MODDERN Cures Act of 2013

HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

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)

HR3116 MODDERN Cures Act of 2013 Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Draft Legislation on Trade Secret Issues

Client expense: $1,430,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

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. 632, STRONG Patents Act of 2015; H.R. 9, Innovation Act; 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: $1,240,000 · Firm income: Not reported

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

H.R. 3116, MODDERN Cures Act of 2013; S. 632, STRONG Patents Act of 2015; H.R. 9, Innovation Act; H.R. 160, Protect Medical Innovation Act of 2015; H.R. 971 & S. 1421, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015; S. 1137, Protecting American Talent and Entrepreneurship Act of 2015; Proposals/Initiatives related to international intellectual property protection;

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

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

H.R. 3116, MODDERN Cures Act of 2013; H.R. 971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015; Proposals/Initiatives related to international intellectual property protection; S. 1720, Patent Transparency and Improvements Act of 2013; H.R. 9, Innovation Act; H.R. 160, Protect Medical Innovation Act of 2015; S. 320, Medical Innovation Act of 2015;

Client expense: $1,870,000 · Firm income: Not reported

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

HR3116 MODDERN Cures Act of 2013 Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Draft Legislation on Trade Secret Issues

Client expense: $1,500,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

H.R. 3116, MODDERN Cures Act of 2013; S. 632, STRONG Patents Act of 2015; H.R. 9, Innovation Act; H.R. 160, Protect Medical Innovation Act of 2015; H.R. 971 & S. 1421, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015; S. 1137, Protecting American Talent and Entrepreneurship Act of 2015; Proposals/Initiatives related to international intellectual property protection;

Client expense: $970,000 · Firm income: Not reported

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

HR3116 MODDERN Cures Act of 2013 Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Draft Legislation on Trade Secret Issues

Client expense: $1,500,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

HR3116 MODDERN Cures Act of 2013 Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Draft Legislation on Trade Secret Issues

Client expense: $2,550,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

H.R. 3116, MODDERN Cures Act of 2013; H.R. 971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015; Proposals/Initiatives related to international intellectual property protection; S. 1720, Patent Transparency and Improvements Act of 2013; H.R. 9, Innovation Act; H.R. 160, Protect Medical Innovation Act of 2015; S. 320, Medical Innovation Act of 2015;

Client expense: $1,860,000 · Firm income: Not reported

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

Intellectual property; HR 3497; MODDERN Cures (HR 3116)

Client expense: $2,290,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), 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. Trade Representative (USTR)

340B (no specific bill), National Diabetes Clinical Care Commission Act (H.R. 1074, S.539), Eliminating Disparities in Diabetes Prevention Act (H.R. 3322), Oncology education (no specific bill), adult vaccine policies (no specific bill), medication adherence, DISARM (H.R. 4187), ACA Implementation (no specific bill), Hepatitis C education (no specific bill), HIV education (no specific bill), MODDERN Cures Act of 2013 (H.R. 3116), Prescription Drug User Fee Act (general planning), 21st Century Cures (no specific bill), Strengthening Medicare Anti-Fraud Measures Act of 2013 (H.R. 2925), Big data (general education), Alzheimer's education (no specific bill), biosimilars (general education, no specific bill), general pharmaceutical industry issues and education.

Client expense: $1,160,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B (no specific bill), National Diabetes Clinical Care Commission Act (H.R. 1074, S.539), Eliminating Disparities in Diabetes Prevention Act (H.R. 3322), Oncology education (no specific bill), adult vaccine policies (no specific bill), medication adherence, DISARM (H.R. 4187), ACA Implementation (no specific bill), Hepatitis C education (no specific bill), HIV education (no specific bill), MODDERN Cures Act of 2013 (H.R. 3116), Prescription Drug User Fee Act (general planning), 21st Century Cures (no specific bill), Strengthening Medicare Anti-Fraud Measures Act of 2013 (H.R. 2925), Big data (general education), Alzheimer's education (no specific bill), biosimilars (general education, no specific bill), general pharmaceutical industry issues and education.

