Preserve Access to Affordable Generics Act

Medicare/General. H.R. 205, H.R. 748, H.R. 1218, H.R. 1277, H.R. 1310, H.R. 1521, H.R. 2009, H.R. 2056, H.R. 2065, H.R. 2149, H.R. 3025, H.R. 3061, H.R. 3162, H.R. 3932, H.R. 6331, S. 137, S. 250, S. 450, S. 706, S. 1887, S. 2089, S. 2115, S. 2219, S. 3101: Medicare/General (continued). provisions relating to enrollment periods and the late enrollment penalty, physician reimbursement rates, creating a Medicare-operated prescription drug plan, drug price negotiations, Medicare beneficiary improvements, repealing cost containment mandates, Medicare Advantage payments, Medicare Advantage stabilization fund, and comparative cost adjustment demonstration projects under the Medicare Modernization Act, therapy caps, liberalizing asset test limits, reducing the Part D benefit gap and guaranteeing prescription drug benefits. Medicare/Prescription Drug Price Negotiation. H.R. 4, H.R. 118, H.R. 5317, S. 3, S. 273: provisions pertaining to the negotiation of prescription drug prices under Medicare Part D. Medicare/Medicare Advantage. H.R. 2945: provision to provide beneficiary protections against excessive cost-sharing under the Medicare Advantage Program. Medicare/Importation of Prescription Drugs. S. 242, H.R. 380, S.Amdt. 4299: provisions pertaining to the importation of prescription drugs. Medicare/Outpatient Psychiatric Services. H.R. 1571, H.R. 1663, H.R. 4897, S. 1715, S. 1854: provisions to eliminate discriminatory copayment rates for outpatient psychiatric services under Medicare Part B. Medicare/Geriatric Assessments. H.R. 2244, S. 1340: provisions to provide Medicare beneficiaries with access to geriatric assessments and chronic care coordination services. Medicare/Generic Drugs Market Exclusivity. H.R. 1432, H.R. 1902, S. 316, S. 1088: pertaining to market exclusivity for generic drugs. Medicare/Prescription Drug Benefits for Low Income Beneficiaries. H.R. 470, H.R. 932, H.R. 1536, H.R. 2058, H.R. 3127, S. 1102, S. 1103, S. 1107, S. 1108, S. 2101: provisions affecting prescription drug benefits for low-income beneficiaries under Medicare Parts B and D. Medicare/Part B Late Enrollment. H.R. 2591: provision limiting the penalty for late enrollment under Medicare Part B. Medicare/Marketing. H.R. 2307, H.R. 4790, S. 1883, S. 2687: provisions relating to the marketing of Medicare Advantage and Medicare Part D plans. Medicare/Health Care Vouchers. H.R. 749: provision to establish health care vouchers for seniors. Medicare/Medicare Savings Accounts. H.R. 2639, S. 173, S. 1019: provisions pertaining to Medicare Savings Accounts. Medicare/End-of-Life Planning. S. 464, S. 465, S. 466: pertaining to advance directives and end-of-life planning. Medicare/Means-testing. H.R. 4295, H.R. 4330, S. 2414, S.Amdt. 4240: pertaining to means-testing of Medicare Part D. Medicare/Presidents Funding Warning. H.R. 5480, S. 2662: proposals responding to the Presidents Medicare funding warning. H. Res. 1368, to suspend section 803 of the Medicare Modernization Act of 2003 (known as the Medicare trigger") for the remainder of the 110th Congress. Medicare/24-month Waiting Period. H.R.154, S. 2101: provisions phasing out the 24-month waiting period for disabled individuals to become eligible for Medicare benefits and eliminating the waiting period for individuals with life-threatening conditions. Medicare/Identity Theft Prevention. H.R. 6600, provisions related to removal of Social Security numbers from Medicare cards. Medicaid/Federal Match. H.R. 5140: provisions pertaining to temporary increases in the federal Medicaid match. Medicaid/Targeted Case Management. Targeted Case Management: interim final rule to implement Section 6052 of the Deficit Reduction Act.

Client expense: $280,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare/General. H.R. 205, H.R. 748, H.R. 1218, H.R. 1277, H.R. 1310, H.R. 1521, H.R. 2009, H.R. 2056, H.R. 2065, H.R. 2149, H.R. 3025, H.R. 3061, H.R. 3162, H.R. 3932, H.R. 6331, S. 137, S. 250, S. 450, S. 706, S. 1887, S. 2089, S. 2115, S. 2219, S. 3101: provisions relating to enrollment periods and the late enrollment penalty, physician reimbursement rates, creating a Medicare-operated prescription drug plan, drug price negotiations, Medicare beneficiary improvements, repealing cost containment mandates, Medicare Advantage payments, Medicare Advantage stabilization fund, and comparative cost adjustment demonstration projects under the Medicare Modernization Act, therapy caps, liberalizing asset test limits, reducing the Part D benefit gap and guaranteeing prescription drug benefits. Medicare/Prescription Drug Price Negotiation. H.R. 4, H.R. 118, H.R. 5317, S. 3, S. 273: provisions pertaining to the negotiation of prescription drug prices under Medicare Part D. Medicare/Medicare Advantage. H.R. 2945: provision to provide beneficiary protections against excessive cost-sharing under the Medicare Advantage Program. Medicare/Importation of Prescription Drugs. S. 242, H.R. 380, S.Amdt. 4299: provisions pertaining to the importation of prescription drugs. Medicare/Outpatient Psychiatric Services. H.R. 1571, H.R. 1663, H.R. 4897, S. 1715, S. 1854: provisions to eliminate discriminatory copayment rates for outpatient psychiatric services under Medicare Part B. Medicare/Geriatric Assessments. H.R. 2244, S. 1340: provisions to provide Medicare beneficiaries with access to geriatric assessments and chronic care coordination services. Medicare/Generic Drugs Market Exclusivity. H.R. 1432, H.R. 1902, S. 316, S. 1088: pertaining to market exclusivity for generic drugs. Medicare/Prescription Drug Benefits for Low Income Beneficiaries. H.R. 470, H.R. 932, H.R. 1536, H.R. 2058, H.R. 3127, S. 1102, S. 1103, S. 1107, S. 1108, S. 2101: provisions affecting prescription drug benefits for low-income beneficiaries under Medicare Parts B and D. Medicare/Part B Late Enrollment. H.R. 2591: provision limiting the penalty for late enrollment under Medicare Part B. Medicare/Marketing. H.R. 2307, H.R. 4790, S. 1883, S. 2687: provisions relating to the marketing of Medicare Advantage and Medicare Part D plans. Medicare/Health Care Vouchers. H.R. 749: provision to establish health care vouchers for seniors. Medicare/Medicare Savings Accounts. H.R. 2639, S. 173, S. 1019: provisions pertaining to Medicare Savings Accounts. Medicare/End-of-Life Planning. S. 464, S. 465, S. 466: pertaining to advance directives and end-of-life planning. Medicare/Means-testing. H.R. 4295, H.R. 4330, S. 2414, S.Amdt. 4240: pertaining to means-testing of Medicare Part D. Medicare/Presidents Funding Warning. H.R. 5480, S. 2662: proposals responding to the Presidents Medicare funding warning. Medicare/24-month Waiting Period. H.R.154, S. 2101: provisions phasing out the 24-month waiting period for disabled individuals to become eligible for Medicare benefits and eliminating the waiting period for individuals with life-threatening conditions. Medicaid/Federal Match. H.R. 5140: provisions pertaining to temporary increases in the federal Medicaid match. Medicaid/Targeted Case Management. Targeted Case Management: Interim final rule to implement Section 6052 of the Deficit Reduction Act.

Client expense: $440,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare/General. H.R. 205, H.R. 748, H.R. 1218, H.R. 1277, H.R. 1310, H.R. 1521, H.R. 2009, H.R. 2056, H.R. 2065, H.R. 2149, H.R. 3025, H.R. 3061, H.R. 3162, H.R. 3932, S. 137, S. 250, S. 450, S. 706, S. 1887, S. 2089, S. 2115, S. 2219: provisions relating to enrollment periods and the late enrollment penalty, physician reimbursement rates, creating a Medicare-operated prescription drug plan, drug price negotiations, Medicare beneficiary improvements, repealing cost containment mandates, Medicare Advantage payments, Medicare Advantage stabilization fund, and comparative cost adjustment demonstration projects under the Medicare Modernization Act, therapy caps, liberalizing asset test limits, Medicare Secondary Payer clarification, reducing the Part D benefit gap and guaranteeing prescription drug benefits. Medicare/Prescription Drug Price Negotiation. H.R. 4, H.R. 118, H.R. 5317, S. 3, S. 273: provisions pertaining to the negotiation of prescription drug prices under Medicare Part D. Medicare/Medicare Advantage. H.R. 2945: provision to provide beneficiary protections against excessive cost-sharing under the Medicare Advantage Program. Medicare/Importation of Prescription Drugs. S. 242, H.R. 380, S.Amdt. 4299: provisions pertaining to the importation of prescription drugs. Medicare/Outpatient Psychiatric Services. H.R. 1571, H.R. 1663, H.R. 4897, S. 1715, S. 1854: provisions to eliminate discriminatory copayment rates for outpatient psychiatric services under Medicare Part B. Medicare/Geriatric Assessments. H.R. 2244, S. 1340: provisions to provide Medicare beneficiaries with access to geriatric assessments and chronic care coordination services. Medicare/Generic Drugs Market Exclusivity. H.R. 1432, H.R. 1902, S. 316, S. 1088: pertaining to market exclusivity for generic drugs. Medicare/Prescription Drug Benefits for Low Income Beneficiaries. H.R. 470, H.R. 932, H.R. 1536, H.R. 2058, H.R. 3127, S. 1102, S. 1103, S. 1107, S. 1108, S. 2101: provisions affecting prescription drug benefits for low-income beneficiaries under Medicare Parts B and D. Medicare/Part B Late Enrollment. H.R. 2591: provision limiting the penalty for late enrollment under Medicare Part B. Medicare/Marketing. H.R. 2307, H.R. 4790, S. 1883, S. 2687: provisions relating to the marketing of Medicare Advantage and Medicare Part D plans. Medicare/Health Care Vouchers. H.R. 749: provision to establish health care vouchers for seniors. Medicare/Medicare Savings Accounts. H.R. 2639, S. 173, S. 1019: provisions pertaining to Medicare Savings Accounts. Medicare/End-of-Life Planning. S. 464, S. 465, S. 466: pertaining to advance directives and end-of-life planning. Medicare/Means-testing. H.R. 4295, H.R. 4330, S. 2414, S.Amdt. 4240: pertaining to means-testing of Medicare Part D. Medicare/Presidents Funding Warning. H.R. 5480, S. 2662: proposals responding to the Presidents Medicare funding warning. Medicare/24-month Waiting Period. H.R.154, S. 2101: provisions phasing out the 24-month waiting period for disabled individuals to become eligible for Medicare benefits and eliminating the waiting period for individuals with life-threatening conditions. Medicaid/Federal Match. H.R. 5140: provisions pertaining to temporary increases in the federal Medicaid match. Medicaid/Targeted Case Management. Targeted Case Management: interim final rule to implement Section 6052 of the Deficit Reduction Act.

Client expense: $480,000 · Firm income: Not reported

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

Physician Payment Sunshine Act S. 2029 Patent Settlements H.R. 1432 S. 316

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

Patent Reform H.R. 1908, Import Safety Act H.R. 2100 Patent Settlements H.R. 1432 S. 316 Generic Biologics S 1685 H.R. 5629 Physician Payment Sunshine Act S. 2029

Client expense: Not reported · Firm income: $102,000

Patent Reform H.R. 1908, Import Safety Act H.R. 2100 Patent Settlements H.R. 1432 S. 316 Generic Biologics S 1685 H.R. 5629 Physician Payment Sunshine Act S. 2029

Client expense: Not reported · Firm income: $102,000

Patent Reform H.R. 1908, Import Safety Act H.R. 2100 Patent Settlements H.R. 1432 S. 316 Generic Biologics S 1685 H.R. 5629 Physician Payment Sunshine Act S. 2029

Client expense: Not reported · Firm income: $102,000

HR. 1432, Preserve Access to Affordable Generics Act (settlements) 3/07 S. 316, Preserve Access to Affordable Generics Act (settlements) 3/07 HR 1902, Protecting Consumer Access to Generic Drugs Act (4/07) S 2300, Lower PRICED Drugs Act, legislation pediatric exclusivity, citizens petitions HR 6022, Lower PRICED Drugs Act, legislation on pediatric exclusivity, citizens petitions S 3695, To Amend the Federal Food, Drug & Cosmetic Act to prohibit the marketing of authorized generic drugs, authorized generics HR 5993, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs HR 5120, To Amend Title 35, United States Code, to confirm certain filing provisions within the Patent and Trademark Office. HR 5418, To establish a pilot program in certain United States district courts to encourage enhancement of expertise in patent cases among district judges S 438, Fair Prescription Drug Competition Act (ban authorized generics) 1/07 HR 780, Counterfeit Drug Prevention Act of 2007 3/07 HR 1908, Patent Reform Act of 2007 S 1145, Patent Reform Act of 2007 S 623, Access to Life-Saving Medication Act (FOBS) 2/07 HR 1038, Access to Life-Saving Medication Act HR 5629, Pathway For Biosimilars Act S. 1145, Patent Reform Act (4/07) HR 1908, Patent Reform Act S. 3325, PL-110-403 (10/13/08) Intellectual Property Enforcement Act

Client expense: $3,250,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, Veterans Affairs, Dept of (VA)

Patent Reform Act of 2008 (S. 3600), Patent Reform Act of 2007 (H.R. 1908 & S. 1145) Preserve Access to Affordable Generics Act (H.R. 1432 & S. 316), Protecting Consumer Access to Generic Drugs Act (H.R 1902), To amend the Federal Food, Drug, and Cosmetic Act to establish requirements for certain petitions submitted to the Food and Drug Administration, and for other purposes (S. 25).

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

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

H.R. 1908-Patent Reform Act, provisions related to pharmaceutical patents H.R. 1432-Preserve Access to Affordable Generics Act, to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market

Client expense: $441,146 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institute on Alcohol Abuse & Alcoholism (NIAA), Natl Institutes of Health (NIH), SENATE, State, Dept of (DOS), Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA)

S.1145/HR1908 Patent Reform. S316/HR1432 Patent Settlements.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Pharmaceutical Issues Physician Payment Sunshine Act S. 2029 Patent Settlements H.R. 1432 S. 316

Client expense: Not reported · Firm income: Not reported

Patent Reform H.R. 1908, Import Safety Act H.R. 2100 Patent Settlements H.R. 1432 S. 316 Generic Biologics S 1685 H.R. 5629 Physician Payment Sunshine Act S. 2029

Client expense: Not reported · Firm income: $102,000

H.R. 1432 - Preserve Access to Affordable Generics Act S. 316 - Preserve Access to Affordable Generics Act H.R. 1908 - Patent Reform Act of 2007 S. 1145 - Patent Reform Act of 2007 H.R. 1902 - Protecting Consumer Access to Generic Drugs Act S. 25 - To amend the Federal Food, Drug, and Cosmetic Act to establish requirements for certain petitions submitted to the Food and Drug Administration, and for other purposes. S. 3600 - Patent Reform Act of 2008

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Health Information Technology, Electronic Prescribing, Comparative Effectiveness, Confidentiality of Health Information, Generic Drugs, Generic Biologics, Carve-out of Generic Drugs from State Generic Substituion Laws HR 971 and S 885 - Community Pharmacy Fairness Act of 2007; all aspects HR 1432 and S. 316 - Preserve Access to Affordable Generics Act; all aspects HR 1956 - Patient Protection and Innovative Biologic Medicines Act of 2007; all aspects HR 2567 and S. 3505 and S 870 - Medicare Home Infusion Therapy Consolidated Coverage Act of 2008; all aspects HR 2914 and S 2990 - Medicare IVIG Access Act of 2007; all aspects HR 3800 - Promoting Health Information Technology Act; all aspects HR 5629 - Pathway for Biosimilars Act; all aspects HR 6357- Protecting Records, Optimizing Treatment and Easing Communcations through Healthcare Technology PRO(TECH)T Act of 2008; all aspects HR 6898 - Health-e-Information Technology Act of 2008; all aspects S 976 - Genomics and Personalized Medicine Act of 2007; all aspects S 1408 - Health Information Technology Act of 2007; all aspects S 1693 - Wired for Health Care Quality Act; all aspects S 1695 - Biologics Price Competition and Innovation Act of 2007; all aspects S. 1814 - Health Information Privacy and Security Act; all aspects

Client expense: $780,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Issues related to drug coverage including pharmacy payments, reimbursement, competition and plan administration; Health Information Technology with respect to data privacy and electronic prescribing of prescription drugs; Promotion of competition in the prescription drug marketplace including the drug approval process; Additional Issues - see addendum Issues related to drug coverage including pharmacy payments, reimbursement, competition and plan administration HR 1474 - Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007; HR 3140 - Saving Our Community Pharmacies Act of 2007 HR 3193 - Access to Community Pharmacy Preservation Act of 2007 S 1954 - Pharmacy Access Improvement (PhAIm) Act of 2007 S 2161 - Community Pharmacy Fairness Act of 2007 Health information technology with respect to data privacy and electronic prescribing of prescription drugs HR 4296 and S 2408 - Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007 HR 3800 - Promoting Health Information Technology Act HR 6357 - Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008 or the PRO(TECH) Act of 2008 HR 6898 - Health e-Information Technology Act S 1408 - Health Information Technology Act of 2007 S 1693 - Wired for Health Care Quality Act S. 1814 - Health Information Privacy and Security Act Promotion of competition in the prescription drug marketplace including the drug approval process HR 1432 and S. 316 - Preserve Access to Affordable Generics Act HR 1956 - Patient Protection and Innovative Biologic Medicines Act of 2007 HR 5629 - Pathway for Biosimilars Act S 28 - Generics First Act of 2007 S 1695 - Biologics Price Competition and Innovation Act of 2007 HR 1038 / S 623 - Access to Life-Saving Medicine Act S 316 Preserve Access to Affordable Generics Act HR 1505 / S 1695 Affordable Biologics for Consumers Act HR 5629 - Pathway for Biosimilars Act Additional Issues HR 5683 - Government Accountability Office Act of 2008 S 1507 - Access to Medicare Data Act of 2007 S 273 - Prescription Drug and Health Improvement Act of 2007 HR 3610 - Food and Drug Import Safety Act of 2007

Client expense: $314,868 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, White House Office

Medicare/General. H.R. 205, H.R. 748, H.R. 1218, H.R. 1277, H.R. 1310, H.R. 1521, H.R. 2009, H.R. 2056, H.R. 2065, H.R. 2149, H.R. 3025, H.R. 3061, H.R. 3162, H.R. 3932, H.R. 6331, S. 137, S. 250, S. 450, S. 706, S. 1887, S. 2089, S. 2115, S. 2219, S. 3101: provisions relating to enrollment periods and the late enrollment penalty, physician reimbursement rates, creating a Medicare-operated prescription drug plan, drug price negotiations, Medicare beneficiary improvements, repealing cost containment mandates, Medicare Advantage payments, Medicare Advantage stabilization fund, and comparative cost adjustment demonstration projects under the Medicare Modernization Act, therapy caps, liberalizing asset test limits, reducing the Part D benefit gap and guaranteeing prescription drug benefits. Medicare/Prescription Drug Price Negotiation. H.R. 4, H.R. 118, H.R. 5317, S. 3, S. 273: provisions pertaining to the negotiation of prescription drug prices under Medicare Part D. Medicare/Medicare Advantage. H.R. 2945: provision to provide beneficiary protections against excessive cost-sharing under the Medicare Advantage Program. Medicare/Importation of Prescription Drugs. S. 242, H.R. 380, S.Amdt. 4299: provisions pertaining to the importation of prescription drugs. Medicare/Outpatient Psychiatric Services. H.R. 1571, H.R. 1663, H.R. 4897, S. 1715, S. 1854: provisions to eliminate discriminatory copayment rates for outpatient psychiatric services under Medicare Part B. Medicare/Geriatric Assessments. H.R. 2244, S. 1340: provisions to provide Medicare beneficiaries with access to geriatric assessments and chronic care coordination services. Medicare/Generic Drugs Market Exclusivity. H.R. 1432, H.R. 1902, S. 316, S. 1088: pertaining to market exclusivity for generic drugs. Medicare/Prescription Drug Benefits for Low Income Beneficiaries. H.R. 470, H.R. 932, H.R. 1536, H.R. 2058, H.R. 3127, S. 1102, S. 1103, S. 1107, S. 1108, S. 2101: provisions affecting prescription drug benefits for low-income beneficiaries under Medicare Parts B and D. Medicare/Part B Late Enrollment. H.R. 2591: provision limiting the penalty for late enrollment under Medicare Part B. Medicare/Marketing. H.R. 2307, H.R. 4790, S. 1883, S. 2687: provisions relating to the marketing of Medicare Advantage and Medicare Part D plans. Medicare/Health Care Vouchers. H.R. 749: provision to establish health care vouchers for seniors. Medicare/Medicare Savings Accounts. H.R. 2639, S. 173, S. 1019: provisions pertaining to Medicare Savings Accounts. Medicare/End-of-Life Planning. S. 464, S. 465, S. 466: pertaining to advance directives and end-of-life planning. Medicare/Means-testing. H.R. 4295, H.R. 4330, S. 2414, S.Amdt. 4240: pertaining to means-testing of Medicare Part D. Medicare/Presidents Funding Warning. H.R. 5480, S. 2662: proposals responding to the Presidents Medicare funding warning. H. Res. 1368, to suspend section 803 of the Medicare Modernization Act of 2003 (known as the Medicare trigger") for the remainder of the 110th Congress. Medicare/24-month Waiting Period. H.R.154, S. 2101: provisions phasing out the 24-month waiting period for disabled individuals to become eligible for Medicare benefits and eliminating the waiting period for individuals with life-threatening conditions. Medicaid/Federal Match. H.R. 5140: provisions pertaining to temporary increases in the federal Medicaid match. Medicaid/Targeted Case Management. Targeted Case Management: interim final rule to implement Section 6052 of the Deficit Medicaid/Targeted Case Management (continued). Reduction Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Patent Reform, including but not limited to: S.1145, S.3600, and H.R.1908 Patent Settlements/Reverse Payments, including but not limited to: S.316, H.R.1432, and H.R.1902 Special 301 Report International Intellectual Property Issues Patent Process Issues, including but not limited to: S.3560, H.R.1778, and H.R.6344 Any other matter that relates to acess to generic drugs

Client expense: $539,634 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

HR 971 and S 885 - Community Pharmacy Fairness Act of 2007; all aspects HR 1432 and S. 316 - Preserve Access to Afforadable Generics Act; all aspects HR 1956 - Patient Protection and Innovative Biologic Medicines Act of 2007; all aspects HR 2567 and S. 3505 and S. 870 - Medicare Home Infusion Therapy Consolidated Coverage Act of 2008; all aspects HR 2914 and S. 2990 - Medicare IVIG Acces Act of 2007; all aspects HR. 3800 - Promoting Health Information Technology Act; all aspects HR 5629 - Pathway for Biosimilars Act; all aspects HR 6357 - Protecting Records, Optimimizing Treatment and Easing Communications through Healthcare Technology (PRO[TECH]HIT) Act of 2008; all aspects HR 6898 - Health-e-Information Technology Act of 2008; all aspects S 976 - Genomics and Personlized Medicine Act of 2007; all aspects S 1408 - Health Information Technology Act of 2007; all aspects S 1693 - Wired for Health Care Quality Act; all aspects S 1695 - Biologics Price Competition and Innovation Act of 2007; all aspects S 1814 - Health Information Privacy and Security Act; all aspects

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S. 25 - To amend the Federal Food, Drug, and Cosmetic Act to establish requirements for certain petitions submitted to the Food and Drug Administration, and for other purposes. S. 1145 - Patent Reform Act of 2007 H.R. 1908 - Patent Reform Act of 2007 H.R. 1432 - Preserve Access to Affordable Generics Act S. 3600 - Patent Reform Act of 2008

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR. 1432, Preserve Access to Affordable Generics Act (settlements) 3/07 S. 316, Preserve Access to Affordable Generics Act (settlements) 3/07 HR 1902, Protecting Consumer Access to Generic Drugs Act (4/07) S 2300, Lower PRICED Drugs Act, legislation pediatric exclusivity, citizens petitions HR 6022, Lower PRICED Drugs Act, legislation on pediatric exclusivity, citizens petitions S 3695, To Amend the Federal Food, Drug & Cosmetic Act to prohibit the marketing of authorized generic drugs, authorized generics HR 5993, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs HR 5120, To Amend Title 35, United States Code, to confirm certain filing provisions within the Patent and Trademark Office. HR 5418, To establish a pilot program in certain United States district courts to encourage enhancement of expertise in patent cases among district judges S 438, Fair Prescription Drug Competition Act (ban authorized generics) 1/07 HR 780, Counterfeit Drug Prevention Act of 2007 3/07 HR 1908, Patent Reform Act of 2007 S 1145, Patent Reform Act of 2007 S 623, Access to Life-Saving Medication Act (FOBS) 2/07 HR 1038, Access to Life-Saving Medication Act HR 5629, Pathway For Biosimilars Act S. 1145, Patent Reform Act (4/07) HR 1908, Patent Reform Act

Client expense: $3,070,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, Veterans Affairs, Dept of (VA)

H.R.2795 - Patent Reform Act. Provisions related to pharmaceutical patents; H.R.5418 - Establishing a pilot program for patent cases; S.3582 - Preserve Access to Affordable Generics Act; H.R.1432 - To prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market. H.R.2642 - Military Construction and Veteran's Affairs.

Client expense: $476,543 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institute on Alcohol Abuse & Alcoholism (NIAA), Natl Institutes of Health (NIH), SENATE, State, Dept of (DOS), Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA)

HR. 1432, Preserve Access to Affordable Generics Act (settlements) 3/07 S. 316, Preserve Access to Affordable Generics Act (settlements) 3/07 HR 1902, Protecting Consumer Access to Generic Drugs Act (4/07) S 2300, Lower PRICED Drugs Act, legislation pediatric exclusivity, citizens petitions HR 6022, Lower PRICED Drugs Act, legislation on pediatric exclusivity, citizens petitions S 3695, To Amend the Federal Food, Drug & Cosmetic Act to prohibit the marketing of authorized generic drugs, authorized generics HR 5993, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs HR 5120, To Amend Title 35, United States Code, to confirm certain filing provisions within the Patent and Trademark Office. HR 5418, To establish a pilot program in certain United States district courts to encourage enhancement of expertise in patent cases among district judges S 438, Fair Prescription Drug Competition Act (ban authorized generics) 1/07 HR 780, Counterfeit Drug Prevention Act of 2007 3/07 HR 1908, Patent Reform Act of 2007 S 1145, Patent Reform Act of 2007 S 623, Access to Life-Saving Medication Act (FOBS) 2/07 HR 1038, Access to Life-Saving Medication Act HR 5629, Pathway For Biosimilars Act S. 1145, Patent Reform Act (4/07) HR 1908, Patent Reform Act

Client expense: $3,060,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, Veterans Affairs, Dept of (VA)

Issues related to drug coverage including pharmacy payments, reimbursement, competition and plan administration; Health Information Technology with respect to data privacy and electronic prescribing of prescription drugs; Promotion of competition in the prescription drug marketplace including the drug approval process; Additional Issues - see addendum Issues related to drug coverage including pharmacy payments, reimbursement, competition and plan administration HR 1474 - Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007; HR 3140 - Saving Our Community Pharmacies Act of 2007 HR 3193 - Access to Community Pharmacy Preservation Act of 2007 S 1954 - Pharmacy Access Improvement (PhAIm) Act of 2007 S 2161 - Community Pharmacy Fairness Act of 2007 Health information technology with respect to data privacy and electronic prescribing of prescription drugs HR 4296 and S 2408 - Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007 HR 3800 - Promoting Health Information Technology Act HR 6357 - Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008 or the PRO(TECH) Act of 2008 HR 6898 - Health e-Information Technology Act S 1408 - Health Information Technology Act of 2007 S 1693 - Wired for Health Care Quality Act S. 1814 - Health Information Privacy and Security Act Promotion of competition in the prescription drug marketplace including the drug approval process HR 1432 and S. 316 - Preserve Access to Affordable Generics Act HR 1956 - Patient Protection and Innovative Biologic Medicines Act of 2007 HR 5629 - Pathway for Biosimilars Act S 28 - Generics First Act of 2007 S 1695 - Biologics Price Competition and Innovation Act of 2007 HR 1038 / S 623 - Access to Life-Saving Medicine Act S 316 Preserve Access to Affordable Generics Act HR 1505 / S 1695 Affordable Biologics for Consumers Act HR 5629 - Pathway for Biosimilars Act Additional Issues HR 5683 - Government Accountability Office Act of 2008 S 1507 - Access to Medicare Data Act of 2007 S 273 - Prescription Drug and Health Improvement Act of 2007 HR 3610 - Food and Drug Import Safety Act of 2007

Client expense: $324,944 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, White House Office

S.1145/HR1908 Patent Reform. S316/HR1432 Patent Settlements.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Patent Reform Act of 2008 (S. 3600), Patent Reform Act of 2007 (H.R. 1908 & S. 1145) Preserve Access to Affordable Generics Act (H.R. 1432 & S. 316), Protecting Consumer Access to Generic Drugs Act (H.R 1902), To amend the Federal Food, Drug, and Cosmetic Act to establish requirements for certain petitions submitted to the Food and Drug Administration, and for other purposes (S. 25).

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

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

Patent Reform, including but not limited to: S.1145, S.3600, and H.R.1908 Patent Settlements/Reverse Payments, including but not limited to: S.316, H.R.1432, and H.R.1902 Special 301 Report International Intellectual Property Issues Patent Process Issues, including but not limited to: S.3560, H.R.1778 and H.R.6344 Any other matter that relates to access to generic drugs

Client expense: $506,976 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

H.R. 1432 - Preserve Access to Affordable Generics Act S. 316 - Preserve Access to Affordable Generics Act H.R. 1908 - Patent Reform Act of 2007 S. 1145 - Patent Reform Act of 2007 H.R. 1902 - Protecting Consumer Access to Generic Drugs Act S. 25 - To amend the Federal Food, Drug, and Cosmetic Act to establish requirements for certain petitions submitted to the Food and Drug Administration, and for other purposes. S. 3600 - Patent Reform Act of 2008

Client expense: $570,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Lobbying issues - Settlement of patent infringement claims, including S. 316, the "Preserve Access to Affordable Generics Act"; H.R. 1902, the "Protecting Consumer Access to Generic Drugs Act of 2007"; and H.R. 1432, the "Preserve Access to Affordable Generics Act."

Client expense: Not reported · Firm income: Not reported

Health Information Technology, Electronic Prescribing, Inappropriate use of Human Growth Hormone, Comparative Effectiveness, 340B Program, Confidentiality of Health Information, Generic Drugs, Generic Biologics, Internet Pharmacies, Carve-out of Generic Drugs from State Generic Substitution Laws HR 971 and S 885 - Community Pharmacy Fairness Act of 2007; all aspects HR 1432 and S. 316 - Preserve Access to Affordable Generics Act; all aspects HR 1474 - Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007; all aspects HR 1956 - Patient Protection and Innovative Biologic Medicines Act of 2007; all aspects HR 2567 and S 870 - Medicare Home Infusion Therapy Coverage Act of 2007; all aspects HR 2606 and S 1376 - 340B Program Improvement and Integrity Act of 2007; all aspects HR 2914 - Medicare IVIG Access Act of 2007; all aspects HR 2970 - Pharmacy Benefit Manager Transparency Act of 2007; all aspects HR 3140 - Saving Our Community Pharmacies Act of 2007; all aspects HR 3090 - Patient and Pharmacy Protection Act of 2007; all aspects HR 3193 - Access to Community Pharmacy Preservation Act of 2007; all aspects HR 3800 - Promoting Health Information Technology Act; all aspects HR 3932 - Medicare Prescription Drug Savings and Choice Act of 2007; all aspects HR 4296 and S 2408 - Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007; all aspects HR 5629 - Pathway for Biosimilars Act; all aspects HR 5683 - Government Accountability Office Act of 2008, section 721 HR 6357 - Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008 or the PRO(TECH) Act of 2008; all aspects HR 6898 - Health e-Information Technology Act; all aspects S 28 - Generics First Act of 2007; all aspects S 242 - Pharmaceutical Market Access and Drug Safety Act of 2007; all aspects S 251 - Pharmaceutical Market Access Act of 2007; all aspects S 273 - Prescription Drug and Health Improvement Act of 2007; all aspects S 596 - Safe Internet Pharmacy Act of 2007; section 511(c) S 976 - Genomics and Personalized Medicine Act of 2007; all aspects S 980 - Ryan Haight Online Pharmacy Consumer Protection Act of 2007; all aspects S 1408 - Health Information Technology Act of 2007; all aspects S 1507 - Access to Medicare Data Act of 2007; all aspects S 1693 - Wired for Health Care Quality Act; all aspects S 1695 - Biologics Price Competition and Innovation Act of 2007; all aspects S. 1814 - Health Information Privacy and Security Act; all aspects S 1954 - Pharmacy Access Improvement (PhAIm) Act of 2007; all aspects S 2161 - Community Pharmacy Fairness Act of 2007; all aspects

Client expense: $434,097 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

HR 1432 and S. 316 - Preserve Access to Affordable Generics Act; all aspects HR 1474 - Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007; all aspects HR 1956 - Patient Protection and Innovative Biologic Medicines Act of 2007; all aspects HR 2567 and S 870 - Medicare Home Infusion Therapy Coverage Act of 2007; all aspects HR 2606 and S 1376 - 340B Program Improvement and Integrity Act of 2007; all aspects HR 2914 - Medicare IVIG Access Act of 2007; all aspects HR 2970 - Pharmacy Benefit Manager Transparency Act of 2007; all aspects HR 3140 - Saving Our Community Pharmacies Act of 2007; all aspects HR 3090 - Patient and Pharmacy Protection Act of 2007; all aspects HR 3193 - Access to Community Pharmacy Preservation Act of 2007; all aspects HR 3800 - Promoting Health Information Technology Act; all aspects HR 3932 - Medicare Prescription Drug Savings and Choice Act of 2007; all aspects HR 4296 and S 2408 - Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007; all aspects HR 5629 - Pathway for Biosimilars Act; all aspects HR 5683 - Government Accountability Office Act of 2008, section 721 HR 6357 - Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008 or the PRO(TECH) Act of 2008; all aspects HR 6898 - Health e-Information Technology Act; all aspects S 28 - Generics First Act of 2007; all aspects S 242 - Pharmaceutical Market Access and Drug Safety Act of 2007; all aspects S 251 - Pharmaceutical Market Access Act of 2007; all aspects S 273 - Prescription Drug and Health Improvement Act of 2007; all aspects S 596 - Safe Internet Pharmacy Act of 2007; section 511(c) S 976 - Genomics and Personalized Medicine Act of 2007; all aspects S 980 - Ryan Haight Online Pharmacy Consumer Protection Act of 2007; all aspects S 1408 - Health Information Technology Act of 2007; all aspects S 1507 - Access to Medicare Data Act of 2007; all aspects S 1693 - Wired for Health Care Quality Act; all aspects S 1695 - Biologics Price Competition and Innovation Act of 2007; all aspects S. 1814 - Health Information Privacy and Security Act; all aspects S 1954 - Pharmacy Access Improvement (PhAIm) Act of 2007; all aspects S 2161 - Community Pharmacy Fairness Act of 2007; all aspects

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Medicare Payment Advisory Commission (MedPAC), SENATE

S. 25 - To amend the Federal Food, Drug, and Cosmetic Act to establish requirements for certain petitions submitted to the Food and Drug Administration, and for other purposes. S. 1145 - Patent Reform Act of 2007 H.R. 1908 - Patent Reform Act of 2007 H.R. 1432 - Preserve Access to Affordable Generics Act S. 3600 - Patent Reform Act of 2008

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare/General. H.R. 205, H.R. 748, H.R. 1218, H.R. 1277, H.R. 1310, H.R. 1521, H.R. 2009, H.R. 2056, H.R. 2065, H.R. 2149, H.R. 3025, H.R. 3061, H.R. 3162, H.R. 3932, H.R. 6331, S. 137, S. 250, S. 450, S. 706, S. 1887, S. 2089, S. 2115, S. 2219, S. 3101: Medicare/General (continued). provisions relating to enrollment periods and the late enrollment penalty, physician reimbursement rates, creating a Medicare-operated prescription drug plan, drug price negotiations, Medicare beneficiary improvements, repealing cost containment mandates, Medicare Advantage payments, Medicare Advantage stabilization fund, and comparative cost adjustment demonstration projects under the Medicare Modernization Act, therapy caps, liberalizing asset test limits, reducing the Part D benefit gap and guaranteeing prescription drug benefits. Medicare/Prescription Drug Price Negotiation. H.R. 4, H.R. 118, H.R. 5317, S. 3, S. 273: provisions pertaining to the negotiation of prescription drug prices under Medicare Part D. Medicare/Medicare Advantage. H.R. 2945: provision to provide beneficiary protections against excessive cost-sharing under the Medicare Advantage Program. Medicare/Importation of Prescription Drugs. S. 242, H.R. 380, S.Amdt. 4299: provisions pertaining to the importation of prescription drugs. Medicare/Outpatient Psychiatric Services. H.R. 1571, H.R. 1663, H.R. 4897, S. 1715, S. 1854: provisions to eliminate discriminatory copayment rates for outpatient psychiatric services under Medicare Part B. Medicare/Geriatric Assessments. H.R. 2244, S. 1340: provisions to provide Medicare beneficiaries with access to geriatric assessments and chronic care coordination services. Medicare/Generic Drugs Market Exclusivity. H.R. 1432, H.R. 1902, S. 316, S. 1088: pertaining to market exclusivity for generic drugs. Medicare/Prescription Drug Benefits for Low Income Beneficiaries. H.R. 470, H.R. 932, H.R. 1536, H.R. 2058, H.R. 3127, S. 1102, S. 1103, S. 1107, S. 1108, S. 2101: provisions affecting prescription drug benefits for low-income beneficiaries under Medicare Parts B and D. Medicare/Part B Late Enrollment. H.R. 2591: provision limiting the penalty for late enrollment under Medicare Part B. Medicare/Marketing. H.R. 2307, H.R. 4790, S. 1883, S. 2687: provisions relating to the marketing of Medicare Advantage and Medicare Part D plans. Medicare/Health Care Vouchers. H.R. 749: provision to establish health care vouchers for seniors. Medicare/Medicare Savings Accounts. H.R. 2639, S. 173, S. 1019: provisions pertaining to Medicare Savings Accounts. Medicare/End-of-Life Planning. S. 464, S. 465, S. 466: pertaining to advance directives and end-of-life planning. Medicare/Means-testing. H.R. 4295, H.R. 4330, S. 2414, S.Amdt. 4240: pertaining to means-testing of Medicare Part D. Medicare/Presidents Funding Warning. H.R. 5480, S. 2662: proposals responding to the Presidents Medicare funding warning. H. Res. 1368, to suspend section 803 of the Medicare Modernization Act of 2003 (known as the Medicare trigger") for the remainder of the 110th Congress. Medicare/24-month Waiting Period. H.R.154, S. 2101: provisions phasing out the 24-month waiting period for disabled individuals to become eligible for Medicare benefits and eliminating the waiting period for individuals with life-threatening conditions. Medicare/Identity Theft Prevention. H.R. 6600, provisions related to removal of Social Security numbers from Medicare cards. Medicaid/Federal Match. H.R. 5140: provisions pertaining to temporary increases in the federal Medicaid match. Medicaid/Targeted Case Management. Targeted Case Management: interim final rule to implement Section 6052 of the Deficit Reduction Act.

Client expense: $280,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.2795 - Patent Reform Act; Provisions related to pharmaceutical patents; H.R.5418 - Establishing a pilot program for patent cases; S.3582 - Preserve Access to Affordable Generics Act; H.R.1432 - To prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market; H.R.2642 - Military Construction and Veteran's Affairs.

Client expense: $515,985 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institute on Alcohol Abuse & Alcoholism (NIAA), Natl Institutes of Health (NIH), SENATE, State, Dept of (DOS), Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA)

HR. 1432, Preserve Access to Affordable Generics Act (settlements) 3/07 S. 316, Preserve Access to Affordable Generics Act (settlements) 3/07 HR 1902, Protecting Consumer Access to Generic Drugs Act (4/07) S 2300, Lower PRICED Drugs Act, legislation pediatric exclusivity, citizens petitions HR 6022, Lower PRICED Drugs Act, legislation on pediatric exclusivity, citizens petitions S 3695, To Amend the Federal Food, Drug & Cosmetic Act to prohibit the marketing of authorized generic drugs, authorized generics HR 5993, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs HR 5120, To Amend Title 35, United States Code, to confirm certain filing provisions within the Patent and Trademark Office. HR 5418, To establish a pilot program in certain United States district courts to encourage enhancement of expertise in patent cases among district judges S 438, Fair Prescription Drug Competition Act (ban authorized generics) 1/07 HR 780, Counterfeit Drug Prevention Act of 2007 3/07 HR 1908, Patent Reform Act of 2007 S 1145, Patent Reform Act of 2007 S 623, Access to Life-Saving Medication Act (FOBS) 2/07 HR 1038, Access to Life-Saving Medication Act HR 5629, Pathway For Biosimilars Act S. 1145, Patent Reform Act (4/07) HR 1908, Patent Reform Act

Client expense: $3,060,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, Veterans Affairs, Dept of (VA)

S. 1640, the Vessel Hull Design Protection Amendments of 2007. S. 242 and H.R. 1432, the Pharmaceutical Market Access and Drug Safety Act of 2007 -Provisions relating to reimportation of patents drugs sold abroad. S. 256, the Platform Equality and Remedies for Rights Holders in Music Act of 2007. S. 522, the Intellectual Property Rights Enforcement Act S. 1145, the Patent Reform Act of 2007. (Patent law reform.) H.R. 1908, the Patent Reform Act of 2007. (Patent law reform.) H.R. 1778, a bill to allow the USPTO to accept unintentionally late filings. H.R. 2365, a bill to limit damages for infringement of patents relating to tax planning methods. H.R. 2033, the Design Piracy Prohibition Act. S. 2913 and H.R. 5889, the Orphan Works Act of 2008. H.R. 4279, the Prioritizing Resources and Organizations for Intellectual Property Act of 2007 H.R. 4789, the Performance Rights Act. H.R. 5638, patent infringement for repair parts. H.R. 6344, the Responsive Government Act. H.R. 6362, appointment of Administrative Patent Judges.

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

Government targets: Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Education, Dept of, Environmental Protection Agency (EPA), Federal Trade Commission (FTC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Justice, Dept of (DOJ), Legal Services Corporation, Library of Congress (LOC), Office of Management & Budget (OMB), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Commission on Civil Rights, U.S. Copyright Office, U.S. Immigration & Customs Enforcement (ICE), U.S. Trade Representative (USTR), White House Office

S.1145/HR1908 Patent Reform. S316/HR1432 Patent Settlements.

Client expense: $150,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health Information Technology, Electronic Prescribing, Genetic Nondiscrimination, Inappropriate use of Human Growth Hormone, Medicare Part D Contract Disclsoure Requirements, Comparative Effectiveness, 340B Program, Confidentiality of Health Information, Generic Drugs, Generic Biologics, Internet Pharmacies, Off-Label Use of Prescription Drugs, Over-the-Counter Drug Dispersement, Carve-out of Generic Drugs from State Medicaid Generic Substitution Laws HR 493 and S 358 - Genetic Information Nondiscrimination Act of 2008; Title I HR 971 and S 885 - Community Pharmacy Fairness Act of 2007; all aspects HR 1432 and S. 316 - Preserve Access to Affordable Generics Act; all aspects HR 1474 - Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007; all aspects HR 1956 - Patient Protection and Innovative Biologic Medicines Act of 2007; all aspects HR 2567 and S 870 - Medicare Home Infusion Therapy Coverage Act of 2007; all aspects HR 2606 and S 1376 - 340B Program Improvement and Integrity Act of 2007; all aspects HR 2914 - Medicare IVIG Access Act of 2007; all aspects HR 2970 - Pharmacy Benefit Manager Transparency Act of 2007; all aspects HR 3140 - Saving Our Community Pharmacies Act of 2007; all aspects HR 3090 - Patient and Pharmacy Protection Act of 2007; all aspects HR 3193 - Access to Community Pharmacy Preservation Act of 2007; all aspects HR 3800 - Promoting Health Information Technology Act; all aspects HR 3932 - Medicare Prescription Drug Savings and Choice Act of 2007; all aspects HR 4296 and S 2408 - Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007; all aspects HR 5629 - Pathway for Biosimilars Act; all aspects HR 5683 - Government Accountability Office Act of 2008, section 721 HR 6357 - Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008 or the PRO(TECH) Act of 2008; all aspects S 28 - Generics First Act of 2007; all aspects S 242 - Pharmaceutical Market Access and Drug Safety Act of 2007; all aspects S 251 - Pharmaceutical Market Access Act of 2007; all aspects S 273 - Prescription Drug and Health Improvement Act of 2007; all aspects S 596 - Safe Internet Pharmacy Act of 2007; section 511(c) S 976 - Genomics and Personalized Medicine Act of 2007; all aspects S 980 - Ryan Haight Online Pharmacy Consumer Protection Act of 2007; all aspects S 1408 - Health Information Technology Act of 2007; all aspects S 1507 - Access to Medicare Data Act of 2007; all aspects S 1693 - Wired for Health Care Quality Act; all aspects S 1695 - Biologics Price Competition and Innovation Act of 2007; all aspects S. 1814 - Health Information Privacy and Security Act; all aspects S 1954 - Pharmacy Access Improvement (PhAIm) Act of 2007; all aspects S 2161 - Community Pharmacy Fairness Act of 2007; all aspects

Client expense: $508,492 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), SENATE

H.R. 1432 - Preserve Access to Affordable Generics Act S. 316 - Preserve Access to Affordable Generics Act H.R. 1908 - Patent Reform Act of 2007 S. 1145 - Patent Reform Act of 2007 H.R. 1902 - Protecting Consumer Access to Generic Drugs Act S. 25 - To amend the Federal Food, Drug, and Cosmetic Act to establish requirements for certain petitions submitted to the Food and Drug Administration, and for other purposes.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Patent Reform, including but not limited to: S.1145 and H.R.1908 Patent Settlements/Reverse Payments, including but not limited to: S.316, H.R.1432, and H.R.1902 Special 301 Report Patent Process Issues, including but not limited to: H.R.1778 and H.R.6344 International Intellectual Property Issues Any other matter that relates to access to generic drugs

Client expense: $459,139 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

HR 493 and S 358 - Genetic Information Nondiscrimination Act of 2007; Title I HR 971 and S 885 - Community Pharmacy Fairness Act of 2007; all aspects HR 1432 and S. 316 - Preserve Access to Affordable Generics Act; all aspects HR 1474 - Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007; all aspects HR 1956 - Patient Protection and Innovative Biologic Medicines Act of 2007; all aspects HR 2567 and S 870 - Medicare Home Infusion Therapy Consolidated Coverage Act of 2007; all aspects HR 2606 and S 1376 - 340B Program Improvement and Integrity Act of 2007; all aspects HR 2914 - Medicare IVIG Access Act of 2007; all aspects HR 2970 - Pharmacy Benefit Manager Transparency Act of 2007; all aspects HR 3140 - Saving Our Community Pharmacies Act of 2007; all aspects HR 3090 - Patient and Pharmacy Protection Act of 2007; all aspects HR 3193 - Access to Community Pharmacy Preservation Act of 2007; all aspects HR 3800 - Promoting Health Information Technology Act; all aspects HR 3932 - Medicare Prescription Drug Savings and Choice Act of 2007; all aspects HR 4296 and S 2408 - Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007; all aspects HR 5629 - Pathway for Biosimilars Act; all aspects HR 5683 - Government Accountability Office Act of 2008, section 721 HR 6357 - Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008 or the PRO(TECH) Act of 2008; all aspects S 28 - Generics First Act of 2007; all aspects S 242 - Pharmaceutical Market Access and Drug Safety Act of 2007; all aspects S 251 - Pharmaceutical Market Access Act of 2007; all aspects S 273 - Prescription Drug and Health Improvement Act of 2007; all aspects S 596 - Safe Internet Pharmacy Act of 2007; section 511(c); all aspects S 976 - Genomics and Personalized Medicine Act of 2007; all aspects S 980 - Online Pharmacy Consumer Protection Act of 2007; all aspects S 1408 - Health Information Technology Act of 2007; all aspects S 1507 - Access to Medicare Data Act of 2007; all aspects S 1693 - Wired for Health Care Quality Act; all aspects S 1695 - Biologics Price Competition and Innovation Act of 2007; all aspects S. 1814 - Health Information Privacy and Security Act; all aspects S 1954 - Pharmacy Access Improvement (PhAIm) Act of 2007; all aspects S 2161 - Community Pharmacy Fairness Act of 2007; all aspects

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

H.R. 1432 - Preserve Access to Affordable Generics Act, S. 316 - Preserve Access to Affordable Generics Act,H.R. 1908 - Patent Reform Act of 2007, S. 1145 - Patent Reform Act of 2007, H.R. 1902 - Protecting Consumer Access to Generic Drugs Act

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

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

S. 25 - To amend the Federal Food, Drug, and Cosmetic Act to establish requirements for certain petitions submitted to the Food and Drug Administration, and for other purposes. S. 1145 - Patent Reform Act of 2007 H.R. 1908 - Patent Reform Act of 2007 H.R. 1432 - Preserve Access to Affordable Generics Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Lobbying issues - Settlement of patent infringement claims, including S. 316, the "Preserve Access to Affordable Generics Act"; H.R. 1902, the "Protecting Consumer Access to Generic Drugs Act of 2007"; and H.R. 1432, the "Preserve Access to Affordable Generics Act."

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

Government targets: Congressional Budget Office (CBO)