Emerging Antitrust Issues in Pharmaceuticals and Life Sciences Sectors
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
- 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
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
- 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
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.
Howard Morse is a Washington, DC-based partner in Cooley's Antitrust & Competition practice group. He represents businesses before the Department of …
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.
Laura Craft is co-founder of OnPoint Analytics, Inc., an economic and statistical consulting firm specializing in antitrust, pharmaceutical industry, health …
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Method Of Presentation:
General knowledge of antitrust laws
NY Category of CLE Credit:
Areas of Professional Practice
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About Cooley LLP
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.
About OnPoint Analytics, Inc.
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.