Preserve Access to Affordable Generics Act

S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214: Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and Patent and Trademark Office (PTO) diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the PTO S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity S. 2733: Venue Equity and Non-Uniformity Elimination Act of 2016 - Provisions related to venue H.R. 4829: Trade Protection Not Troll Protection Act - Provisions related to proceedings at the International Trade Commission (ITC) H.R. 5573: Price Relief, Innovation, and Competition for Essential Drugs Act or PRICED Act - Provisions related to exclusivity Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues Bayh-Dole Act march-in rights policy issues

Client expense: $4,550,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Security Council (NSC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214: Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and Patent and Trademark Office (PTO) diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the PTO S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity S. 2733: Venue Equity and Non-Uniformity Elimination Act of 2016 - Provisions related to venue H.R. 9: Innovation Act - Provisions related to patent litigation reform Provisions related to exclusivity Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues Bayh-Dole Act march-in rights policy issues

Client expense: $4,130,000 · Firm income: Not reported

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

S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214: Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and Patent and Trademark Office (PTO) diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the PTO S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity S. 2733: Venue Equity and Non-Uniformity Elimination Act of 2016 - Provisions related to venue H.R. 4829: Trade Protection Not Troll Protection Act - Provisions related to proceedings at the International Trade Commission (ITC) H.R. 5573: Price Relief, Innovation, and Competition for Essential Drugs Act or PRICED Act - Provisions related to exclusivity Other: - Issues related to abuse deterrent exclusivity incentives - Patent litigation reform issues and issues related to post-grant proceedings at the PTO - Patent settlement policy issues - Biopharmaceutical innovation and patent policy issues - Bayh-Dole Act march-in rights policy issues

Client expense: $1,070,000 · Firm income: Not reported

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

S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214: Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and Patent and Trademark Office (PTO) diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the PTO S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity S. 2733: Venue Equity and Non-Uniformity Elimination Act of 2016 - Provisions related to venue H.R. 4829: Trade Protection Not Troll Protection Act - Provisions related to proceedings at the International Trade Commission (ITC) H.R. 5573: Price Relief, Innovation, and Competition for Essential Drugs Act or PRICED Act - Provisions related to exclusivity Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues Bayh-Dole Act march-in rights policy issues

Client expense: $5,820,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Security Council (NSC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214: Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and Patent and Trademark Office (PTO) diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the PTO S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 1890: Defend Trade Secrets Act of 2016 - Provisions related to improving trade secret protection S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity S. 2733: Venue Equity and Non-Uniformity Elimination Act of 2016 - Provisions related to venue H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 3326: Defend Trade Secrets Act of 2015 - Provisions related to improving trade secret protection H.R. 4829: Trade Protection Not Troll Protection Act - Provisions related to proceedings at the International Trade Commission (ITC) Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues Bayh-Dole Act march-in rights policy issues

Client expense: $1,490,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), Vice President of the U.S.

S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214: Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and Patent and Trademark Office (PTO) diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the PTO S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 1890: Defend Trade Secrets Act of 2016 - Provisions related to improving trade secret protection S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity S. 2733: Venue Equity and Non-Uniformity Elimination Act of 2016 - Provisions related to venue H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 3326: Defend Trade Secrets Act of 2015 - Provisions related to improving trade secret protection H.R. 4829: Trade Protection Not Troll Protection Act - Provisions related to proceedings at the International Trade Commission (ITC) Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues Bayh-Dole Act march-in rights policy issues

Client expense: $5,950,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), Vice President of the U.S.

S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214: Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 1890: Defend Trade Secrets Act of 2015 - Provisions related to improving trade secret protection S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues

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

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

S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214: Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and Patent and Trademark Office (PTO) diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the PTO S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 1890: Defend Trade Secrets Act of 2015 - Provisions related to improving trade secret protection S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues

Client expense: $3,820,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

H.R. 3116, MODDERN Cures Act of 2013; S. 3004, Dormant Therapies Act of 2014; H.R. 406 & S. 1767, Combination Drug Development Incentive Act of 2015; H.R. 1537 & S. 1878, Advancing Hope Act of 2015; S. 1720, Patent Transparency and Improvements Act of 2013; S. 632, STRONG Patents Act of 2015; H.R. 9, Innovation Act; H.R. 160, Protect Medical Innovation Act of 2015; S. 214, Preserve Access to Affordable Generics Act of 2013; H.R. 3709, Protecting Consumer Access to Generic Drugs Act of 2013; H.R. 971 & S. 1421, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015; Proposals/Initiatives related to international intellectual property protection;

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

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

S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues

Client expense: $4,240,000 · Firm income: Not reported

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

S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues

Client expense: $842,000 · Firm income: Not reported

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

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

Client expense: $580,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Patent Issues. Patent Reform. S. 214: Preserve Access to Affordable Generics Act. S. 1720: Patent Transparency and Improvements Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 460, Patients' Access to Treatments Act (McKinley) - cost sharing in a specialty drug tier H.R. 1367, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act (Lynch) - FEHBP prescription drugs S. 214, Preserve Access to Affordable Generics Act (Klobuchar) - access to generic drugs Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Client expense: $2,010,000 · Firm income: Not reported

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

Issues relating to Patent Settlements. S. 214, Preserve Access to Affordable Generics Act

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

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

S. 1720, Patent Transparency and Improvements Act of 2013; H.R. 3309, Innovation Act; S. 214, Preserve Access to Affordable Generics Act of 2013; H.R. 3709, Protecting Consumer Access to Generic Drugs Act of 2013; H.R. 3116, MODDERN Cures Act of 2013; H.R. 2985, Combination Drug Development Incentive Act of 2013; various international intellectual property issues and proposals

Client expense: $1,520,000 · Firm income: Not reported

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

Oversight of implementation of the America Invents Act. Issues relating to patent settlements, including S. 214: Preserve Access to Affordable Generics Act. H.R. 3309: Innovation Act. S. 1720: Patent Transparency and Improvements Act of 2013.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3709 Protecting Consumer Access to Generic Drugs Act, S. 214 Preserve Access to Affordable Generics Act, H.R. 3309 Innovation Act

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

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

H.R. 3116, MODDERN Cures Act of 2013; Proposals/Initatives related to international intellectual property protection; S. 1720, Patent Transparency and Improvements Act of 2013; H.R. 3309, Innovation Act; S. 214, Preserve Access to Affordable Generics Act of 2013; H.R. 5750, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014

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

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

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

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

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

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Discussed importance of potential savings both to consumers and to the federal government of granting Secretarial Negotiating Authority to Secretary of HHS on Medicare Part D. (no bill)Discussed legislative intent with respect to biologic drugs and the exclusivity period; and discussed importance of potential savings to the health care system generally. (no bill) Discussed need for greater consumer safety protections both in OTC and prescription drugs. (no bill) Discussed need for doctors to get unbiased information on prescription pharmaceuticals through programs like academic detailing. (no bill) Discussed possible savings and better health care outcomes that could result from Medication Therapy Management. (no bill) Pub. Law 111-148 and 111-152 - Discussed implementation of health care legislation to reform the health care system to provide quality healthcare, expand access to long-term services and supports, and reduced prescription drug costs. Discussed greater affordability of generic versions of both generic and biologic drugs. S. 319, Pharmaceutical Market Access and Drug Safety Act of 2011 - Discussed legislation that establishes a framework for the safe, legal importation of lower-priced prescription drugs from abroad. S. 1206, Medicare Drug Savings Act of 2011 - Discussed rebates in Medicare Part D as a cost savings measure in Medicare that does not harm beneficiaries. H. R. 3342, Affordable Medicines Utilization Act of 2011 - Lobbied on legislation to encourage state Medicaid programs to use safe, effective generic medications. S. 27, Preserve Access to Affordable Generics Act of 2011- Lobbied for this legislation preventing abuses in patent settlements between generic and brand name prescription drug companies. S. 1886/H.R. 3468 of 2011- Discussed counterfeit drug penalty enhancement. Discussed prescription drug safety, drug shortage, and medical device safety, and related user fee legislation. S. 2193 of 2012, the Ensuring Safe Medical Devices for Patients Act - Discussed legislation to include devices in the post-market risk identification and analysis system for prescription drugs and to expedite the implementation of the unique device identification system for medical devices. Discussed draft legislation to address the issue of whether generic drug manufacturers have a duty to include new warnings about potentially serious side effects on their labels as they become known by giving generic drug makers the same ability to update their labeling as manufacturers of brand name drugs. (no bill) S.3187, Food and Drug Administration safety and Innovation Act - FDA user fee agreement legislation focusing on the review process for prescription drugs and medical devices, prescription drug safety, drug shortages, medical device safety and access to generic drugs. S.3212, Cody Miller Initiative for Safer Prescriptions Act - To require the Secretary of Health and Human Services to promulgate regulations regarding the authorship, content, format, and dissemination of Patient Medication information. Discussed pay-for-delay agreements as tactic by drug manufacturers to block lower cost drugs from entering the market, and the Fair and Immediate Release of Generics Drugs Act that would address the underlying issue of "parked exclusivities" in the Hatch-Waxman Act (S.1882). Discussed the issue of biosimilar drug naming and how biosimilars should use a common International Non-proprietary name as reference originator biologic products. (no bill) S. 504, the Fair and Immediate Release of Generic Drugs Act/S.214, the Preserve Access to Affordable Generics Act - Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill) H.R. 83, Consolidated and Further Continuing Appropriations, 2015 - Lobbied to protect and enhance funding levels for FDA to enable it to effectively manage it's food safety and medical product programs. H.J. Res. 124, Continuing Appropriations Resolutions, 2015 - Lobbied to protect senior housing and nutrition programs, and FDA programs from disproportionate reduction under the bill.Discussed Unique Device Identification (UDI) issues including proposed rules and implementation. (no bill) Discussed oversight of laboratory genetic testing. (no bill) Discussed AARP's concerns with prescription drug costs. (no bill) S.117, Medicare Prescription Drug Price Negotiation Act - Discussed bill that allows medicare to negotiate medicare prescription drug prices with drug companies. Discussed the exclusivity period for biologic drugs. (no bill) Discussed the Patient Safety and Generic Labeling Improvement Act. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) S. 504, the Fair and Immediate Release of Generics Drugs Act/S. 214, the Preserve Access to Affordable Generics - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market. Discussed the exclusivity period ofr biologic drugs. (no bill) Discussed the Food and Drug Administration proposed rule to enable generic drug makers to independently update their drug labeling. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) S. 1720/S.2049/S.866, - Discussed patent reform legislation and related provisions. Discussed the importance of potential savings to both consumers and the federal government of granting Secretarial negotiating authority to the HHS Secretary under Medicare Part D. (no bill) Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market (the Fair and Immediate Release of Generic Drugs Act (S. 504) and (the Preserve Access to Affordable Generics Act) (S.214). Discussed the Food and Drug Administration proposed rule to enable generic drug makers to independently update their drug labeling. (no bill) Discussed other prescription drug issues and potential legislation on drug importation and "least costly alternative" payment for Part B durgs. (no bill) S.504/S.214 - Discussed legislation to address pay-for-delay agreements used by drug manufacturers to block lower cost drugs from entering the market (the Fair and Immediate Release of Generics Drugs Act) and the Preserve Access to Affordable Generics Act. Discussed the Food and Drug Administration proposed rule to enable generic drug makers to independently update their drug labeling. (no bill) Discussed biologic drug issues including implementation of the new approval pathway for biosimilar drugs. (no bill) S.1720/S.2040/S.866 - Discussed patent reform legislation and related provisions. Discussed other prescription drug issues and potential legislation on drug importation and "least costly alternative" payment for Part B drugs. (no bill) Discussed the need to data transparency on prescription drug research and development costs and drug prices, and enhanced data reporting on coverage determinations, exception, and redeterminations under Part D appeals process. (no bill) Discussed the House Energy and Commerce Committee 21st Century Cures Initiative focused on drug and medical device innovation issues. (no bill)

Client expense: $2,180,000 · Firm income: Not reported

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

S.214, Preserve Access to Affordable Generics Act S.1720, Patent Transparency and Improvements Act of 2013 S.1013, Patent Abuse Reduction Act of 2013

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 22, Foreign Counterfeit Merchandise Prevention Act (entire bill)* H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes (SHIELD) Act (entire bill)* H.R. 1663, Promoting Automotive Repair. Trade and Sales (PARTS) Act (entire bill)* S. 780, Promoting Automotive Repair. Trade and Sales (PARTS) Act (entire bill)* H.R. 2024, the End Anonymous Patents Act (entire bill)* H.R. 2236, the Promoting Startup Innovation Act (entire bill)* H.R. 2582, the PATENT Jobs Act (entire bill)* S. 214, Prohibiting the delay of generic drugs into the market (entire bill)* S. 662, Trade Facilitation and Trade Enforcement Reauthorization Act of 2013 (IP-related provisions)* S. 866, To Make Improvements to Transitional Program for Covered Business Method Patents (entire bill)* S. 1013 Patent Abuse Reduction Act of 2013 (entire bill).* S. 712, Patents for Humanity Program Improvement Act of 2013 (entire bill)* S. 1478 PACES Act (entire bill)* H.R. 2766, Stopping the Offensive Use of Patents Act (entire bill)* H.R. 2639, Patent Litigation and Innovation Act of 2013 (entire bill)* H.R. 2466, Private Right of Action Against Theft of Trade Secrets Act of 2013 (entire bill)* H.R. 3309, the Innovation Act (entire bill) H.R. 3349, Innovation Protection Act (entire bill)* S. 1720, Patent Transparency and Improvements Act (entire bill) S. 1612, Patent Litigation Integrity Act of 2013 (entire bill) H.R. 3219, Free Market Royalty Act (entire bill)* H.R. 3713, to provide for the registration of marks consisting of a flag, coat of arms, or other insignia of the United States, or any State or local government (entire bill)* S. 1770, Future of American Innovation and Research (FAIR) (entire bill)* S. 1816, to provide for the registration of marks consisting of a flag, coat of arms, or other insignia of the United States, or any State or local government (entire bill)* S. 2146, Patent Fee Integrity Act (entire bill)* S. 2049, Transparency in Assertion of Patents Act (entire bill)* H.R. 4079 Songwriter Equity Act (entire bill)* S. 2321 Songwriter Equity Act (entire bill)* H.R. 4103, American Royalties Too Act (entire bill)* S. 2045, American Royalties Too Act (entire bill)* H.R. 4287, Independent Innovator and Repurposing Act (entire bill)* S. 2150, Independent Innovator and Repurposing Act (entire bill)* S. 2267, the Defend Trade Secrets Act (entire bill) H.R. ____, Targeting Rogue and Opaque Letters Act (entire bill) H.R. 5036, Satellite Television Access Reauthorization Act (entire bill) S. 2454, Satellite Television Access Reauthorization Act (entire bill) H.R. 3540, the Demand Letter Transparency Act of 2013 (entire bill)* H.R. 4763, Trade Protection Not Troll Protection Act (entire bill)* H.R. 4772, RESPECT Act (entire bill) H.R. 5108, Regarding the USPTO Law School Clinic Certification Program (entire bill) H.R. 5233, Trade Secrets Protection Act of 2014 (entire bill) H.R. 5586 You Own Devices Act (YODA)* H.R. 4660, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2015 S. 2437, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2015 H.R. 4487, Legislative Branch Appropriations Act, 2015 H.J. Res 124, Continuing Appropriations Resolution, 2015 H.R. 83, FY2015 Omnibus; Consolidated and Further Continuing Appropriations Act (IP-related provisions only) Issues related to USPTO Director and IPEC Nominations Issues related to USPTO PTAB Proceedings

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

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

H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisions H.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2639, Patent Litigation and Innovation Act: Patent litigation provisions H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985, Combination Drug Development Incentive Act of 2013: Provisions related to exclusivity H.R. 3116, MODDERN Cures Act of 2013: Provisions related to exclusivity H.R. 3309, Innovation Act: Provisions related to patent litigation reform H.R. 3349, Innovation Protection Act: PTO Fee Diversion H.R. 3540, Demand Letter Transparency Act: Provisions related to patent demand letters H.R. 3709, Protecting Consumer Access to Generic Drugs: Provisions related to patent settlements H.R. 4287, Independent Innovator and Repurposing Act: Provisions related to patent term restoration H.R. 4763, Trade Protection not Troll Protection Act: Patent and trade provisions H.R. 5233, Trade Secrets Protection Act of 2014: Provisions related to trade secrets H.R. 5750, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014: Provisions related to targeted IP incentives for new indications for rare diseases or conditions S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions S. 1612, Patent Litigation Integrity Act: Patent litigation provisions including bonding S. 1720, Patent Transparency and Improvements Act: Patent litigation provisions S. 2049, Transparency in Assertion of Patents Act: Provisions related to patent demand letters S. 2150, Independent Innovator and Repurposing Act: Provisions related to patent term restoration S. 2196, Patent Fee Integrity Act: Patent fee diversion prohibition S. 2267, Defend Trade Secrets Act of 2014: Provisions related to trade secrets S. 3004, Dormant Therapies Act of 2014: Provisions related to incentives to develop biopharmaceutical products Biopharmaceutical innovation and patent policy issues Biologics data protection issues Draft legislation on demand letters, including Targeting Rogue and Opaque Letters (TROL) Act Issues related to biopharmaceutical economic incentives and intellectual property

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

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

S. 214, Preserve Access to Affordable Generics Act; implementation of P.L. 111-148, Patient Protection and Affordable Care Act; implementation of P.L. 113-54, Drug Quality and Security Act; 21st Century Cures initiative

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Oversight of implementation of the America Invents Act; issues relating to patent settlements, including S. 214 (Preserve Access to Affordable Generics Act); H.R. 3309 (The Innovation Act); S. 1720 (Patent Transparency and Improvements Act of 2013).

Client expense: $540,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2582 - PATENT Jobs Act; provisions related to patent user fees H.R. 2639 - Patent Litigation and Innovation Act; patent litigation proposols H.R. 2766 - STOP Act; provisions related to business method patents H.R. 3116 - MODDERN Cures Act of 2013; Provisions related to exclusivity H.R. 3309 - Innovation Act; provisions related to patent litigation reform H.R. 3349 - Innovation Protection Act; provisions related to PTO fee diversion H.R. 3540 - Demand Letter Transparency Act; provisions related to patent demand letters H.R. 3709 - Protecting Consumer Access to Generic Drugsprovisions related to patent settlements H.R. 4287 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 214 - The Preserve Access to Affordable Generics Act; provisions relating to patent settlements S. 504 - Fair and Immediate Release of Generic Drugs Act; provisions related to patent settlements S. 866 - Patent Quality Improvement Act of 2013Business methods patents provisions S. 1013 - Patent Abuse Reduction Act of 2013; provisions related to patent litigation reform S. 1612 - Patent Litigation Integrity Act; Patent litigation provisions including bonding S. 1720 - Patent Transparency and Improvements Act S. 2049 - Transparency in Assertion of Patents Act; Provisions related to patent demand letters S. 2150 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 2196 - Patent Fee Integrity Act; patent fee diversion prohibition No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Biologics data protection issues No bill # assigned - Intellectual property issues; Additional data exclusivity request that was part of 21st Century Cures submission

Client expense: $580,000 · Firm income: Not reported

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

Patent Issues. Patent Reform. S. 214: Preserve Access to Affordable Generics Act. S. 1720: Patent Transparency and Improvements Act of 2013.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 22, Foreign Counterfeit Merchandise Prevention Act (entire bill)* H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes (SHIELD) Act (entire bill)* H.R. 1663, Promoting Automotive Repair. Trade and Sales (PARTS) Act (entire bill)* S. 780, Promoting Automotive Repair. Trade and Sales (PARTS) Act (entire bill)* H.R. 2024, the End Anonymous Patents Act (entire bill)* H.R. 2236, the Promoting Startup Innovation Act (entire bill)* H.R. 2582, the PATENT Jobs Act (entire bill)* S. 214, Prohibiting the delay of generic drugs into the market (entire bill)* S. 662, Trade Facilitation and Trade Enforcement Reauthorization Act of 2013 (IP-related provisions)* S. 866, To Make Improvement

Client expense: Not reported · Firm income: Not reported

H.R. 3709 Protecting Consumer Access to Generic Drugs Act of 2013, S. 214 Preserve Access to Affordable Generics Act

Client expense: $700,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

H.R. 22, Foreign Counterfeit Merchandise Prevention Act (entire bill)* H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes (SHIELD) Act (entire bill)* H.R. 1663, Promoting Automotive Repair. Trade and Sales (PARTS) Act (entire bill)* S. 780, Promoting Automotive Repair. Trade and Sales (PARTS) Act (entire bill)*H.R. 2024, the End Anonymous Patents Act (entire bill)* H.R. 2236, the Promoting Startup Innovation Act (entire bill)* H.R. 2582, the PATENT Jobs Act (entire bill)* S. 214, Prohibiting the delay of generic drugs into the market (entire bill)* S. 662, Trade Facilitation and Trade Enforcement Reauthorization Act of 2013 (IP-related provisions)* S. 866, To Make Improvements to Transitional Program for Covered Business Method Patents (entire bill)* S. 1013 Patent Abuse Reduction Act of 2013 (entire bill).* S. 712, Patents for Humanity Program Improvement Act of 2013 (entire bill)* S. 1478 PACES Act (entire bill)* H.R. 2766, Stopping the Offensive Use of Patents Act (entire bill)* H.R. 2639, Patent Litigation and Innovation Act of 2013 (entire bill)* H.R. 2466, Private Right of Action Against Theft of Trade Secrets Act of 2013 (entire bill)* H.R. 3309, the Innovation Act (entire bill) H.R. 3349, Innovation Protection Act (entire bill)* S. 1720, Patent Transparency and Improvements Act (entire bill) S. 1612, Patent Litigation Integrity Act of 2013 (entire bill) H.R. 3219, Free Markey Royalty Act (entire bill)* H.R. 3713, to provide for the registration of marks consisting of a flag, coat of arms, or other insignia of the United States, or any State or local government (entire bill)* S. 1770, Future of American Innovation and Research (FAIR) (entire bill)* S. 1816, to provide for the registration of marks consisting of a flag, coat of arms, or other insignia of the United States, or any State or local government (entire bill)* S. 2146, Patent Fee Integrity Act (entire bill)* S. 2049, Transparency in Assertion of Patents Act (entire bill)* H.R. 4079 Songwriter Equity Act (entire bill)* S. 2321 Songwriter Equity Act (entire bill)* H.R. 4103, American Royalties Too Act (entire bill)* S. 2045, American Royalties Too Act (entire bill)* H.R. 4287, Independent Innovator and Repurposing Act (entire bill)* S. 2150, Independent Innovator and Repurposing Act (entire bill)* S. 2267, the Defend Trade Secrets Act (entire bill) H.R. ____, Targeting Rogue and Opaque Letters Act (entire bill) H.R. 1123, Unlocking Consumer Choice and Wireless Competition Act (entire bill) S. 517, Unlocking Consumer Choice and Wireless Competition Act (entire bill) H.R. 5036, Satellite Television Access Reauthorization Act (entire bill) S. 2454, Satellite Television Access Reauthorization Act (entire bill) H.R. 3540, the Demand Letter Transparency Act of 2013 (entire bill)* H.R. 4763, Trade Protection Not Troll Protection Act (entire bill) H.R. 4772, RESPECT Act (entire bill) H.R. 5108, Regarding the USPTO Law School Clinic Certification Program (entire bill) H.R. 5233, Trade Secrets Protection Act of 2014 (entire bill) H.R. 5586 You Own Devices Act (YODA) H.R. 4660, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2015 S. 2437, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2015 H.R. 4487, Legislative Branch Appropriations Act, 2015 H.J. Res 124, Continuing Appropriations Resolution, 2015

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

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

Preserve Access to Affordable Generics Act (S. 214), Patent Quality Improvement Act of 2013 (S. 866, H.R. 2766), Patent Abuse Reduction Act of 2013 (S. 1013, H.R. 2639); The Innovation Act (HR 3309); Patent Transparency and Improvements Act of 2013 (S. 1720); General issues related to intellectual property and potential changes to the patent system

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation H.R. 2024, End Anonymous Patents Act: Patent owner information provisions H.R. 2582, PATENT Jobs Act: Provisions related to patent user fees H.R. 2605, Manufacturing Innovation in America Act of 2013: Provisions related to patent tax boxes H.R. 2639, Patent Litigation and Innovation Act: Patent litigation proposals H.R. 2766, STOP Act: Provisions related to business method patents H.R. 2985, Combination Drug Development Incentive Act of 2013: Provisions related to exclusivity H.R. 3116, MODDERN Cures Act of 2013: Provisions related to exclusivity H.R. 3309, Innovation Act: Provisions related to patent litigation reform H.R. 3349, Innovation Protection Act: PTO Fee Diversion H.R. 3540, Demand Letter Transparency Act: Provisions related to patent demand letters H.R. 3709, Protecting Consumer Access to Generic Drugs: Provisions related to patent settlements H,R, 4287, Independent Innovator and Repurposing Act: Provisions related to patent term restoration H.R. 4763, Trade Protection not Troll Protection Act: Patent and trade provisions H.R. 5233, Trade Secrets Protection Act of 2014: Provisions related to trade secrets S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements S. 626, Prize Fund for HIV/AIDS Act: Medical prize provisions S. 627, Medical Innovation Prize Fund Act: Medical prize provisions S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions S. 1612, Patent Litigation Integrity Act: Patent litigation provisions including bonding S. 1720, Patent Transparency and Improvements Act S, 2049, Transparency in Assertion of Patents Act: Provisions related to patent demand letters S.2150, Independent Innovator and Repurposing Act: Provisions related to patent term restoration S. 2196, Patent Fee Integrity Act: Patent fee diversion prohibition S. 2267, Defend Trade Secrets Act of 2014: Provisions related to trade secrets Biopharmaceutical innovation policy issues Biologics data protection issues Draft legislation on demand letters, including Targeting Rogue and Opaque Letters (TROL) Act Issues related to biopharmaceutical economic incentives and intellectual property

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

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

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 460, Patients' Access to Treatments Act (McKinley) - cost sharing in a specialty drug tier H.R. 1367, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act (Lynch) - FEHBP prescription drugs S. 214, Preserve Access to Affordable Generics Act (Klobuchar) - access to generic drugs Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Client expense: $2,010,000 · Firm income: Not reported

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

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

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

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

H.R. 460, Patients' Access to Treatments Act (McKinley) - cost sharing in a specialty drug tier. H.R. 1367, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act (Lynch) - FEHBP prescription drugs. S. 214, Preserve Access to Affordable Generics Act (Klobuchar) - access to generic drugs.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Oversight of implementation of the America Invents Act. Issues relating to patent settlements, including S. 214: Preserve Access to Affordable Generics Act. H.R. 3309: Innovation Act. S. 1720: Patent Transparency and Improvements Act of 2013.

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

Government targets: HOUSE OF REPRESENTATIVES

S. 1720, Patent Transparency and Improvements Act of 2013; H.R. 3309, Innovation Act; S. 214, Preserve Access to Affordable Generics Act of 2013; H.R. 3709, Protecting Consumer Access to Generic Drugs Act of 2013; H.R. 3116, MODDERN Cures Act of 2013; H.R. 2985, Combination Drug Development Incentive Act of 2013; various international intellectual property issues and proposals

Client expense: $1,600,000 · Firm income: Not reported

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

Patent Issues. Patent Reform. S. 214: Preserve Access to Affordable Generics Act. S. 1720: Patent Transparency and Improvements Act of 2013.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2582 - PATENT Jobs Act; provisions related to patent user fees H.R. 2605 - Manufacturing Innovation in America Act of 2013; provisions related to patent tax boxes H.R. 2639 - Patent Litigation and Innovation Act; patent litigation proposols H.R. 2766 - STOP Act; provisions related to business method patents H.R. 3116 - MODDERN Cures Act of 2013; Provisions related to exclusivity H.R. 3309 - Innovation Act; provisions related to patent litigation reform H.R. 3349 - Innovation Protection Act; provisions related to PTO fee diversion H.R. 3540 - Demand Letter Transparency Act; provisions related to patent demand letters H.R. 3709 - Protecting Consumer Access to Generic Drugsprovisions related to patent settlements H.R. 4287 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 214 - The Preserve Access to Affordable Generics Act; provisions relating to patent settlements S. 504 - Fair and Immediate Release of Generic Drugs Act; provisions related to patent settlements S. 866 - Patent Quality Improvement Act of 2013; Business methods patents provisions S. 1013 - Patent Abuse Reduction Act of 2013; provisions related to patent litigation reform S. 1612 - Patent Litigation Integrity Act; Patent litigation provisions including bonding S. 1720 - Patent Transparency and Improvements Act S. 2049 - Transparency in Assertion of Patents Act; Provisions related to patent demand letters S. 2150 - Independent Innovator and Repurposing Act; provisions related to patent term restoration S. 2196 - Patent Fee Integrity Act; patent fee diversion prohibition No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Biologics data protection issues No bill # assigned - Intellectual property issues; Additional data exclusivity request that was part of 21st Century Cures submission

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

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

S.214, Preserve Access to Affordable Generics Act S.1720, Patent Transparency and Improvements Act of 2013 S.1013, Patent Abuse Reduction Act of 2013

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE