Protecting Consumer Access to Generic Drugs Act of 2013

H.R. 406 & S. 1767, Combination Drug Development Incentive Act of 2015; H.R. 1537 & S. 1878, Advancing Hope Act of 2015; S. 632, STRONG Patents Act of 2015; H.R. 9, Innovation Act; S. 2733, Venue Equity and Non-Uniformity Elimination Act of 2016; H.R. 3709, Protecting Consumer Access to Generic Drugs Act of 2013; H.R. 971 & S. 1421, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015; S. 2615, Increasing Competition in Pharmaceuticals Act; Proposals/Initiatives related to international intellectual property protection;

Client expense: $2,630,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

H.R. 3116, MODDERN Cures Act of 2013; S. 3004, Dormant Therapies Act of 2014; H.R. 406 & S. 1767, Combination Drug Development Incentive Act of 2015; H.R. 1537 & S. 1878, Advancing Hope Act of 2015; S. 1720, Patent Transparency and Improvements Act of 2013; S. 632, STRONG Patents Act of 2015; H.R. 9, Innovation Act; H.R. 160, Protect Medical Innovation Act of 2015; S. 214, Preserve Access to Affordable Generics Act of 2013; H.R. 3709, Protecting Consumer Access to Generic Drugs Act of 2013; H.R. 971 & S. 1421, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015; Proposals/Initiatives related to international intellectual property protection;

Client expense: $1,180,000 · 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), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

S. 1720, Patent Transparency and Improvements Act of 2013; H.R. 3309, Innovation Act; S. 214, Preserve Access to Affordable Generics Act of 2013; H.R. 3709, Protecting Consumer Access to Generic Drugs Act of 2013; H.R. 3116, MODDERN Cures Act of 2013; H.R. 2985, Combination Drug Development Incentive Act of 2013; various international intellectual property issues and proposals

Client expense: $1,520,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)

H.R. 3709 Protecting Consumer Access to Generic Drugs Act, S. 214 Preserve Access to Affordable Generics Act, H.R. 3309 Innovation Act

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

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

H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisions H.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2639, Patent Litigation and Innovation Act: Patent litigation provisions H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985, Combination Drug Development Incentive Act of 2013: Provisions related to exclusivity H.R. 3116, MODDERN Cures Act of 2013: Provisions related to exclusivity H.R. 3309, Innovation Act: Provisions related to patent litigation reform H.R. 3349, Innovation Protection Act: PTO Fee Diversion H.R. 3540, Demand Letter Transparency Act: Provisions related to patent demand letters H.R. 3709, Protecting Consumer Access to Generic Drugs: Provisions related to patent settlements H.R. 4287, Independent Innovator and Repurposing Act: Provisions related to patent term restoration H.R. 4763, Trade Protection not Troll Protection Act: Patent and trade provisions H.R. 5233, Trade Secrets Protection Act of 2014: Provisions related to trade secrets H.R. 5750, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014: Provisions related to targeted IP incentives for new indications for rare diseases or conditions S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions S. 1612, Patent Litigation Integrity Act: Patent litigation provisions including bonding S. 1720, Patent Transparency and Improvements Act: Patent litigation provisions S. 2049, Transparency in Assertion of Patents Act: Provisions related to patent demand letters S. 2150, Independent Innovator and Repurposing Act: Provisions related to patent term restoration S. 2196, Patent Fee Integrity Act: Patent fee diversion prohibition S. 2267, Defend Trade Secrets Act of 2014: Provisions related to trade secrets S. 3004, Dormant Therapies Act of 2014: Provisions related to incentives to develop biopharmaceutical products Biopharmaceutical innovation and patent policy issues Biologics data protection issues Draft legislation on demand letters, including Targeting Rogue and Opaque Letters (TROL) Act Issues related to biopharmaceutical economic incentives and intellectual property

H.R. 2582 - PATENT Jobs Act; provisions related to patent user fees H.R. 2639 - Patent Litigation and Innovation Act; patent litigation proposols H.R. 2766 - STOP Act; provisions related to business method patents H.R. 3116 - MODDERN Cures Act of 2013; Provisions related to exclusivity H.R. 3309 - Innovation Act; provisions related to patent litigation reform H.R. 3349 - Innovation Protection Act; provisions related to PTO fee diversion H.R. 3540 - Demand Letter Transparency Act; provisions related to patent demand letters H.R. 3709 - Protecting Consumer Access to Generic Drugsprovisions related to patent settlements H.R. 4287 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 214 - The Preserve Access to Affordable Generics Act; provisions relating to patent settlements S. 504 - Fair and Immediate Release of Generic Drugs Act; provisions related to patent settlements S. 866 - Patent Quality Improvement Act of 2013Business methods patents provisions S. 1013 - Patent Abuse Reduction Act of 2013; provisions related to patent litigation reform S. 1612 - Patent Litigation Integrity Act; Patent litigation provisions including bonding S. 1720 - Patent Transparency and Improvements Act S. 2049 - Transparency in Assertion of Patents Act; Provisions related to patent demand letters S. 2150 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 2196 - Patent Fee Integrity Act; patent fee diversion prohibition No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Biologics data protection issues No bill # assigned - Intellectual property issues; Additional data exclusivity request that was part of 21st Century Cures submission

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

H.R. 3709 Protecting Consumer Access to Generic Drugs Act of 2013, S. 214 Preserve Access to Affordable Generics Act

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

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

H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisions H.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes H.R. 2639, Patent Litigation and Innovation Act: Patent litigation proposals H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985, Combination Drug Development Incentive Act of 2013: Provisions related to exclusivity H.R. 3116, MODDERN Cures Act of 2013: Provisions related to exclusivity H.R. 3309, Innovation Act: Provisions related to patent litigation reform H.R. 3349, Innovation Protection Act: PTO Fee Diversion H.R. 3540, Demand Letter Transparency Act: Provisions related to patent demand letters H.R. 3709, Protecting Consumer Access to Generic Drugs: Provisions related to patent settlements H,R, 4287, Independent Innovator and Repurposing Act: Provisions related to patent term restoration H.R. 4763, Trade Protection not Troll Protection Act: Patent and trade provisions H.R. 5233, Trade Secrets Protection Act of 2014: Provisions related to trade secrets S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions S. 1612, Patent Litigation Integrity Act: Patent litigation provisions including bonding S. 1720, Patent Transparency and Improvements Act S, 2049, Transparency in Assertion of Patents Act: Provisions related to patent demand letters S.2150, Independent Innovator and Repurposing Act: Provisions related to patent term restoration S. 2196, Patent Fee Integrity Act: Patent fee diversion prohibition S. 2267, Defend Trade Secrets Act of 2014: Provisions related to trade secrets Biopharmaceutical innovation policy issues Biologics data protection issues Draft legislation on demand letters, including Targeting Rogue and Opaque Letters (TROL) Act Issues related to biopharmaceutical economic incentives and intellectual property

S. 1720, Patent Transparency and Improvements Act of 2013; H.R. 3309, Innovation Act; S. 214, Preserve Access to Affordable Generics Act of 2013; H.R. 3709, Protecting Consumer Access to Generic Drugs Act of 2013; H.R. 3116, MODDERN Cures Act of 2013; H.R. 2985, Combination Drug Development Incentive Act of 2013; various international intellectual property issues and proposals

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

Government targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)

H.R. 2582 - PATENT Jobs Act; provisions related to patent user fees H.R. 2605 - Manufacturing Innovation in America Act of 2013; provisions related to patent tax boxes H.R. 2639 - Patent Litigation and Innovation Act; patent litigation proposols H.R. 2766 - STOP Act; provisions related to business method patents H.R. 3116 - MODDERN Cures Act of 2013; Provisions related to exclusivity H.R. 3309 - Innovation Act; provisions related to patent litigation reform H.R. 3349 - Innovation Protection Act; provisions related to PTO fee diversion H.R. 3540 - Demand Letter Transparency Act; provisions related to patent demand letters H.R. 3709 - Protecting Consumer Access to Generic Drugsprovisions related to patent settlements H.R. 4287 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 214 - The Preserve Access to Affordable Generics Act; provisions relating to patent settlements S. 504 - Fair and Immediate Release of Generic Drugs Act; provisions related to patent settlements S. 866 - Patent Quality Improvement Act of 2013; Business methods patents provisions S. 1013 - Patent Abuse Reduction Act of 2013; provisions related to patent litigation reform S. 1612 - Patent Litigation Integrity Act; Patent litigation provisions including bonding S. 1720 - Patent Transparency and Improvements Act S. 2049 - Transparency in Assertion of Patents Act; Provisions related to patent demand letters S. 2150 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 2196 - Patent Fee Integrity Act; patent fee diversion prohibition No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Biologics data protection issues No bill # assigned - Intellectual property issues; Additional data exclusivity request that was part of 21st Century Cures submission

H.R. 3309, Innovation Act, H.R. 3709, Protecting Consumers Access to Generic Drugs Act of 2013, S. 214, Preserve Access to Affordable Generics Act, S. 1720, Patent Transparency and Improvements Act of 2013, S. 2049, Transparency in Assertion of Patents Act, H.R. 3709, Protecting Consumer Access to Generic Drugs Act of 2013

Client expense: $655,940 · Firm income: Not reported

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

S. 1720, Patent Transparency and Improvements Act of 2013; H.R. 3309, Innovation Act; S. 214, Preserve Access to Affordable Generics Act of 2013; H.R. 3709, Protecting Consumer Access to Generic Drugs Act of 2013; H.R. 3116, MODDERN Cures Act of 2013; H.R. 2985, Combination Drug Development Incentive Act of 2013

Client expense: $880,000 · Firm income: Not reported

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

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes H.R. 2639, Patent Litigation and Innovation Act: Patent litigation proposals H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985, Combination Drug Development Incentive Act of 2013: Provisions related to exclusivity H.R. 3116, MODDERN Cures Act of 2013: Provisions related to exclusivity H.R. 3309, Innovation Act: Provisions related to patent litigation reform H.R. 3349, Innovation Protection Act: PTO Fee Diversion H.R. 3540, Demand Letter Transparency Act: Provisions related to patent demand letters H.R. 3709, Protecting Consumer Access to Generic Drugs: Provisions related to patent settlements H,R, 4287, Independent Innovator and Repurposing Act: Provisions related to patent term restoration H.R. 4763, Trade Protection not Troll Protection Act: Patent and trade provisions S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions S. 1612, Patent Litigation Integrity Act: Patent litigation provisions including bonding S. 1720, Patent Transparency and Improvements Act S, 2049, Transparency in Assertion of Patents Act: Provisions related to patent demand letters S.2150, Independent Innovator and Repurposing Act: Provisions related to patent term restoration S. 2196, Patent Fee Integrity Act: Patent fee diversion prohibition Biopharmaceutical innovation policy issues Biologics data protection issues Draft legislation on trade secret issues Draft legislation on demand letters Issues related to biopharmaceutical economic incentives and intellectual property

H.R. 2582 - PATENT Jobs Act; provisions related to patent user fees H.R. 2605 - Manufacturing Innovation in America Act of 2013; provisions related to patent tax boxes H.R. 2639 - Patent Litigation and Innovation Act; patent litigation proposals H.R. 2766 - STOP Act; provisions related to business method patents H.R. 3116 - MODDERN Cures Act of 2013; provisions related to exclusivity H.R. 3309 - Innovation Act; provisions related to patent litigation reform H.R. 3349 - Innovation Protection Act; provisions related to PTO fee diversion H.R. 3540 - Demand Letter Transparency Act; provisions related to patent demand letters H.R. 3709 - Protecting Consumer Access to Generic Drugsprovisions related to patent settlements H.R. 4287 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 214 - The Preserve Access to Affordable Generics Act; provisions relating to patent settlements S. 504 - Fair and Immediate Release of Generic Drugs Act; provisions related to patent settlements S. 866 - Patent Quality Improvement Act of 2013; provisions related to business methods patents provisions S. 1013 - Patent Abuse Reduction Act of 2013; provisions related to patent litigation reform S. 1612 - Patent Litigation Integrity Act; Patent litigation provisions including bonding S. 1720 - Patent Transparency and Improvements Act S. 2049 - Transparency in Assertion of Patents Act; provisions related to patent demand letters S. 2150 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S.2196 - Patent Fee Integrity Act; patent fee diversion prohibition No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Biologics data protection issues No bill # assigned - Intellectual property issues; Additional data exclusivity request that was part of 21st Century Cures submission

Patent Reform, H.R. 3309 Innovation Act, H.R. 3709 Protecting Consumers Access to Generic Drugs Act of 2013, S. 214 Preserve Access to Affordable Generics Act, S. 1720 Patent Transparency and Improvements Act of 2013, S. 2049 Transparency in Assertion of Patents Act

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, Vice President of the U.S., White House Office

S. 1720, Patent Transparency and Improvements Act of 2013; H.R. 3309, Innovation Act; S. 214, Preserve Access to Affordable Generics Act of 2013; H.R. 3709, Protecting Consumer Access to Generic Drugs Act of 2013; H.R. 3116, MODDERN Cures Act of 2013; H.R. 2985, Combination Drug Development Incentive Act of 2013

Client expense: $1,450,000 · Firm income: Not reported

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

Patent Reform, H.R. 3309 Innovation Act, H.R. 3709 Protecting Consumers Access to Generic Drugs Act of 2013, S. 214 - Preserve Access to Affordable Generics Act, S. 1720 Patent Transparency and Improvements Act of 2013, S. 2049 - Transparency in Assertion of Patents Act

Client expense: $660,626 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of the Vice President of the United States, SENATE, U.S. Trade Representative (USTR), White House Office

Implementation of Biosimilars in the Affordable Care Act (ACA), Implementation of FDASIA and GDUFA, Counterfeit Drugs/Import Safety, Prescription Drug Importation/Re-Importation, Drug Shortages, Labeling of Generic Drugs, Risk Evaluation Mitigation Strategies, Biosimilar Naming, Electronic Labeling for Pharmaceuticals, H.R. 486 - Stop Tampering of Prescription Pills Act of 2013, H.R. 2725 - FDA Safety over Sequestration Act, H.R. 3204 - Drug Quality and Security Act,H.R. 3709 - Protecting Consumers Access to Generic Drugs Act of 2013 S. 214 - Preserve Access to Affordable Generics Act S. 957 - Drug Supply Chain Security Act S. 1413 FDA User Fee Protection Act

Client expense: $660,626 · Firm income: Not reported

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes H.R. 2639, Patent Litigation and Innovation Act: Patent litigation proposals H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985, Combination Drug Development Incentive Act of 2013 H.R. 3116, MODDERN Cures Act of 2013 H.R. 3309, Innovation Act: Provisions related to patent litigation reform H.R. 3349, Innovation Protection Act: PTO Fee Diversion H.R. 3540, Demand Letter Transparency Act of 2013: Provisions related to patent demand letters H.R. 3709, Protecting Consumer Access to Generic Drugs Act of 2013: Provisions related to patent settlements H.R. 4287, Independent Innovator and Repurposing Act: Provisions related to patent term restoration S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions S. 1612, Patent Litigation Integrity Act of 2013: Patent litigation provisions including bonding S. 1720, Patent Transparency and Improvements Act of 2013: Provisions related to patent litigation, demand letters and the patent system S, 2049, Transparency in Assertion of Patents Act: Provisions related to patent demand letters S. 2150, Independent Innovator and Repurposing Act: Provisions related to patent term restoration S. 2146, Patent Fee Integrity Act: Patent fee diversion prohibition Biopharmaceutical innovation policy issues Biologics data protection issues Draft legislation on trade secret issues

H.R. 2582 - PATENT Jobs Act, provisions related to patent user fees H.R. 2605 - Manufacturing Innovation in America Act of 2013, provisions related to patent tax boxes H.R. 2639 - Patent Litigation and Innovation Act, patent litigation proposols H.R. 2766 - STOP Act, provisions related to business method patentsH.R. 3309 - Innovation Act, provisions related to patent litigation reform H.R. 3349 - Innovation Protection Act, provisions related to PTO fee diversion H.R. 3540 - Demand Letter Transparency Act H.R. 3709 - Protecting Consumer Access to Generic Drugs, provisions related to patent settlements H.R. 4287 - Independent Innovator and Repurposing Act, provisions related to patent term restoration S. 214 - The Preserve Access to Affordable Generics Act, provisions relating to patent settlements S. 504 - Fair and Immediate Release of Generic Drugs Act, provisions related to patent settlements S. 866 - Patent Quality Improvement Act of 2013, provisions related to business methods patents S. 1013 - Patent Abuse Reduction Act of 2013, provisions related to patent litigation reform S. 1612 - Patent Litigation Integrity Act, patent litigation provisions including bonding S. 1720 - Patent Transparency and Improvements Act S. 2049 - Transparency in Assertion of Patents Act, provisions related to patent demand letters S. 2150 - Independent Innovator and Repurposing Act, provisions related to patent term restoration S. 2196 - Patent Fee Integrity Act, patent fee diversion prohibition No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Biologics data protection issues No bill # assigned - Counterfeit drug issues

Client expense: $1,630,000 · Firm income: Not reported

S. 1720, Patent Transparency and Improvements Act of 2013; H.R. 3309, Innovation Act; S. 214, Preserve Access to Affordable Generics Act of 2013; H.R. 3709, Protecting Consumer Access to Generic Drugs Act of 2013

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

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

S. 214 - Preserve Access to Affordable Generics Act; S.504 - Fair and Immediate Release of Generic Drugs Act, H.R. 3309 Innovation Act, HR 3709 Protecting Consumers Access to Generic Drugs Act of 2013

Client expense: $604,408 · Firm income: Not reported

Government targets: Congressional Budget Office (CBO), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE

Implementation of Health Care Reform, Implementation of Generic Biologics, Counterfeit Drugs/Import Safety, Prescription Drug Importation/Re-Importation, Drug Shortages, Labeling of Generic Drugs, Risk Evaluation Mitigation Strategies, Biosimilar NamingH.R.486 - Stop Tampering of Prescription Pills Act of 2013 H.R.1285 - To amend the Controlled Substances Act to make any substance containing hydrocodone a schedule II drug. H.R. 1919 - Safeguarding America's Pharmaceuticals Act of 2013 H.R.1958 - Gray Market Drug Reform and Transparency Act of 2013 H.R.2186 - VALID Compounding Act of 2013 H.R. 2725 FDA Safety over Sequestration Act H.R. 3019 SAFE Compounded Drugs Act H.R. 3089 Compounding Clarity Act of 2013 H.R. 3204 Drug Quality and Security Act H.R. 3709 Protecting Consumers Access to Generic Drugs Act of 2013 H. Con. Res. 25 - Establishing the budget for the United States Government for fiscal year 2014 and setting forth appropriate budgetary levels for fiscal years 2015 through 2023 H Res - 161 Expressing the sense of the House of Representatives that the Food and Drug Administration should encourage the use of abuse-deterrent formulations of drugs S.214 - Preserve Access to Affordable Generics Act S.504 - Fair and Immediate Release of Generic Drugs Act S.621 - Safe Prescribing Act of 2013 S 957 - Drug Supply Chain Security Act S 959 - Pharmaceutical Quality, Security, and Accountability Act

Client expense: $604,408 · Firm income: Not reported

H.R. 22, Foreign Counterfeit Merchandise Prevention Act: Provisions related to counterfeiting H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisionsH.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes H.R. 2639, Patent Litigation and Innovation Act: Patent litigation proposals H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985, Combination Drug Development Incentive Act of 2013: Provisions related to exclusivity for combination drugs H.R. 3116, MODDERN Cures Act of 2013: Provisions related to diagnostics and exclusivity H.R. 3309, Innovation Act: Provisions related to patent litigation reform H.R. 3349, Innovation Protection Act: PTO Fee Diversion H.R. 3540, Demand Letter Transparency Act: Provisions related to patent demand letters H.R. 3709, Protecting Consumer Access to Generic Drugs: Provisions related to patent settlements S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions S. 1612, Patent Litigation Integrity Act: Patent litigation provisions including bonding S. 1720, Patent Transparency and Improvements Act of 2013: Provisions related to patent litigation and other reforms Biopharmaceutical innovation policy issues Biologics data protection issues Draft legislation on trade secret issues