FAIR Generics Act

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

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

Patent LegislationS. 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

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

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. 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

Client expense: $3,680,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

S. 214 - Preserve Access to Affordable Generics Act;S. 504 - Fair And Immediate Release of Generic Drugs Act; patent settlements, Patent Reform bills

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The Prescription Drug Marketing Act;conterfit/pedigree issues Drug importation issues; Drug safety and inspection of drug manufacturing facilities; Prescription Drug Abuse;H.R. 1285 - To amend the Controlled Substances Act; H.R. 486 Stop Tampering of Prescription Pills Act of 2013;H.R. 672 - Prescription Drug Abuse Prevention and Treatment Act of 2013S. 216 - Safe Prescribing Act of 2013;S. 504 - Fair And Immediate Release of Generic Drugs Act;S. 348

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Discussed importance of potential savings both to consumers and to the federal government of granting Secretarial Negotiating Authority to Secretary of HHS on Medicare Part D. (no bill)Discussed legislative intent with respect to biologic drugs and the exclusivity period; and discussed importance of potential savings to the health care system generally. (no bill) Discussed need for greater consumer safety protections both in OTC and prescription drugs. (no bill) Discussed need for doctors to get unbiased information on prescription pharmaceuticals through programs like academic detailing. (no bill) Discussed possible savings and better health care outcomes that could result from Medication Therapy Management. (no bill) Pub. Law 111-148 and 111-152 - Discussed implementation of health care legislation to reform the health care system to provide quality healthcare, expand access to long-term services and supports, and reduced prescription drug costs. Discussed greater affordability of generic versions of both generic and biologic drugs. S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011 - Discussed legislation that establishes a framework for the safe, legal importation of lower-priced prescription drugs from abroad. S. 1206, Medicare Drug Savings Act of 2011 - Discussed rebates in Medicare Part D as a cost savings measure in Medicare that does not harm beneficiaries. H. R. 3342, Affordable Medicines Utilization Act of 2011 - Lobbied on legislation to encourage state Medicaid programs to use safe, effective generic medications. S. 27, Preserve Access to Affordable Generics Act of 2011- Lobbied for this legislation preventing abuses in patent settlements between generic and brand name prescription drug companies. S. 1886/H.R. 3468 of 2011- Discussed counterfeit drug penalty enhancement. Discussed prescription drug safety, drug shortage, and medical device safety, and related user fee legislation. S. 2193 of 2012, the Ensuring Safe Medical Devices for Patients Act - Discussed legislation to include devices in the post-market risk identification and analysis system for prescription drugs and to expedite the implementation of the unique device identification system for medical devices. Discussed draft legislation to address the issue of whether generic drug manufacturers have a duty to include new warnings about potentially serious side effects on their labels as they become known by giving generic drug makers the same ability to update their labeling as manufacturers of brand name drugs. (no bill) S.3187, Food and Drug Administration safety and Innovation Act - FDA user fee agreement legislation focusing on the review process for prescription drugs and medical devices, prescription drug safety, drug shortages, medical device safety and access to generic drugs. S.3212, Cody Miller Initiative for Safer Prescriptions Act - To require the Secretary of Health and Human Services to promulgate regulations regarding the authorship, content, format, and dissemination of Patient Medication information. Discussed pay-for-delay agreements as tactic by drug manufacturers to block lower cost drugs from entering the market, and the Fair and Immediate Release of Generics Drugs Act that would address the underlying issue of "parked exclusivities" in the Hatch-Waxman Act (S.1882). Discussed the issue of biosimilar drug naming and how biosimilars should use a common International Non-proprietary name as reference originator biologic products. (no bill) S. 504, the Fair and Immediate Release of Generic Drugs Act/S.214, the Preserve Access to Affordable Generics Act - Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill) H.R. 4800/S. 2389, Agriculture Appropriations bill, 2015 - Lobbied to protect and enhance funding levels for FDA to enable it to effectively manage it's food safety and medical product programs. H.J. Res. 124, Continuing Appropriations Resolutions, 2015 - Lobbied to protect senior housing and nutrition programs, and FDA programs from disproportionate reduction under the bill.Discussed Unique Device Identification (UDI) issues including proposed rules and implementation. (no bill) Discussed oversight of laboratory genetic testing. (no bill) Discussed AARP's concerns with prescription drug costs. (no bill) S.117, Medicare Prescription Drug Price Negotiation Act - Discussed bill that allows medicare to negotiate medicare prescription drug prices with drug companies. S.504/S.214, The Fair and Immediate Release of Generics Drugs Act/Preserve Access to Affordable Generics Act - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. Discussed the exclusivity period for biologic drugs. (no bill) Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) S. 504, the Fair and Immediate Release of Generics Drugs Act/S. 214, the Preserve Access to Affordable Generics - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. Discussed the exclusivity period ofr biologic drugs. (no bill) Discussed the Food and Drug Administration proposed rule to enable generic drug makers to independently update their drug labeling. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) S. 1720/S.2049/S.866, - Discussed patent reform legislation and related provisions. Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market (the Fair and Immediate Release of Generic Drugs Act (S. 504) and (the Preserve Access to Affordable Generics Act) (S.214). Discussed the exclusivity period for biologic drugs. (no bill) Discussed the Food and Drug Administration proposed rule to enable generic drug makers to independently update their drug labeling. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) S. 1720/S. 2049/S.866 - Discussed patent reform legislation and related provisions. Discussed other prescription drug issues and potential legislation on drug importation and "least costly alternative" payment for Part B durgs. (no bill) Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) S.504/S.214 - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market (the Fair and Immediate Release of Generics Drugs Act) and the Preserve Access to Affordable Generics Act. Discussed the exclusivity period for biologic drugs. (no bill) Discussed the Food and Drug Administration proposed rule to enable generic drug makers to independently update their drug labeling. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) S.1720/S.2040/S.866 - Discussed patent reform legislation and related provisions. Discussed other prescription drug issues and potential legislation on drug importation and "least costly alternative" payment for Part B drugs. (no bill) Discussed the need to data transparency on prescription drug research and development costs and drug prices, and enhanced data reporting on coverage determinations, exception, and redeterminations under Part D appeals process. (no bill) Discussed the House Energy and Commerce Committee 21st Century Cures Initiative focused on drug and medical device innovation issues. (no bill)

