Hatch-Waxman Integrity Act of 2018

Preserve Access to Affordable Generics Act (S. 124); Regulatory exclusivity; Improving Access To Affordable Prescription Drugs Act (S. 771/H.R. 1776); Drug pricing; SUPPORT for Patients and Communities Act (H.R. 6); Biosimilars Competition Act of 2018 (H.R. 6478); Patient Right to Know Drug Prices Act (S. 2554/H.R. 6143); Medicare Negotiation and Competitive Licensing Act of 2018 (H.R. 6505); Making Objective Drug Evidence Revisions for New (MODERN) Labeling Act (S. 3519); citizen petitions; Medicare Part B international reference pricing; Hatch-Waxman Integrity Act of 2018 (S. 3738/H.R. 7251); Affordable Drug Manufacturing Act of 2018 (H.R. 7348/S. 3775); Preserve Access to Affordable Generics and Biosimilars Act (S. 3792); Direct-to-consumer pharmaceutical advertising.

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

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

H.R. 5340: The Support Technology & Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act of 2018 - Provisions related to reforms of Patent Trial and Appeal Board (PTAB) proceedings and other patent system reforms H.R. 7251: Hatch-Waxman Integrity Act of 2018 - Provisions related to PTAB proceedings S. 124: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 3738: Hatch-Waxman Integrity Act of 2018 - Provisions related to PTAB proceedings Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Bayh-Dole march-in rights policy issues

Client expense: $6,030,000 · Firm income: Not reported

Bayh-Dole Act/Tech Transfer ---March-In Rights Intellectual Property International Enforcement ---Compulsory Licensing ---Chile ---Malaysia ---India Inter Partes Review ---Implementation of the America Invents Act of 2011 ---H.R. 5340/S. 1390: STRONGER Patents Act ---H.R. 6264: Restoring America's Leadership Act ---H.R. 7251: Hatch-Waxman Integrity Act of 2018 The United States-Mexico-Canada Agreement ---IP Provisions Patent Reform ---H.R. 5340/S. 1390: STRONGER Patents Act Compulsory Licensing in Federal Programs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 Small Business IP Training ---H.R. 2655/S.791: Small Business Innovation Protection Act of 2017 Drug Patent Settlements Patenting of Biological Inventions ---Section 101 Modernization US-UK Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions

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

S. 297, Increasing Competition in Pharmaceuticals Act (Collins-McCaskill) - prescription drug costs S. 974, CREATES Act (Leahy-Grassley) - access to generic drugs and biosimilars S. 1115, Making Pharmaceutical Markets More Competitive Act (Collins-McCaskill) - accelerated approval of generic therapies S. 1131, FAIR Drug Pricing Act (Baldwin-McCain) - transparency in prescription drug pricing S. 2553, Know the Lowest Price Act (Stabenow) - pharmacist-patient communications S. 2554, Patient Right to Know Drug Prices Act (Collins) - pharmacist-patient communications, reporting of biosimilar pay-for-delay settlements S. 3194, Capping Prescription Costs Act (Warren) - capping prescription copays S. 3738, Hatch-Waxman Integrity Act (Hatch) - inter partes review process S. 3792, Preserve Access to Affordable Generics and Biosimilars Act (Klobuchar-Grassley) - pay-for-delay settlements H.R. 749, Lower Drug Costs Through Competition Act (Schrader-Bilirakis) - prescription drug costs H.R. 1703, Medical Product Communication Act (Griffith) - off-label exchange of information H.R. 2026, Pharmaceutical Information Exchange Act (Guthrie) - pre-approval health care economic information to payors H.R. 2051, Fair Access for Safe and Timely Generics Act (McKinley-Welch) - access to generic drugs H.R. 2212, CREATES Act (Marino-Cicilline) - access to generic drugs and biosimilars H.R. 2439, FAIR Drug Pricing Act (Schakowsky) - transparency in prescription drug pricing H.R. 2562, Making Pharmaceutical Markets More Competitive Act (Kelly) - accelerated approval of generic therapies H.R. 2999, Patients' Access to Treatments Act (McKinley) - limiting cost sharing in specialty drug tiers H.R. 5247, Right to Try Act (Fitzpatrick) - use of unapproved investigational drugs by patients with life-threatening conditions H.R. 6142, Reducing Drug Waste Act (Doggett) - packaging of medications H.R. 6157, Defense-Labor-HHS-Education Appropriations Act (Granger) -pharmaceutical price transparency in DTC advertising H.R. 6340, Capping Prescription Costs Act (Rosen) - capping prescription copays H.R. 6478, Biosimilars Competition Act (Sarbanes) - reporting of pay-for-delay settlements H.R. 6576, Drug-Price Transparency in Communications Act (Schakowsky) - disclosure of drug prices in DTC advertising H.R. 6733, Know the Cost Act (Carter) - pharmacist-patient communications H.R. 7251, Hatch-Waxman Integrity Act (Flores) - inter partes review process Regulatory Issues: 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 price of drugs and biologics; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Inter Partes Review (IPR) Process. H.R.7251/S.3738: Hatch-Waxman Integrity Act of 2018. Patent Settlements. S.1390: STRONGER Patents Act of 2017. S.2514: PACED Act.

Client expense: $1,570,000 · Firm income: Not reported

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

S 3702/HR 7223 - Tax legislation, provisions regarding generic drugs S 3738/HR 7251 - Patent legislation regarding inter partes review HR 302 - FAA Re-authorization (provisions related to air ambulance services HR 7217 - IMPROVE Act Blueprint on Drug Pricing State Reinsurance Program H.R. 6 - The Support for Patients and Communities Act S 1835 - Lower Premiums through Reinsurance Act of 2017. Collins (R-ME) HR 3545 - Overdose Prevention and Patient Safety Act. Murphy (R-PA) S 1850 - Protecting Jessica Grubbs Legacy Act. Manchin (D-WV) HR 4200 & S 2052 - To provide for temporary funding for health insurance cost-sharing reduction payments and provide targeted tax relief, and for other purposes. HR 2212 & S 974 - Creating and Restoring Equal Access To Equivalent Samples Act of 2017: A bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. Marino (R-PA) & Leahy (D-VT) S 1354 - Individual Health Insurance Marketplace Improvement Act: A bill to establish an individual market reinsurance fund to provide funding for state individual market stabilization reinsurance programs. Carper (D-DE) S 1859 - Healthcare Tax Relief Act: A bill to extend the moratorium on the annual fee on health insurance providers. Gardner (R-CO) H.R. 1215 - Protecting Access to Care Act of 2017: To improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system. King (R-IA) H.R.1101 - Small Business Health Fairness Act of 2017: To amend title I of the Employee Retirement Income Security Act of 1974 to improve access and choice for entrepreneurs with small businesses with respect to medical care for their employees. Johnson (R-TX). S. 974 and H.R. 2212 - Creates Act of 2017: To promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. Leahy (D-VT) & Marino (R-PA). HR 173 and S 40 - Middle Class Health Benefits Tax Repeal Act of 2017: To amend the Internal Revenue Code of 1986 to repeal the excise tax on high cost employer-sponsored health coverage. Kelly (R-PA) & Heller (R-NV). HR 708 - State Age Rating Flexibility Act of 2017: To amend title XXVII of the Public Health Service Act to change the permissible age variation in health insurance premium rates. Buschon (R-IN). HR 710 -Health Coverage State Flexibility Act of 2017: To amend the Patient Protection and Affordable Care Act to better align the grace period required for non-payment of premiums before discontinuing coverage under qualified health plans with such grace periods provided for under State law. Flores (R-TX). HR 749 - Lower Drug Costs through Competition Act: To increase competition in the pharmaceutical industry. Schrader (D-OR) H.R.1121 - Pre-existing Conditions Protection Act of 2017: To amend the Public Health Service Act to prohibit application of pre-existing condition exclusions and to guarantee availability of health insurance coverage in the individual and group market, contingent on the enactment of legislation repealing the Patient Protection and Affordable Care Act, and for other purposes. Walden (R-OR). HR 1175 and S 403 - Health Savings Act of 2017: To amend the Internal Revenue Code of 1986 to improve access to health care through expanded health savings accounts, and for other purposes. Paulsen (R-MN) & Hatch (R-UT). HR 1304 - Self-Insurance Protection Act: To amend the Employee Retirement Income Security Act of 1974, the Public Health Service Act, and the Internal Revenue Code of 1986 to exclude from the definition of health insurance coverage certain medical stop-loss insurance obtained by certain plan sponsors of group health plans. Roe (R-TN) HR 1776 & S 771 Improving Access To Affordable Prescription Drugs Act: To improve access to affordable prescription drugs. Schakowsky (D-IL) & Franken (D-MN) HR 2051 - To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes. McKinley (R-WV) S 191 - Patient Freedom Act of 2017: To improve patient choice by allowing States to adopt market based alternatives to the Affordable Care Act that increase access to affordable health insurance and reduce costs while ensuring important consumer protections and improving patient care. Cassidy (R-LA) S 637 - Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017: To amend titles XI and XVIII of the Social Security Act to provide greater transparency of discounts provided by drug manufacturers. Wyden (D-OR) HR - 6082 Overdose Prevention and Patient Safety Act S 2554 Patient Right to Know Drug Prices Act

Advocate for Inter Partes Review (IPR) reform concerning pharmaceuticals. Specifically, this includes HR 7251 and S 3738, the "Hatch-Waxman Integrity Act."

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

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