Client expense: $1,160,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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)

340B (no specific bill), National Diabetes Clinical Care Commission Act (H.R. 1074, S.539), Eliminating Disparities in Diabetes Prevention Act (H.R. 3322), Oncology education (no specific bill), adult vaccine policies (no specific bill), medication adherence, DISARM (H.R. 4187), ACA Implementation (no specific bill), Hepatitis C education (no specific bill), HIV education (no specific bill), MODDERN Cures Act of 2013 (H.R. 3116), biosimilars (no specific bill), Alzheimer's education (no specific bill)21st Century Cures (no specific bill), general pharmaceutical industry issues and education

Client expense: $490,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Cost Sharing (Preserving Access to Medicines); "Hard to Obtain," Risk Evaluation and Mitigation Strategies (REMS); Healthcare Exchanges; HR 2985 Combined Drug Development Incentive Act; HR 3116 Modernizing our Drug & Diagnostic Evaluation & Regulatory Network

Client expense: $650,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B (no specific bill), National Diabetes Clinical Care Commission Act (H.R. 1074, S.539), Eliminating Disparities in Diabetes Prevention Act (H.R. 3322), Oncology education (no specific bill), adult vaccine policies (no specific bill), medication adherence, DISARM (H.R. 4187), ACA Implementation (no specific bill), Hepatitis C education (no specific bill), HIV education (no specific bill), MODDERN Cures Act of 2013 (H.R. 3116), Prescription Drug User Fee Act (general planning), 21st Century Cures (no specific bill), Strengthening Medicare Anti-Fraud Measures Act of 2013 (H.R. 2925), Big data (general education), Alzheimer's education (no specific bill), biosimilars (general education, no specific bill), general pharmaceutical industry issues and education.

Client expense: $1,160,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

issues surrounding oral parity and specialty tiers (H.R. 460 and H.R. 1801); issues surrounding potential new incentives for research into unmet medical needs (H.R. 3116)

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

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

Implementation of P.L. 111-148, Patient Protection & Affordable Health Care Act 340B Issues Drug Shortage Issues Health Technology Assessment of Orphan DrugsH.R. 1281, Newborn Screening Saves Lives Reauthorization Act of 2013 S. 1417, Newborn Screening Saves Lives Reauthorization Act of 2013 Sequestration of FDA User Fees H.R. 2315, Preserving Access to Orphan Drugs Act of 2013 S. 1128, Preserving Access to Orphan Drugs Act of 2013 H.R. 2090, Patient Choice Act of 2013 H.R. 4475, Compassionate Freedom of Choice Act of 2014 H.R. 1239, Accessing Medicare Therapies Act of 2013 H.R. 460, Patients' Access to Treatments Act of 2013 21st Century Cures Initiatives H.R. 3805, Andrea Sloan CURE Act H.R. 3116, MODDERN Cures Act of 2013 S. 3004, Dormant Therapies Act of 2014 H.R. 5771, To amend the Internal Revenue Code of 1986 to extend certain expiring provisions and make technical corrections, to amend the Internal Revenue Code of 1986 to provide for the tax treatment of ABLE accounts established under State programs for the care of family members with disabilities, and for other purposes. H.R. 5750, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014

Client expense: $370,000 · Firm income: Not reported

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

Implementation of FDASIA and GDUFA, Drug Shortages, Labeling of Generic Drugs, Risk Evaluation and Mitigation Strategies, Biosimilars Naming, Electronic Labeling for Pharmaceuticals, H.R. 5657 Fair Access for Safe and Timely Generics Act, H.R. 3116 MODDERN Cures Act, H.R. 2985 Combination Drug Development Incentive Act, H.R. 4437 Generic Drug Pricing Fairness Act, S. 3004 Dormant Therapies Act, Issues Regarding Market Exclusivity, Drug Quality and Security Act Implementation

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

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

H.R. 3116, MODDERN Cures Act of 2013; Proposals/Initatives related to international intellectual property protection; 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. 5750, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014

Client expense: $1,010,000 · Firm income: Not reported

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

H.R. 460, Patients' Access to Treatments Act (McKinley) - cost sharing in a specialty drug tier H.R. 1367, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act (Lynch) - FEHBP prescription drugs H.R. 3116, MODDERN Cures Act (Lance) - innovations in diagnostics, drug exclusivity H.R. 3742, Antibiotic Development to Advance Patient Treatment Act (Gingrey) - treatments for serious or life-threatening diseases S. 214, Preserve Access to Affordable Generics Act (Klobuchar) - access to generic drugs Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Client expense: $2,230,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Pension & Welfare Benefits Administration, SENATE, Treasury, Dept of, White House Office

Implementation of the Biologics Price Competition and Innovation Act (BPCIA); H.R. 3116 - Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act of 2013

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

FDA proposed rule, Supplemental Applications Proposing Labeling Changes For Approved Drugs And Biological Products, Docket Number FDA-2013-N-0500, provisions relating to generic drug labeling changes; Federal policy relating to issues affecting the generic drug industry within the House Energy and Commerce Committee's 21st Century Cures initiative; Federal policy relating to International Nonproprietary Names for Biosimilars; HR 5657, the Fair Access for Safe and Effective Generics Act, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing; HR 5748/S 2948, the Medicaid Generic Drug Fairness Act, provisions relating to Medicaid rebates for generic pharmaceuticals; Federal policy relating to the use of generic drugs in the Medicare Part D program; Federal policy relating to the implementation of the Biologic Price Competition and Innovation Act, Title VII, Subtitle A, of Public Law 111-148, the Patient Protection and Affordable Care Act; and HR 3116, the MODDERN Cures Act, provisions relating to the exclusivity term for dormant therapies

Client expense: $220,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 460, Patients' Access to Treatments Act (McKinley) - cost sharing in a specialty drug tier. H.R. 1367, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act (Lynch) - FEHBP prescription drugs. H.R. 3116, MODDERN Cures Act (Lance) - innovations in diagnostics, drug exclusivity. H.R. 3742, Antibiotic Development to Advance Patient Treatment Act (Gingrey) - treatments for serious or life-threatening diseases. S. 214, Preserve Access to Affordable Generics Act (Klobuchar) - access to generic drugs.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Biopharmaceutical-related IP protection issues, including those associated with the MODDERN Cures Act (H.R. 3116, 113th Cong.)and Dormant Therapies Act (S. 3004, 113th Cong.)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Biopharmaceutical-related IP protection issues, including those associated with the MODDERN Cures Act (H.R. 3116, 113th Cong.)and Dormant Therapies Act (S. 3004, 113th Cong.)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Biopharmaceutical-related IP protection issues, including those associated with the MODDERN Cures Act (H.R. 3116, 113th Cong.)and Dormant Therapies Act (S. 3004, 113th Cong.)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Biopharmaceutical-related IP protection issues, including those associated with the MODDERN Cures Act (H.R. 3116, 113th Cong.)and Dormant Therapies Act (S. 3004, 113th Cong.)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Biopharmaceutical-related IP protection issues, including those associated with the MODDERN Cures Act (H.R. 3116, 113th Cong.)and Dormant Therapies Act (S. 3004, 113th Cong.)

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Biopharmaceutical-related IP protection issues, including those associated with the MODDERN Cures Act (H.R. 3116, 113th Cong.)and Dormant Therapies Act (S. 3004, 113th Cong.)

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Biopharmaceutical-related IP protection issues, including those associated with the MODDERN Cures Act (H.R. 3116, 113th Cong.)and Dormant Therapies Act (S. 3004, 113th Cong.)

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Biopharmaceutical-related IP protection issues, including those associated with the MODDERN Cures Act (H.R. 3116, 113th Cong.)and Dormant Therapies Act (S. 3004, 113th Cong.)

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Regulatory and legislative activities regarding 340B program. HR 3116, "MODDERN Cures Act of 2013."

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B (no specific bill), National Diabetes Clinical Care Commission Act (H.R. 1074, S.539), Eliminating Disparities in Diabetes Prevention Act (H.R. 3322), Oncology education (no specific bill), adult vaccine policies (no specific bill), medication adherence, DISARM (H.R. 4187), ACA Implementation (no specific bill), Hepatitis C education (no specific bill), HIV education (no specific bill), MODDERN Cures Act of 2013 (H.R. 3116), biosimilars (no specific bill), Alzheimer's education (no specific bill)21st Century Cures (no specific bill), general pharmaceutical industry issues and education

Client expense: $460,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Public Law No. 112-144, the "Food and Drug Administration Safety and Innovation Act," specifically those sections relating to implementation of the Prescription Drug User Fee program. Policy and implementation issues relating to Public Law No. 111-148, the "Patient Protection and Affordable Care Act." H.R. 3116, the "Modernizing Our Drug and Diagnostics Evaluation and Regulatory Network Cures Act."

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

Government targets: HOUSE OF REPRESENTATIVES, 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

Client expense: $3,960,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Medicare Payment Advisory Commission (MedPAC), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)

Issues related to patent/IP protections for biotech and pharmaceutical drugs. Support for Modern Cures Act (H.R. 3116).

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

Government targets: HOUSE OF REPRESENTATIVES

Public Law No. 112-144, the "Food and Drug Administration Safety and Innovation Act," specifically those sections relating to the implementation of the Prescription Drug User Fee program. Public Law No. 111-148, the "Patient Protection and Affordable Care Act," including policy and implementation issues. Public Law No. 110-85, the "Food and Drug Administration Amendments Act," including current policy issues relating to FDA's Risk Evaluation and Mitigation Strategy authority. H.R. 5657, the "Fair Access for Safe and Timely Generics Act." H.R. 3230, the "Veterans' Access to Care through Choice, Accountability and Transparency Act." H.R. 3116, the "Modernizing Our Drug and Diagnostics Evaluation and Regulatory Network Cures Act." Policy issues relating to orphan drugs and medicines for rare diseases.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to patent exclusivity, including H.R. 3116, the MODDERN Cures Act.

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

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

H.R.3116 MODDERN Cures Act of 2013 Data Exclusivity Trade Secrets Intellectual PropertyBiopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Draft Legislation on Trade Secret Issues

Client expense: $1,020,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

Medicare and Medicaid reform; Medicare competitive bidding; PL 108-173: Medicare Prescription Drug and Modernization Act of 2003; Budget Resolutions; Community Choice Act; PL 111-148: Patient Protection and Affordable Care Act; PL 111-152, 124 Stat. 1029: Health Care and Education Reconciliation Act of 2010; HR 132: ObamaCare Repeal Act; HR 3116: MODDERN (Modernizing Our Drug and Diagnostics Evaluation and Regulatory Network) Cures Act; and S 2449/HR 4631: Autism CARES (Collaboration, Accountability, Research, Education and Support) Act of 2014.

Client expense: $74,594 · Firm income: Not reported

Government targets: Administration for Children & Families (ACF), Defense, Dept of (DOD), Education, Dept of, Equal Employment Opportunity Commission (EEOC), Federal Communications Commission (FCC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Council on Disability, SENATE, Transportation, Dept of (DOT), U.S. Architectural & Transportation Barriers Compliance Board (ACCESS), Veterans Affairs, Dept of (VA), White House Office

Intellectual property; HR 3497; MODDERN Cures (HR 3116)

Client expense: $2,290,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), 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. Trade Representative (USTR)

H.R. 1427, Truth in Healthcare Marketing Act of 2013 H.R. 1171, Palliative Care Bill H.R. 2817, Protect Patient Access to Quality Health Professionals Act of 2013 H.R. 4106, Saving Lives, Saving Costs H.R. 1150, Preservation of Antibiotics for Medical Treatment Act of 2013 H.R. 3116, MODERN Cures Act (21st Century Cures) H.R. 3204, Drug Quality and Security Act Drug Shortages - FDA, DEA, HHS, CMS, GAO, House Energy and Commerce Committee, Senate HELP Committee DEA Scheduling Propofol Comparative Effectiveness Research HITECH Implementation, Electronic Health Records, Final and Proposed Rules, HIT Meaningful Use HHS/OIG Anesthesia Practice Arrangements, Company Model FDA Risk Evaluation and Mitigation Strategies FDA Safe Use Initiative Pain Management Proposed Federal CME requirements by ONDCP FTC Letters to states regarding Interventional Pain Medicine and Advanced Practice Nurses Propofol shortage - European Union export restrictions Scope of Practice FDA Operating Room fires State Exchanges pursuant to PPACA FDA Patient Prescriber working group Naloxone ICD-10-CM/PCS and proposed delay of implementation date HHS AIDE Action Plan FDA Opioids Prescription Drug Abuse FDA Network of Experts NIH Interagency Pain Research Coordinating Committee FDA SMART TOTS USP - US Pharmacopeia ESI- Epidural Steroid Injections

Client expense: $210,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA)