Counterfeit Drug Penalty Enhancement Act of 2011

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. 83, Consolidated and Further Continuing Appropriations, 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. 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 Food and Drug Administration proposed rule to enable generic drug makers to independently update their drug labeling. (no bill) Discussed other prescription drug issues and potential legislation on drug importation and "least costly alternative" payment for Part B durgs. (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 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: $2,180,000 · 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. 22, Foreign Counterfeit Merchandise Prevention Act H.R. 624, Cyber Intelligence Sharing and Protection Act H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 H.R. 1123, Unlocking Consumer Choice and Wireless Competition Act H.R. 1580, To Affirm the policy of the United States regarding Internet Governance H.R. 2024, End Anonymous Patents Act H.R. 2236, Promoting Startup Innovation Act H.R. 2454, Aarons Law Act of 2013 H.R. 2639, Patent Litigation and Innovation Act of 2013 H.R. 2766, Stopping the Offensive Use of Patents (STOP) Act H.R. 3004, Reducing Waste and Increasing Efficiency in Trade Act H.R. 3309, Innovation Act S. 660, Innovation Through Trade Act S. 662, Trade Facilitation and Trade Enforcement Reauthorization Act of 2013 S. 866, Patent Quality Improvement Act of 2013 S. 1013, Patent Abuse Reduction Act of 2013 S. 1612, Patent Litigation Integrity Act of 2013 S. 1720, Patent Transparency and Improvements Act of 2013 S. 2267, Defend Trade Secrets Act of 2014 S. 2588, Cybersecurity Information Sharing Act of 2014 Fiscal Year 2015 Appropriations legislation, including provisions relating to IP enforcement funding and the authorization and funding for the IPR Center Potential legislation similar to H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011 Potential legislation similar to H.R. 3668, Counterfeit Drug Penalty Enhancement Act of 2012 Potential legislation similar to H.R. 4095, Online Pharmacy Safety Act of 2012 Potential legislation similar to H.R. 4216, Foreign Counterfeit Prevention Act of 2012 Potential legislation similar to H.R. 6654, Foreign Counterfeit Prevention Act of 2012 Potential legislation similar to S. 832, Security and Accountability for Every Port Reauthorization Act of 2011 Potential legislation similar to S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011 Potential legislation similar to S. 2002, Online Pharmacy Safety Act of 2012 Potential legislation similar to S. 3523, Innovative Design Protection Act of 2012 Nomination of Michelle Lee, as the Director of the United States Patent and Trademark Office (USPTO) Nomination of Danny Marti, Esq., as the U.S. Intellectual Property Enforcement Coordinator (IPEC) Various issues relating to the Anti-Counterfeiting Trade Agreement; IP agreements in the Trans-Pacific Partnership Agreement (TPP); Transatlantic Trade and Investment Partnership (TTIP); Trade Promotion Authority (TPA); IP issues relating to the Asia-Pacific Economic Cooperation (APEC); IP issues relating to United Nations Framework Convention on Climate Change (UNFCCC); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; USPTO IP Attache Program;World Intellectual Property Organization; World Trade Organization (WTO); World Health Organization (WHO); International Telecommunications Union; implementation of Section 182 of the Trade Act of 1974 (P.L. 93-618), as amended by the Omnibus Trade and Competitiveness Act of 1988 (P.L. 100-418) and the Uruguay Round Agreements Act (P.L. 103-465) (the "Special 301 Report"); Digital Millennium Copyright Act (P.L. 105-304), including safe harbor provision and notice and takedown provisions; appropriations relating to the PRO-IP Act of 2008 (P.L. 110-403); Executive Order 13636, Improving Critical Infrastructure Cybersecurity, including data breach provisions; creation of a Patent Prosecution Highway (PPH) with foreign governments; review/reform of U.S. copyright law; patent litigation reform; copyright and trademark infringement; privacy legislation; securing clarification that criminal copyright infringement through unauthorized streaming is a felony; ICANN proposal for a Limited Preventative Registration (LPR) mechanism; cyber theft of trade secrets; digital copyrights; funding issues relating to the USPTO; IP issues relating to Australia, Brazil, Canada, China, Europe, India, Mexico, and Russia; IP issues relating to internet counterfeiting and piracy; IP issues relating to trade secret theft; expanded use of software asset management by the Federal Government and its contractors; patent linkage and regulatory data protection; plain packaging

Client expense: $21,250,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Product Safety Commission (CPSC), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Bureau of Investigation (FBI), Federal Deposit Insurance Corporation (FDIC), Federal Housing Finance Agency (FHFA), Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), General Services Administration (GSA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Fish & Wildlife Service (USFWS), U.S. Forest Service, U.S. Trade Representative (USTR), White House Office

H.R. 22, Foreign Counterfeit Merchandise Prevention Act H.R. 624, Cyber Intelligence Sharing and Protection Act H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 H.R. 1123, Unlocking Consumer Choice and Wireless Competition Act H.R. 1580, To Affirm the policy of the United States regarding Internet Governance H.R. 2024, End Anonymous Patents Act H.R. 2236, Promoting Startup Innovation Act H.R. 2454, Aarons Law Act of 2013 H.R. 2639, Patent Litigation and Innovation Act of 2013 H.R. 2766, Stopping the Offensive Use of Patents (STOP) Act H.R. 3004, Reducing Waste and Increasing Efficiency in Trade Act H.R. 3309, Innovation Act H.R. 5233, Trade Secrets Protection Act of 2014 S. 660, Innovation Through Trade Act S. 662, Trade Facilitation and Trade Enforcement Reauthorization Act of 2013 S. 866, Patent Quality Improvement Act of 2013 S. 1013, Patent Abuse Reduction Act of 2013 S. 1612, Patent Litigation Integrity Act of 2013 S. 1720, Patent Transparency and Improvements Act of 2013 S. 2267, Defend Trade Secrets Act of 2014 S. 2588, Cybersecurity Information Sharing Act of 2014 Fiscal Year 2015 Appropriations legislation, including provisions relating to IP enforcement funding and the authorization and funding for the IPR Center Potential legislation similar to H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011 Potential legislation similar to H.R. 3668, Counterfeit Drug Penalty Enhancement Act of 2012 Potential legislation similar to H.R. 4095, Online Pharmacy Safety Act of 2012 Potential legislation similar to H.R. 4216, Foreign Counterfeit Prevention Act of 2012 Potential legislation similar to H.R. 6654, Foreign Counterfeit Prevention Act of 2012 Potential legislation similar to S. 832, Security and Accountability for Every Port Reauthorization Act of 2011 Potential legislation similar to S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011 Potential legislation similar to S. 2002, Online Pharmacy Safety Act of 2012 Potential legislation similar to S. 3523, Innovative Design Protection Act of 2012 Various issues relating to the Anti-Counterfeiting Trade Agreement; IP agreements in the Trans-Pacific Partnership Agreement (TPP); Transatlantic Trade and Investment Partnership (TTIP); Russia Permanent Normal Trade Relations (PNTR); Trade Promotion Authority (TPA); IP issues relating to the Asia-Pacific Economic Cooperation (APEC); IP issues relating to United Nations Framework Convention on Climate Change (UNFCCC); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; USPTO IP Attache Program;World Intellectual Property Organization; World Trade Organization (WTO); World Health Organization (WHO); International Telecommunications Union; implementation of Section 182 of the Trade Act of 1974 (P.L. 93-618), as amended by the Omnibus Trade and Competitiveness Act of 1988 (P.L. 100-418) and the Uruguay Round Agreements Act (P.L. 103-465) (the "Special 301 Report"); appropriations relating to the PRO-IP Act (P.L. 110-403); Digital Millennium Copyright Act (P.L. 105-304), safe harbor provision, notice and takedown provisions ; Executive Order 13636, Improving Critical Infrastructure Cybersecurity, including data breach provisions; creation of a Patent Prosecution Highway (PPH) with foreign governments; review/reform of U.S. copyright law; patent litigation reform; copyright and trademark infringement; customs facilitation and trade enforcement reauthorization; privacy legislation; securing clarification that criminal copyright infringement through unauthorized streaming is a felony; ICANN proposal for a Limited Preventative Registration (LPR) mechanism; cyber theft of trade secrets; digital copyrights; funding issues relating to the USPTO; IP issues relating to Australia, Canada, China, India, Brazil, Russia, Europe, and Mexico; IP issues relating to internet counterfeiting and piracy; IP issues relating to trade secret theft; expanded use of software asset management by the Federal Government and its contractors; patent linkage and regulatory data protection; plain packaging

Client expense: $28,350,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Product Safety Commission (CPSC), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Bureau of Investigation (FBI), Federal Deposit Insurance Corporation (FDIC), Federal Housing Finance Agency (FHFA), Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Fish & Wildlife Service (USFWS), U.S. Forest Service, 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) 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

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

H.R. 22, Foreign Counterfeit Merchandise Prevention Act H.R. 624, Cyber Intelligence Sharing and Protection Act H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 H.R. 1123, Unlocking Consumer Choice and Wireless Competition Act H.R. 1580, To Affirm the policy of the United States regarding Internet Governance H.R. 2024, End Anonymous Patents Act H.R. 2236, Promoting Startup Innovation Act H.R. 2454, Aarons Law Act of 2013 H.R. 2639, Patent Litigation and Innovation Act of 2013 H.R. 2766, Stopping the Offensive Use of Patents (STOP) Act H.R. 3004, Reducing Waste and Increasing Efficiency in Trade Act H.R. 3309, Innovation Act S. 660, Innovation Through Trade Act S. 662, Trade Facilitation and Trade Enforcement Reauthorization Act of 2013 S. 866, Patent Quality Improvement Act of 2013 S. 1013, Patent Abuse Reduction Act of 2013 S. 1720, Patent Transparency and Improvements Act of 2013 S. 2267, Defend Trade Secrets Act of 2014 Fiscal Year 2015 Appropriations legislation, including provisions relating to IP enforcement funding and the authorization and funding for the IPR Center Potential legislation similar to H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011 Potential legislation similar to H.R. 3668, Counterfeit Drug Penalty Enhancement Act of 2012 Potential legislation similar to H.R. 4095, Online Pharmacy Safety Act of 2012 Potential legislation similar to H.R. 4216, Foreign Counterfeit Prevention Act of 2012 Potential legislation similar to H.R. 6654, Foreign Counterfeit Prevention Act of 2012 Potential legislation similar to S. 832, Security and Accountability for Every Port Reauthorization Act of 2011 Potential legislation similar to S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011 Potential legislation similar to S. 2002, Online Pharmacy Safety Act of 2012 Potential legislation similar to S. 3523, Innovative Design Protection Act (112th Congress) Various issues relating to the Anti-Counterfeiting Trade Agreement; IP agreements in the Trans-Pacific Partnership Agreement (TPP); Transatlantic Trade and Investment Partnership (TTIP); Russia Permanent Normal Trade Relations (PNTR); Trade Promotion Authority (TPA); IP issues related to the Asia-Pacific Economic Cooperation (APEC); IP issues related to United Nations Framework Convention on Climate Change (UNFCCC); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; USPTO IP Attache Program; World Intellectual Property Organization; World Trade Organization (WTO); World Health Organization (WHO); International Telecommunications Union; implementation of Section 182 of the Trade Act of 1974 (P.L. 93-618), as amended by the Omnibus Trade and Competitiveness Act of 1988 (P.L. 100-418) and the Uruguay Round Agreements Act (P.L. 103-465) (the "Special 301 Report"); notice and takedown provisions of the Digital Millennium Copyright Act (P.L. 105-304); appropriations related to the PRO-IP Act (P.L. 110-403); safe harbor provisions of the Digital Millennium Copyright Act (17 USC 512); Executive Order 13636, Improving Critical Infrastructure Cybersecurity, including data breach provisions; creation of a Patent Prosecution Highway (PPH) with foreign governments; review/reform of U.S. copyright law; patent litigation reform; copyright and trademark infringement; customs facilitation and trade enforcement reauthorization; privacy legislation; securing clarification that criminal copyright infringement through unauthorized streaming is a felony; ICANN proposal for a Limited Preventative Registration (LPR) mechanism; cyber theft of trade secrets; digital copyrights; funding issues related to the USPTO; IP issues related to Australia, Canada, China, India, Brazil, Russia, Europe, and Mexico; IP issues related to Internet counterfeiting and piracy; IP issues related to trade secret theft; expanded use of software asset management by the Federal Government and its contractors; patent linkage and regulatory data protection; plain packaging

Client expense: $21,610,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Product Safety Commission (CPSC), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Bureau of Investigation (FBI), Federal Deposit Insurance Corporation (FDIC), Federal Housing Finance Agency (FHFA), Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Fish & Wildlife Service (USFWS), 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) 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. 22, Foreign Counterfeit Merchandise Prevention Act H.R. 624, Cyber Intelligence Sharing and Protection Act H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 H.R. 1123, Unlocking Consumer Choice and Wireless Competition Act H.R. 1580, To Affirm the policy of the United States regarding Internet Governance H.R. 2024, End Anonymous Patents Act H.R. 2236, Promoting Startup Innovation Act H.R. 2454, Aarons Law Act of 2013 H.R. 2639, Patent Litigation and Innovation Act of 2013 H.R. 2766, Stopping the Offensive Use of Patents (STOP) Act H.R. 3004, Reducing Waste and Increasing Efficiency in Trade Act H.R. 3309, Innovation Act S. 660, Innovation Through Trade Act S. 662, Trade Facilitation and Trade Enforcement Reauthorization Act of 2013 S. 866, Patent Quality Improvement Act of 2013 S. 1013, Patent Abuse Reduction Act of 2013 S. 1720, Patent Transparency and Improvements Act of 2013 Fiscal Year 2014 Appropriations legislation, including provisions relating to IP enforcement funding Fiscal Year 2015 Appropriations legislation, including provisions relating to IP enforcement funding and the authorization and funding for the IPR Center Potential legislation similar to H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011 Potential legislation similar to H.R. 3668, Counterfeit Drug Penalty Enhancement Act of 2012 Potential legislation similar to H.R. 4095, Online Pharmacy Safety Act of 2012 Potential legislation similar to H.R. 4216, Foreign Counterfeit Prevention Act of 2012 Potential legislation similar to H.R. 6654, Foreign Counterfeit Prevention Act of 2012 Potential legislation similar to S. 832, Security and Accountability for Every Port Reauthorization Act of 2011 Potential legislation similar to S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011 Potential legislation similar to S. 2002, Online Pharmacy Safety Act of 2012 Potential legislation similar to S. 3523, Innovative Design Protection Act (112th Congress) Various issues relating to the Anti-Counterfeiting Trade Agreement; Trans-Pacific Partnership Agreement (TPP); Transatlantic Trade and Investment Partnership (TTIP); Russia Permanent Normal Trade Relations (PNTR); Trade Promotion Authority (TPA); IP issues related to the Asia-Pacific Economic Cooperation (APEC); IP issues related to United Nations Framework Convention on Climate Change (UNFCCC); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; USPTO IP Attache Program; World Intellectual Property Organization; World Trade Organization (WTO); World Health Organization (WHO); International Telecommunications Union; implementation of Section 182 of the Trade Act of 1974 (P.L. 93-618), as amended by the Omnibus Trade and Competitiveness Act of 1988 (P.L. 100-418) and the Uruguay Round Agreements Act (P.L. 103-465) (the "Special 301 Report"); review/reform of U.S. copyright law; patent litigation reform; copyright and trademark infringement; customs facilitation and trade enforcement reauthorization; privacy legislation; securing clarification that criminal copyright infringement through unauthorized streaming is a felony; White House Cyber Security Executive Order, including data breach provisions; ICANN proposal for a Limited Preventative Registration (LPR) mechanism; cyber theft of trade secrets, including IP issues; digital copyrights; safe harbor provisions of the Digital Millennium Copyright Act (17 U.S.C. 512); notice and takedown provisions of the Digital Millennium Copyright Act (P.L. 105-304); appropriations related to the PRO-IP Act (P.L. 110-403); funding issues related to the USPTO; IP issues related to Australia, Brazil, Canada, China, Europe, India, Mexico, and Russia; IP issues related to Internet counterfeiting and piracy; expanded use of software asset management by the Federal Government and its contractors; patent linkage and regulatory data protection; plain packaging

Client expense: $18,960,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Product Safety Commission (CPSC), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Deposit Insurance Corporation (FDIC), Federal Housing Finance Agency (FHFA), Federal Reserve System, Federal Trade Commission (FTC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

H.R. 22, Foreign Counterfeit Merchandise Prevention Act H.R. 491, Global Online Freedom Act of 2013 H.R. 624, Cyber Intelligence Sharing and Protection Act H.R. 684 / S. 336 / S. 743, Marketplace Fairness Act of 2013 H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 H.R. 1123, Unlocking Consumer Choice and Wireless Competition Act H.R. 1580, To Affirm the policy of the United States regarding Internet Governance H.R. 2024, End Anonymous Patents Act H.R. 2236, Promoting Startup Innovation Act H.R. 2454, Aarons Law Act of 2013 H.R. 2639, Patent Litigation and Innovation Act of 2013 H.R. 2766, Stopping the Offensive Use of Patents (STOP) Act H.R. 3309, Innovation Act S. 660, Innovation Through Trade Act S. 662, Trade Facilitation and Trade Enforcement Reauthorization Act of 2013 S. 866, Patent Quality Improvement Act of 2013 S. 1013, Patent Abuse Reduction Act of 2013 S. 1720, Patent Transparency and Improvements Act of 2013 Potential legislation similar to H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011 Potential legislation similar to H.R. 3668, Counterfeit Drug Penalty Enhancement Act of 2012 Potential legislation similar to H.R. 4095, Online Pharmacy Safety Act of 2012 Potential legislation similar to H.R. 4216, Foreign Counterfeit Prevention Act of 2012 Potential legislation similar to H.R. 6654, Foreign Counterfeit Prevention Act of 2012 Potential legislation similar to S. 832, Security and Accountability for Every Port Reauthorization Act of 2011 Potential legislation similar to S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011 Potential legislation similar to S. 2002, Online Pharmacy Safety Act of 2012 Potential legislation similar to S. 3523, Innovative Design Protection Act (112th Congress) Various issues relating to IP enforcement funding; review/reform of U.S. copyright law; patent litigation reform; the Anti-Counterfeiting Trade Agreement; copyright and trademark infringement; the Trans-Pacific Partnership (TPP) Agreement, Russia Permanent Normal Trade Relations (PNTR), and other trade agreements; customs facilitation and trade enforcement reauthorization; privacy legislation; Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; USPTO IP Attache Program; securing clarification that criminal copyright infringement through unauthorized streaming is a felony; the White House Cyber Security Executive Order, including data breach provisions; ICANN proposal for a Limited Preventative Registration (LPR) mechanism; cyber theft of trade secrets; digital copyrights; appropriations related to the PRO-IP Act (P.L. 110-403); funding issues related to the USPTO; IP issues related to Australia, Canada, China, India, Brazil, Russia, Europe, and Mexico; IP issues related to Internet counterfeiting and piracy; IP issues related to trade secret theft; expanded use of software asset management by the Federal Government and its contractors; patent linkage and regulatory data protection; plain packaging; implementation of Section 182 of the Trade Act of 1974 (P.L. 93-618), as amended by the Omnibus Trade and Competitiveness Act of 1988 (P.L. 100-418) and the Uruguay Round Agreements Act (P.L. 103-465) (the "Special 301 Report"); World Intellectual Property Organization; World Trade Organization (WTO); World Health Organization (WHO); International Telecommunications Union; Transatlantic Trade and Investment Partnership (TTIP); Trade Promotion Authority (TPA); IP issues related to the Asia-Pacific Economic Cooperation (APEC); IP issues related to United Nations Framework Convention on Climate Change (UNFCCC)

Client expense: $16,490,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Accounting Standards Advisory Board (FASAB), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, 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

Discussed legislative intent with respect to Biologic drugs and exclusivity period.(no bill) 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 to end industry tactics like Pay for Delay which inappropriately extends patents with effect of keeping prices high for consumers and government. (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 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 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 legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. 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. 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, 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: $2,520,000 · 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), 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, White House Office

H.R. 22, Foreign Counterfeit Merchandise Prevention Act H.R. 491, Global Online Freedom Act of 2013 H.R. 624, Cyber Intelligence Sharing and Protection Act H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 H.R. 1123, Unlocking Consumer Choice and Wireless Competition Act H.R. 1580, To Affirm the policy of the United States regarding Internet Governance H.R. 2024, End Anonymous Patents Act H.R. 2236, Promoting Startup Innovation Act H.R. 2454, Aarons Law Act of 2013 H.R. 2639, Patent Litigation and Innovation Act of 2013 H.R. 2766, Stopping the Offensive Use of Patents (STOP) Act S. 660, Innovation Through Trade Act S. 662, Trade Facilitation and Trade Enforcement Reauthorization Act of 2013 S. 866, Patent Quality Improvement Act of 2013 S. 1013, Patent Abuse Reduction Act of 2013 Potential legislation similar to H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011 Potential legislation similar to H.R. 3668, Counterfeit Drug Penalty Enhancement Act of 2012 Potential legislation similar to H.R. 4095, Online Pharmacy Safety Act of 2012 Potential legislation similar to H.R. 4216, Foreign Counterfeit Prevention Act of 2012 Potential legislation similar to H.R. 6654, Foreign Counterfeit Prevention Act of 2012 Potential legislation similar to S. 832, Security and Accountability for Every Port Reauthorization Act of 2011 Potential legislation similar to S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011 Potential legislation similar to S. 2002, Online Pharmacy Safety Act of 2012 Potential legislation similar to S. 3523, Innovative Design Protection Act (112th Congress) Various issues relating to IP enforcement funding; review/reform of U.S. copyright law; patent litigation reform; the Anti-Counterfeiting Trade Agreement; copyright and trademark infringement; the Trans-Pacific Partnership (TPP) Agreement, Russia Permanent Normal Trade Relations (PNTR), and other trade agreements; customs facilitation and trade enforcement reauthorization; privacy legislation; Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; USPTO IP Attache Program; securing clarification that criminal copyright infringement through unauthorized streaming is a felony; the White House Cyber Security Executive Order, including data breach provisions; ICANN proposal for a Limited Preventative Registration (LPR) mechanism; cyber theft of trade secrets; appropriations related to the PRO-IP Act (P.L. 110-403); funding issues related to the USPTO; IP issues related to Australia, Canada, China, India, Brazil, Russia, Europe, and Mexico; IP issues related to Internet counterfeiting and piracy; IP issues related to trade secret theft; expanded use of software asset management by the Federal Government and its contractors; patent linkage and regulatory data protection; plain packaging; implementation of Section 182 of the Trade Act of 1974 (P.L. 93-618), as amended by the Omnibus Trade and Competitiveness Act of 1988 (P.L. 100-418)and the Uruguay Round Agreements Act (P.L. 103-465) (the "Special 301 Report"); the World Intellectual Property Organization; the World Trade Organization; the World Health Organization; the International Telecommunications Union; Transatlantic Trade and Investment Partnership (TTIP); Trade Promotion Authority (TPA); IP issues related to the Asia-Pacific Economic Cooperation (APEC); IP issues related to United Nations Framework Convention on Climate Change (UNFCCC)

Client expense: $12,160,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Accounting Standards Advisory Board (FASAB), Federal Aviation Administration (FAA), Federal Reserve System, General Services Administration (GSA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade & Development Agency (USTDA), U.S. Trade Representative (USTR), White House Office

H.R. 22, Foreign Counterfeit Merchandise Prevention Act H.R. 491, Global Online Freedom Act of 2013 H.R. 624, Cyber Intelligence Sharing and Protection Act H.R. 684 / S. 743, Marketplace Fairness Act of 2013 H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 H.R. 1123, Unlocking Consumer Choice and Wireless Competition Act H.R. 1580, To Affirm the policy of the United States regarding Internet Governance H.R. 2024, End Anonymous Patents Act H.R. 2454, Aarons Law Act of 2013 S. 336, Marketplace Fairness Act of 2013 S. 660, Innovation Through Trade Act S. 662, Trade Facilitation and Trade Enforcement Reauthorization Act of 2013 S. 866, Patent Quality Improvement Act of 2013 S. 1013, Patent Abuse Reduction Act of 2013 Potential legislation similar to H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011 Potential legislation similar to H.R. 3668, Counterfeit Drug Penalty Enhancement Act of 2012 Potential legislation similar to H.R. 4095, Online Pharmacy Safety Act of 2012 Potential legislation similar to H.R. 4216, Foreign Counterfeit Prevention Act of 2012 Potential legislation similar to H.R. 6654, Foreign Counterfeit Prevention Act of 2012 Potential legislation similar to S. 832, Security and Accountability for Every Port Reauthorization Act of 2011 Potential legislation similar to S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011 Potential legislation similar to S. 2002, Online Pharmacy Safety Act of 2012 Potential legislation similar to S. 3523, Innovative Design Protection Act (112th Congress) Various issues relating to IP enforcement funding; review/reform of U.S. copyright law; patent litigation reform; the Anti-Counterfeiting Trade Agreement; copyright and trademark infringement; the Trans-Pacific Partnership (TPP) Agreement, Russia Permanent Normal Trade Relations (PNTR), and other trade agreements; customs facilitation and trade enforcement reauthorization; privacy legislation; Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; USPTO IP Attache Program; securing clarification that criminal copyright infringement through unauthorized streaming is a felony; the White House Cyber Security Executive Order, including data breach provisions; ICANN proposal for a Limited Preventative Registration (LPR) mechanism; appropriations related to the PRO-IP Act (P.L. 110-403); funding issues related to the USPTO; IP issues related to Australia, Canada, China, India, Brazil, Russia, Europe, and Mexico; IP issues related to Internet counterfeiting and piracy; IP issues related to trade secret theft; expanded use of software asset management by the Federal Government and its contractors; patent linkage and regulatory data protection; plain packaging; implementation of Section 182 of the Trade Act of 1974 (P.L. 93-618), as amended by the Omnibus Trade and Competitiveness Act of 1988 and the Uruguay Round Agreements Act (the "Special 301 Report"); the World Intellectual Property Organization; the World Trade Organization; the World Health Organization; the International Telecommunications Union; Transatlantic Trade and Investment Partnership (TTIP); Trade Promotion Authority (TPA); IP issues related to the Asia-Pacific Economic Cooperation (APEC); IP issues related to United Nations Framework Convention on Climate Change (UNFCCC)

Client expense: $13,970,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, Federal Trade Commission (FTC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade & Development Agency (USTDA), U.S. Trade Representative (USTR), White House Office

Discussed legislative intent with respect to Biologic drugs and exclusivity period.(no bill) 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 to end industry tactics like Pay for Delay which inappropriately extends patents with effect of keeping prices high for consumers and government. (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 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 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 legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. 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.

Client expense: $2,460,000 · 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), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Comptroller of the Currency (OCC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, White House Office

H.R. 22, Foreign Counterfeit Merchandise Prevention Act H.R. 491, Global Online Freedom Act of 2013 H.R. 624, Cyber Intelligence Sharing and Protection Act H.R. 684 / S. 336, Marketplace Fairness Act of 2013 H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 S. 660, Innovation Through Trade Act S. 662, A bill to reauthorize trade facilitation and trade enforcement functions and activities, and for other purposes Potential legislation similar to H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011 Potential legislation similar to H.R. 3668, Counterfeit Drug Penalty Enhancement Act of 2012 Potential legislation similar to H.R. 4095, Online Pharmacy Safety Act of 2012 Potential legislation similar to H.R. 4216, Foreign Counterfeit Prevention Act of 2012 Potential legislation similar to H.R. 6654, Foreign Counterfeit Prevention Act of 2012 Potential legislation similar to S. 832, Security and Accountability for Every Port Reauthorization Act of 2011 Potential legislation similar to S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011 Potential legislation similar to S. 2002, Online Pharmacy Safety Act of 2012 Potential legislation similar to S. 3523, Innovative Design Protection Act (112th Congress) Fiscal Year 2014 Appropriations legislation, including provisions relating to IP enforcement funding Various issues relating to the Anti-Counterfeiting Trade Agreement; copyright and trademark infringement; the Trans-Pacific Partnership (TPP) Agreement, Russia Permanent Normal Trade Relations (PNTR), and other trade agreements; customs facilitation and trade enforcement reauthorization; privacy legislation; Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; USPTO IP Attache Program; securing clarification that criminal copyright infringement through unauthorized streaming is a felony; the White House Cyber Security Executive Order, including data breach provisions; ICANN proposal for a Limited Preventative Registration (LPR) mechanism; appropriations related to the PRO-IP Act (P .L. 11 0-403); funding issues related to the USPTO; IP issues related to Australia, Canada, China, India, Brazil, Russia, Europe, and Mexico; IP issues related to Internet counterfeiting and piracy; IP issues related to trade secret theft; expanded use of software asset management by the Federal Government and contractors; patent linkage and regulatory data protection; plain packaging; implementation of Section 182 of the Trade Act of 1974 (P .L. 93-618), as amended by the Omnibus Trade and Competitiveness Act of 1988 and the Uruguay Round Agreements Act (the "Special 301 Report"); the World Intellectual Property Organization; the World Trade Organization; the World Health Organization; the International Telecommunications Union; Transatlantic Trade and Investment Partnership (TTIP); Trade Promotion Authority (TPA); IP issues related to the Asia-Pacific Economic Cooperation (APEC); IP issues related to United Nations Framework Convention on Climate Change (UNFCCC)

Client expense: $10,140,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Trade & Development Agency (USTDA), U.S. Trade Representative (USTR), White House Office

Discussed legislative intent with respect to Biologic drugs and exclusivity period.(no bill) 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 to end industry tactics like Pay for Delay which inappropriately extends patents with effect of keeping prices high for consumers and government. (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. The bill would accomplish this by giving generic drug makers the same ability to update their labeling as currently exists for 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 prescription drugs. S. 3604, Improving Preventive Care Treatment in Older Adults Act - Discussed legislation to address the inaproppriate use of antipsychotics in nursing home facilities. 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 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) 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 Generic Drugs Act/S.214, the 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 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. Discussed use of anti-psychaotic drugs in nursing home residents and the Long-Term Services and Supports Scorecard. (no bill)

Client expense: $2,130,000 · 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), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Comptroller of the Currency (OCC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, White House Office

"S. 27 -- Preserve Access to Affordable Generics Act (entire bill)* "H.R. 2276, study on genetic testing (entire bill)* "S. 968, PROTECT IP Act (entire bill)* "H.R.3261, Stop Online Piracy Act (SOPA)* S.2029, Online Protection and Enforcement of Digital Trade Act (OPEN)(entire bill)* H.R. 3782, Online Protection and Enforcement of Digital Trade Act (OPEN)(entire bill)* S. 978, regarding penalties for copyright infringement (entire bill)* H.R. 2511, Innovative Design Protection and Piracy Prevention Act (entire bill)* S. 3523, Innovative Design Protection Act of 2012* S. 1228, Combating Military Counterfeits Act of 2011 (entire bill)* H.R. 2933, Sound Recording Simplification Act.(entire bill)* S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011 (entire bill)* H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011 (entire bill)* H.R. 3889, the PARTS Act (entire bill)* H.R. 3995, Protecting Consumer Access to Generic Drugs Act (entire bill)* H.R. 4216, the Foreign Counterfeit Prevention Act (entire bill) H.R. 6432, Patent Law Treaties Implementation Act of 2012 (entire bill) S. 3486, Patent Law Treaties Implementation Act of 2012 (entire bill) S. 3389, Protecting American Trade Secrets and Innovation Act of 2012 (entire bill) H.R. 6245, Saving High-Tech Innovators from Egregious Legal Disputes (SHIELD) Act (entire bill)* H.R. 6029, Foreign Economic Espionage Penalty Enhancement Act H.R. 6621, To correct certain provisions of the Leahy-Smith America Invents Act and title 35, United States Code (entire bill) S. 3642, Theft of Trade Secrets Clarification Act of 2012 (entire bill) H.R. 6654, Foreign Counterfeit Merchandise Prevention Act (entire bill) S. 3652, Patents for Humanity Program Improvement Act of 2012 (entire bill)

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

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)

H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provisions related to authorized generics H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3995, Protect Consumer Access to Generic Drugs Act: Provisions related to patent settlements H.R. 4216, Foreign Counterfeit Protection Act: Provisions related to anti-counterfeiting H.R. 6502, Life-Threatening Diseases Compassion through Combination Therapy Act: Provisions related to market exclusivity and expedited review H.R. 6621, a bill to make technical corrections to the America Invents Act H.R. 6654, Foreign Counterfeit Merchandise Prevention Act: Provisions related to trade enforcement S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics S. 968, Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011: Provisions related to anti-counterfeiting S. 1734, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 1882, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting S. 3486, Patent Law Treaties Implementation Act of 2012: Patent law treaties S. 3652, Patents for Humanity Program Improvements Act of 2012: Provisions related to transferability of PTO acceleration certificates International intellectual property issues Biopharmaceutical innovation policy issues

Client expense: $4,120,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

Discussed legislative intent with respect to Biologic drugs and exclusivity period.(no bill) 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 to end industry tactics like Pay for Delay which inappropriately extends patents with effect of keeping prices high for consumers and government. (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 - Lobbied for this legislation preventing abuses in patent settlements between generic and brand name prescription drug companies. S. 1886/H.R. 3468, Discussed counterfeit drug penalty enhancement. Discussed prescription drug safety, drug shortage, and medical device safety, and related user fee legislation. S. 2193, 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. The bill would accomplish this by giving generic drug makers the same ability to update their labeling as currently exists for 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 prescription drugs. S. 3604, Improving Preventive Care Treatment in Older Adults Act - Discussed legislation to address the inaproppriate use of antipsychotics in nursing home facilities. (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) 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)

Client expense: $2,490,000 · 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 Energy Regulatory Commission (FERC), 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), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Comptroller of the Currency (OCC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, White House Office

H.R. 3261, Stop Online Piracy Act H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 201 1 H.R. 3523, Cyber Intelligence and Sharing Protection Act HR. 3668 / S. 1886, Counterfeit Drug Penalty Enhancement Act of 2012 HR. 4095, Online Pharmacy Safety Act HR. 4216, Foreign Counterfeit Prevention Act H.R. 5326 / S. 2323, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2013, including provisions relating to IP enforcement funding H.R. 6029, Foreign and Economic Espionage Penalty Enhancement Act of 2012 H.R. 6642, Customs Trade Facilitation and Enforcement Act H.R. 6654, Foreign Counterfeit Prevention Act S. 678, Economic Espionage Penalty Enhancement Act S. 832, Security and Accountability for Every Port Act Reauthorization Act of 2011 S. 968, Preventing Real Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011 S. 1223, Location Privacy Protection Act of 2012 S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011 S. 2002, Online Pharmacy Safety Act S. 2105, Cybersecurity Act of 2012 S. 2151, SECURE IT S. 3187, Food and Drug Administration Safety and Innovation Act S. 3342, SECURE IT S. 3414, CSA2012 S. 3523, Innovative Design Protection Act of 2012 S. 3642, Theft of Trade Secrets Clarification Act of 2012 H. RES. 57, Expressing the sense of the House of Representatives that the United Nations and other international governmental organizations shall not be allowed to exercise control over the Internet H. Con. Res. 127, Expressing the sense of Congress regarding actions to preserve and advance the multi-stakeholder governance model under which the Internet has thrived S. Con. Res. 50, A concurrent resolution expressing the sense of Congress regarding actions to preserve and advance the multi-stakeholder governance model under which the Internet has thrived Various issues relating to the Trans-Pacific Partnership (TTP) Agreement, Russia Permanent Normal Trade Relations (PNTR) and other trade agreements; Customs Facilitation and Trade Enforcement Reauthorization; draft privacy legislation; Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; USPTO IP Attache Program; securing clarification that criminal copyright infringement through unauthorized streaming is a felony; White House Cyber Security Legislative Proposal, including data breach provisions; the Anti-Counterfeiting Trade Agreement; appropriations related to the PRO-IP Act (P.L. 110-403); funding issues related to the USPTO; IP issues related to Australia, Canada, China, India, Brazil, Russia, Europe, and Mexico; IP issues related to Internet counterfeiting and piracy; IP issues related to trade secret theft; the expanded use of software asset management by the Federal Government and its contractors; patent linkage and regulatory data protection; plain packaging; the implementation of Section 182 of the Trade Act of 1974 (P.L. 93-618), as amended by the Omnibus Trade and Competitiveness Act of 1988 and the Uruguay Round Agreements Act (the Special 301 Report); the World Intellectual Property Organization; the World Trade Organization; the World Health Organization; the International Telecommunications Union

Client expense: $29,510,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Deposit Insurance Corporation (FDIC), Federal Highway Administration (FHA), Federal Reserve System, Federal Trade Commission (FTC), Federal Transit Administration (FTA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Maritime Administration (MARAD), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

Legislation H.R. 6564 EPA Science Advisory Board Reform Act of 2012 H.R. 4078 Regulatory Freeze for Jobs Act of 2012 H.R. 3468 Independent Agency Regulatory Analysis Act of 2012 S. 3415 Government Transparency and Recordkeeping Act of 2012 S. 3382 Sunshine for Regulatory Decrees and Settlements Act S. 1720 The Jobs Through Growth Act S. 2042 A bill to reinstate the reporting provision relating to fees and expenses awarded to prevailing parties in civil actions involving the United States H.R. 4607 the Midnight Rule Relief Act of 2012 H.R. 4377, the Responsibility and Professionally Invigorating Developmental Act of 201 Ribble Amendment #4 to H.R. 3438, The Service Transportation Act, Part II H.R. 3041 Federal Consent Decrees Fairness Act of 2012 H.R. 3862 Sunshine for Regulatory Decrees and Settlements Act of 2012 H.R. 10 Regulations From the Executive in Need of Scrutiny Act of 2011 H.R. 3010 Regulatory Accountability Act of 2011 H.R. 527 Regulatory Flexibility Improvements Act of 2011 S. 493, The SBIR/STTR Reauthorization Act of 2011, Ensign Amendment #202 "The Casting Light on EAJA Agency Records for Oversight Act of 2011" S.549 Casting Light on EAJA Agency Records for Oversight Act of 2011 S. 1061 Government Litigation Savings Act H.R. 1996 Government Litigation Savings Act

Client expense: $107,291 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Bureau of Land Management (BLM), Commerce, Dept of (DOC), Council on Environmental Quality (CEQ), Environmental Protection Agency (EPA), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Interior, Dept of (DOI), Minerals Management Service, Natl Oceanic & Atmospheric Administration (NOAA), Office of Surface Mining Reclamation & Enforcement, SENATE, U.S. Fish & Wildlife Service (USFWS), U.S. Forest Service

General issues related to intellectual property issues H.R.3468 - Counterfeit Drug Penalty Enhancement Act of 2011 S. 1886 - Counterfeit Drug Penalty Enhancement Act of 2011 Issues related to federal deficit reduction

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.23, H.R. 1249, S.139 (America Invents Act) S.27 (Preserve Access to Affordable Generics Act) S. 139 (Equal Access to Tax Planning Act) S.373, H.R. 741 (Fair Prescription Drug Competition Act) S.603, H.R. 1166 (Trademarks Seized by Cuban Government) S. 623, H.R. 592 (Sunshine in Litigation Act of 2011) S. 678 (Economic Espionage Act) S. 968, H.R. 3261, S. 2029 (Online Piracy/Rogue Websites legislation) S. 968, H.R. 1540 (Customs Redaction legislation) S. 978, H.R. 3261 (Copyright Streaming bill) S. 1228, H.R. 1540, H.R. 3261 (Combating Military Counterfeits Act) S. 1830 (Protect American Innovation Act of 2011) S. 1866 (AGREE Act) S. 1886, H.R. 3261, H.R. 3468 (Counterfeiting Drug Penalty Enhancement Acts) S. 2029 (Online Protection and Enforcement of Digital Trade Act) S. 2258 (Songwriters Tax Simplification Reauthorization Act) S. 2269 (Anti-Trust Freedom Act of 2012) S. 3389 (Trade Secrets EEA) S. 3486 (Patent Law Treaties Implementation Act of 2012) S. 3609 (Internet Radio Fairness Act) S. 3642 (Theft of Trade Secrets Clarification Act) S. 3652 (Bill to allow acceleration certificates awarded under the Patents for Humanity program to be transferable) S. Con. Res 50 (Internet governance) H.R. 1, H.R. 1362, H.J.Res. 48, H.R. 1363, H.R. 1473, H.J. Res. 79, H.R. 2608; House Report 112-284 (FY 2012 Budget) H.R. 243 (Rep. Latta's False Patent Marking Bill) H.R. 307 (Seed Availability and Competition Act) H.R. 592 (Sunshine in Litigation Act) H.R. 741 (Fair Prescription Drug Competition Act) H.R. 768 (Soldiers Targeted by Offensive Profiteering Act of 2011) H.R. 1056 (Rep. Issa's False Patent Marking Bill) H.R. 1166 (No Stolen Trademarks Honored in America Act) H.R. 2511 (Fashion Design Legislation) H.R. 3010 (Federal Regulations Bill Coble) H.R. 3261 (Stop Online Piracy Act) H.R. 3375 (Imposing Duties on China for IP Piracy) H.R. 3468 (Counterfeit Drug Penalty Enhancement Act) H.R. 3699 (Research Works Act) H.R. 3782 (Online Protection and Enforcement of Digital Trade Act) H.R. 3889 (Promoting Automotive Repair, Trade, and Sales Act) H.R. 3995 (Protecting Consumer Access to Generic Drugs Act) H.R. 4216 (Foreign Counterfeit Prevention Act) H.R. 6012 (Customs Redaction Bill for Semiconductor Chips) H.R. 6029 (Economic Espionage) H.R. 6215 (Trademark Dilution) H.R. 6245 (Saving High-Tech Innovators from Egregious Legal Disputes Act) H.R. 6353 (Patent Box, Manufacturing American Innovation Act) H.R. 6432 (Patent Law Treaties Implementation Act) H.R. 6480 (Internet Radio Fairness Act) H.R. 6621 (AIA Technical Corrections Bill) H. Con. Res. 42 (The Creativity and Innovation Resolution) H. Con. Res. 127 (Internet Governance)

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

Government targets: Commerce, Dept of (DOC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)

"S. 27 -- Preserve Access to Affordable Generics Act (entire bill)* "H.R. 2276, study on genetic testing (entire bill)* "S. 968, PROTECT IP Act (entire bill)* "H.R.3261, Stop Online Piracy Act (SOPA)* S.2029, Online Protection and Enforcement of Digital Trade Act (OPEN)(entire bill)* H.R. 3782, Online Protection and Enforcement of Digital Trade Act (OPEN)(entire bill)* S. 978, regarding penalties for copyright infringement (entire bill)* S. 623, Sunshine in Litigation Act (entire bill)* H.R. 966, Lawsuit Abuse Reduction Act (entire bill)* S. 533, Lawsuit Abuse Reduction Act (entire bill)* H.R. 2511, Innovative Design Protection and Piracy Prevention Act (entire bill) S. 3523, Innovative Design Protection Act of 2012 S. 1228, Combating Military Counterfeits Act of 2011 (entire bill)* H.R. 2933, Sound Recording Simplification Act.(entire bill)* S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011 (entire bill)* H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011 (entire bill)* H.R. 3889, the PARTS Act (entire bill) H.R. 3995, Protecting Consumer Access to Generic Drugs Act (entire bill)* H.R. 4216, the Foreign Counterfeit Prevention Act (entire bill) H.R.5326, the Commerce, Justice, Science, and Related Agencies Appropriations Act, (PTO-related Provisions) S. 2323, the Commerce, Justice, Science, and Related Agencies Appropriations Act, (PTO-related Provisions) H.J. Res 117, Continuing Appropriations Act (PTO-related provisions) Issues related to ICANN and new gltds H.R. 6215 related to the Trademark Dilution Act (entire bill) H.R. 6432, Patent Law Treaties Implementation Act of 2012 (entire bill) S. 3486, Patent Law Treaties Implementation Act of 2012 (entire bill) S. 3389, Protecting American Trade Secrets and Innovation Act of 2012 (entire bill) H.R. 4078, the Red Tape Reduction and Small Business Creation Act (PTO-related amendment) H.R. 6245, Saving High-Tech Innovators from Egregious Legal Disputes (SHIELD) Act (entire bill)

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

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)

Discussed legislative intent with respect to Biologic drugs and exclusivity period.(no bill) 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 to end industry tactics like Pay for Delay which inappropriately extends patents with effect of keeping prices high for consumers and government. (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 - Lobbied for this legislation preventing abuses in patent settlements between generic and brand name prescription drug companies. S. 1886/H.R. 3468, Discussed counterfeit drug penalty enhancement. Discussed prescription drug safety, drug shortage, and medical device safety, and related user fee legislation. S. 2193, 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. The bill would accomplish this by giving generic drug makers the same ability to update their labeling as currently exists for 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. 1882, Fair and Immediate Release of Generic Drugs Act or the FAIR Generics Act - Discussed pay-for-delay amendment to the FDA user fee agreement legislation based the stand-alone bill. 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 prescription drugs. Discussed legislation to address the inaproppriate use of antipsychotics in nursing home facilities. (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; discussed the need for greater protections for consumers related to prescription drugs. (no bill)

Client expense: $2,720,000 · 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 Energy Regulatory Commission (FERC), 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), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Comptroller of the Currency (OCC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, White House Office

H.R. 3261, Stop Online Piracy Act H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011 H.R. 3523, Cyber Intelligence and Sharing Protection Act H.R. 3668 / S. 1886, Counterfeit Drug Penalty Enhancement Act of 2012 H.R. 4095, Online Pharmacy Safety Act H.R. 4216, Foreign Counterfeit Prevention Act H.R. 5326 / S. 2323, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2013, including provisions relating to IP enforcement funding H.R. 6029, Foreign and Economic Espionage Penalty Enhancement Act of 2012 S. 678, Economic Espionage Penalty Enhancement Act S. 832, Security and Accountability for Every Port Act Reauthorization Act of 2011 S. 968, Preventing Real Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011 S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011 S. 2002, Online Pharmacy Safety Act S. 2105, Cybersecurity Act of 2012 S. 2151, SECURE IT S. 3187, Food and Drug Administration Safety and Innovation Act and other bills related to the Prescription Drug User Fee Act (PDUFA) S. 3342, SECURE IT S. 3414, CSA2012 S. 3523, Innovative Design Protection Act of 2012 H. RES. 57, Expressing the sense of the House of Representatives that the United Nations and other international governmental organizations shall not be allowed to exercise control over the Internet H. Con. Res. 127, Expressing the sense of Congress regarding actions to preserve and advance the multi-stakeholder governance model under which the Internet has thrived S. Con. Res. 50, A concurrent resolution expressing the sense of Congress regarding actions to preserve and advance the multi-stakeholder governance model under which the Internet has thrived Legislation similar to H.R. 496, Trade Enforcement Act of 2009 (specific legislation not yet introduced) Various issues relating to the Trans-Pacific Partnership (TPP) Agreement, Russia Permanent Normal Trade Relations (PNTR) and other trade agreements; Customs Facilitation and Trade Enforcement Reauthorization; draft privacy legislation; office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; USPTO IP Attache Program; securing clarification that criminal copyright infringement through unauthorized streaming is a felony; White House Cyber Security Legislative Proposal, including data breach provisions; the Anti-Counterfeiting Trade Agreement; appropriations related to the PRO-IP Act (P.L. 110-403); funding issues related to the USPTO; IP issues related to Canada, China, India, Brazil, and Mexico; IP issues related to Internet counterfeiting and piracy; IP issues related to trade secret theft; the expanded use of software asset management by the Federal Government and its contractors; patent linkage and regulatory data protection; plain packaging; the implementation of Section 182 of the Trade Act of 1974 (P.L. 93-618), as amended by the Omnibus Trade and Competitiveness Act of 1988 and the Uruguay Round Agreements Act (the Special 301 Report)

Client expense: $31,650,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Highway Administration (FHA), Federal Reserve System, Federal Trade Commission (FTC), Federal Transit Administration (FTA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Maritime Administration (MARAD), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

H.R. 741, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: Provisions related to authorized generics H.R. 2182, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3497, MODDERN Cures Act of 2011: Provisions related to data protection H.R. 3995, Protect Consumer Access to Generic Drugs Act: Provisions related to patent settlements S. 27, The Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 373, The Fair Prescription Drug Competition Act: Provisions related to authorized generics S. 968, Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011: Provisions related to anti-counterfeiting S. 1734, Generating Antibiotic Incentives Now Act of 2011: Provisions related to antibiotics and incentives S. 1882, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting S. 3486, Patent Law Treaties Implementation Act of 2012: Patent law treaties Patents for Humanity Program Improvements Act of 2012: Provisions related to transferability of PTO acceleration certificates [no bill number] Technical changes to America Invents Act [H.R. 1249 and S.23] International intellectual property issues Biopharmaceutical innovation policy issues

Client expense: $4,140,000 · Firm income: Not reported

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

Legislation H.R. 4078 Regulatory Freeze for Jobs Act of 2012 H.R. 3468 Independent Agency Regulatory Analysis Act of 2012 S. 3415 Government Transparency and Recordkeeping Act of 2012 S. 3382 Sunshine for Regulatory Decrees and Settlements Act S. 1720 the Jobs Through Growth Act S. 2042 A bill to reinstate the reporting provision relating to fees and expenses awarded to prevailing parties in civil actions involving the United States H.R. 4607 the Midnight Rule Relief Act of 2012 H.R. 4377, the Responsibility and Professionally Invigorating Developmental Act of 201 Ribble Amendment #4 to H.R. 3438, The Service Transportation Act, Part II H.R. 3041 Federal Consent Decrees Fairness Act of 2012 H.R. 3862 Sunshine for Regulatory Decrees and Settlements Act of 2012 H.R. 10 Regulations From the Executive in Need of Scrutiny Act of 2011 H.R. 3010 Regulatory Accountability Act of 2011 H.R. 527 Regulatory Flexibility Improvements Act of 2011 S. 493, The SBIR/STTR Reauthorization Act of 2011, Ensign Amendment #202 "The Casting Light on EAJA Agency Records for Oversight Act of 2011" S.549 Casting Light on EAJA Agency Records for Oversight Act of 2011 S. 1061 Government Litigation Savings Act H.R. 1996 Government Litigation Savings Act

Client expense: $175,079 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Bureau of Land Management (BLM), Commerce, Dept of (DOC), Council on Environmental Quality (CEQ), Energy, Dept of, Environmental Protection Agency (EPA), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Interior, Dept of (DOI), Minerals Management Service, Natl Oceanic & Atmospheric Administration (NOAA), Office of Surface Mining Reclamation & Enforcement, SENATE, U.S. Fish & Wildlife Service (USFWS), U.S. Forest Service

General issues related to intellectual property issues H.R.3468 - Counterfeit Drug Penalty Enhancement Act of 2011 S. 1886 - Counterfeit Drug Penalty Enhancement Act of 2011

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General issues related to intellectual property issues H.R.3468 - Counterfeit Drug Penalty Enhancement Act of 2011 S. 1886 - Counterfeit Drug Penalty Enhancement Act of 2011

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.23, H.R. 1249, S.139 (America Invents Act) S.27 (Preserve Access to Affordable Generics Act) S. 139 (Equal Access to Tax Planning Act) S.373, H.R. 741 (Fair Prescription Drug Competition Act) S.603, H.R. 1166 (Trademarks Seized by Cuban Government) S. 623, H.R. 592 (Sunshine in Litigation Act of 2011) S. 678 (Economic Espionage Act) S. 968, H.R. 3261, S. 2029 (Online Piracy/Rogue Websites legislation) S. 968, H.R. 1540 (Customs Redaction legislation) S. 978, H.R. 3261 (Copyright Streaming bill) S. 1228, H.R. 1540, H.R. 3261 (Combating Military Counterfeits Act) S. 1830 (Protect American Innovation Act of 2011) S. 1866 (AGREE Act) S. 1886, H.R. 3261, H.R. 3468 (Counterfeiting Drug Penalty Enhancement Acts) S. 2029 (Online Protection and Enforcement of Digital Trade Act) S. 2258 (Songwriters Tax Simplification Reauthorization Act) S. 2269 (Anti-Trust Freedom Act of 2012) S. 3389 (Trade Secrets EEA) S. 3486 (Patent Law Treaties Implementation Act of 2012) S. Con. Res 50 (Internet governance) H.R. 1, H.R. 1362, H.J.Res. 48, H.R. 1363, H.R. 1473, H.J. Res. 79, H.R. 2608; House Report 112-284 (FY 2012 Budget) H.R. 243 (Rep. Latta's False Patent Marking Bill) H.R. 307 (Seed Availability and Competition Act) H.R. 741 (Fair Prescription Drug Competition Act) H.R. 768 (Soldiers Targeted by Offensive Profiteering Act of 2011) H.R. 1056 (Rep. Issa's False Patent Marking Bill) H.R. 1166 (No Stolen Trademarks Honored in America Act) H.R. 2511 (Fashion Design Legislation) H.R. 3010 (Federal Regulations Bill Coble) H.R. 3375 (Imposing Duties on China for IP Piracy) H.R. 3468 (Counterfeit Drug Penalty Enhancement Act) H.R. 3699 (Research Works Act) H.R. 3782 (Online Protection and Enforcement of Digital Trade Act) H.R. 3889 (Promoting Automotive Repair, Trade, and Sales Act) H.R. 3995 (Protecting Consumer Access to Generic Drugs Act) H.R. 4216 (Foreign Counterfeit Prevention Act) H.R. 6012 (Customs Redaction Bill for Semiconductor Chips) H.R. 6029 (Economic Espionage) H.R. 6215 (Trademark Dilution) H.R. 6245 (Saving High-Tech Innovators from Egregious Legal Disputes Act) H.R. 6353 (Patent Box, Manufacturing American Innovation Act) H. Con. Res. 42 (The Creativity and Innovation Resolution) H. Con. Res. 127 (Internet Governance)

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

Government targets: Commerce, Dept of (DOC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)

H.R. 3590, S 1790 (as enacted into PL 111-148 and PL 111-152) issues related to Medicare and Medicaid reform, including possible changes to Part D and changes to Medicaid price reporting requirements H.R. 2245, S. 296, H.R. 3839(Preserving Access to Life-Saving Medications Act of 2011) and related legislative proposals regarding issues surrounding potential drug shortages including notification and public reporting H.R. 2182, S. 1734 GAIN (Generating Antibiotic Incentives Now Act of 2011) - issues related to the development of antibiotics H.R. 452 IPAB (Independent Payment Advisory Board) Medicare Decisions Accountability Act of 2011 S.1882, H.R. 3026 and related legislative proposals regarding establishment/implementation of pharmaceutical pedigrees and tracking/tracing of pharmaceuticals from manufacturer to consumer; HR 1483 - issues related to drug safety, supply chain, and facility inspections HR 3468 - issues related to increased penalties for counterfeiting drugs Discussions regarding use of psychotropic drugs by children in foster care HR 1254 (Synthetic Drug Control Act) - issues related to propsed controlled substance amendments S 2113 (Transforming Regulatory Environment to Accelerate Access to Treatments Act) - issues related to acceleration of innovation and approvals of medical treatments

Client expense: $1,110,000 · Firm income: Not reported

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

S. 27 -- Preserve Access to Affordable Generics Act (entire bill) H.R. 2276, study on genetic testing (entire bill) S. 968, PROTECT IP Act (entire bill) H.R.3261, Stop Online Piracy Act (SOPA) S.2029, Online Protection and Enforcement of Digital Trade Act (OPEN)(entire bill) H.R. 3782, Online Protection and Enforcement of Digital Trade Act (OPEN)(entire bill) S. 978, regarding penalties for copyright infringement (entire bill) H.R. 2511, Innovative Design Protection and Piracy Prevention Act (entire bill) S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011 (entire bill) H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011 (entire bill) H.R. 3889, the PARTS Act (entire bill) H.R. 3995, Protecting Consumer Access to Generic Drugs Act (entire bill) H.R. 4216, the Foreign Counterfeit Prevention Act (entire bill) H.R.5326, the Commerce, Justice, Science, and Related Agencies Appropriations Act, (PTO-related Provisions) S. 2323, the Commerce, Justice, Science, and Related Agencies Appropriations Act, (PTO-related Provisions) Issues related to possible trademark law legislation Issues related to possible patent law legislation

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

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)

H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 H.R. 4332, Generic Drug Application Review Fairness Act of 2012: Provisions related to FDA review and exclusivity H.R. 5651, Food and Drug Administration Reform Act of 2012: Provisions related to user fee reauthorization and FDA reform S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting S. 2002, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues

Client expense: $4,840,000 · 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), Health Resources & Services Administration (HRSA), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

H.R. 2112, Consolidated and Further Continuing Appropriations Act, 2012, including provisions relating to IP enforcement funding H.R. 2596/S. 1572, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2012, including provisions relating to IP enforcement funding H.R. 3261, Stop Online Piracy Act H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011 H.R. 3523, Cyber Intelligence Sharing and Protection Act H.R. 3668, Counterfeit Drug Penalty Enhancement Act of 2012 H.R. 4095, Online Pharmacy Safety Act H.R. 4216, Foreign Counterfeit Prevention Act S. 678, Economic Espionage Penalty Enhancement Act S. 832, Security and Accountability for Every Port Act Reauthorization Act of 2011 S. 968, Preventing Real Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011 S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011 S. 2002, Online Pharmacy Safety Act S. 2105, Cybersecurity Act of 2012 S. 2151, SECURE IT S. 3187, Food and Drug Administration Safety and Innovation Act and other bills related to the Prescription Drug User Fee Act (PDUFA) Legislation similar to H.R. 496, Trade Enforcement Act of 2009 (specific legislation not yet introduced) Various issues relating to Trans Pacific Partnership (TPP) Agreement, Permanent Normal Trade Relations (PNTR) with Russia, and other trade agreements; Customs Facilitation and Trade Enforcement Reauthorization; draft privacy legislation; the office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; USPTO IP Attache Program; funding issues related to the USPTO; securing clarification that criminal copyright infringement through unauthorized streaming is a felony; White House Cyber Security Legislative Proposal, including data breach provisions; addressing cyber threats and attacks; the Anti-Counterfeiting Trade Agreement; appropriations related to the PRO-IP Act (P.L. 110-403); IP issues related to Canada, China, India, Brazil, and Mexico; IP issues related to Internet counterfeiting and piracy; IP issues related to trade secret theft; the expanded use of software asset management by the Federal Government and its contractors; patent linkage and regulatory data protection; plain packaging; the implementation of Section 182 of the Trade Act of 1974 (P.L. 93-618), as amended by the Omnibus Trade and Competitiveness Act of 1988 and the Uruguay Round Agreements Act (the "Special 301 Report")

Client expense: $22,520,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Deposit Insurance Corporation (FDIC), Federal Highway Administration (FHA), Federal Reserve System, Federal Transit Administration (FTA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

Intellectual Property Enforcement and Training. International Protection for Intellectual Property Rights. S 2002, S 1886, HR 4095, HR 3668, HR 3468, HR 4216.

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

Government targets: HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), SENATE

Drug shortages - Proposed legislation re these issues. Opiate abuse - HR 1316, Stop Oxy Abuse Act of 2011; HR 2119, Ryan Creedon Act of 2011; HR 866, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2011; HR 1065, Pill Mill Crackdown Act of 2011; S 507, Prescription Drug Abuse Prevention and Treatment Act of 2011; Executive Branch action re this issue. Pharmaceutical issues, including tracking and tracing medicines, fostering competition between generic and brand-name pharmaceutical manufacturers - HR 5651, Food and Drug Administration Reform Act of 2012; S 3187, Food and Drug Administration Safety and Innovation Act. Incentives to develop antibiotics - HR 2182, Generating Antibiotic Incentives Now Act of 2011; S 1734, Generating Antibiotic Incentives Now Act of 2011. Establish criminal penalties for trafficking in counterfeit drugs - HR 3468, Counterfeit Drug Penalty Enhancement Act of 2011; S 1886, Counterfeit Drug Penalty Enhancement Act of 2011. National Center for Advancing Transformational Sciences at FDA; agreement to review compounds for potential new uses - Executive Branch actions re these issues. *Follow-on biologics generally. *Certified Importer Program. *Drug safety - HR 1483, Drug Safety Enhancement Act of 2011.

Client expense: Not reported · Firm income: $100,000

Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

Discussed legislative intent with respect to Biologic drugs and exclusivity period.(no bill) 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 to end industry tactics like Pay for Delay which inappropriately extends patents with effect of keeping prices high for consumers and government. (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 - Lobbied for this legislation preventing abuses in patent settlements between generic and brand name prescription drug companies. S. 1886/H.R. 3468, Discussed counterfeit drug penalty enhancement. Discussed prescription drug safety, drug shortage, and medical device safety, and related user fee legislation. S. 2193, 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. The bill would accomplish this by giving generic drug makers the same ability to update their labeling as currently exists for 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. 1882, Fair and Immediate Release of Generic Drugs Act or the FAIR Generics Act - Discussed pay-for-delay amendment to the FDA user fee agreement legislation based the stand-alone bill. 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.

Client expense: $2,740,000 · Firm income: Not reported

Government targets: Administration on Aging, Agriculture, Dept of (USDA), Bureau of the Census, Centers For Medicare and Medicaid Services (CMS), Energy, Dept of, Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Energy Regulatory Commission (FERC), 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), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Comptroller of the Currency (OCC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, White House Office

S.23, H.R. 1249, S.139 (America Invents Act) S.27 (Preserve Access to Affordable Generics Act) S. 139 (Equal Access to Tax Planning Act) S.373, H.R. 741 (Fair Prescription Drug Competition Act) S.603, H.R. 1166 (Trademarks Seized by Cuban Government) S. 623, H.R. 592 (Sunshine in Litigation Act of 2011) S. 678 (Economic Espionage Act) S. 968, H.R. 3261, S. 2029 (Online Piracy/Rogue Websites legislation) S. 968, H.R. 1540 (Customs Redaction legislation) S. 978, H.R. 3261 (Copyright Streaming bill) S. 1228, H.R. 1540, H.R. 3261 (Combating Military Counterfeits Act) S. 1830 (Protect American Innovation Act of 2011) S. 1866 (AGREE Act) S. 1886, H.R. 3261, H.R. 3468 (Counterfeiting Drug Penalty Enhancement Acts) S. 2029 (Online Protection and Enforcement of Digital Trade Act) S. 2258 (Songwriters Tax Simplification Reauthorization Act) S. 2269 (Anti-Trust Freedom Act of 2012) S. Con. Res 50 (Internet governance) H.R. 1, H.R. 1362, H.J.Res. 48, H.R. 1363, H.R. 1473, H.J. Res. 79, H.R. 2608; House Report 112-284 (FY 2012 Budget) H.R. 243 (Rep. Latta's False Patent Marking Bill) H.R. 307 (Seed Availability and Competition Act) H.R. 741 (Fair Prescription Drug Competition Act) H.R. 768 (Soldiers Targeted by Offensive Profiteering Act of 2011) H.R. 1056 (Rep. Issa's False Patent Marking Bill) H.R. 1166 (No Stolen Trademarks Honored in America Act) H.R. 2511 (Fashion Design Legislation) H.R. 3010 (Federal Regulations Bill Coble) H.R. 3375 (Imposing Duties on China for IP Piracy) H.R. 3468 (Counterfeit Drug Penalty Enhancement Act) H.R. 3699 (Research Works Act) H.R. 3782 (Online Protection and Enforcement of Digital Trade Act) H.R. 3889 (Promoting Automotive Repair, Trade, and Sales Act) H.R. 3995 (Protecting Consumer Access to Generic Drugs Act) H.R. 4216 (Foreign Counterfeit Prevention Act) H.R. 6012 (Customs Redaction Bill for Semiconductor Chips) H.R. 6029 (Economic Espionage) H. Con. Res. 42 (The Creativity and Innovation Resolution) H. Con. Res. 127 (Internet Governance)

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

Government targets: Commerce, Dept of (DOC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)

General issues related to intellectual property issues H.R.3468 - Counterfeit Drug Penalty Enhancement Act of 2011 S. 1886 - Counterfeit Drug Penalty Enhancement Act of 2011

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Advocacy in support of NOACA policy and funding priorities in SAFETEA-LU reauthorization bills S. 1813, H.R. 7, H.R. 4348, H.R. 3404 and H.R. 3468, and FY 2013 Transportation/HUD appropriations bills H.R. 5972 and S. 2322.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3590, S 1790 (as enacted into PL 111-148 and PL 111-152) issues related to Medicare and Medicaid reform, including possible changes to Part D and changes to Medicaid price reporting requirements H.R. 2245, S. 296, H.R. 3839(Preserving Access to Life-Saving Medications Act of 2011) and related legislative proposals regarding issues surrounding potential drug shortages including notification and public reporting H.R. 2182, S. 1734 GAIN (Generating Antibiotic Incentives Now Act of 2011) - issues related to the development of antibiotics H.R. 452 IPAB (Independent Payment Advisory Board) Medicare Decisions Accountability Act of 2011 S.1882, H.R. 3026 and related legislative proposals regarding establishment/implementation of pharmaceutical pedigrees and tracking/tracing of pharmaceuticals from manufacturer to consumer; HR 1483 - issues related to drug safety, supply chain, and facility inspections HR 3468 - issues related to increased penalties for counterfeiting drugs Discussions regarding use of psychotropic drugs by children in foster care HR 1254 (Synthetic Drug Control Act) - issues related to propsed controlled substance amendments S 2113 (Transforming Regulatory Environment to Accelerate Access to Treatments Act) - issues related to acceleration of innovation and approvals of medical treatments

Client expense: $1,190,000 · Firm income: Not reported

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

"S. 27 -- Preserve Access to Affordable Generics Act (entire bill) "H.R. 516 -- Bring Jobs Back to America (Section 7) "H.R. 1056 -- Patent Continuing Disclosure Act (entire bill) "H.R. 2276, study on genetic testing (entire bill) S. 968, PROTECT IP Act (entire bill) H.R.3261, Stop Online Piracy Act (SOPA) S.2029, Online Protection and Enforcement of Digital Trade Act (OPEN)(entire bill) H.R. 3782, Online Protection and Enforcement of Digital Trade Act (OPEN)(entire bill) S. 978, regarding penalties for copyright infringement (entire bill) S. 623, Sunshine in Litigation Act (entire bill) H.R. 966, Lawsuit Abuse Reduction Act (entire bill) S. 533, Lawsuit Abuse Reduction Act (entire bill) H.R. 2511, Innovative Design Protection and Piracy Prevention Act (entire bill) S. 1228, Combating Military Counterfeits Act of 2011 (entire bill) H.R. 2933, Sound Recording Simplification Act.(entire bill) S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011 (entire bill) H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011 (entire bill) H.R. 3889, the PARTS Act (entire bill) H.R. 3995, Protecting Consumer Access to Generic Drugs Act (entire bill) H.R. 4216, the Foreign Counterfeit Prevention Act (entire bill) Issues related to ICANN and new gltds Issues related to possible trademark law legislation

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

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)

H.R. 3590, S 1790 (as enacted into PL 111-148 and PL 111-152) issues related to Medicare and Medicaid reform, including possible changes to Part D and changes to Medicaid price reporting requirements H.R. 2245, S. 296, H.R. 3839(Preserving Access to Life-Saving Medications Act of 2011) and related legislative proposals regarding issues surrounding potential drug shortages including notification and public reporting H.R. 2182, S. 1734 GAIN (Generating Antibiotic Incentives Now Act of 2011) - issues related to the development of antibiotics H.R. 452 IPAB (Independent Payment Advisory Board) Medicare Decisions Accountability Act of 2011 S.1882, H.R. 3026 and related legislative proposals regarding establishment/implementation of pharmaceutical pedigrees and tracking/tracing of pharmaceuticals from manufacturer to consumer; HR 1483 - issues related to drug safety, supply chain, and facility inspections HR 3468 - issues related to increased penalties for counterfeiting drugs Discussions regarding use of psychotropic drugs by children in foster care HR 1254 (Synthetic Drug Control Act) - issues related to propsed controlled substance amendments S 2113 (Transforming Regulatory Environment to Accelerate Access to Treatments Act) - issues related to acceleration of innovation and approvals of medical treatments

Client expense: $1,180,000 · Firm income: Not reported

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

Discussed legislative intent with respect to Biologic drugs and exclusivity period.(no bill) 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 need for greater consumer safety protections both in OTC and prescription drugs. (no bill) Discussed need to end industry tactics like Pay for Delay which inappropriately extends patents with effect of keeping prices high for consumers and government. (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 - Lobbied for this legislation preventing abuses in patent settlements between generic and brand name prescription drug companies. S. 1886/H.R. 3468, Discussed counterfeit drug penalty enhancement. Discussed prescription drugs and medical device issues. Discussed prescription drug safety, drug shortage, and medical device safety, and related user fee legislation. S. 2193, 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. The bill would accomplish this by giving generic drug makers the same ability to update their labeling as currently exists for manufacturers of brand name drugs. (no bill)

Client expense: $1,950,000 · Firm income: Not reported

Government targets: Administration on Aging, Agriculture, Dept of (USDA), Bureau of the Census, Centers For Medicare and Medicaid Services (CMS), Energy, Dept of, Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Energy Regulatory Commission (FERC), 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), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Comptroller of the Currency (OCC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, White House Office