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No CRS summary is available for this bill yet. The source title, actions, sponsors, and text versions below come from Congress.gov.
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Filing registrants (5)
2024 · fourth_quarter · Copyright/Patent/Trademark
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
H.R. 5475, Prohibiting Adversarial Patents Act of 2023 H.R. 8070, National Defense Authorization Act for Fiscal Year 2025 S. 79, Interagency Patent Coordination and Improvement Act of 2023 S. 142, Preserve Access to Affordable Generics and Biosimilars Act S. 150, Affordable Prescriptions for Patients Act of 2023 S. 315, Taxpayer Research and Contributions Knowledge (TRACK) Act of 2023, including provisions related to university tech transfer S. 1264, Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act S. 2140, Patent Eligibility Restoration Act of 2023 S. 2220, Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act S. 2780, Medication Affordability and Patent Integrity Act S.5160, A bill to expand the sharing of information with respect to suspected violations of intellectual property rights in trade Potential legislation similar to H.R. 5376, Inflation Reduction Act of 2022 Potential legislation similar to S. 1416, Affordable Prescriptions for Patients Act of 2019 Potential legislation regarding revisions to the tech transfer framework established under the Bayh-Dole Act (P.L. 96-517) Potential legislation amending the Inflation Reduction Act (P.L. 117-169) Potential legislation seeking to impose pharmaceutical price controls to private sector payers Potential legislation related to artificial intelligence and intellectual property rights Potential legislation related to patent eligibility reform Potential legislation related to changes in Patent Trial and Appeal Board Proceedings Potential legislation related to digital copyright piracy Potential legislation making omnibus year-end appropriations, with a focus on appropriations for USPTO and the United States Copyright Office Potential legislation related to the NIST Draft Framework on the use of march-in rights for federally funded research. Proposed rulemaking regarding changes to Patent Trial and Appeal Board Proceedings (Fed. Reg. 28,693-28,706, April 19, 2024) Various issues relating to implementation of Trade Facilitation and Trade Enforcement Act of 2015 (P.L. 114-125); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; modernization of the U.S. Copyright Office; patent examination practices and patent quality; patent filing fees; U.S. Patent and Trademark Office and Food and Drug Administration collaboration efforts; State Departments Office of Authentication; IP issues related to counterfeiting; patent linkage and regulatory data protection; pharmaceutical price controls; IP issues related to prescription drug pricing and labeling; implementation of the Inflation Reduction Act of 2022, Drug Price Negotiation Program (P.L. 117-169, subtitle B); implementation of the Bayh-Dole Act (P.L. 96-517), including march-in rights; implementation of the NIST draft interagency guidance for the use of march-in rights on federally funded inventions; emerging issues surrounding artificial intelligence, intellectual property, and data protection; IP issues related to digital piracy; increase utilization of federal criminal penalties resulting from the passage of the Protect Lawful Streaming Act (PSLA) (P.L. 116-260, Div. Q, Title II), for certain types of copyright infringement via illicit streaming of copyrighted works; intellectual property enforcement priorities at the U.S.-Mexico border; licensing negotiations and remedies for standard-essential patents subject to voluntary F/RAND Commitments; funding for the Intellectual Property Enforcement Program in FY25 Appropriations Legislation; the "Reasonable Price Clause" in reauthorization draft of the Pandemic and All Hazards Preparedness Act (PAHPA, P.L. 109-417); WHOIS policy for .us web domains; March-In rights under the Bayh-Dole Act (P.L. 96-517); inventorship guidance for AI-assisted inventions
Client expense: $22,410,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Natl Institute of Standards & Technology (NIST), Natl Telecommunications & Information Administration (NTIA), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR), White House Office
2024 · fourth_quarter · Pharmacy
GLP-1 pricing and licensing, Medical Innovation Act, Medicare drug price negotiation implementation, Medicines for All Act, pharmaceutical manufacturer-sponsored telehealth platforms, S.2140 PERA, S.2220 PREVAIL Act, S.Res.684 supporting GAVI; PILLS Act, H.R.885, S.315 TRACK Act, Medicare drug price negotiation, international reference price negotiation price caps, number of drugs negotiated, out of pocket caps, inflation rebates, negotiation delay periods, S.2044 End Price Gouging for Medications Act, S.2140 PERA; S.2220 PREVAIL Act; S. 79, Interagency Patent Coordination and Improvement Act; S. 142, Preserve Access to Affordable Generics and Biosimilars Act; S. 148, Stop STALLING Act; S. 150, Affordable Prescriptions for Patients Act, We PAID Act; march-in rights, S.2140 PERA; S.2220 PREVAIL Act, intramural access plan and licensing policy, march-in rights guidance.
Client expense: $65,190 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, White House Office
2024 · third_quarter · Copyright/Patent/Trademark
H.R. 5475, Prohibiting Adversarial Patents Act of 2023 H.R. 8070, National Defense Authorization Act for Fiscal Year 2025 S. 79, Interagency Patent Coordination and Improvement Act of 2023 S. 142, Preserve Access to Affordable Generics and Biosimilars Act S. 150, Affordable Prescriptions for Patients Act of 2023 S. 315, Taxpayer Research and Contributions Knowledge (TRACK) Act of 2023, including provisions related to university tech transfer S. 1264, Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act S. 2140, Patent Eligibility Restoration Act of 2023 S. 2220, Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act S. 2780, The Medication Affordability and Patent Integrity Act S.5160, A bill to expand the sharing of information with respect to suspected violations of intellectual property rights in trade Potential legislation similar to H.R. 7430, Protecting American Innovation Act Potential legislation similar to H.R. 5376, Inflation Reduction Act of 2022 Potential legislation similar to S. 1416, Affordable Prescriptions for Patients Act of 2019 Potential legislation regarding revisions to the tech transfer framework established under the Bayh-Dole Act (P.L. 96-517) Potential legislation amending the Inflation Reduction Act (P.L. 117-169) Potential legislation seeking to impose pharmaceutical price controls to private sector payers Potential legislation related to artificial intelligence and intellectual property rights Potential legislation related to patent eligibility reform Potential legislation related to changes in Patent Trial and Appeal Board Proceedings Potential legislation related to digital copyright piracy Potential legislation making omnibus year-end appropriations, with a focus on appropriations for USPTO and the United States Copyright Office Potential legislation related to the NIST Draft Framework on the use of march-in rights for federally funded research. Proposed rulemaking regarding changes to Patent Trial and Appeal Board Proceedings (Fed. Reg. 28,693-28,706, April 19, 2024) Various issues relating to implementation of Trade Facilitation and Trade Enforcement Act of 2015 (P.L. 114-125); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; modernization of the U.S. Copyright Office; patent examination practices and patent quality; patent filing fees; U.S. Patent and Trademark Office and Food and Drug Administration collaboration efforts; State Departments Office of Authentication; IP issues related to internet counterfeiting and piracy; patent linkage and regulatory data protection; pharmaceutical price controls; IP issues related to prescription drug pricing and labeling; implementation of the Inflation Reduction Act of 2022, Drug Price Negotiation Program (P.L. 117-169, subtitle B); implementation of the Bayh-Dole Act (P.L. 96-517), including march-in rights; implementation of the NIST draft interagency guidance for the use of march-in rights on federally funded inventions; emerging issues surrounding artificial intelligence, intellectual property, and data protection; domain name system abuse; increase utilization of federal criminal penalties resulting from the passage of the Protect Lawful Streaming Act (PSLA) (P.L. 116-260, Div. Q, Title II), for certain types of copyright infringement via illicit streaming of copyrighted works; intellectual property enforcement priorities at the U.S.-Mexico border; licensing negotiations and remedies for standard-essential patents subject to voluntary F/RAND Commitments; funding for the Intellectual Property Enforcement Program in FY25 Appropriations Legislation; the Reasonable Price Clause in reauthorization draft of the Pandemic and All Hazards Preparedness Act (PAHPA, P.L. 109-417); WHOIS policy for .us web domains; march-in rights under the Bayh-Dole Act (P.L. 96-517); inventorship guidance for AI-assisted inventions
Client expense: $14,750,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Natl Institute of Standards & Technology (NIST), Natl Telecommunications & Information Administration (NTIA), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR), White House Office
2024 · second_quarter · Copyright/Patent/Trademark
H.R. 5475, Prohibiting Adversarial Patents Act of 2023 H.R. 8070, National Defense Authorization Act for Fiscal Year 2025 S. 79, Interagency Patent Coordination and Improvement Act of 2023 S. 142, Preserve Access to Affordable Generics and Biosimilars Act S. 150, Affordable Prescriptions for Patients Act of 2023 S. 315, Taxpayer Research and Contributions Knowledge (TRACK) Act of 2023, including provisions related to university tech transfer S. 1264, Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act S. 2140, Patent Eligibility Restoration Act of 2023 S. 2220, Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act Potential legislation similar to H.R. 7430, Protecting American Innovation Act Potential legislation similar to H.R. 5376, Inflation Reduction Act of 2022 Potential legislation similar to S. 1416, Affordable Prescriptions for Patients Act of 2019 Potential legislation similar to S. 3700, Affordable Insulin Now Act 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 amending the Inflation Reduction Act (P.L. 117-169) Potential legislation seeking to impose pharmaceutical price controls to private sector payers Potential legislation related to artificial intelligence and intellectual property rights Potential legislation related to patent eligibility reform Potential legislation related to changes in Patent Trial and Appeal Board Proceedings Potential legislation related to digital copyright piracy Potential legislation related to proposed reforms of the National Institutes of Health Potential legislation making omnibus year-end appropriations, with a focus on appropriations for USPTO and the United States Copyright Office Potential legislation related to the NIST Draft Framework on the use of march-in rights for federally funded research Proposed Rule, Federal Trade Commission; Petition for Rulemaking of PIRG and iFixit (89 Fed. Reg. 286, January 3, 2024) Request for Comment, United States Patent and Trademark Office, Department of Commerce; Unlocking the Full Potential of Intellectual Property by Translating More Innovation to the Marketplace (89 Fed. Reg. 18,907-18,911 March 15, 2024) Notice of Proposed Rulemaking, United States Patent and Trademark Office, Department of Commerce; Setting and Adjusting Patent Fees During Fiscal Year 2025 (89 Fed. Reg. 23,226-23,291, April 3, 2024) Proposed rulemaking regarding changes to Patent Trial and Appeal Board Proceedings (Fed. Reg. 28,693-28,706, April 19, 2024) Various issues relating to implementation of Trade Facilitation and Trade Enforcement Act of 2015 (P.L. 114-125); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; modernization of the U.S. Copyright Office; patent examination practices and patent quality; patent filing fees; U.S. Patent and Trademark Office and Food and Drug Administration collaboration efforts; State Departments Office of Authentication; IP issues related to internet counterfeiting and piracy; patent linkage and regulatory data protection; pharmaceutical price controls; IP issues related to prescription drug pricing and labeling; implementation of the Inflation Reduction Act of 2022, Drug Price Negotiation Program (P.L. 117-169, subtitle B); implementation of the Bayh-Dole Act (P.L. 96-517), including march-in rights; implementation of the NIST draft interagency guidance for the use of march-in rights on federally funded inventions; emerging issues surrounding artificial intelligence, intellectual property, and data protection; domain name system abuse; increase utilization of federal criminal penalties resulting from the passage of the Protect Lawful Streaming Act (PSLA) (P.L. 116-260, Div. Q, Title II), for certain types of copyright infringement via illicit streaming of copyrighted works; intellectual property enforcement priorities at the U.S.-Mexico border; licensing negotiations and remedies for standard-essential patents subject to voluntary F/RAND Commitments; funding for the Intellectual Property Enforcement Program in FY24 Appropriations Legislation; the "Reasonable Price Clause" in reauthorization draft of the Pandemic and All Hazards Preparedness Act (PAHPA, P.L. 109-417); WHOIS policy for .us web domains; March-In rights under the Bayh-Dole Act (P.L. 96-517); establishment of IP attache position for U.S. Embassy in the Republic of Korea; inventorship guidance for AI-Assisted Inventions
Client expense: $13,930,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Natl Institute of Standards & Technology (NIST), Natl Telecommunications & Information Administration (NTIA), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR), White House Office
2024 · first_quarter · Copyright/Patent/Trademark
H.R. 5475, Prohibiting Adversarial Patents Act of 2023 H.R. 6943, No AI FRAUD Act S. 79, Interagency Patent Coordination and Improvement Act of 2023 S. 142, Preserve Access to Affordable Generics and Biosimilars Act S. 150, Affordable Prescriptions for Patients Act of 2023 S. 315, Taxpayer Research and Contributions Knowledge (TRACK) Act of 2023, including provisions related to university tech transfer S. 1264, Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act S. 2140, Patent Eligibility Restoration Act of 2023 S. 2220, Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act Draft legislation titled Nurture Originals, Foster Art, and Keep Entertainment Safe (NO FAKES) Act of 2023 Potential legislation similar to H.R. 7430, Protecting American Innovation Act Potential legislation similar to H.R. 5376, Inflation Reduction Act of 2022 Potential legislation similar to 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 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 amending the Inflation Reduction Act (P.L. 117-169) Potential legislation seeking to impose pharmaceutical price controls to private sector payers Potential legislation related to artificial intelligence and intellectual property rights Potential legislation related to patent eligibility reform Potential legislation related to changes in Patent Trial and Appeal Board Proceedings Potential legislation related to right to repair issues in intellectual property rights Proposed Rule, Federal Trade Commission; Petition for Rulemaking of PIRG and iFixit (89 Fed. Reg. 286, January 3, 2024) Various issues relating to implementation of Trade Facilitation and Trade Enforcement Act of 2015 (P.L. 114-125); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; modernization of the U.S. Copyright Office; patent examination practices and patent quality; U.S. Patent and Trademark Office and Food and Drug Administration collaboration efforts; World Trade Organization pending proposal related to pharmaceuticals 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 Trade Organization; the World Health Organization; pharmaceutical price controls; IP issues related to prescription drug pricing and labeling; promoting inclusive innovation and diversity initiatives in the intellectual property system; proposed rulemaking regarding changes to Patent Trial and Appeal Board Proceedings; implementation of the Inflation Reduction Act of 2022, Drug Price Negotiation Program (P.L. 117-169, subtitle B); implementation of the Bayh-Dole Act (P.L. 96-517), including march-in rights; right-to-repair issues; emerging issues surrounding artificial intelligence, intellectual property, and data protection; domain name system abuse; increase utilization of federal criminal penalties resulting from the passage of the Protect Lawful Streaming Act (PSLA) (P.L. 116-260, Div. Q, Title II), for certain types of copyright infringement via illicit streaming of copyrighted works; intellectual property enforcement priorities at the U.S.-Mexico border; licensing negotiations and remedies for standard-essential patents subject to voluntary F/RAND Commitments; USPTO's IP Attache Program; funding for the Intellectual Property Enforcement Program in FY24 Appropriations Legislation; the "Reasonable Price Clause" in reauthorization draft of the Pandemic and All Hazards Preparedness Act (PAHPA, P.L. 109-417); WHOIS policy for .us web domains;
Client expense: $23,370,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Natl Institute of Standards & Technology (NIST), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR), White House Office
2023 · fourth_quarter · Health Issues
H.R. 167: Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1503: Prescription Information Modernization Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2500: Protecting Americans from Unsafe Drugs Act of 2023 H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 2893: Seniors Securing Access to Vital and Essential Prescription Drugs Act H.R. 2940/S. 1355: PASTEUR Act - authorizes the Department of Health and Human Services (HHS) to enter into subscription contracts for critical-need antimicrobial drugs. Inflation Reduction Act - provisions related to vaccines and pharmaceuticals. H.R. 2959: Health Savings Act of 2023 H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3160: Pharmaceutical Research Transparency Act of 2023 H.R. 3281: Transparent PRICE Act H.R. 3284: Providers and Payers COMPETE Act H.R. 3285: Fairness for Patient Medications Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3791: Improving DATA in Public Health Act H.R. 3793: Ensuring Access to Lifesaving Drugs Act of 2023 H.R. 3810: Drug Origin Transparency Act of 2023 H.R. 3839: Increasing Transparency in Generic Drug Applications Act H.R. 4115: The Lower Drug Costs for Families Act H.R. 4370: PREVAIL Act - Provisions related to the PTAB H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4507: Transparency in Coverage Act of 2023 H.R. 4508: Hidden Fee Disclosure Act H.R. 4822: Health Care Price Transparency Act of 2023 H.R. 4882: Clinical Laboratory Price Transparency Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging (DRUG) Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 315: Taxpayer Research And Contributions Knowledge Act of 2023 or TRACK Act of 2023 - To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development, and for other purposes S. 476: Maintaining Investments in New Innovation Act S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1114: Expanding Access to Low-Cost Generics Act 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1217: Prescription Drug Impact Act of 2023 S. 1250: Drug-price Transparency for Consumers Act of 2023 S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1374: Patient Right to Shop Act S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2840: Bipartisan Primary Care and Health Workforce Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 4953: Protect Drug Innovation Act User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Anticounterfeiting policy issues Artificial intelligence policy issues H.R.5143 - Vaccine Access Improvement Act - reform the vaccine injury compensation program H.R. 5142 - Vaccine Injury Compensation Modernization Act -- reform the vaccine injury compensation program S.1542/H.R.6283 - Delinking Revenue from Unfair Gouging Act - commercial delinking of PBM prices Labor HHS Appropriations Inflation Reduction Act of 2022, provisions related to Part D redesign and Medicare negotiation; 340B reform proposals
2023 · fourth_quarter · Health Issues
H.R. 167: Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1503: Prescription Information Modernization Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2500: Protecting Americans from Unsafe Drugs Act of 2023 H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 2893: Seniors Securing Access to Vital and Essential Prescription Drugs Act H.R. 2959: Health Savings Act of 2023 H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3134: Emergency Access to Insulin Act of 2023 H.R. 3160: Pharmaceutical Research Transparency Act of 2023 H.R. 3281: Transparent PRICE Act H.R. 3284: Providers and Payers COMPETE Act H.R. 3285: Fairness for Patient Medications Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3791: Improving DATA in Public Health Act H.R. 3793: Ensuring Access to Lifesaving Drugs Act of 2023 H.R. 3810: Drug Origin Transparency Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4115: Lower Drug Costs for Families Act H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4507: Transparency in Coverage Act of 2023 H.R. 4508: Hidden Fee Disclosure Act of 2023 H.R. 4822: Health Care Price Transparency Act of 2023 H.R. 4882: Clinical Laboratory Price Transparency Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 315: Taxpayer Research And Contributions Knowledge Act of 2023 or TRACK Act of 2023 - To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development, and for other purposes S. 476: Maintaining Investments in New Innovation Act S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 954: Affordable Insulin Now Act of 2023 S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1114: Expanding Access to Low-Cost Generics Act 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1217: Prescription Drug Impact Act of 2023 S. 1250: Drug-price Transparency for Consumers Act of 2023 S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1374: Patient Right to Shop Act S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1497: Emergency Access to Insulin Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2840: Bipartisan Primary Care and Health Workforce Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 4953: Protect Drug Innovation Act User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Nomination of Dr. Monica Bertagnolli as NIH director Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain policy issues Mental health policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Cybersecurity policy issues Anticounterfeiting policy issues Artificial intelligence policy issues
2023 · fourth_quarter · Copyright/Patent/Trademark
H.R. 2670/S. 2226, National Defense Authorization Act H.R. 5475, Prohibiting Adversarial Patents Act of 2023 S. 79, Interagency Patent Coordination and Improvement Act of 2023 S. 142, Preserve Access to Affordable Generics and Biosimilars Act S. 150, Affordable Prescriptions for Patients Act of 2023 S. 315, Taxpayer Research and Contributions Knowledge (TRACK) Act of 2023, including provisions related to university tech transfer S. 1264, Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act S. 2140, Patent Eligibility Restoration Act of 2023 S. 2220, Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act Potential legislation similar to H.R. 7430, Protecting American Innovation Act Potential legislation similar to H.R. 5376, Inflation Reduction Act of 2022 Potential legislation similar to 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 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 amending the Inflation Reduction Act (P.L. 117-169) Potential legislation seeking to impose pharmaceutical price controls to private sector payers Potential legislation related to artificial intelligence and intellectual property rights Potential legislation related to patent eligibility reform Potential legislation related to changes in Patent Trial and Appeal Board Proceedings Potential legislation related to right to repair issues in intellectual property rights Request for Information, National Institute of Standards and Technology, Department of Commerce; Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights (88 Fed. Reg. 85,593-85,605, December 8, 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 Trade Organization; pharmaceutical price controls; IP issues related to prescription drug pricing and labeling; promoting inclusive innovation and diversity initiatives in the intellectual property system; proposed rulemaking regarding changes to Patent Trial and Appeal Board Proceedings; implementation of the Inflation Reduction Act of 2022, Drug Price Negotiation Program (P.L. 117-169, subtitle B); implementation of the Bayh-Dole Act (P.L. 96-517), including march-in rights; right to repair issues; emerging issues surrounding artificial intelligence, intellectual property, and data protection; confirmation of NIH Director; domain name system abuse; increase utilization of federal criminal penalties resulting from the passage of the Protect Lawful Streaming Act (PSLA) (P.L. 116-260, Div. Q, Title II), for certain types of copyright infringement via illicit streaming of copyrighted works; intellectual property enforcement priorities at the U.S.-Mexico border; licensing negotiations and remedies for standard-essential patents subject to voluntary F/RAND Commitments; draft 2022-2026 USPTO strategic plan; USPTOs IP Attache Program; funding for the Intellectual Property Enforcement Program in FY24 Appropriations Legislation; the "Reasonable Price Clause" in reauthorization draft of the Pandemic and All Hazards Preparedness Act (PAHPA, P.L. 109-417)
2023 · third_quarter · Health Issues
H.R. 167: Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2500: Protecting Americans from Unsafe Drugs Act of 2023 H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefit Manager Accountability Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 2940/S. 1355: PASTEUR Act - authorizes the Department of Health and Human Services (HHS) to enter into subscription contracts for H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3281: Transparent PRICE Act H.R. 3284: Providers and Payers COMPETE Act H.R. 3285: Fairness for Patient Medications Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3791: Improving DATA in Public Health Act H.R. 3793: Ensuring Access to Lifesaving Drugs Act of 2023 H.R. 3810: Drug Origin Transparency Act of 2023 HR 4223 - National AI Commission Act H.R. 4507: Transparency in Coverage Act of 2023 H.R. 4508: Hidden Fee Disclosure Act H.R. 4822: Health Care Price Transparency Act H.R. 4882: Clinical Laboratory Price Transparency Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 HR 5027 - Chronic Kidney Disease Improvement in Research and Treatment Act of 2023 H.R. 5142 - Vaccine Injury Compensation Modernization Act -- reform the vaccine injury compensation program H.R.5143 - Vaccine Access Improvement Act - reform the vaccine injury compensation program H.R. 5376: Share the Savings with Seniors Act HR 5378 - Lower Costs, More Transparency Act (PBM transparency provisions, Q1/Q2 provisions) S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 315: Taxpayer Research And Contributions Knowledge Act of 2023 or TRACK Act of 2023 - To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development, and for other purposes S. 476: Maintaining Investments in New Innovation Act S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1114: Expanding Access to Low-Cost Generics Act 2023 S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1909, The Pharmacy DIR Reform to Reduce Senior Drug Costs Act. HR 830 HELP Copays Act. S. 2076 PASTEUR Act of 2021. S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333 - Pandemic and All Hazards Preparedness Act reauthorization PBB S. 2474: Share the Savings with Seniors Act S 2965 - Modernizing and Ensuring PBM Accountability Act Inflation Reduction Act of 2022 (P.L. 117-169) Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Cybersecurity policy issues Anticounterfeiting policy issues White Paper on AI in Healthcare Labor HHS Appropriations Modernizing and Ensuring PBM Accountability Post-TDAPA policies at CMS - seeking Congressional letter to CMS
2023 · third_quarter · Health Issues
H.R. 167: Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2500: Protecting Americans from Unsafe Drugs Act of 2023 H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3281: Transparent PRICE Act H.R. 3284: Providers and Payers COMPETE Act H.R. 3285: Fairness for Patient Medications Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3791: Improving DATA in Public Health Act H.R. 3793: Ensuring Access to Lifesaving Drugs Act of 2023 H.R. 3810: Drug Origin Transparency Act of 2023 H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4507: Transparency in Coverage Act of 2023 H.R. 4508: Hidden Fee Disclosure Act H.R. 4822: Health Care Price Transparency Act of 2023 H.R. 4882: Clinical Laboratory Price Transparency Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act H.R. 5378: Lower Costs, More Transparency Act H.R. 5539: ORPHAN Cures Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 315: Taxpayer Research And Contributions Knowledge Act of 2023 or TRACK Act of 2023 - To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development, and for other purposes S. 476: Maintaining Investments in New Innovation Act S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1114: Expanding Access to Low-Cost Generics Act 2023 S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2474: Share the Savings with Seniors Act S. 2840: Bipartisan Primary Care and Health Workforce Act Inflation Reduction Act of 2022 (P.L. 117-169) Nomination of Dr. Monica Bertagnolli as NIH director Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain policy issues Mental health policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Cybersecurity policy issues Anticounterfeiting policy issues
2023 · second_quarter · Copyright/Patent/Trademark
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)
2023 · second_quarter · Health Issues
Maintaining Investments in New Innovation Act (S. 476); Increasing Prescription Drug Competition Act (S. 574); Implementation and proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biologics Competition Act of 2023 (H.R. 1790); Bayh-Dole Act; Affordable Prescriptions for Patients Act of 2023 (S. 150); Stop STALLING Act (S. 148); Increasing Transparency in Generic Drug Applications Act (S. 4338/S. 775); Ensuring Timely Access to Generics Act of 2023 (S. 1067); Taxpayer Research and Contributions Knowledge Act of 2023 (S.315); S.1114 - Expanding Access to Low-Cost Generics Act of 2023; Generic drug labeling and regulation; Method of Use patents and use codes; Potential amendments to S.1339 - Pharmacy Benefit Manager Reform Act; S.6 - Biosimilar Red Tape Elimination Act; H.R.3433 - Give Kids a Chance Act of 2023.
Client expense: Not reported · Firm income: $140,000
2023 · first_quarter · Health Issues
H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 382: Pandemic is Over Act - This bill terminates the COVID-19 public health emergency that was declared on January 31, 2020, on the date of the bill's enactment H.R. 4121, PRO Seniors Act, provisions related to drug rebates Protecting American Innovation Act, provisions related to intellectual property PDUFA Riders provisions related to disclosure of trade secrets H.R. 4390: Protect 340B Act - Provision related to 340B Program H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 7032: Increasing Transparency in Generic Drug Application Act - This bill requires the Food and Drug Administration to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why). S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 315: Taxpayer Research And Contributions Knowledge Act of 2023 or TRACK Act of 2023 - To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development, and for other purposes. S. 898: Fair Accountability and Innovative Research Drug Pricing Act of 2021 - Provisions related to drug pricing S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B Drug Pricing Program - drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act policy issues
2023 · first_quarter · Health Issues
Maintaining Investments in New Innovation Act (S. 476); Interagency Patent Coordination and Improvement Act of 2023 (S. 79/H.R. 1717); Increasing Prescription Drug Competition Act (S. 574); Implementation and proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biologics Competition Act of 2023 (H.R. 1790); Bayh-Dole Act; Affordable Prescriptions for Patients Act of 2023 (S. 150); Preserve Access to Affordable Generics and Biosimilars Act (S. 142); Stop STALLING Act (S. 148); Increasing Transparency in Generic Drug Applications Act (S. 4338); Ensuring Timely Access to Generics Act of 2021 (S. 562); Taxpayer Research and Contributions Knowledge Act of 2023 (S.315).
Client expense: Not reported · Firm income: $140,000
2023 · first_quarter · Health Issues
H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 1790: Biologics Competition Act of 2023 - Directs the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 4390: Protect 340B Act - Provisions related to 340B Program H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 7032: Increasing Transparency in Generic Drug Application Act - Requires the Food and Drug Administration to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why) S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 315: Taxpayer Research And Contributions Knowledge Act of 2023 or TRACK Act of 2023 - Directs the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development, and for other purposes S. 898: Fair Accountability and Innovative Research Drug Pricing Act of 2021 - Provisions related to drug pricing S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Mental health policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act policy issues
Client expense: $1,500,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
Client expense: $6,430,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
Client expense: $19,080,000 · 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), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR), White House Office
Client expense: $1,030,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
Client expense: $6,370,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
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
Government targets: SENATE
Client expense: $1,700,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
Government targets: Health & Human Services, Dept of (HHS), SENATE
Client expense: $7,990,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE