Preserve Access to Affordable Generics Act

S. 1145 / HR 1908 Patent Reform. S316/HR 1432 Patent Settlements.

Client expense: $300,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), 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. 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

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

H.R.1908, S.1145 Patent Reform Act of 2007 H.R.806 To Amend the FD&C Act to Prohibit the Marketing of Authorized Generics S.438 Fair Prescription Drug Competition Act H.R.1038, S.623 Access to Life Saving Medicines Act H.R.1956 Patient Protection and Innovative Biologic Medicines Act of 2007 H.R.5629 Pathway for Biosimilars Act H.R.1902 Protecting Consumers Access to Generic Drugs Act of 2007 S.316 Preserve Access to Affordable Generics Act

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

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

S.316, Preserve Access to Affordable Biologics

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Advance proposal to create an FDA process for the approval of generic biological products; S. 316 - Preserve Access to Affordable Generics Act; H.R. 1902 - Protecting Consumer Access to Generic Drugs Act; H.R. 1038 - Access to Life Saving Medicine Act.

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

Government targets: 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

H.R.1038, Access to Life-Saving Medicine Act; H.R.1908, Patent Reform Act of 2007; H.R.5629, Pathway for Biosimilars Act; S.316, Preserve Access to Affordable Generics Act; S.623, Access to Life-Saving Medicine Act; S.1082, Food and Drug Administration Revitalization Act; S.1145, Patent Reform Act of 2007; S.1505, Affordable Biologics for Consumers Act; S.3463, A bill to amend the trade Act of 1974; S.3600, A bill to amend Title 35 US Code. Legislative proposals effecting US patent system: H.R.1908, Patent Reform Act of 2007; S.1145, Patent Reform Act of 2007; S.3463, A bill to amend the Trade Act of 1974 to improve the international protection and enforcement of intellectual property rights, and for other purposes; S.3600, A bill to amend title 35 US Code, to provide for patent reforms. Legislative proposals regarding follow-on biologics: H.R.1038, Access to Life-Saving Medicine Act; H.R.5629, Pathway for Biosimilars Act; S.623, Access to Life-Saving Medicine Act; S.1082, Food and Drug Administration Revitalization Act; S.1505, Affordable Biologics for Consumers Act. Legislative proposals regarding brand-generic drug firm agreements: S.316, Preserve Access to Affordable Generics Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

PHA (Pharmacy) (Legislative): H.R. 971: Community Pharmacy Fairness Act (Weiner); H.R. 1038: Access to Life-Saving Medicine Act (Waxman); H.R. 5629: Pathway for Biosimilars Act (Eshoo-Barton) (continued) PHA (Legislative) (continued): S. 316: Preserve Access to Affordable Generics Act (Kohl); S. 623: Access to Life-Saving Medicine Act (Schumer); S. 885: Community Pharmacy Fairness Act (Isakson); S. 1505: Affordable Biologics for Consumers Act (Gregg); S. 1695: Biologics Price Competition and Innovation Act (Kennedy) PHA (Regulatory): Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to access for investigational drugs; and issues related to electronic prescribing requirements; issues relating to e-prescribing of DEA controlled substances.

Client expense: $2,240,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), 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), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Personnel Management (OPM), SENATE, Social Security Administration (SSA), Treasury, Dept of

S 1145, Patent Reform Act of 2007, patent issues HR 1908, Patent Reform Act of 2007, patent issues S 316, Preserve Access to Affordable Generics Act, patent settlements International Property issues.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Veterans Healthcare issues Electronic Prescribing Comparative Effectiveness Research S. 2408, Medicare Electronic Medication and Safety Protection Act 2007 HR. 4296, Medicare Electronic Medication and Safety Protection Act 12/07 HR. 3800, Promoting Health Information Technology Act 10/07 HR. 2406, (no title) authorize the NIST to increase its efforts in support of the integration of the healthcare information enterprise in the United States 11/07 S. 1693, The Wired for Health Care Quality Act 10/07 S. 438, Fair Prescription Drug Competition Act 1/07 S. 1082, Food and Drug Administration Revitalization Act 5/07 HR. 806 2/07 S. 1432, Preserve Access to Affordable Generics Act 5/07 S. 316, Preserve Access to Affordable Generics Act 3/07 S. 2029 Physician Payments Sunshine Act HR 5605 Physician Payments Sunshine Act HR 962 Preservation of Antibioties for Medical Treatment Act S. 349 Preservation of Antibioties for Medical Treatment Act S. 2313 Strategies to Address Antimicrobial Resistance HR 3697 Strategies to Address Antimicrobial Resistance HR 1424. The Paul Wellstone Mental Health and Addiction Equity Act H.R. 6331 Medicare Improvements for Patients & Providers Act H.R. 6376 and H.R. 6378 - Strengthening FDA Integrity Act (6/08) S. 877 - Stop Abuse of Growth Hormone Act (3/07) H.R. 4911 - Human Growth Hormone Restriction Act (12/07) H.R. 6357 - Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008 or The Pro(TECH)T Act of 2008 H.R. 6898 - the Health-e Information Technology Act of 2008 S. 3396 - Independent Drug Education and Outreach Act of 2008

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)

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)

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1902, Protecting Consumer Access to Generic Drugs Act of 2007: patent settlements H.R. 1908, Patent Reform Act of 2007: patent system reform and related issues such as obtaining/opposing patents and remedies H.R. 4279, Prioritizing Resources and Organization for Intellectual Property Act of 2007: enforcement S. 316, Preserve Access to Affordable Generics Act: patent settlements S. 522, Intellectual Property Rights Enforcement Act: anti-counterfeiting and enforcement S. 1145, Patent Reform Act of 2007: patent system reform and related issues such as obtaining/opposing patents and remedies S. 2317, Intellectual Property Enforcement Act of 2007: enforcement S. 3325, Prioritizing Resources and Organization for Intellectual Property Act of 2008: enforcement S. 3464, International Intellectual Property Protection and Enforcement Act of 2008: enforcement S. 3600, Patent Reform Act of 2008: patent system reform and related issues such as obtaining/opposing patents and remedies International intellectual property issues

Client expense: $6,170,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Economic Council (NEC), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

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

Generic Drug Settlements S.316, Preserve Access to Affordable Generics Act. H.R. 1902, Protecting Consumer Access to Generic Drugs Act of 2007.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 316, the Preserve Access to Affordable Pharmaceuticals Act H.R. 1902, the Protecting Consumer Access to Generic Drugs Act H.R. 1038, the Access to Life Savings Medicine Act H.R. 5629, the Pathway for Biosimilars Act S. 1695, the Biologivs Price Competition and Innovation Act H.R. 5829, the Safeguarding America's Pharmaceuticals Act H.R. 3610, the Food and Drug Import Safety Act, Section 4 User Fees Regarding Drug Safety PL 110-85, the Food and Drug Amendments Act of 2007, Title VIII Clinical Trials Abbreviated New Drug Applicatin No. 76-396 for calcitonin salmon nasal spray

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

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, 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. 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

S 623/HR 1038 (Access to Life Saving Medicine Act), HR 1956 (Patient Protection and Innovative Biologic Medicines Act of 2007), HR 5629 (Pathway for Biosimilars Act) - Lobbied to ensure that Waxman Biogenerics legislation is enacted particularly provisions related to ensuring a safe, effective pathway for the approval of comparable, interchangeable biologics. HR 1902 (Protecting Consumer Access to Generic Drugs Act of 2007)/ S 316 (Preserve Access to Affordable Generics Act -Provisions related to preventing abuses in patent settlements between generic and brand name prescription drug manufactures. S 1145 Patient Reform Act of 2007- Ensuring that the existing inequitable conduct provisions in Patent Law Act are not weakened. Discussion regarding prescription drug affordability (no Bill). S 3230 Labor/HHS/Education Appropriations FY 2009 - Lobbying for spending levels for Rx comparative effectiveness. S 3289 Agriculture and Rural Development Appropriations, FY 2009 - Lobbied to reduce FDA generic drug processing backlog.

Client expense: $6,870,000 · Firm income: Not reported

Government targets: Administration on Aging, Commerce, Dept of (DOC), Equal Employment Opportunity Commission (EEOC), Federal Communications Commission (FCC), Federal Reserve System, Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), SENATE, Social Security Administration (SSA), Treasury, Dept of, White House Office

Pharmacy issues - S 623, Access to Life-Saving Medicine Act; HR 1038, Access to Life-Saving Medicine Act; S 1505, Affordable Biologics for Consumers Act; S 316, Preserve Access to Affordable Generics Act; S 1695, Biologics Price Competition and Innovation Act of 2007; HR 971, Community Pharmacy Fairness Act of 2007; S 885, Community Pharmacy Fairness Act of 2007; HR 5629, Pathway for Biosimilars Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1038/HR 1956/HR5629--creation of a regulatory pathway for generic biologics S 1088/S 28/S 316/HR 1902--issues related to bringing generics to market in a timely fashion S. 596/S 980/HR 6353--internet pharmacy regulations HR 5839--issues relating to prescription drug pedigree/drug safety

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Defense, Dept of (DOD), 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), Legal Services Corporation, Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), 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

S.316, Preserve Access to Affordable Biologics

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

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: 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

H.R.1908, S.1145 Patent Reform Act of 2007 H.R.806 To Amend the FD&C Act to Prohibit the Marketing of Authorized Generics S.438 Fair Prescription Drug Competition Act H.R.1038, S.623 Access to Life Saving Medicines Act H.R.1956 Patient Protection and Innovative Biologic Medicines Act of 2007 H.R.5629 Pathway for Biosimilars Act H.R.1902 Protecting Consumers Access to Generic Drugs Act of 2007 S.316 Preserve Access to Affordable Generics Act

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

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

H.R.1908, S.1145 Patent Reform Act of 2007 H.R.806 To Amend the FD&C Act to Prohibit the Marketing of Authorized Generics S.438 Fair Prescription Drug Competition Act H.R.1038, S.623 Access to Life Saving Medicines Act H.R.1956 Patient Protection and Innovative Biologic Medicines Act of 2007 H.R.5629 Pathway for Biosimilars Act H.R.1902 Protecting Consumers Access to Generic Drugs Act of 2007 S.316 Preserve Access to Affordable Generics Act

Client expense: Not reported · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), 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

Advance proposal to create an FDA process for the approval of generic biological products; S. 316 - Preserve Access to Affordable Generics Act; H.R. 1902 - Protecting Consumer Access to Generic Drugs Act; H.R. 1038 - Access to Life Saving Medicine Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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 1893, Children's Health Insurance Program Reauthorization Act of 2007 (Expansion/extension of SCHIP ); S558/HR 1424, Mental Health Parity Act of 2007 (Secure equal treatment for mental health benefits); HR 1038/S 623, Access to Life-Saving Medicine Act (Biogenerics-approving generic Bio pharmaceuticals); S 316, Preserve Access to Affordable Generics Act (Regulate Generic/Brand patent settlements); S 1501/S 1695, Affordable Biologics for Consumers Act (Generic Bio-pharmaceuticals); S 334, Healthy Americans Act (Universal health coverage replaces employer coverage); S 1899, Universal Health Coverage Act of 2007 (Mandatory health insurance coverage); S 242/HR 380, Pharmaceutical Market Access and Drug Safety Act of 2007 (Drug importation-Canada, et al.); HR 1076/S616, HIPAA Recreational Injury Technical/Correction Act (Mandatory coverage for recretional activity); HR 676, United States National Health Insurance Act (National health insurance); HR 1368, Personalized Health Information Act of 2007 (Financial incentives for personal health records); S 1490, Federal Employees Electronic Personal Health Records Act of 2007 (health information technology); S 1544, Medicare Quality Enhancement Act of 2007 (CMS data release); S 1693, Wired for Health Care Quality Act (Health information technology); HR 1368, Personalized Health Information Act of 2007; HR 5422, TRUST in Health Information Act of 2008; S 1693, Wired for Health Care Quality Act; S 1814, Health Information Privacy and Security Act; HR 6357, ProTecht Act of 2008; HR 6898, Health Information Technology Act of 2008; HR 6582, Small Business Choice Act of 2008; S 2795, SHOP Act; HR 6210, SHOP Act; S 2818, Small Busienss Health Plans Act of 2008.

Client expense: $517,594 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of

H.R. 1038 & S. 623, Access to Life-Saving Medicine Act; H.R. 1956, Patient Protection & Innovative Biologic Medicines Act; H.R. 5629, Pathway for Biosimilars Act; S. 316, Preserve Access to Affordable Generics Act; H.R. 1902, Protecting Consumer Access to Generic Drugs Act; Development of "Pedigree" or National Drug Trafficking System; H.R. 2900, Food & Drug Administration Amendments Act; H.R. 1980 & S. 1145, Patent Reform Act; FDA Globalization Act; Tax Incentives/Extensions (R&D Tax Credit)

Client expense: $1,560,000 · Firm income: Not reported

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

Veterans Healthcare issues Electronic Prescribing Comparative Effectiveness Research Genetic Information Non-Discrimination S. 2408, Medicare Electronic Medication and Safety Protection Act 2007 HR. 4296, Medicare Electronic Medication and Safety Protection Act 12/07 HR. 3800, Promoting Health Information Technology Act 10/07 HR. 2406, (no title) authorize the NIST to increase its efforts in support of the integration of the healthcare information enterprise in the United States 11/07 S. 1693, The Wired for Health Care Quality Act 10/07 S. 438, Fair Prescription Drug Competition Act 1/07 S. 1082, Food and Drug Administration Revitalization Act 5/07 HR. 806 2/07 S. 358, Genetic Information Nondiscrimination Act 4/07 S. 1432, Preserve Access to Affordable Generics Act 5/07 S. 316, Preserve Access to Affordable Generics Act 3/07 S. 2029 Physician Payments Sunshine Act HR 5605 Physician Payments Sunshine Act HR 962 Preservation of Antibioties for Medical Treatment Act S. 349 Preservation of Antibioties for Medical Treatment Act S. 2313 Strategies to Address Antimicrobial Resistance HR 3697 Strategies to Address Antimicrobial Resistance HR 1424. The Paul Wellstone Mental Health and Addiction Equity Act S 2731, The Tom Lantos and Henry J. Hyde United States Global Leadership Against HIVAIDS, Tuberculosis, and Malaria Reauthorization Act (Also HR 5501) H.R. 6331 Medicare Improvements for Patients & Providers Act H.R. 6376 and H.R. 6378 - Strengthening FDA Integrity Act (6/08) S. 877 - Stop Abuse of Growth Hormone Act (3/07) H.R. 4911 - Human Growth Hormone Restriction Act (12/07) H.R. 6357 - Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008 or The Pro(TECH)T Act of 2008 H.R. 6898 - the Health-e Information Technology Act of 2008 S. 3396 - Independent Drug Education and Outreach Act of 2008

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)

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.1038, Access to Life-Saving Medicine Act; H.R.1908, Patent Reform Act of 2007; H.R.5629, Pathway for Biosimilars Act; S.316, Preserve Access to Affordable Generics Act; S.623, Access to Life-Saving Medicine Act; S.1082, Food and Drug Administration Revitalization Act; S.1145, Patent Reform Act of 2007; S.1505, Affordable Biologics for Consumers Act. Legislative proposals effecting US patent system: H.R.1908, Patent Reform Act of 2007; S.1145, Patent Reform Act of 2007. Legislative proposals regarding follow-on biologics: H.R.1038, Access to Life-Saving Medicine Act; H.R.5629, Pathway for Biosimilars Act; S.623, Access to Life-Saving Medicine Act; S.1082, Food and Drug Administration Revitalization Act; S.1505, Affordable Biologics for Consumers Act. Legislative proposals regarding brand-generic drug firm agreements: S.316, Preserve Access to Affordable Generics Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 1145, Patent Reform Act of 2007, patent issues HR 1908, Patent Reform Act of 2007, patent issues S 316, Preserve Access to Affordable Generics Act, patent settlements International Property Issues.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Veterans Healthcare issues Electronic Prescribing Comparative Effectiveness Research Genetic Information Non-Discrimination S. 2408, Medicare Electronic Medication and Safety Protection Act 2007 HR. 4296, Medicare Electronic Medication and Safety Protection Act 12/07 HR. 3800, Promoting Health Information Technology Act 10/07 HR. 2406, (no title) authorize the NIST to increase its efforts in support of the integration of the healthcare information enterprise in the United States 11/07 S. 1693, The Wired for Health Care Quality Act 10/07 S. 438, Fair Prescription Drug Competition Act 1/07 S. 1082, Food and Drug Administration Revitalization Act 5/07 HR. 806 2/07 S. 358, Genetic Information Nondiscrimination Act 4/07 S. 1432, Preserve Access to Affordable Generics Act 5/07 S. 316, Preserve Access to Affordable Generics Act 3/07 S. 2029 Physician Payments Sunshine Act HR 5605 Physician Payments Sunshine Act HR 962 Preservation of Antibioties for Medical Treatment Act S. 349 Preservation of Antibioties for Medical Treatment Act S. 2313 Strategies to Address Antimicrobial Resistance HR 3697 Strategies to Address Antimicrobial Resistance HR 1424. The Paul Wellstone Mental Health and Addiction Equity Act S 2731, The Tom Lantos and Henry J. Hyde United States Global Leadership Against HIVAIDS, Tuberculosis, and Malaria Reauthorization Act (Also HR 5501) H.R. 6331 Medicare Improvements for Patients & Providers Act H.R. 6376 and H.R. 6378 - Strengthening FDA Integrity Act (6/08) S. 877 - Stop Abuse of Growth Hormone Act (3/07) H.R. 4911 - Human Growth Hormone Restriction Act (12/07) H.R. 6357 - Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008 or The Pro(TECH)T Act of 2008 H.R. 6898 - the Health-e Information Technology Act of 2008 S. 3396 - Independent Drug Education and Outreach Act of 2008

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)