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Skadden, Arps, Slate, Meagher & Flom LLP and affiliates (“Skadden”) provides focused, strategic legal counsel to all types of health care and life sciences clients across the areas of transactions, litigation, regulatory and enforcement, intellectual property and technology, and more. We represent companies and investors across the globe in every sector of the industry, including pharmaceuticals, medical devices, biotechnology, and hospitals and services providers. Our clients include one-half of the top 40 global pharmaceutical companies and one-quarter of the top 40 global medical device companies by market capitalization, as well as numerous emerging biotechnology and health care businesses. For 2013, Skadden ranked first by volume in global biotech and pharma M&A (BioPharm Insight) and first based on deal value for health care M&A in the U.S. (Thomson Reuters). We also ranked among the leading firms in health care by Chambers USA 2014. In 2012, the Financial Times ranked Skadden second in the country in its “US Innovative Lawyers” report, in which four out of our eight ranked matters involved our representation of clients in the health care industry. We also were named among Law360’s Health Care and Life Sciences Groups of 2012.
In the past three years, we have represented companies including Amylin, Cephalon, Chattem, Endo, Express Scripts, Gilead Sciences, HCP, McKesson, Merck KGaA, OSI, Pfizer, Schering-Plough and Valeant in some of the largest M&A deals in the sector; and Allergan, Amgen, Bausch & Lomb, GlaxoSmithKline, Medtronic, Merck, Pfizer and Watson Pharmaceuticals in complex litigation. To best serve the needs of our health care and life sciences clients, Skadden marshals the resources and experience of attorneys across our practices, including:
Skadden provides health care and life sciences clients with advice on the full spectrum of transactional and other corporate matters. Our areas of concentration include:
Mergers and Acquisitions. Health care has been among the most active industries in recent mergers and acquisitions, and Skadden’s longstanding reputation as the leading law firm for M&A is evidenced by our activity in this area. We offer clients M&A-related capabilities in the U.S. and globally in the areas of corporate transactions, private equity, strategic investing and joint ventures, as well as the antitrust, intellectual property, regulatory and other matters that follow such transactions.
Corporate Finance. We provide a full range of services enabling our health care, biotechnology and life sciences clients to achieve their financing objectives. Our attorneys understand the unique timing, disclosure, intellectual property and regulatory issues that health care companies often face, particularly in their early stages of development, and we have the experience to steer our clients through the legal and other requirements necessary to promptly and efficiently access capital.
Insurance Transactions and Corporate Counseling. As the insurance industry has undergone substantial change through consolidation and has turned increasingly to the international capital markets, Skadden has been active in representing participants in the health insurance industry worldwide. Our attorneys represent health insurance companies and their financial advisors and underwriters in a wide variety of corporate transactions, as well as provide regulatory advice in connection with their deals.
Tax. Our tax attorneys are experienced in intercompany pricing and licensing between U.S. parent companies and international manufacturing affiliates; the tax structuring of transactions and myriad agreements; and the tax treatment of research and development and other technology-related expenses. We frequently represent pharmaceutical, life sciences and other health care companies in resolving IRS audits of technology, transfer pricing and international tax planning issues.
Litigation and Regulatory/Enforcement
Our litigation and regulatory/enforcement attorneys, many of whom have held senior positions in government, work together to provide health care and life sciences clients with a seamless representation at the nexus of the assessment, compliance and controversy issues they constantly face. Our areas of concentration include:
False Claims Act Litigation. Our team represents health care providers, suppliers, pharmaceutical companies and physicians in all stages of internal, state and federal investigations and prosecutions of potential violations of the False Claims Act (FCA) and health care fraud and abuse laws. This includes defending FCA proceedings brought against health care providers by qui tam relators.
Health Care Regulatory and Compliance. We counsel clients on regulatory compliance matters and voluntary disclosure of potential statutory and regulatory violations to appropriate government agencies, including disclosures to the Centers of Medicare and Medicaid, and the U.S. Department of Health & Human Services’ Office of the Inspector General. We also have advised clients regarding compliance with federal regulatory requirements in the areas of sales, marketing and pricing practices; medical affairs and clinical research; research funding; and grants for investigative studies.
FDA Enforcement, Compliance and Risk Assessment. Skadden advises pharmaceutical, biotechnology and medical device manufacturers on the full range of FDA regulatory and compliance issues, including those arising in the context of clinical development, manufacturing, advertising and promotion, medical affairs and drug safety. We frequently work with clients to develop strategies and conduct risk assessments to help resolve their regulatory issues while minimizing litigation risks. We have represented numerous global pharmaceutical and medical device companies in government investigations into alleged violations of various laws, including the Federal Food, Drug and Cosmetic Act.
FCPA and Criminal Investigations. Skadden represents health care clients in connection with Foreign Corrupt Practices Act (FCPA) investigations conducted by the DOJ and Securities and Exchange Commission (SEC), and in connection with criminal allegations involving Medicaid and Medicare fraud, violations of the Anti-Kickback Statute and Stark Law, and insurance fraud. We have conducted internal investigations on behalf of boards of directors and special board management committees of health care companies. Our attorneys have significant experience defending pharmaceutical and life sciences companies, and their officers and directors, in investigations and actions brought by the SEC.
Legislation. Our health care attorneys have been active participants in litigation reform initiatives before Congress, state legislatures and judicial committees. In recent years, our partners have testified numerous times on class action and claims aggregation issues before the U.S. Senate and House Judiciary Committees and before state legislative committees. Our attorneys also have worked extensively on state laws regulating pharmaceutical and medical device companies, and on physician-industry conflict-of-interest law.
Mass Torts, Insurance and Consumer Litigation. Our team is comprised of experienced litigators who have defended health-care-related cases on every level — from formulating and implementing national strategy in multijurisdictional litigation to conducting Daubert hearings and trials, as well as pursuing significant appeals. For example, we served as national counsel for a major pharmaceutical company in the defense of product liability actions and nationwide consumer fraud and third-party payor putative class actions involving certain prescription cardiovascular medications; and represented a major medical device manufacturer in litigation involving pacemaker leads and other medical devices and successfully defeated MDL consolidation and class certification in such cases.
Securities Litigation. Skadden attorneys have been at the forefront of securities and transaction-related litigation faced by pharmaceutical companies and their officers and directors. We represent clients in state and federal individual and class action cases, as well as related MDL proceedings.
Antitrust and Competition. We advise hospitals, managed care companies, and generic and branded pharmaceutical, biotechnology and medical device manufacturers globally regarding the antitrust and competition aspects of mergers and acquisitions, business collaborations and other strategic transactions. We also have extensive experience in antitrust litigation on behalf of our health care clients and have represented several global pharmaceutical and medical device companies in government investigations into alleged violations of the antitrust and competition laws in the U.S. and Europe. Our health care clients also turn to us for counseling and regulatory advice in the U.S. and EU on matters including review of distribution agreements, intellectual property licenses (e.g., patents, know-how, trademarks and copyrights) and other proposed business practices. We also help health care clients design, implement and monitor global antitrust audit and compliance programs.
Intellectual Property and Technology
Skadden attorneys provide a full range of services relating to all aspects of intellectual property and technology protection and enforcement to pharmaceutical, biotechnology, medical devices and other health care-related companies. Our areas of concentration include:
Collaborations, Licensing and Other Transactions. We handle IP and technology transactions for clients in the pharmaceutical, biotechnology and medical device industries and related areas. These transactions include strategic alliances, collaborations, in- and out-licensing, manufacturing and supply arrangements, and marketing, promotion and distribution arrangements, as well as IP and technology aspects of spin-offs and acquisitions and divestitures of product lines and divisions.
In collaboration with other Skadden groups, we also advise clients on royalty interest sales, IP securitizations and IP/royalty collateralized loans, and other monetization and alternative R&D financing transactions.
Patent Litigation and Analysis. We have litigated patent and technology cases relating to pharmaceuticals, biotechnology and medical devices at both the trial and appellate levels in federal and state courts, as well as before the International Trade Commission, the U.S. Patent Office and international courts of other countries. Many attorneys in the group have science backgrounds (including advanced degrees) in the pharmaceutical/biological/chemistry areas, and our partners have substantial trial experience in key patent jurisdictions, such as New York, New Jersey, Delaware, Massachusetts, Pennsylvania, California, Virginia and Texas. In addition to matters involving infringement of patents and other intellectual property rights, we regularly litigate disputes regarding intellectual property license agreements.
Our patent work in the biosciences area also includes providing clients with high-level review and analysis of the patents and unpatented technology of targets and competitors; “deep-dives” to review the background, scope, strengths and weaknesses of target and competitor patent portfolios; analysis regarding the strengths and weaknesses of patents and proprietary technology strategies used by targets; and counseling regarding key patent and patent portfolio practices.
Trademarks and False Advertising. We advise clients in the health care and life sciences industries with all aspects of trademark prosecution and protection, as well as false advertising and unfair competition matters.
Outsourcing. We advise health care clients in connection with the outsourcing of all types of business processes and information technology. Our work encompasses all areas of outsourcing, including negotiating and drafting the overall service agreement and the service level agreement, handling any related asset acquisitions, and advising on employment and tax matters.
Privacy. Our attorneys counsel a wide range of clients on privacy-related matters, including compliance with the Privacy Rule and Security Rule of the Health Insurance Portability and Accountability Act (HIPAA).