Client expense: $2,380,000 · Firm income: Not reported

Government targets: Administration on Aging, Agriculture, Dept of (USDA), Bureau of the Census, Centers For Medicare and Medicaid Services (CMS), Commodity Futures Trading Commission (CFTC), Congressional Budget Office (CBO), Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Highway Administration (FHA), Federal Reserve System, Federal Trade Commission (FTC), Federal Transit Administration (FTA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Natl Highway Traffic Safety Administration (NHTSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Comptroller of the Currency (OCC), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, Veterans Affairs, Dept of (VA), White House Office

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

Client expense: $1,140,000 · Firm income: Not reported

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

Pharmaceutical Distribution Supply Chain Security (H.R. 1919 / S. 957 / S. 959); Electronic distribution of prescribing information; School Access to Emergency Epinephrine (H.R. 2094); Biosimilars; H.R. 8; H.R. 486 - the Stop Tampering of Prescription Pills (STOPP) Act; S.504 - Fair and Immediate Release of Generic Drugs Act; S.621 - The Safe Prescribing Act of 2013 /H.R.1285 H.R.460 - Patients Access to Treatments Act of 2013; House Energy & Commerce Committee's 21st Century Cures initiative

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Discussed importance of potential savings both to consumers and to the federal government of granting Secretarial Negotiating Authority to Secretary of HHS on Medicare Part D. (no bill)Discussed legislative intent with respect to biologic drugs and the exclusivity period; and discussed importance of potential savings to the health care system generally. (no bill) Discussed need for greater consumer safety protections both in OTC and prescription drugs. (no bill) Discussed need for doctors to get unbiased information on prescription pharmaceuticals through programs like academic detailing. (no bill) Discussed possible savings and better health care outcomes that could result from Medication Therapy Management. (no bill) Pub. Law 111-148 and 111-152 - Discussed implementation of health care legislation to reform the health care system to provide quality healthcare, expand access to long-term services and supports, and reduced prescription drug costs. Discussed greater affordability of generic versions of both generic and biologic drugs. S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011 - Discussed legislation that establishes a framework for the safe, legal importation of lower-priced prescription drugs from abroad. S. 1206, Medicare Drug Savings Act of 2011 - Discussed rebates in Medicare Part D as a cost savings measure in Medicare that does not harm beneficiaries. H. R. 3342, Affordable Medicines Utilization Act of 2011 - Lobbied on legislation to encourage state Medicaid programs to use safe, effective generic medications. S. 27, Preserve Access to Affordable Generics Act of 2011- Lobbied for this legislation preventing abuses in patent settlements between generic and brand name prescription drug companies. S. 1886/H.R. 3468 of 2011- Discussed counterfeit drug penalty enhancement. Discussed prescription drug safety, drug shortage, and medical device safety, and related user fee legislation. S. 2193 of 2012, the Ensuring Safe Medical Devices for Patients Act - Discussed legislation to include devices in the post-market risk identification and analysis system for prescription drugs and to expedite the implementation of the unique device identification system for medical devices. Discussed draft legislation to address the issue of whether generic drug manufacturers have a duty to include new warnings about potentially serious side effects on their labels as they become known by giving generic drug makers the same ability to update their labeling as manufacturers of brand name drugs. (no bill) S.3187, Food and Drug Administration safety and Innovation Act - FDA user fee agreement legislation focusing on the review process for prescription drugs and medical devices, prescription drug safety, drug shortages, medical device safety and access to generic drugs. S.3212, Cody Miller Initiative for Safer Prescriptions Act - To require the Secretary of Health and Human Services to promulgate regulations regarding the authorship, content, format, and dissemination of Patient Medication information. Discussed pay-for-delay agreements as tactic by drug manufacturers to block lower cost drugs from entering the market, and the Fair and Immediate Release of Generics Drugs Act that would address the underlying issue of "parked exclusivities" in the Hatch-Waxman Act (S.1882). Discussed the issue of biosimilar drug naming and how biosimilars should use a common International Non-proprietary name as reference originator biologic products. (no bill) S. 504, the Fair and Immediate Release of Generic Drugs Act/S.214, the Preserve Access to Affordable Generics Act - Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill) H.R. 4800/S. 2389, Agriculture Appropriations bill, 2015 - Lobbied to protect and enhance funding levels for FDA to enable it to effectively manage it's food safety and medical product programs.Discussed Unique Device Identification (UDI) issues including proposed rules and implementation. (no bill) Discussed oversight of laboratory genetic testing. (no bill) Discussed AARP's concerns with prescription drug costs. (no bill) S.117, Medicare Prescription Drug Price Negotiation Act - Discussed bill that allows medicare to negotiate medicare prescription drug prices with drug companies. S.504/S.214, The Fair and Immediate Release of Generics Drugs Act/Preserve Access to Affordable Generics Act - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. Discussed the exclusivity period for biologic drugs. (no bill) Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) S. 504, the Fair and Immediate Release of Generics Drugs Act/S. 214, the Preserve Access to Affordable Generics - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. Discussed the exclusivity period ofr biologic drugs. (no bill) Discussed the Food and Drug Administration proposed rule to enable generic drug makers to independently update their drug labeling. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) S. 1720/S.2049/S.866, - Discussed patent reform legislation and related provisions. Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market (the Fair and Immediate Release of Generic Drugs Act (S. 504) and (the Preserve Access to Affordable Generics Act) (S.214). Discussed the exclusivity period for biologic drugs. (no bill) Discussed the Food and Drug Administration proposed rule to enable generic drug makers to independently update their drug labeling. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) S. 1720/S. 2049/S.866 - Discussed patent reform legislation and related provisions. Discussed other prescription drug issues and potential legislation on drug importation and "least costly alternative" payment for Part B durgs. (no bill)

Client expense: $2,360,000 · Firm income: Not reported

Government targets: Administration on Aging, Agriculture, Dept of (USDA), Bureau of the Census, Centers For Medicare and Medicaid Services (CMS), Commodity Futures Trading Commission (CFTC), Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Highway Administration (FHA), Federal Reserve System, Federal Trade Commission (FTC), Federal Transit Administration (FTA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Natl Highway Traffic Safety Administration (NHTSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Comptroller of the Currency (OCC), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, Veterans Affairs, Dept of (VA), White House Office

S.214, Preserve Access to Affordable Generics Act; and S.504, A bill to amend the Federal Food, Drug and Cosmetic Act to ensure that valid generic drugs may enter the market

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

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

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

Client expense: $4,190,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

H.R. 3204, Drug Quality and Security Act H.R. 2725, Food and Drug Administration Safety Over Sequestration Act of 2013 S. 1413, FDA User Fee Protection Act S. 504, Fair And Immediate Release of Generic Drugs Act

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR), White House Office

Pharmaceutical Distribution Supply Chain Security (H.R. 1919 / S. 957 / S. 959); Electronic distribution of prescribing information; School Access to Emergency Epinephrine (H.R. 2094); Biosimilars; H.R. 8; H.R. 486 - the Stop Tampering of Prescription Pills (STOPP) Act; S.504 - Fair and Immediate Release of Generic Drugs Act; S.621 - The Safe Prescribing Act of 2013 /H.R.1285 H.R.460 - Patients Access to Treatments Act of 2013; House Energy & Commerce Committee's 21st Century Cures initiative

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The Prescription Drug Marketing Act;conterfit/pedigree issues Drug importation issues; Drug safety and inspection of drug manufacturing facilities; Prescription Drug Abuse;H.R. 1285 - To amend the Controlled Substances Act; H.R. 486 Stop Tampering of Prescription Pills Act of 2013;H.R. 672 - Prescription Drug Abuse Prevention and Treatment Act of 2013S. 216 - Safe Prescribing Act of 2013;S. 504 - Fair And Immediate Release of Generic Drugs Act;S. 348

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 214 - Preserve Access to Affordable Generics Act;S. 504 - Fair And Immediate Release of Generic Drugs Act; patent settlements, Patent Reform bills

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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. Trade Representative (USTR)

Discussed importance of potential savings both to consumers and to the federal government of granting Secretarial Negotiating Authority to Secretary of HHS on Medicare Part D. (no bill)Discussed legislative intent with respect to biologic drugs and the exclusivity period; and discussed importance of potential savings to the health care system generally. (no bill) Discussed need for greater consumer safety protections both in OTC and prescription drugs. (no bill) Discussed need for doctors to get unbiased information on prescription pharmaceuticals through programs like academic detailing. (no bill) Discussed possible savings and better health care outcomes that could result from Medication Therapy Management. (no bill) Pub. Law 111-148 and 111-152 - Discussed implementation of health care legislation to reform the health care system to provide quality healthcare, expand access to long-term services and supports, and reduced prescription drug costs. Discussed greater affordability of generic versions of both generic and biologic drugs. S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011 - Discussed legislation that establishes a framework for the safe, legal importation of lower-priced prescription drugs from abroad. S. 1206, Medicare Drug Savings Act of 2011 - Discussed rebates in Medicare Part D as a cost savings measure in Medicare that does not harm beneficiaries. H. R. 3342, Affordable Medicines Utilization Act of 2011 - Lobbied on legislation to encourage state Medicaid programs to use safe, effective generic medications. S. 27, Preserve Access to Affordable Generics Act of 2011- Lobbied for this legislation preventing abuses in patent settlements between generic and brand name prescription drug companies. S. 1886/H.R. 3468 of 2011- Discussed counterfeit drug penalty enhancement. Discussed prescription drug safety, drug shortage, and medical device safety, and related user fee legislation. S. 2193 of 2012, the Ensuring Safe Medical Devices for Patients Act - Discussed legislation to include devices in the post-market risk identification and analysis system for prescription drugs and to expedite the implementation of the unique device identification system for medical devices. Discussed draft legislation to address the issue of whether generic drug manufacturers have a duty to include new warnings about potentially serious side effects on their labels as they become known by giving generic drug makers the same ability to update their labeling as manufacturers of brand name drugs. (no bill) S.3187, Food and Drug Administration safety and Innovation Act - FDA user fee agreement legislation focusing on the review process for prescription drugs and medical devices, prescription drug safety, drug shortages, medical device safety and access to generic drugs. S.3212, Cody Miller Initiative for Safer Prescriptions Act - To require the Secretary of Health and Human Services to promulgate regulations regarding the authorship, content, format, and dissemination of Patient Medication information. Discussed pay-for-delay agreements as tactic by drug manufacturers to block lower cost drugs from entering the market, and the Fair and Immediate Release of Generics Drugs Act that would address the underlying issue of "parked exclusivities" in the Hatch-Waxman Act (S.1882). Discussed the issue of biosimilar drug naming and how biosimilars should use a common International Non-proprietary name as reference originator biologic products. (no bill) S. 504, the Fair and Immediate Release of Generic Drugs Act/S.214, the Preserve Access to Affordable Generics Act - Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill)Discussed Unique Device Identification (UDI) issues including proposed rules and implementation. (no bill) Discussed oversight of laboratory genetic testing. (no bill) Discussed AARP's concerns with prescription drug costs. (no bill) S.117, Medicare Prescription Drug Price Negotiation Act - Discussed bill that allows medicare to negotiate medicare prescription drug prices with drug companies. S.504/S.214, The Fair and Immediate Release of Generics Drugs Act/Preserve Access to Affordable Generics Act - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. Discussed the exclusivity period for biologic drugs. (no bill) Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) S. 504, the Fair and Immediate Release of Generics Drugs Act/S. 214, the Preserve Access to Affordable Generics - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. Discussed the exclusivity period ofr biologic drugs. (no bill) Discussed the Food and Drug Administration proposed rule to enable generic drug makers to independently update their drug labeling. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) S. 1720/S.2049/S.866, - Discussed patent reform legislation and related provisions

Client expense: $1,990,000 · Firm income: Not reported

Government targets: Administration on Aging, Agriculture, Dept of (USDA), Bureau of the Census, Centers For Medicare and Medicaid Services (CMS), Commodity Futures Trading Commission (CFTC), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Highway Administration (FHA), Federal Reserve System, Federal Trade Commission (FTC), Federal Transit Administration (FTA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Natl Highway Traffic Safety Administration (NHTSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Comptroller of the Currency (OCC), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, Veterans Affairs, Dept of (VA), White House Office

H.R. 3204, Drug Quality and Security Act H.R. 2725, Food and Drug Administration Safety Over Sequestration Act of 2013 S. 1413, FDA User Fee Protection Act S. 504, Fair And Immediate Release of Generic Drugs Act

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

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

Pharmaceutical Distribution Supply Chain Security; Electronic distribution of prescribing information; H.R. 3204, the Drug Quality and Security Act; Compounding; Generic Labeling; Biosimilars; H.R. 486, the Stop Tampering of Prescription Pills (STOPP) Act; S. 214, the Preserve Access to Affordable Generics; S. 504, the Fair and Immediate Release of Generic Drugs Act; H.R. 2725, the FDA Safety Over Sequestration Act of 2013; S. 621, the Safe Prescribing Act of 2013Risk Evaluation Mitigation Strategies; H.R. 460, Patients' Access to Treatments Act of 2013; implementation of the Generic Drug User Fee Act

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

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

Client expense: $4,680,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), 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), White House Office

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

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

S.214, Preserve Access to Affordable Generics Act; and S.504, A bill to amend the Federal Food, Drug and Cosmetic Act to ensure that valid generic drugs may enter the market

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

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

Pharmaceutical Distribution Supply Chain Security (H.R. 1919 / S. 957 / S. 959); Electronic distribution of prescribing information; School Access to Emergency Epinephrine (H.R. 2094); Biosimilars; H.R. 8; H.R. 486 - the Stop Tampering of Prescription Pills (STOPP) Act; S.504 - Fair and Immediate Release of Generic Drugs Act; S.621 - The Safe Prescribing Act of 2013 /H.R.1285 H.R.460 - Patients Access to Treatments Act of 2013

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Pharmaceutical Distribution Supply Chain Security (H.R. 1919 / S. 957 / S. 959); Electronic distribution of prescribing information; School Access to Emergency Epinephrine (H.R. 2094); Biosimilars; H.R. 8; H.R. 486 - the Stop Tampering of Prescription Pills (STOPP) Act; S.504 - Fair and Immediate Release of Generic Drugs Act; S.621 - The Safe Prescribing Act of 2013 /H.R.1285 H.R.460 - Patients Access to Treatments Act of 2013

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The Prescription Drug Marketing Act;conterfit/pedigree issues Drug importation issues; Drug safety and inspection of drug manufacturing facilities; Prescription Drug Abuse;H.R. 1285 - To amend the Controlled Substances Act; H.R. 486 Stop Tampering of Prescription Pills Act of 2013;H.R. 672 - Prescription Drug Abuse Prevention and Treatment Act of 2013S. 216 - Safe Prescribing Act of 2013;S. 504 - Fair And Immediate Release of Generic Drugs Act;S. 348

Client expense: $420,000 · Firm income: Not reported

Government targets: Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, SENATE

S. 214 - Preserve Access to Affordable Generics Act;S. 504 - Fair And Immediate Release of Generic Drugs Act; patent settlements, Patent Reform bills

Client expense: $420,000 · Firm income: Not reported

Government targets: Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, SENATE

Pharmaceutical Distribution Supply Chain Security (H.R. 1919 / S. 957 / S. 959); Electronic distribution of prescribing information; School Access to Emergency Epinephrine (H.R. 2094); Biosimilars; H.R. 8; H.R. 486 - the Stop Tampering of Prescription Pills (STOPP) Act; S.504 - Fair and Immediate Release of Generic Drugs Act; S.621 - The Safe Prescribing Act of 2013 /H.R.1285 H.R.460 - Patients Access to Treatments Act of 2013

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The Prescription Drug Marketing Act;conterfit/pedigree issues Drug importation issues; Drug safety and inspection of drug manufacturing facilities; Prescription Drug Abuse;H.R. 1285 - To amend the Controlled Substances Act; H.R. 486 Stop Tampering of Prescription Pills Act of 2013;H.R. 672 - Prescription Drug Abuse Prevention and Treatment Act of 2013S. 216 - Safe Prescribing Act of 2013;S. 504 - Fair And Immediate Release of Generic Drugs Act;S. 348

Client expense: $730,000 · Firm income: Not reported

Government targets: Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, SENATE

S. 214 - Preserve Access to Affordable Generics Act;S. 504 - Fair And Immediate Release of Generic Drugs Act; patent settlements, Patent Troll bills

Client expense: $730,000 · Firm income: Not reported

Government targets: Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, SENATE

Pharmaceutical Distribution Supply Chain Security (H.R. 1919 / S. 957 / S. 959); Electronic distribution of prescribing information; School Access to Emergency Epinephrine (H.R. 2094); Biosimilars; H.R. 8; H.R. 486 - the Stop Tampering of Prescription Pills (STOPP) Act; S.504 - Fair and Immediate Release of Generic Drugs Act; S.621 - The Safe Prescribing Act of 2013 /H.R.1285 H.R.460 - Patients Access to Treatments Act of 2013

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

Client expense: $4,050,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), 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), White House Office

Discussed importance of potential savings both to consumers and to the federal government of granting Secretarial Negotiating Authority to Secretary of HHS on Medicare Part D. (no bill)Discussed legislative intent with respect to biologic drugs and the exclusivity period; and discussed importance of potential savings to the health care system generally. (no bill) Discussed need for greater consumer safety protections both in OTC and prescription drugs. (no bill) Discussed need for doctors to get unbiased information on prescription pharmaceuticals through programs like academic detailing. (no bill) Discussed possible savings and better health care outcomes that could result from Medication Therapy Management. (no bill) Pub. Law 111-148 and 111-152 - Discussed implementation of health care legislation to reform the health care system to provide quality healthcare, expand access to long-term services and supports, and reduced prescription drug costs. Discussed greater affordability of generic versions of both generic and biologic drugs. S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011 - Discussed legislation that establishes a framework for the safe, legal importation of lower-priced prescription drugs from abroad. S. 1206, Medicare Drug Savings Act of 2011 - Discussed rebates in Medicare Part D as a cost savings measure in Medicare that does not harm beneficiaries. H. R. 3342, Affordable Medicines Utilization Act of 2011 - Lobbied on legislation to encourage state Medicaid programs to use safe, effective generic medications. S. 27, Preserve Access to Affordable Generics Act of 2011- Lobbied for this legislation preventing abuses in patent settlements between generic and brand name prescription drug companies. S. 1886/H.R. 3468 of 2011- Discussed counterfeit drug penalty enhancement. Discussed prescription drug safety, drug shortage, and medical device safety, and related user fee legislation. S. 2193 of 2012, the Ensuring Safe Medical Devices for Patients Act - Discussed legislation to include devices in the post-market risk identification and analysis system for prescription drugs and to expedite the implementation of the unique device identification system for medical devices. Discussed draft legislation to address the issue of whether generic drug manufacturers have a duty to include new warnings about potentially serious side effects on their labels as they become known by giving generic drug makers the same ability to update their labeling as manufacturers of brand name drugs. (no bill) S.3187, Food and Drug Administration safety and Innovation Act - FDA user fee agreement legislation focusing on the review process for prescription drugs and medical devices, prescription drug safety, drug shortages, medical device safety and access to generic drugs. S.3212, Cody Miller Initiative for Safer Prescriptions Act - To require the Secretary of Health and Human Services to promulgate regulations regarding the authorship, content, format, and dissemination of Patient Medication information. Discussed pay-for-delay agreements as tactic by drug manufacturers to block lower cost drugs from entering the market, and the Fair and Immediate Release of Generics Drugs Act that would address the underlying issue of "parked exclusivities" in the Hatch-Waxman Act (S.1882). Discussed the issue of biosimilar drug naming and how biosimilars should use a common International Non-proprietary name as reference originator biologic products. (no bill) S. 504, the Fair and Immediate Release of Generic Drugs Act/S.214, the Preserve Access to Affordable Generics Act - Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill)Discussed Unique Device Identification (UDI) issues including proposed rules and implementation. (no bill) Discussed oversight of laboratory genetic testing. (no bill) Discussed AARP's concerns with prescription drug costs. (no bill) S.117, Medicare Prescription Drug Price Negotiation Act - Discussed bill that allows medicare to negotiate medicare prescription drug prices with drug companies. S.504/S.214, The Fair and Immediate Release of Generics Drugs Act/Preserve Access to Affordable Generics Act - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. Discussed the exclusivity period for biologic drugs. (no bill) Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill)

Client expense: $2,500,000 · Firm income: Not reported

Government targets: Administration on Aging, Agriculture, Dept of (USDA), Bureau of the Census, Centers For Medicare and Medicaid Services (CMS), Commodity Futures Trading Commission (CFTC), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Highway Administration (FHA), Federal Reserve System, Federal Trade Commission (FTC), Federal Transit Administration (FTA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Natl Council on Disability, Natl Highway Traffic Safety Administration (NHTSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Comptroller of the Currency (OCC), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, Veterans Affairs, Dept of (VA), White House Office

Pharmaceutical Distribution Supply Chain Security, Electronic distribution of prescribing information, H.R. 2094, the School Access to Emergency Epinephrine Act, S.214, Preserve Access to Affordable Generics Act, S.504, Fair and Immediate Release of Generic Drugs ActH.R.460 - Patients' Access to Treatments Act of 2013, Generic Drug User Fees, Biosimilar User Fees, Compounding, S. 959: Pharmaceutical Compounding Quality and Accountability Act, H.R. 1919: Safeguarding Americas Pharmaceuticals Act of 2013, S.957, the Drug Supply Chain Security Act, Global HIV/AIDS programs

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3204, Drug Quality and Security Act H.R. 2725, Food and Drug Administration Safety Over Sequestration Act of 2013 S. 214, Preserve Access to Affordable Generics Act S. 504, Fair And Immediate Release of Generic Drugs Act

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

S.214, Preserve Access to Affordable Generics Act; and S.504, A bill to amend the Federal Food, Drug and Cosmetic Act to ensure that valid generic drugs may enter the market

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

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

H.R. 2582 - PATENT Jobs Act; provisions related to patent user fees H.R. 2766 - STOP Act; provisions related to business method patents H.R. 3309 - Innovation Act; provisions related to patent litigation reform H.R. 3349 - Innovation Protection Act ; provisions related to PTO fee diversionH.R. 3540 - Demand Letter Transparency Act 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 Biopharmaceutical innovation policy issues Biologics data protection issues Counterfeit drug issues

Client expense: $420,000 · Firm income: Not reported

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

S. 504, The Fair and Immediate Release of Generics Act, provisions relating to market blockages caused by parked 180 day exclusivity periods; S. 214, The Preserve Access to Affordable Pharmaceuticals Act, provisions relating to the legality of "reverse payment" patent settlements;Federal Trade Commission v. Actavis Supreme Court Case No. 12-416 as this case pertains to S. 504, S. 214, and to federal policy on "reverse payment" settlements; Potential legislation relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing; HR 3204, the Drug Quality and Security Act, Title II, Drug Supply Chain Security, provisions relating to the establishment of a federal track and trace system for pharmaceuticals; Implementation of Public Law 112-144 The Food and Drug Administration Safety and Innovation Act, federal policy relating to provisions in Title 3 regarding generic drug user fees; H.R. 2725, FDA Safety Over Sequestration Act, provisions relating to the exemption of FDA user fees from sequestration-imposed cuts to the federal budget; FDA proposed rule titled Supplemental Applications Proposing Labeling Changes For Approved Drugs And Biological Products, Docket Number FDA-2013-N-0500, provisions relating to generic drug labeling changes

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 504: Fair and Immediate Release of Generic Drugs Act S. 214: Preserve Access to Affordable Generics Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 504 Fair And Immediate Release of Generic Drugs Act S. 214 Preserve Access to Affordable Generics Act generic drug label changes and preemption of federal law

Client expense: Not reported · Firm income: $51,000

Government targets: SENATE

H.R. 3204, Drug Quality and Security Act H.R. 2725, Food and Drug Administration Safety Over Sequestration Act of 2013 S. 214, Preserve Access to Affordable Generics Act S. 504, Fair And Immediate Release of Generic Drugs Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.214, Preserve Access to Affordable Generics Act; and S.504, A bill to amend the Federal Food, Drug and Cosmetic Act to ensure that valid generic drugs may enter the market

Client expense: $810,000 · Firm income: Not reported

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

The Prescription Drug Marketing Act;conterfit/pedigree issues Drug importation issues; Drug safety and inspection of drug manufacturing facilities; Prescription Drug Abuse;H.R. 1285 - To amend the Controlled Substances Act; H.R. 486 Stop Tampering of Prescription Pills Act of 2013;H.R. 672 - Prescription Drug Abuse Prevention and Treatment Act of 2013S. 216 - Safe Prescribing Act of 2013;S. 504 - Fair And Immediate Release of Generic Drugs Act;S. 348

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE