Affordable Prescriptions for Patients Act of 2019

S. 142, Preserve Access to Affordable Generics and Biosimilars Act S. 150, Affordable Prescriptions for Patients Act of 2023 S. 315, Taxpayer Research and Contributions Knowledge (TRACK) Act of 2023, including provisions related to university tech transfer S. 1264, Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act Draft legislation titled Digital Copyright Act of 2021 (discussion draft) Potential legislation similar to H.R. 7776, James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 Potential legislation similar to H.R. 7430, Protecting American Innovation Act Potential legislation similar to H.R. 5502/S. 936, Integrity, Notification, and Fairness in Online Retail Marketplaces for (INFORM) Consumers Act Potential legislation similar to H.R. 5376, Inflation Reduction Act of 2022 Potential legislation similar to H.R. 5429, Save our Stages Extension Act Potential legislation similar to H.R. 6058, Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce (SHOP SAFE) Act of 2020 Potential legislation similar to S. 1416, Affordable Prescriptions for Patients Act of 2019 Potential legislation similar to S. 3700, Affordable Insulin Now Act Potential legislation revising the Family Entertainment and Copyright Act of 2005 Potential legislation making omnibus year-end appropriations Potential legislation regarding the establishment of a SEP royalty court Potential legislation regarding revisions to the tech transfer framework established under the Bayh-Dole Act (P.L. 96-517) Potential legislation seeking to impose pharmaceutical price controls to private sector payers Potential legislation related to artificial intelligence and intellectual property rights Potential legislation related to patent eligibility reform Potential legislation related to changes in Patent Trial and Appeal Board Proceedings Advance Notice of Proposed Rulemaking, United States Patent and Trademark Office, Department of Commerce; Changes Under Consideration to Discretionary Institution Practices, Petition Word-Count Limits, and Settlement Practices for America Invents Act Trial Proceedings Before the Patent Trial and Appeal Board (88 Fed. Reg. 24,503-24,518, April 21, 2023) Various issues relating to implementation of Trade Facilitation and Trade Enforcement Act of 2015 (P.L. 114-125); nomination vacancies relating to intellectual property, including for an Intellectual Property Enforcement Coordinator (IPEC); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; the U.S. Patent and Trademark Office; modernization of the U.S. Copyright Office; patent examination practices and patent quality; U.S. Patent and Trademark Office and Food and Drug Administration collaboration efforts; World Trade Organization pending proposal related to COVID-19 and intellectual property rights; State Departments Office of Authentication; IP issues related to internet counterfeiting and piracy; patent linkage and regulatory data protection; the World Intellectual Property Organization; the World Trade Organization; the World Health Organization; the United Nations; IP issues related to prescription drug pricing and labeling; increased utilization of federal criminal penalties resulting from the passage of the Protect Lawful Streaming Act (PSLA) (P.L. 116-260, Div. Q, Title II), for certain types of copyright infringement via illicit streaming of copyrighted works; intellectual property enforcement priorities at the U.S.-Mexico border; licensing negotiations and remedies for standard-essential patents subject to voluntary F/RAND commitments; draft 2022-2026 USPTO strategic plan; USPTOs IP Attache Program; funding for the Intellectual Property Enforcement Program in FY24 Appropriations Legislation; FY2023 Financial Services and General Government Appropriations bill (including funding for the Office of the Intellectual Property Enforcement Coordinator and other federal agencies appropriations related to intellectual property enforcement)

Client expense: $16,390,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR), White House Office

H.R. 4521, United States Innovation and Competition Act of 2021 H.R. 5376, Inflation Reduction Act of 2022 H.R. 5429, Save our Stages Extension Act H.R. 5502/S. 936, Integrity, Notification, and Fairness in Online Retail Marketplaces for (INFORM) Consumers Act H.R. 7430, Protecting American Innovation Act H.R. 7582/S. 4063, No Free TRIPS Act H.R. 7776, James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 S. 1260, United States Innovation and Competition Act of 2021, including provisions related to research funding and cybersecurity S. 1428, Preserve Access to Affordable Generics and Biosimilars Act S. 1435, Affordable Prescriptions for Patients Act of 2021 S. 1843, Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce (SHOP SAFE) Act of 2021 Fiscal Year 2022 Financial Services and General Government Appropriations bill, including provisions related to funding for the Office of Intellectual Property Enforcement Coordinator and other federal agencies appropriations related to intellectual property enforcement Draft legislation titled Digital Copyright Act of 2021 (discussion draft) Potential legislation similar to H.R. 6058, Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce (SHOP SAFE) Act of 2020 Potential legislation similar to S. 1416, Affordable Prescriptions for Patients Act of 2019 Potential legislation revising the Family Entertainment and Copyright Act of 2005 Potential legislation making omnibus year-end appropriations Nomination of Chris Wilson to be Chief Intellectual Property Negotiator for the Office of the U.S. Trade Representative Notice, Patent Subject Matter Eligibility Guidance, U.S. Patent and Trademark Office (87 Fed. Reg. 53,736-53,737, September 1, 2022) Request for Comment, Office of the United States Trade Representative; 2022 Review of Notorious Markets for Counterfeiting and Piracy (87 Fed. Reg. 52,609-52,611, August 26, 2022) Various issues relating to implementation of Trade Facilitation and Trade Enforcement Act of 2015 (P.L. 114-125); nomination vacancies relating to intellectual property, including for an Intellectual Property Enforcement Coordinator (IPEC); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; the U.S. Patent and Trademark Office; World Trade Organization pending proposal related to COVID-19 and intellectual property rights; State Department Office of Authentication; IP issues related to Australia, Canada, China, India, Brazil, Europe, Mexico and South Africa; IP issues related to internet counterfeiting and piracy; patent linkage and regulatory data protection; the World Intellectual Property Organization; the World Trade Organization; the World Health Organization; the International Telecommunications Union; IP issues related to prescription drug pricing and labeling; modernization of the U.S. Copyright Office; increased utilization of federal criminal penalties resulting from the passage of the Protect Lawful Streaming Act (PSLA) (P.L. 116-260, Div. Q, Title II), for certain types of copyright infringement via illicit streaming of copyrighted works; intellectual property enforcement priorities at the U.S.-Mexico border; licensing negotiations and remedies for standard-essential patents subject to voluntary F/RAND commitments; third party litigation funding and patent litigation

Client expense: $20,990,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR), White House Office

H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act, including provisions related to price controls and prescription drugs H.R. 4521, United States Innovation and Competition Act of 2021 H.R. 5376, Inflation Reduction Act of 2022 H.R. 5429, Save our Stages Extension Act H.R. 5502/S. 936, Integrity, Notification, and Fairness in Online Retail Marketplaces for (INFORM) Consumers Act H.R. 7430, Protecting American Innovation Act H.R. 7582/S. 4063, No Free TRIPS Act S. 1260, United States Innovation and Competition Act of 2021, including provisions related to research funding and cybersecurity S. 1428, Preserve Access to Affordable Generics and Biosimilars Act S. 1435, Affordable Prescriptions for Patients Act of 2021 S. 1843, Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce (SHOP SAFE) Act of 2021 Fiscal Year 2022 Financial Services and General Government Appropriations bill, including provisions related to funding for the Office of Intellectual Property Enforcement Coordinator and other federal agencies appropriations related to intellectual property enforcement Draft legislation titled Digital Copyright Act of 2021 (discussion draft) Potential legislation similar to H.R. 6058, Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce (SHOP SAFE) Act of 2020 Potential legislation similar to S. 1416, Affordable Prescriptions for Patients Act of 2019 Potential legislation revising the Family Entertainment and Copyright Act of 2005 Nomination of Chris Wilson to be Chief Intellectual Property Negotiator for the Office of the U.S. Trade Representative Various issues relating to implementation of Trade Facilitation and Trade Enforcement Act of 2015 (P.L. 114-125); nomination vacancies relating to intellectual property, including for an Intellectual Property Enforcement Coordinator (IPEC); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; the U.S. Patent and Trademark Office; World Trade Organization pending proposal related to COVID-19 and intellectual property rights; State Department Office of Authentication; IP issues related to Australia, Canada, China, India, Brazil, Europe, Mexico and South Africa; IP issues related to internet counterfeiting and piracy; patent linkage and regulatory data protection; the World Intellectual Property Organization; the World Trade Organization; the World Health Organization; the International Telecommunications Union; IP issues related to the U.S.-Mexico, Canada Agreement (USMCA); IP issues related to prescription drug pricing and labeling; modernization of the U.S. Copyright Office; increased utilization of federal criminal penalties resulting from the passage of the Protect Lawful Streaming Act (PSLA) (P.L. 116-260, Div. Q, Title II), for certain types of copyright infringement via illicit streaming of copyrighted works; intellectual property enforcement priorities at the U.S.-Mexico border licensing negotiations and remedies for standard-essential patents subject to voluntary F/RAND commitments

Client expense: $23,940,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR), White House Office

H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act, including provisions related to price controls and prescription drugs H.R. 5502/S. 936, Integrity, Notification, and Fairness in Online Retail Marketplaces for (INFORM) Consumers Act H.R. 7430, Protecting American Innovation Act H.R. 7582/S. 4063, No Free TRIPS Act S. 1260, United States Innovation and Competition Act of 2021, including provisions related to research funding and cybersecurity S. 1428, Preserve Access to Affordable Generics and Biosimilars Act S. 1435, Affordable Prescriptions for Patients Act of 2021 S. 1843, Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce (SHOP SAFE) Act of 2021 Fiscal Year 2022 Financial Services and General Government Appropriations bill, including provisions related to funding for the Office of Intellectual Property Enforcement Coordinator and other federal agencies appropriations related to intellectual property enforcement Draft legislation titled Digital Copyright Act of 2021 (discussion draft) Potential legislation similar to H.R. 6058, Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce (SHOP SAFE) Act of 2020 Potential legislation similar to S. 1416, Affordable Prescriptions for Patients Act of 2019 Potential legislation revising the Family Entertainment and Copyright Act of 2005 Nomination of Chris Wilson to be Chief Intellectual Property Negotiator for the Office of the U.S. Trade Representative Nomination of Katherine Vidal to be Director of the U.S. Patent and Trademark Office (USPTO) Request for Information, Department of Agriculture; Regarding Competition and the Intellectual Property System: Seeds and Other Agricultural Inputs (87 Fed. Reg. 29,730, March 17, 2022) Various issues relating to implementation of Trade Facilitation and Trade Enforcement Act of 2015 (P.L. 114-125); nomination vacancies relating to intellectual property, including for an Intellectual Property Enforcement Coordinator (IPEC); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; the U.S. Patent and Trademark Office; World Trade Organization pending proposal related to COVID-19 and intellectual property rights; State Department Office of Authentication; IP issues related to Australia, Canada, China, India, Brazil, Europe, Mexico and South Africa; IP issues related to internet counterfeiting and piracy; patent linkage and regulatory data protection; the World Intellectual Property Organization; the World Trade Organization; the World Health Organization; the International Telecommunications Union; IP issues related to the U.S.-Mexico, Canada Agreement (USMCA); IP issues related to prescription drug pricing and labeling; modernization of the U.S. Copyright Office; increased utilization of federal criminal penalties resulting from the passage of the Protect Lawful Streaming Act (PSLA) (P.L. 116-260, Div. Q, Title II), for certain types of copyright infringement via illicit streaming of copyrighted works; intellectual property enforcement priorities at the U.S.-Mexico border; licensing negotiations and remedies for standard-essential patents subject to voluntary F/RAND commitments

Client expense: $15,800,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR), White House Office

H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act, including provisions related to price controls and prescription drugs H.R. 5502/S. 936, Integrity, Notification, and Fairness in Online Retail Marketplaces for (INFORM) Consumers Act S. 1260, United States Innovation and Competition Act of 2021, including provisions related to research funding and cybersecurity S. 1428, Preserve Access to Affordable Generics and Biosimilars Act S. 1435, Affordable Prescriptions for Patients Act of 2021 S. 1843, Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce (SHOP SAFE) Act of 2021 Fiscal Year 2022 Financial Services and General Government Appropriations bill, including provisions related to funding for the Office of Intellectual Property Enforcement Coordinator and other federal agencies appropriations related to intellectual property enforcement Draft legislation titled Digital Copyright Act of 2021 (discussion draft) Potential legislation similar to H.R. 6058, Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce (SHOP SAFE) Act of 2020 Potential legislation similar to S. 1416, Affordable Prescriptions for Patients Act of 2019 Nomination of Chris Wilson to be Chief Intellectual Property Negotiator for the Office of the U.S. Trade Representative Various issues relating to implementation of Trade Facilitation and Trade Enforcement Act of 2015 (P.L. 114-125); nomination vacancies relating to intellectual property, including for an Intellectual Property Enforcement Coordinator (IPEC); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; the U.S. Patent and Trademark Office; World Trade Organization pending proposal related to COVID-19 and intellectual property rights; prospective nomination of Laurie Hill to be Director of U.S. Patent and Trademark Office; State Department Office of Authentication; IP issues related to Australia, Canada, China, India, Brazil, Europe, Mexico and South Africa; IP issues related to internet counterfeiting and piracy; patent linkage and regulatory data protection; the World Intellectual Property Organization; the World Trade Organization; the World Health Organization; the International Telecommunications Union; IP issues related to the U.S.-Mexico, Canada Agreement (USMCA); IP issues related to prescription drug pricing and labeling; modernization of the U.S. Copyright Office; increased utilization of federal criminal penalties resulting from the passage of the Protect Lawful Streaming Act (PSLA) (P.L. 116-260, Div. Q, Title II), for certain types of copyright infringement via illicit streaming of copyrighted works; intellectual property enforcement priorities at the U.S.-Mexico border; licensing negotiations and remedies for standard-essential patents subject to voluntary F/RAND commitments

Client expense: $18,660,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR), White House Office

Biopharmaceutical innovation and patent policy issues; Affordable Prescriptions for Patients Act of 2019 (S.1416).

Client expense: $450,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Regulatory exclusivity; Drug pricing; Medicare Part B international reference pricing; Generic drug competition; Drug patent issues; Affordable Prescriptions for Patients Act of 2019 (S. 1416); Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (H.R. 5133/H.R. 4398); H.R. 3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; Executive Order 13944 (List of Essential Medicines, Medical Countermeasures, and Critical Inputs); Executive Order 14001 on a Sustainable Public Health Supply Chain; Compulsory licensing; S.Res.625 - A resolution encouraging the Government and the people of the United States to "Buy American"; Executive Order 13922; Executive Order 13911; Executive Order 13938; Domestic manufacturing incentives; Potential amendments to PREP Act; Bayh-Dole Act; Learnings from Pandemic; Safe Authorization for Vaccines during Emergencies Act (S. 4427); Executive Order 13948 (Lowering Drug Prices by Putting America First); Advancing Americas Interests Act (H.R. 8037); Safeguarding American Innovation Act (S. 3997); Safe to Work Act (S. 4317); 340B drug discounts; Executive Order 13962 (Ensuring Access to United States Government COVID-19 Vaccines); Competition and Antitrust Law Enforcement Reform Act (S. 225); Pioneering Antimicrobial Subscriptions To End Up surging Resistance Act of 2020 (S. 4760/H.R. 8920);Protecting Our Pharmaceutical Supply Chain from China Act of 2020 (H.R. 6482); Part D noninterference; Return on Investment (ROI) Initiative for Unleashing American Innovation; 85 Fed. Reg. 76180; Suitability petitions; Securing America's Vaccines for Emergencies (SAVE) Act of 2020 (H.R. 6399/S. 3715); Pandemic Emergency Manufacturing Act of 2021 (S. 187); H.R.153 - Protecting Consumer Access to Generic Drugs Act of 2021; Lower Costs, More Cures Act (H.R. 19/ S. 3129); S.164 - Advancing Education on Biosimilars Act of 2021; Drug recalls; drug shortages; Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3); Medicare reimbursement of prescription drugs; S. 1435, Affordable Prescriptions for Patients Act of 2021; H.R. 2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act; H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; H.R. 2387, STOP GAMES Act of 2019; H.R. 4384, Patient Safety and Drug Labeling Improvement; Transparency of EUA Information and FDA-State Information Sharing; Cures 2.0 Act Discussion Draft; H.R. 2883, Stop Stalling Access to Affordable Medications; S. 1425, Stop STALLING Act; Clinical Trial Diversity; S. 1644, Promising Pathway Act; Preserve Access to Affordable Generics and Biosimilars Act (S. 1428/ H.R. 2891); STOP Fentanyl Act of 2021 (S. 1457/H.R. 2366); S. 1508 - A bill to provide for the use of emergency use authorization data and real world evidence gathered during an emergency to support premarket applications for drugs, biological products, and devices, and for other purposes; S. 1260, United States Innovation and Competition Act of 2021; H.R. 2731, Endless Frontier Act; draft Fiscal Year 2022 Labor, Health and Human Services, Education, and Related Agencies funding bill; draft legislation to amend provisions of the National Childhood Vaccination Injury Act to establish new criteria and procedures for covering vaccines in the Vaccine Injury Compensation Program; Country of origin labeling; Supply chain issues; Quality Systems; National Institute of Standards and Technologys (NIST) January 4, 2021 Notice of Proposed Rulemaking (NPRM) on 37 CFR Parts 401 and 404, the implementing regulations of the Bayh-Dole Act; Health Advanced Research Projects Agency (HARPA) proposal.

Client expense: Not reported · Firm income: $480,000

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

H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act, including provisions related to price controls and prescription drugs S. 1260, United States Innovation and Competition Act of 2021, including provisions related research funding and cybersecurity Fiscal Year 2022 Financial Services and General Government Appropriations Act, including provisions related to funding for the Office of Intellectual Property Enforcement Coordinator and other federal agencies appropriations related to intellectual property enforcement Potential legislation similar to H.R. 6058, Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce (SHOP SAFE) Act of 2020 Potential legislation similar to S. 1416, Affordable Prescriptions for Patients Act of 2019 Draft legislation titled Shop Safe Act of 2021 Draft legislation titled Digital Copyright Act of 2021 (discussion draft) Prospective nomination of Laurie Hill to be Director of U.S. Patent and Trademark Office; Various issues relating to implementation of Trade Facilitation and Trade Enforcement Act of 2015 (P.L. 114-125); nomination vacancies relating to intellectual property; Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; the U.S. Patent and Trademark Office; World Trade Organization pending proposal related to COVID-19 and intellectual property rights; State Department Office of Authentication; IP issues related to Australia, Canada, China, India, Brazil, Europe, Mexico and South Africa; IP issues related to internet counterfeiting and piracy; patent linkage and regulatory data protection; the World Intellectual Property Organization; the World Trade Organization; the World Health Organization; the International Telecommunications Union; IP issues related to the U.S.-Mexico, Canada Agreement (USMCA); IP issues related to prescription drug pricing and labeling; modernization of the U.S. Copyright Office; increased utilization of federal criminal penalties resulting from the passage of the Protect Lawful Streaming Act (PSLA) (P.L. 116-260, Div. Q, Title II, for certain types of copyright infringement via illicit streaming of copyrighted works

Client expense: $11,640,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), 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 Energy Regulatory Commission (FERC), Federal Reserve System, Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), 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

Biopharmaceutical innovation and patent policy issues; Affordable Prescriptions for Patients Act of 2019 (S.1416).

Client expense: $450,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Regulatory exclusivity; Drug pricing; Medicare Part B international reference pricing; Generic drug competition; Drug patent issues; Affordable Prescriptions for Patients Act of 2019 (S. 1416); Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (H.R. 5133/H.R. 4398); H.R. 3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; Executive Order 13944 (List of Essential Medicines, Medical Countermeasures, and Critical Inputs); Executive Order 14001 on a Sustainable Public Health Supply Chain; Compulsory licensing; Real world evidence; National Defense Authorization Act for Fiscal Year 2021 (S. 4049); S.Res.625 - A resolution encouraging the Government and the people of the United States to "Buy American"; Executive Order 13922; Executive Order 13911; Executive Order 13938; Domestic manufacturing incentives; Potential amendments to PREP Act; Bring Entrepreneurial Advancements To Consumers Here In North America Act (H.R. 6690); Bayh-Dole Act; Learnings from Pandemic; Safe Authorization for Vaccines during Emergencies Act (S.4427); Executive Order 13948 (Lowering Drug Prices by Putting America First); Advancing Americas Interests Act (H.R. 8037); Safeguarding American Innovation Act (S. 3997); Safe to Work Act (S. 4317); 340B drug discounts; Executive Order 13962 (Ensuring Access to United States Government COVID-19 Vaccines); antitrust reform proposals; Competition and Antitrust Law Enforcement Reform Act (S. 225); Pioneering Antimicrobial Subscriptions To End Up surging Resistance Act of 2020 (S. 4760/H.R. 8920); Lower Health Care Costs Act (S. 1895); Protecting Our Pharmaceutical Supply Chain from China Act of 2020 (H.R. 6482); Part D non-interference; Ensuring Innovation Act (S.1636); Return on Investment (ROI) Initiative for Unleashing American Innovation; 85 Fed. Reg. 76180; Suitability petitions; Securing America's Vaccines for Emergencies (SAVE) Act of 2020 (H.R. 6399/S. 3715); Pandemic Emergency Manufacturing Act of 2021 (S. 187); H.R.153 - Protecting Consumer Access to Generic Drugs Act of 2021; Lower Costs, More Cures Act (H.R. 19/ S. 3129); Fairness in Orphan Drug Exclusivity Act (S. 250/ H.R. 4712); S. 415 - A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity; S.164 - Advancing Education on Biosimilars Act of 2021; Preserve Access to Affordable Generics and Biosimilars Act (S. 64/HR 2375); Drug recalls; drug shortages; Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3); Medicare reimbursement of prescription drugs; Unnamed bill regarding FDA demand reporting with respect to drugs.

Client expense: Not reported · Firm income: $380,000

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

Potential legislation similar to H.R. 6058, Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce (SHOP SAFE) Act of 2020 Potential legislation similar to S. 1416, Affordable Prescriptions for Patients Act of 2019 Draft legislation titled Digital Copyright Act of 2021 (discussion draft) Development of a national consumer awareness campaign on combating the trafficking in counterfeit and pirated products (86 Fed. Reg. 8894-8895, March 12, 2021) Various issues relating to implementation of Trade Facilitation and Trade Enforcement Act of 2015 (P.L. 114-125); nomination vacancies relating to intellectual property; Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; the U.S. Patent and Trademark Office; World Trade Organization pending proposal related to COVID-19 and intellectual property rights; prospective nomination of Laurie Hill to be Director of U.S. Patent and Trademark Office; IP issues related to Australia, Canada, China, India, Brazil, Europe, Mexico and South Africa; IP issues related to internet counterfeiting and piracy; patent linkage and regulatory data protection; the World Intellectual Property Organization; the World Trade Organization; the World Health Organization; the International Telecommunications Union; IP issues related to the U.S.-Mexico, Canada Agreement (USMCA); IP issues related to prescription drug pricing and labeling; modernization of the U.S. Copyright Office; increasing federal criminal penalties for certain types of copyright infringement via illicit streaming of copyrighted works

Client expense: $17,190,000 · 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), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), 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

Bayh-Dole Act/Tech Transfer ---Bayh-Dole 40th Anniversary ---Domestic Manufacturing Requirement ---March-In Rights Compulsory licensing ---S.2387: We Protect American Investment in Drugs Act of 2019 Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Restrictions on Intellectual Property Rights Drug Patenting ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Intellectual Property International Enforcement ---China ---S.3952: A bill to require the imposition of sanctions with respect to foreign persons that have engaged in significant theft of trade secrets of United States persons, and for other purposes. Patent Reform ---H.R.7259/S.2814: Patents for Humanity Program Improvement Act of 2020 Patenting of Biological Inventions ---Section 101 Modernization The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions

Client expense: $3,320,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Home Administration of Part B Drugs ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions Drug Pricing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Implementation of CREATES Act of 2019 ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Potential Administration Executive Orders ---Pricing-related Provisions Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Pricing and Rebates Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Reimbursement and Coverage of Innovative Products ---H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020

Client expense: $3,320,000 · 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), Natl Economic Council (NEC), Office of the Vice President of the United States, SENATE, White House Office

21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---340B Pause Act (Discussion Draft House/Senate) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---Biosimilar Copay ---Brazil Biologics Regulations ---BSUFA ---Canada Biologics Regulations ---Coding ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Implementation of CREATES Act of 2019 ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Reimbursement Climate Change ---RFI from House Select Committee on the Climate Crisis Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6206: Pandemic Response and Emergency Preparedness (PREP) Act of 2020 ---H.R.6260/S.3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Drug Supply Chain Management ---Healthcare Disparities ---Home Administration of Part B Drugs ---Liability ---Medicare reimbursement policies ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper Drug Evaluation and Review ---S.1617: Second Look at Drug Patents Act of 2019 ---S.3872: Promising Pathway Act ---Compassionate Use/Expanded Access ---Expedited Pathways ---Priority Review Voucher Programs Drug Manufacturing, Quality & Distribution ---Drug Shortages ---Drug Supply Chain Management Drug Patenting ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Drug Pricing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1425: The Patient Protection and Affordable Care Enhancement Act of 2020 ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Implementation of CREATES Act of 2019 ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Potential Administration Executive Orders ---Pricing-related Provisions Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Pricing and Rebates Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Orphan Drug Issues ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 ---H.R.4712: Fairness in Orphan Drug Exclusivity Act of 2019 ---Tax Credit Rare Pediatric Disease Priority Review ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 Reimbursement and Coverage of Innovative Products ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions Trade and Foreign Drug Price Controls US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions Vaccines and Infectious Diseases ---H.R.2862/S.1619: Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Adult Immunization Education ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Maternal Immunization ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program

Client expense: $3,320,000 · 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), Natl Economic Council (NEC), Natl Security Council (NSC), Office of the Vice President of the United States, SENATE, U.S. Trade Representative (USTR), White House Office

21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Home Administration of Part B Drugs ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions Drug Pricing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Implementation of CREATES Act of 2019 ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Potential Administration Executive Orders ---Pricing-related Provisions Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Pricing and Rebates Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Reimbursement and Coverage of Innovative Products ---H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020

Client expense: $3,320,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), 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), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---340B Pause Act (Discussion Draft House/Senate) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---Biosimilar Copay ---Brazil Biologics Regulations ---BSUFA ---Canada Biologics Regulations ---Coding ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Implementation of CREATES Act of 2019 ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Reimbursement Climate Change ---RFI from House Select Committee on the Climate Crisis Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6206: Pandemic Response and Emergency Preparedness (PREP) Act of 2020 ---H.R.6260/S.3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Drug Supply Chain Management ---Healthcare Disparities ---Home Administration of Part B Drugs ---Liability ---Medicare reimbursement policies ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper Drug Evaluation and Review ---S.1617: Second Look at Drug Patents Act of 2019 ---S.3872: Promising Pathway Act ---Compassionate Use/Expanded Access ---Expedited Pathways ---Priority Review Voucher Programs Drug Manufacturing, Quality & Distribution ---Drug Shortages ---Drug Supply Chain Management Drug Patenting ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Drug Pricing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1425: The Patient Protection and Affordable Care Enhancement Act of 2020 ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Implementation of CREATES Act of 2019 ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Potential Administration Executive Orders ---Pricing-related Provisions Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Pricing and Rebates Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Orphan Drug Issues ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 ---H.R.4712: Fairness in Orphan Drug Exclusivity Act of 2019 ---Tax Credit Rare Pediatric Disease Priority Review ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 Reimbursement and Coverage of Innovative Products ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions Trade and Foreign Drug Price Controls US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions Vaccines and Infectious Diseases ---H.R.2862/S.1619: Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Adult Immunization Education ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Maternal Immunization ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program

Client expense: $3,320,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), 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), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Bayh-Dole Act/Tech Transfer ---Bayh-Dole 40th Anniversary ---Domestic Manufacturing Requirement ---March-In Rights Compulsory licensing ---S.2387: We Protect American Investment in Drugs Act of 2019 Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Restrictions on Intellectual Property Rights Drug Patenting ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Intellectual Property International Enforcement ---China ---S.3952: A bill to require the imposition of sanctions with respect to foreign persons that have engaged in significant theft of trade secrets of United States persons, and for other purposes. Patent Reform ---H.R.7259/S.2814: Patents for Humanity Program Improvement Act of 2020 Patenting of Biological Inventions ---Section 101 Modernization The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions

Client expense: $3,320,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), 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), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

S. 1224, Stop STALLING 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. 5133--Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 H.R. 7296, Medications Affordable by Preventing Pandemic Price Gouging Act (MMAPPP) Act of 2020 H.R. 1503 - the Orange Book Transparency Act; and H.R. 1520 - Orange Book Transparency Act of 2019; H.R. 3 - Lower Drug Costs Now Act of 2019 - Intellectual property and process patent issues - Patent litigation reform - IPR process - Section 101 Reform - Domestic and international compulsory licensing issues - March-in Rights - Product hopping - Orange and purple book disclosures - Hatch Waxman litigation - Trade secret protections

Client expense: $2,030,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office

S.659 - Biologic Patent Transparency Act S. 1227, Prescription Pricing for the People Act of 2019 S. 1224, Stop STALLING Act S.1416 - Affordable Prescriptions for Patients Act of 2019 H.R. 7296, Medications Affordable by Preventing Pandemic Price Gouging Act (MMAPPP) Act of 2020 H.R. 7288 Taxpayer Research and Coronavirus Knowledge (TRACK) Act H.R. 4398 Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 H.R. 1503, the Orange Book Transparency Act;consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; - Intellectual property and process patent issues - Patent litigation reform - IPR process - Section 101 Reform - Compulsory licensing issues

Client expense: $2,750,000 · Firm income: Not reported

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

S.659 - Biologic Patent Transparency Act S. 1227, Prescription Pricing for the People Act of 2019 S. 1224, Stop STALLING Act S.1416 - Affordable Prescriptions for Patients Act of 2019 H.R. 7296, Medications Affordable by Preventing Pandemic Price Gouging Act (MMAPPP) Act of 2020 H.R. 7288 Taxpayer Research and Coronavirus Knowledge (TRACK) Act - Intellectual property and process patent issues - Patent litigation reform - IPR process - Section 101 Reform - Compulsory licensing issues

Client expense: $1,930,000 · Firm income: Not reported

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

S.659 - Biologic Patent Transparency Act S. 1227, Prescription Pricing for the People Act of 2019 S. 1224, Stop STALLING Act S.1416 - Affordable Prescriptions for Patients Act of 2019 - Issues related to Intellectual property and process patent - Patent litigation reform - IPR process - Section 101 Reform - Compulsory licensing issues

Client expense: $2,790,000 · Firm income: Not reported

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

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)

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)

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)

Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543 - Prescription Drug Pricing Reduction Act S. 1416 - Affordable Prescriptions for Patients Act S. 1895 - Lower Health Care Costs Act of 2019 H.R. 3 - Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act H.R. 6179 - Increasing Access to Biosimilars Act of 2020 S. 2723 - Mitigating Emergency Drug Shortages Act H.R. 5304 - PBM Transparency in Prescription Drug Costs Act H.R. 748 - CARES Act H.R. 6431 - Made in America Emergency Preparedness Act S. 4134 - Increasing Access to Biosimilars Act of 2020 Electronic Labeling of Prescription Drugs H.R. 133 - Consolidated Appropriations Act, 2021 H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 8644 - Secure Americas Medicine Act of 2020 H.R. 8588 - Improving the American Drug Supply Chain Act of 2020

Client expense: $580,000 · 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

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

Issues related to Inter Partes Review, including S. 2082, Support Technology and Research for Our Nation's Growth and Economic Resilience Patents Act of 2019 and H.R. 3666, STRONGER Patents Act of 2019; S. 1416, Affordable Prescriptions for Patients Act of 2019.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Biopharmaceutical innovation and patent policy issues; Affordable Prescriptions for Patients Act of 2019 (S.1416).

Client expense: $450,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543 - Prescription Drug Pricing Reduction Act S. 1416 - Affordable Prescriptions for Patients Act S. 1895 - Lower Health Care Costs Act of 2019 H.R. 3 - Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act H.R. 6179 - Increasing Access to Biosimilars Act of 2020 S. 2723 - Mitigating Emergency Drug Shortages Act H.R. 5304 - PBM Transparency in Prescription Drug Costs Act H.R. 748 - CARES Act H.R. 6431 - Made in America Emergency Preparedness Act S. 4134 - Increasing Access to Biosimilars Act of 2020 Electronic Labeling of Prescription Drugs H.R. 133 - Consolidated Appropriations Act, 2021 H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 8644 - Secure Americas Medicine Act of 2020 H.R. 8588 - Improving the American Drug Supply Chain Act of 2020

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

Intellectual property and patent eligibility, generally; Affordable Prescriptions for Patients Through Promoting Competition Act (H.R. 4398), (H.R. 5133); Affordable Prescriptions for Patients Act of 2019 (S. 1416)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity 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 biologic patent listings H.R. 3666: STRONGER Patents Act of 2019 - Provisions related to 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. 5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug exclusivity periods and manufacturer behavior 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. 659: Biologic Patent Transparency Act - Provisions related to biologic patent disclosures S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents S. 1636: Ensuring Innovation Act - Provisions related to new chemical entity exclusivity Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Bayh-Dole march-in rights policy issues

Client expense: $5,130,000 · 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), Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE

Drug safety issues; Prescription drug abuse; Monitor drug pricing legislation; H.R. 987, Strengthening Health Care and Lowering Prescription Drug Costs Act; S. 1895, Lower Health Care Costs Act; S. 1416, Affordable Prescriptions for Patients Act of 2019; H.R. 5133, Affordable Prescriptions for Patients Through Promoting Competition Act of 2019; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act; Public Law 116-136, CARES Act; H.R. 1425, Patient Protection and Affordable Care Enhancement Act (PPACEA); Issues related to Priority Review Voucher extension; H.R. 6800, The Heroes Act; H.R. 925, The Heroes Act; H.R. 133, Consolidated Appropriations Act, 2021 (Public Law 116-260)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 1224, Stop STALLING 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. 5133--Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 H.R. 7296, Medications Affordable by Preventing Pandemic Price Gouging Act (MMAPPP) Act of 2020 H.R. 1503 - the Orange Book Transparency Act; and H.R. 1520 - Orange Book Transparency Act of 2019; H.R. 3 - Lower Drug Costs Now Act of 2019 - Intellectual property and process patent issues - Patent litigation reform - IPR process - Section 101 Reform - Domestic and international compulsory licensing issues - March-in Rights - Product hopping - Orange and purple book disclosures - Hatch Waxman litigation - Trade secret protections

Client expense: $2,020,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office

H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019 H.R. 2426/S. 1273, Copyright Alternative in Small-Claims Enforcement (CASE) Act of 2019 H.R. 6058, Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce (SHOP SAFE) Act of 2020 H.R. 6196, Trademark Modernization (TM) Act of 2020 S. 1416, Affordable Prescriptions for Patients Act of 2019 Draft legislation titled Protecting Lawful Streaming Act (PLSA) Request for comments and notice of a public hearing regarding the 2020 Special 301 review (84 Fed. Reg. 70,613-70,615, December 23, 2019) Request for comments United States Trade Representative regarding 2020 Review of Notorious Markets for Counterfeiting and Piracy (85 Fed. Reg. 62,006-62,008, October 1, 2020) Various issues relating to implementation of Trade Facilitation and Trade Enforcement Act of 2015 (P.L. 114-125); Anti-Counterfeiting Trade Agreement; Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; USPTO IP Attache Program, fee change, and strategic plan; appropriations related to the PRO-IP Act (P.L. 110-403); funding issues related to the USPTO; IP issues related to Australia, Canada, China, India, Brazil, Europe, and Mexico; IP issues related to internet counterfeiting and piracy; IP issues related to trade secret theft; expanded use of software asset management by the Federal Government and its contractors; patent linkage and regulatory data protection; the implementation of Section 182 of the Trade Act of 1974 (P.L. 93-618), as amended by the Omnibus Trade and Competitiveness Act of 1988 and the Uruguay Round Agreements Act (the Special 301 Report); the World Intellectual Property Organization; the World Trade Organization; the World Health Organization; the International Telecommunications Union; IP issues related to the U.S.-Mexico, Canada Agreement (USMCA); IP issues related to prescription drug pricing and labeling; Federal Trade Commission competition and consumer protection; modernization of the U.S. Copyright Office; increasing federal criminal penalties for certain types of copyright infringement via illicit streaming of copyrighted works; registration modernization; intellectual property and copyright during the coronavirus pandemic; U.S. involvement and engagement in the World Intellectual Property Organization (WIPO); Indias non-personal data governance framework

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

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

S.1416--Affordable Prescriptions for Patients Act, Discussion Draft on Section 101 reform of the Patent Act--Issues related to intellectual property, data exclusivity, patent eligibility & patent law reform

Client expense: $400,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Intellectual property, data exclusivity and patent eligibility, generally; Affordable Prescriptions for Patients Act (S.1416); Affordable Prescriptions for Patients Through Promoting Competition Act (H.R. 4398), (H.R. 5133); Issues related to march-in rights under Bayh-Dole Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to patient access Issues related to pharmaceutical manufacturing Issues related to treatment of endometriosis Patent reform - S. 1416 - Affordable Prescriptions for Patients Act of 2019 Medicare Part D H.R. 748 CARES Act - Issues related to COVID-19 relief S. 4397/H.R.6383 - Uterine Fibroid Research and Education Act of 2020 H.R.133 - Consolidated Appropriations Act, 2021

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

Government targets: Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Natl Economic Council (NEC), SENATE, U.S. Trade Representative (USTR)

Issues related to patient access Issues related to pharmaceutical manufacturing Issues related to treatment of endometriosis Patent reform - S. 1416 - Affordable Prescriptions for Patients Act of 2019 Medicare Part D H.R. 748 CARES Act - Issues related to COVID-19 relief S. 4397/H.R.6383 - Uterine Fibroid Research and Education Act of 2020 H.R.133 - Consolidated Appropriations Act, 2021

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

Government targets: Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Natl Economic Council (NEC), SENATE, U.S. Trade Representative (USTR)

Regulatory exclusivity; Drug pricing; Medicare Part B international reference pricing; Generic drug competition; Drug patent issues; Affordable Prescriptions for Patients Act of 2019 (S. 1416); Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (H.R. 5133/H.R. 4398); H.R. 3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; Executive Order 13944 (List of Essential Medicines, Medical Countermeasures, and Critical Inputs); Compulsory licensing; Real world evidence; National Defense Authorization Act for Fiscal Year 2021 (S. 4049); S.Res.625 - A resolution encouraging the Government and the people of the United States to "Buy American"; Executive Order 13922; Executive Order 13911; Executive Order 13938; Domestic manufacturing incentives; Potential amendments to PREP Act; Bring Entrepreneurial Advancements To Consumers Here In North America Act (H.R. 6690); Bayh-Dole Act; Prescription Drug User Fee Act reauthorization; Learnings from Pandemic; Safe Authorization for Vaccines during Emergencies Act (S.4427); Executive Order 13948 (Lowering Drug Prices by Putting America First); Advancing Americas Interests Act (H.R. 8037); Safeguarding American Innovation Act (S. 3997); Safe to Work Act (S. 4317); 340B drug discounts; Executive Order 13962 (Ensuring Access to United States Government COVID-19 Vaccines); antitrust reform proposals; Pioneering Antimicrobial Subscriptions To End Up surging Resistance Act of 2020 (S. 4760/H.R. 8920); Lower Health Care Costs Act (S. 1895); Orange Book Transparency Act of 2020 (H.R. 1503); Purple Book Continuity Act of 2020 (H.R. 1520); Consolidated Appropriations Act, 2021 (H.R. 133); Protecting Our Pharmaceutical Supply Chain from China Act of 2020 (H.R. 6482); Part D non-interference; Ensuring Innovation Act (S.1636); Return on Investment (ROI) Initiative for Unleashing American Innovation; 85 Fed. Reg. 76180.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity 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 biologic patent listings H.R. 3666: STRONGER Patents Act of 2019 - Provisions related to 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. 5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug exclusivity periods and manufacturer behavior 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. 659: Biologic Patent Transparency Act - Provisions related to biologic patent disclosures S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents S. 1636: Ensuring Innovation Act - Provisions related to new chemical entity exclusivity Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Bayh-Dole march-in rights policy issues

Client expense: $750,000 · Firm income: Not reported

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

S. 1416 - Affordable Prescriptions For Patients Act of 2019 S. 1895 - Lower Health Care Costs Act H.R. 3 - Lower Drug Costs Now Act S. 2543 - Prescription Drug Pricing Reduction Act S. 3013 - Encouraging Innovative Benefit Design to Lower Costs for Seniors Act S. 3129 - Lower Costs, More Cures Act of 2019 H.R. 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201 - Families First Coronavirus Response Act S. 3548 - CARES Act H.R. 6800 - The Heroes Act H.R. 133 - Consolidated Appropriations Act, 2021 no specific bills, non-interference, dormant therapies, drug shortages, prescription drug access and affordability, transparency, insulin policy, authorized generics, 340B

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Biopharmaceutical Intellectual Property Data exclusivity 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.1046 - Medicare Negotiation and Competitive Licensing Act of 2019 Bayh-Dole Act Section 101 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 S.1617 - Second Look at Drug Patents Act of 2019 HR 4712 - Fairness in Orphan Drug Exclusivity Act HR 4850 - Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures HR 5133 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 Intellectual Property Issues in Response to coronavirus S.2387 - We Protect American Investment in Drugs Act of 2019 S.64 - Preserve Access to Affordable Generics & Biosimilars Act of 2019

Client expense: $660,000 · 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), Veterans Affairs, Dept of (VA), 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)

Medicare Part D coverage and reimbursement Value of Prescription Drugs Innovative Payment Model (VBAs) Price Transparency Medicaid and 340B issues & drug discount program H.R. 1499, Protecting Consumer Access to Generic Drugs Act S. 1416, Affordable prescriptions for Patients Act H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs ANPRM: Importation of Prescription drugs and Most Favored Nations

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

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