HomeWebcastEmerging Antitrust Issues in Pharmaceuticals and Life Sciences Sectors
Online CLE Pharmaceutical Antitrust/Life Sciences Antitrust CLE

Emerging Antitrust Issues in Pharmaceuticals and Life Sciences Sectors

Live Webcast Date: Tuesday, November 19, 2019 from 12:00 pm to 2:00 pm (ET)
Antitrust (CLE)Live Webcast
Registration & Pricing Options
Add to Calendar 11/19/2019 12:00 pm 11/19/2019 2:00 pm America/New_York The Knowledge Group Webinar: Emerging Antitrust Issues in Pharmaceuticals and Life Sciences Sectors If you haven’t registered for this event please click here:https://www.theknowledgegroup.org/checkout/?add-to-cart=132483\r\n Antitrust litigation and investigations of conduct in the pharmaceutical, biotech, and medical device industries continue to increase. Moreover, compliance has never been more critical as the application of antitrust law remains to be a rapidly moving target. Recent judicial decisions and enforcement actions have added both risk and guidance to settlements of patent litigation, product reformulations (“hopping”), refusals to cooperate with proposed generic competitors, contracting practices, and transaction review. Standards for certifying putative classes are rife with conflict among the Circuits, and courts are only now beginning to acknowledge the robust transactional data available in this industry. \n \nTo reduce exposure to an investigation, adverse publicity, and million-dollar treble damage judgements, it is imperative that counsel to businesses are in the know of the latest trends and developments in this evolving regulatory paradigm. They must be able to identify effective strategies to guide their clients from further antitrust disputes. \n \nJoin a panel of key thought leaders and practitioners assembled by The Knowledge Group as they bring you up to date on the latest developments and provide insights about what the future is likely to hold both for regulatory enforcement and litigation. \n \nThis LIVE Webcast will discuss the following: \n \n \n Risks in settling patent litigation \n Unilateral refusals to provide samples to prospective generic competitors \n Biosimilar litigation and contracting practices \n Pharmaceutical mergers \n Regulatory enforcement authority \n Generics price-fixing litigation \n Class certification standards \n Supply chain payments including coupons, rebates, and PBM compensation \n Pharmaceutical data and what it covers \n Election season: Candidates proposals on drug pricing \n https://www.theknowledgegroup.org/webcasts/pharmaceuticals-and-life-sciences-sector/

Online CLE Pharmaceutical Antitrust/Life Sciences Antitrust

Join us for this Knowledge Group Online CLE Pharmaceutical Antitrust/Life Sciences Antitrust Webinar. Antitrust litigation and investigations of conduct in the pharmaceutical, biotech, and medical device industries continue to increase. Moreover, compliance has never been more critical as the application of antitrust law remains to be a rapidly moving target. Recent judicial decisions and enforcement actions have added both risk and guidance to settlements of patent litigation, product reformulations (“hopping”), refusals to cooperate with proposed generic competitors, contracting practices, and transaction review. Standards for certifying putative classes are rife with conflict among the Circuits, and courts are only now beginning to acknowledge the robust transactional data available in this industry.

To reduce exposure to an investigation, adverse publicity, and million-dollar treble damage judgements, it is imperative that counsel to businesses are in the know of the latest trends and developments in this evolving regulatory paradigm. They must be able to identify effective strategies to guide their clients from further antitrust disputes.

Join a panel of key thought leaders and practitioners assembled by The Knowledge Group as they bring you up to date on the latest developments and provide insights about what the future is likely to hold both for regulatory enforcement and litigation.

This LIVE Webcast will discuss the following:

  • Risks in settling patent litigation
  • Unilateral refusals to provide samples to prospective generic competitors
  • Biosimilar litigation and contracting practices
  • Pharmaceutical mergers
  • Regulatory enforcement authority
  • Generics price-fixing litigation
  • Class certification standards
  • Supply chain payments including coupons, rebates, and PBM compensation
  • Pharmaceutical data and what it covers
  • Election season: Candidates proposals on drug pricing

Agenda

Howard Morse, Partner
Cooley LLP
  • The Latest Risks in Settling Patent Litigation in the Pharmaceutical Industry
    • The Supreme Court’s Actavis Framework for Analyzing Reverse Payment Settlements
    • Learning from the FTC Impax/Endo, 1-800 Contacts, and FTC Settlement Reports
  • Unilateral Refusals to Provide Samples to Prospective Generic Competitors
    • Risks in REMS Safety Programs; FTC Amicus Briefs, Comments to HHS and Support for Legislation
  • Product Hopping
    • The FTC’s Reckitt Benckiser Suboxone Enforcement Action
  • The Presidential Election, Politics and Implications for Antitrust Enforcement in the Pharmaceutical Industry
    • Candidates’ Proposals and Legislative Initiatives
    • The Limits of Antitrust: FTC Report on Use of FTC 5 to Address High Prices

Andrew J. Forman, Partner
Paul Weiss
  • Reverse Settlement Developments:
    • Biosimilar “pay-for-delay” cases have recently entered the courts.  In March, a proposed class action was filed alleging that AbbVie has delayed the entry of biosimilar versions of its blockbuster drug, Humira, by, among other things, entering into agreements with seven biosimilar manufacturers, which allow entry in Europe, but delay entry in the U.S.
    • Although the FDA has approved 23 biosimilars, few have launched since obtaining approval, in part due to patent litigation.  We should expect to continue seeing antitrust challenges in the courts, as well.   
    • The California Senate has passed a bill that would make agreements between branded and generic drug manufacturers (or biologics and biosimilar manufacturers) presumptively unlawful, which is in contrast to the burden of proof outlined in Activis.  Under Activis, plaintiffs carry the burden of establishing that such agreements are anticompetitive.  The bill, if signed into law, does not provide for a private right of action and caps the penalties the California Attorney General may recover under the law.  The law would be the first of its kind in the U.S.
  • Biosimilar Litigation - Contracting Practices: 
    • In 2018, the U.S. District Court of the Eastern District of Pennsylvania held that Pfizer, the maker of a biosimilar version of Johnson & Johnson’s (“J&J”) Remicade, had sufficiently alleged that J&J had engaged in anticompetitive conduct that caused antitrust injury.  Pfizer had alleged that J&J had entered into exclusive dealing arrangements and bundled rebates with insurers and providers to foreclose biosimilars.  Pfizer’s lawsuit was the first antitrust case between the maker of a biosimilar and a biologic manufacturer, and, unsurprisingly, direct and indirect class actions followed the Pfizer suit. 
  • Pharmaceutical Mergers:
    • While we continue to see announcements for multi-billion dollar pharmaceutical mergers, members of Congress, public interest groups, and unions are urging the FTC to apply greater scrutiny to these mergers in light of concerns regarding rising drug prices. 
    • The FTC is currently reviewing the AbbVie / Allergan Plc and Roche / Spark Therapeutics transactions.  Additionally, the FTC has required Celgene to divest certain assets as a condition to closing the Bristol-Myers Squibb transaction.  
    • Regarding merger remedies, the FTC is applying greater scrutiny on pipeline or R&D-related divestitures in the pharmaceutical space.
  • Generics:
    • This year, 44 state attorneys general brought a lawsuit against 20 generic drug manufacturers alleging that the manufacturers had conspired to fix prices for several popular generic drugs.  The lawsuit is one of many examples demonstrating that lawmakers and enforcement agencies are hampering down on rising pharmaceutical prices.

Laura Craft, President
OnPoint Analytics, Inc.
  • Certifying End-Payor Classes:
    • Conflict in the Circuits, Asacol, Loestrin, Suboxone
    • “Ascertainability” as a new and higher standard
    • “Brand Loyalists” –do they really exist?
  • Off-line Contributors to Drug Price
    • Pharmacy Benefit Managers
    • Rebates
    • Coupons
  • Pharma Data: Who has what? 

Who Should Attend

  • Antitrust Lawyers
  • Healthcare and Pharma Lawyers
  • Health and Pharma Professionals
  • Pharmaceutical and Healthcare Industries
  • Litigation Officers
  • Business Developers
  • Business Executives
  • General Counsel in Life Sciences and Healthcare Industries
  • Chief Compliance Officers
  • Drug Manufacturing Executives
  • Pharmaceutical Companies
  • Other related/interested professionals and organizations

Online CLE Pharmaceutical Antitrust/Life Sciences Antitrust

Howard Morse, Partner
Cooley LLP
  • The Latest Risks in Settling Patent Litigation in the Pharmaceutical Industry
    • The Supreme Court’s Actavis Framework for Analyzing Reverse Payment Settlements
    • Learning from the FTC Impax/Endo, 1-800 Contacts, and FTC Settlement Reports
  • Unilateral Refusals to Provide Samples to Prospective Generic Competitors
    • Risks in REMS Safety Programs; FTC Amicus Briefs, Comments to HHS and Support for Legislation
  • Product Hopping
    • The FTC’s Reckitt Benckiser Suboxone Enforcement Action
  • The Presidential Election, Politics and Implications for Antitrust Enforcement in the Pharmaceutical Industry
    • Candidates’ Proposals and Legislative Initiatives
    • The Limits of Antitrust: FTC Report on Use of FTC 5 to Address High Prices

Andrew J. Forman, Partner
Paul Weiss
  • Reverse Settlement Developments:
    • Biosimilar “pay-for-delay” cases have recently entered the courts.  In March, a proposed class action was filed alleging that AbbVie has delayed the entry of biosimilar versions of its blockbuster drug, Humira, by, among other things, entering into agreements with seven biosimilar manufacturers, which allow entry in Europe, but delay entry in the U.S.
    • Although the FDA has approved 23 biosimilars, few have launched since obtaining approval, in part due to patent litigation.  We should expect to continue seeing antitrust challenges in the courts, as well.   
    • The California Senate has passed a bill that would make agreements between branded and generic drug manufacturers (or biologics and biosimilar manufacturers) presumptively unlawful, which is in contrast to the burden of proof outlined in Activis.  Under Activis, plaintiffs carry the burden of establishing that such agreements are anticompetitive.  The bill, if signed into law, does not provide for a private right of action and caps the penalties the California Attorney General may recover under the law.  The law would be the first of its kind in the U.S.
  • Biosimilar Litigation - Contracting Practices: 
    • In 2018, the U.S. District Court of the Eastern District of Pennsylvania held that Pfizer, the maker of a biosimilar version of Johnson & Johnson’s (“J&J”) Remicade, had sufficiently alleged that J&J had engaged in anticompetitive conduct that caused antitrust injury.  Pfizer had alleged that J&J had entered into exclusive dealing arrangements and bundled rebates with insurers and providers to foreclose biosimilars.  Pfizer’s lawsuit was the first antitrust case between the maker of a biosimilar and a biologic manufacturer, and, unsurprisingly, direct and indirect class actions followed the Pfizer suit. 
  • Pharmaceutical Mergers:
    • While we continue to see announcements for multi-billion dollar pharmaceutical mergers, members of Congress, public interest groups, and unions are urging the FTC to apply greater scrutiny to these mergers in light of concerns regarding rising drug prices. 
    • The FTC is currently reviewing the AbbVie / Allergan Plc and Roche / Spark Therapeutics transactions.  Additionally, the FTC has required Celgene to divest certain assets as a condition to closing the Bristol-Myers Squibb transaction.  
    • Regarding merger remedies, the FTC is applying greater scrutiny on pipeline or R&D-related divestitures in the pharmaceutical space.
  • Generics:
    • This year, 44 state attorneys general brought a lawsuit against 20 generic drug manufacturers alleging that the manufacturers had conspired to fix prices for several popular generic drugs.  The lawsuit is one of many examples demonstrating that lawmakers and enforcement agencies are hampering down on rising pharmaceutical prices.

Laura Craft, President
OnPoint Analytics, Inc.
  • Certifying End-Payor Classes:
    • Conflict in the Circuits, Asacol, Loestrin, Suboxone
    • “Ascertainability” as a new and higher standard
    • “Brand Loyalists” –do they really exist?
  • Off-line Contributors to Drug Price
    • Pharmacy Benefit Managers
    • Rebates
    • Coupons
  • Pharma Data: Who has what? 

Online CLE Pharmaceutical Antitrust/Life Sciences Antitrust

Online CLE Pharmaceutical Antitrust/Life Sciences Antitrust

Howard MorsePartnerCooley LLP

Howard Morse is a Washington, DC-based partner in Cooley's Antitrust & Competition practice group. He represents businesses before the Department of Justice, Federal Trade Commission, and state attorneys general in investigations of mergers, acquisitions and joint ventures, as well as alleged monopolization, restraint of trade and unfair and deceptive practices. Howard has been at the forefront of applying antitrust law to the high-tech sector and the intersection of antitrust and intellectual property law, and regularly represents clients in technology, life sciences and other high-tech industries.

Before joining Cooley, Howard served for 10 years at the FTC, where he was Assistant Director of the Bureau of Competition and responsible for more than 50 enforcement actions. In the private sector, Howard has recently represented Rovi in its $1.1 billion acquisition of Tivo, combining two media and entertainment innovators, and Zeltiq in its $2.5 billion sale to Allergan, combining leaders in medical aesthetics.

Online CLE Pharmaceutical Antitrust/Life Sciences Antitrust

Andrew J. FormanPartnerPaul Weiss

A partner in the Antitrust Group, Andy Forman focuses his practice on counseling clients in a wide range of antitrust matters, with an emphasis on mergers and acquisitions, joint ventures and investigations by the U.S. Department of Justice and U.S. Federal Trade Commission. Throughout his career, Andy has represented numerous leading companies including Cigna, Eli Lilly & Company, Goodyear Tire and Rubber Co., Microsoft Corporation, Pfizer Inc., Salix Pharmaceuticals, Ltd., Smith & Nephew and US Airways Inc.

Andy previously worked for the FTC’s Bureau of Competition (Mergers I), where he helped lead antitrust investigations in large mergers and acquisitions in the pharmaceutical, medical device, consumer products, industrial products and aircraft components industries.  He has been recognized by The Legal 500Benchmark Litigation and The Best Lawyers in America. Andy received a J.D. from Georgetown University Law Center and a B.A. from Washington University. He has worked on multiple matters that won the Global Competition Review’s antitrust matter of the year.

Online CLE Pharmaceutical Antitrust/Life Sciences Antitrust

Laura CraftPresidentOnPoint Analytics, Inc.

Laura Craft is co-founder of OnPoint Analytics, Inc., an economic and statistical consulting firm specializing in antitrust, pharmaceutical industry, health care, class action and intellectual property litigation. She has overseen the development of expert testimony in more than sixty pharmaceutical industry cases, spanning almost all major classes of drug treatments. Her recent publications include the book Empirical Challenges in Pharma Litigation. Recent antitrust cases in which she has served as testifying expert include  In re: Suboxone (Buprenorphine Hydrochloride and Naloxone) Antitrust Litigation (End Payor Actions); In re: Niaspan Antitrust Litigation (End Payor Actions); In re: Loestrin Antitrust Litigation (End Payor Actions); and In re: Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litigation.


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Online CLE Pharmaceutical Antitrust/Life Sciences Antitrust

Course Level:
   Intermediate

Advance Preparation:
   Print and review course materials

Method Of Presentation:
   Live Webcast

Prerequisite:
   General knowledge of antitrust laws

Course Code:
   148316

NY Category of CLE Credit:
   Areas of Professional Practice

Total Credits:
    2.0 CLE

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About the Knowledge Group

The Knowledge Group

The Knowledge Group has been a leading global provider of Continuing Education (CLE, CPE) for over 13 Years. We produce over 450 LIVE webcasts annually and have a catalog of over 4,000 on-demand courses.

About the Knowledge Group

The Knowledge Group

The Knowledge Group has been a leading global provider of Continuing Education (CLE, CPE) for over 13 Years. We produce over 450 LIVE webcasts annually and have a catalog of over 4,000 on-demand courses.

Cooley’s attorneys solve legal issues for entrepreneurs, investors, financial institutions and established companies. Clients partner with Cooley on transformative deals, complex IP and regulatory matters, and high-stakes litigation, where innovation meets the law. Cooley has 900 lawyers across 12 offices in the United States, China and Europe. Cooley's antitrust & competition team is recognized as one of the top-tier practices in the area of antitrust by Legal 500, Chambers USA and Global Competition Review. We handle all aspects of antitrust and competition law matters – including counseling, litigation, agency representation and arbitration services – for Fortune 500 corporations, as well as growing companies.

Website: https://www.cooley.com/

Paul, Weiss (www.paulweiss.com) is a firm of more than 1,000 lawyers with diverse backgrounds, personalities, ideas and interests who provide innovative and effective solutions to our clients’ most complex legal and business challenges. We take great pride in representing the world’s leading companies in their critical legal matters and most significant business transactions, as well as individuals and organizations in need of pro bono assistance.

Website: http://www.paulweiss.com/

OnPoint Analytics is an economic, statistical and financial consulting firm located in the San Francisco Bay Area. It is known for its intensive data analyses in complex litigation, including antitrust and other forms of unfair competition, intellectual property, and breach of contract. Much of OnPoint’s work involves the health care industry, spanning network creation, premium pricing, and reimbursement practices. OnPoint has a dedicated team addressing pharmaceutical products and markets. Its drug cases include antitrust class actions, patent litigation, injunction proceedings, and a wide range of competition disputes including interference with contract to eliminate competitor products.

Website: https://onpointanalytics.com/

Howard Morse is a Washington, DC-based partner in Cooley's Antitrust & Competition practice group. He represents businesses before the Department of Justice, Federal Trade Commission, and state attorneys general in investigations of mergers, acquisitions and joint ventures, as well as alleged monopolization, restraint of trade and unfair and deceptive practices. Howard has been at the forefront of applying antitrust law to the high-tech sector and the intersection of antitrust and intellectual property law, and regularly represents clients in technology, life sciences and other high-tech industries.

Before joining Cooley, Howard served for 10 years at the FTC, where he was Assistant Director of the Bureau of Competition and responsible for more than 50 enforcement actions. In the private sector, Howard has recently represented Rovi in its $1.1 billion acquisition of Tivo, combining two media and entertainment innovators, and Zeltiq in its $2.5 billion sale to Allergan, combining leaders in medical aesthetics.

A partner in the Antitrust Group, Andy Forman focuses his practice on counseling clients in a wide range of antitrust matters, with an emphasis on mergers and acquisitions, joint ventures and investigations by the U.S. Department of Justice and U.S. Federal Trade Commission. Throughout his career, Andy has represented numerous leading companies including Cigna, Eli Lilly & Company, Goodyear Tire and Rubber Co., Microsoft Corporation, Pfizer Inc., Salix Pharmaceuticals, Ltd., Smith & Nephew and US Airways Inc.

Andy previously worked for the FTC’s Bureau of Competition (Mergers I), where he helped lead antitrust investigations in large mergers and acquisitions in the pharmaceutical, medical device, consumer products, industrial products and aircraft components industries.  He has been recognized by The Legal 500Benchmark Litigation and The Best Lawyers in America. Andy received a J.D. from Georgetown University Law Center and a B.A. from Washington University. He has worked on multiple matters that won the Global Competition Review’s antitrust matter of the year.

Laura Craft is co-founder of OnPoint Analytics, Inc., an economic and statistical consulting firm specializing in antitrust, pharmaceutical industry, health care, class action and intellectual property litigation. She has overseen the development of expert testimony in more than sixty pharmaceutical industry cases, spanning almost all major classes of drug treatments. Her recent publications include the book Empirical Challenges in Pharma Litigation. Recent antitrust cases in which she has served as testifying expert include  In re: Suboxone (Buprenorphine Hydrochloride and Naloxone) Antitrust Litigation (End Payor Actions); In re: Niaspan Antitrust Litigation (End Payor Actions); In re: Loestrin Antitrust Litigation (End Payor Actions); and In re: Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litigation.

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