review ---H.R.3666/S.2082: Support Technology and Research for Our Nation's Growth and Economic Resilience (STRONGER) Patents Act of 2019 ---S.440: Preserving Access to Cost Effective Drugs Act (PACED) Act of 2019 Patent Reform ---H.R.3666/S.2082: Support Technology and Research for Our Nation's Growth and Economic Resilience (STRONGER) Patents Act of 2019 Patenting of Biological Inventions ---Argentina Biotech Patentability Guidelines ---DNA Patenting and Licensing ---PTO Examination Guidelines ---Section 101 Modernization The United States-Mexico-Canada Agreement ---IP Provisions US-China Trade Negotiations ---IP Provisions US-Japan Trade Agreement ---IP Provisions

Client expense: $3,120,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Council of Economic Advisers (CEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), 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: $6,450,000 · 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), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

S.659 - Biologic Patent Transparency Act Data Exclusivity Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection issues Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO BPCIA Patents Inter Partes Review at PTO Biosimilars S 1416 - Affordable Prescriptions for Patients Act of 2019 H.R.465 - Prescription Drug Price Relief Act of 2019 H.R.938 - BLOCKING Act of 2019 H.R.987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.990 - Hatch-Waxman Integrity Act of 2019 H.R.1046 - Medicare Negotiation and Competitive Licensing Act of 2019 H.R.2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R.2700 - Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act S.64 - Preserve Access to Affordable Generics and Biosimilars Act S.102 - Prescription Drug Price Relief Act of 2019 Bayh-Dole march-in rights policy issues S.440 - Preserving Access to Cost Effective Drugs Act (PACED Act)(Sovereign immunity issues before the PTAB) Section 101 H.R.1344 - Competitive DRUGS Act of 2019 H.R.1499 - Protecting Consumer Access to Generic Drugs Act of 2019 H.R.1503 - Orange Book Transparency Act of 2019 H.R.1520 - Purple Book Continuity Act of 2019 H.R.2374 - Stop STALLING Act H.R.3666 - STRONGER Patents 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 H.R.4712 - Born-Alive Abortion Survivors Protection Act H.R.4850 - Biologic Patent Transparency Act H.R.5133 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 H.R.5444 - Taxpayer First Act S.344 - Hatch-Waxman Integrity Act of 2019 S.1416 - Affordable Prescriptions for Patients Act of 2019 S.1617 - Second Look at Drug Patents Act of 2019 S.2082 - Support Technology and Research for Our Nation's Growth and Economic Resilience Patents Act of 2019

Client expense: $620,000 · 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), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

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 proposed trademark legislation

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

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

Tribal Sovereignty, S. 440

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General tribal matters and appropriations; Tribal Labor Sovereignty Act (H.R.779; S.226);Indian Programs Advanced Appropriations Act (S.229; H.R.1128); 2018 Farm Bill implementation; Carcieri legislation (S.2808; H.R.375); fee-to-trust issues; implementation of the Native American Business Development, Trade Promotion and Tourism Act; Indian Buffalo Management Act (H.R.5153); Tax Fairness for Tribal Youth Act of 2019 (H.R.2810; S.2079); Youth Tax Fairness Act of 2019 (H.R.4728); FY2020 appropriations legislation; PACED Act (S.440); Indian Community Economic Development Enhancement Act of 2019 (S.212; H.R.1937); PROGRESS for Indian Tribes Act (S.209); Indian Tribal Regulatory Reform Authority; Tribal Indigenous People's Day; Tribal trade and development legislation; Native American Millennium Challenge Demonstration Act (S.126); Energy Re-authorization Act (S.2610); American Indian Empowerment Act; Violence Against Women Act Re-authorization; federal health care legislation; nomination of Adm. Weahkee to be Director, IHS.

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

Government targets: Agriculture, Dept of (USDA), Bureau of Indian Affairs (BIA), Defense, Dept of (DOD), Energy, Dept of, HOUSE OF REPRESENTATIVES, Interior, Dept of (DOI), SENATE

Issues related to the sovereign immunity for patent protection. Issues related to patents and inter partes review. S. 440 - PACED Act H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019

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

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

Medicaid and Medicare drug pricing. Prescription drug pricing. S. 340 - CREATES Act of 2019. H.R. 965 - CREATES Act of 2019. H.R. 985 - FAST Generics Act of 2019. S.1895 - Lower Health Care Costs Act. S. 1416 - Affordable Prescriptions for Patients Act of 2019 S. 440 - PACED Act H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019 H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 938 - BLOCKING Act of 2019 H.R. 1520 - Purple Book Continuity Act of 2019 H.R. 1503 - Orange Book Transparency Act of 2019 H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act S. 2543 - Prescription Drug Pricing Reduction Act of 2019 H.R. 1865 - Further Consolidated Appropriations Act, 2020

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

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

H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. S. 340, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents Act, regarding all bio-pharmaceutical related provisions

Client expense: $690,000 · 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)

S. 440, the PACED Act. Support for H.R. 990/S. 344, the Hatch-Waxman Integrity Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Patent abuse. S. 440 - PACED Act H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019 S. 617 - Second Look at Drug Patents Act of 2019 S. 1416 - The Affordable Prescriptions for Patients Act S. 1224 - The Stop STALLING Act

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

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

Prescription drug pricing. S. 1895 - Lower Health Care Costs Act S. 1416 - Affordable Prescriptions for Patients Act S. 1224 and H.R. 2374 - Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act S. 440 - Preserving Access to Cost Effective Drugs Act S. 340 and H.R. 965 - CREATES Act S. 1391 & H.R. 2296 - Fair Accountability and Innovative Research Drug Pricing Act H.R. 1520 - Purple Book Continuity Act H.R. 1503 - Orange Book Continuity Act S. 659 - Biologic Patent Transparency Act S. 551 - Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act S. 1209 - Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act H.R. 2113 - Prescription Drug STAR Act S. 617 - Second Look at Drug Patents Act of 2019 S. 2543 - Prescription Drug Pricing Reduction Act of 2019 H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act H.R. 1865 - Further Consolidated Appropriations Act, 2020 USMCA

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

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

Prescription drug pricing. S. 1895 - Lower Health Care Costs Act S. 1416 - Affordable Prescriptions for Patients Act S. 1224 and H.R. 2374 - Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act S. 440 - Preserving Access to Cost Effective Drugs Act S. 340 and H.R. 965 - CREATES Act S. 1391 & S. 2296 - Fair Accountability and Innovative Research Drug Pricing Act H.R. 1520 - Purple Book Continuity Act H.R. 1503 - Orange Book Continuity Act S. 659 - Biologic Patent Transparency Act S. 551 - Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act S. 1209 - Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act H.R. 2113 - Prescription Drug STAR Act H.R. 985 - FAST Generics Act of 2019 S. 2543 - Prescription Drug Pricing Reduction Act of 2019 H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act

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

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

Patent abuse S. 440 - PACED Act H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019 S. 617 - Second Look at Drug Patents Act of 2019 S. 1416 - The Affordable Prescriptions for Patients Act S. 1224 - The Stop STALLING Act

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

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

Prescription drug pricing S. 1895 - Lower Health Care Costs Act S. 1416 - Affordable Prescriptions for Patients Act S. 1224 and H.R. 2374 - Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act S. 440 - Preserving Access to Cost Effective Drugs Act S. 340 and H.R. 965 - CREATES Act S. 1391 and H.R. 2296 - Fair Accountability and Innovative Research Drug Pricing Act H.R. 1520 - Purple Book Continuity Act H.R. 1503 - Orange Book Continuity Act S. 659 - Biologic Patent Transparency Act S. 551 - Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act S. 1209 - Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act H.R. 2113 - Prescription Drug STAR Act H.R. 985 - FAST Generics Act of 2019 H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act S. 2543 - Prescription Drug Pricing Reduction Act of 2019

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

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

Prescription drug pricing S. 1895 - Lower Health Care Costs Act S. 1416 - Affordable Prescriptions for Patients Act S. 1224 and H.R. 2374 - Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act S. 440 - Preserving Access to Cost Effective Drugs Act S. 340 and H.R. 965 - CREATES Act S. 1391 and H.R. 2296 - Fair Accountability and Innovative Research Drug Pricing Act H.R. 1520 - Purple Book Continuity Act H.R. 1503 - Orange Book Continuity Act S. 659 - Biologic Patent Transparency Act S. 551 - Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act S. 1209 - Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act H.R. 2113 - Prescription Drug STAR Act S. 617 - Second Look at Drug Patents Act of 2019 H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act S. 2543 - Prescription Drug Pricing Reduction Act of 2019 H.R. 1865 - Further Consolidated Appropriations Act, 2020 USMCA

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

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

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: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to drug pricing; issues related to the IPI CMMI demonstration; monitored issues related to the RFI, the Blueprint to Lower Drug Prices and Reduce Out of Pocket Costs. H.R. 3 - The Lower Drug Costs Now Act H.R. 965/ S. 340, CREATES Act of 2019 S. 1895 - Lower Health Care Costs Act S. 1416 - Affordable Prescriptions for Patients Act S. 440 - Preserving Access to Cost Effective Drugs Act S. 1391 & H.R. 2296 - Fair Accountability and Innovative Research Drug Pricing Act H.R. 1520 - Purple Book Continuity Act H.R. 1503 - Orange Book Continuity Act S. 659 - Biologic Patent Transparency Act S. 1209 - Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act

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

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

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 proposed trademark legislation

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

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