Overview

Skadden, Arps, Slate, Meagher & Flom LLP and affiliates (“Skadden, Arps” or “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 pharmaceutical, medical device, biotechnology, provider, facilities and others. Our clients include one-half of the top 40 pharmaceutical companies and one-quarter of the top 40 medical device companies, as well as numerous emerging biotechnology and health care businesses.

Skadden is at the center of major health care and life sciences matters. In the past two years alone, we have represented companies including Cephalon, Chattem, Express Scripts, Endo, Greenhill Capital Partners, 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:

Corporate

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 provide a broad range of M&A-related services 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 increasingly turned 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. Skadden’s 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 closely 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. We counsel and defend 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 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 have 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 have represented a major medical device manufacturer in litigation involving pacemaker leads and other medical devices and have 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 have represented clients in state and federal individual and class action cases, as well as related MDL proceedings.

Intellectual Property and Technology

Skadden attorneys provide a full range of services relating to all aspects of intellectual property and technology exploitation, protection and enforcement to pharmaceutical, biotechnology, medical devices and other health care-related companies. Our areas of concentration include:

Collaborations, Licensing and Other Transactions. Skadden has extensive experience handling 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. Skadden has extensive experience advising 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).

Sector Representations

We represent companies and professionals in and investors involved with all sectors of the health care and life sciences industry. Our partners’ representations during the last five years have included, among others:

Pharmaceuticals

• 3SBio (China) (as co-counsel) in its $123 million initial public offering of American depositary shares. This was the first Chinese biopharmaceutical company to be listed on Nasdaq.

• Allergan in resolving a multiyear investigation by the DOJ into the sales and marketing of the therapeutic version of BOTOX for certain uses not approved by the FDA.

• Bausch & Lomb in the dismissal of a class certification seeking recovery of the money consumers spent to purchase an allegedly defective contact lens solution.

• Cephalon in its $6.8 billion acquisition by Teva.

• Chattem in its approximately $1.9 billion acquisition by sanofi-aventis.

• Endo Pharmaceuticals in its $2.9 billion acquisition of American Medical Systems; its $1.2 billion acquisition of Qualitest Pharmaceuticals; and in certain “deep-dive” patent analyses relating to pharmaceutical products.

• GlaxoSmithKline in litigation related to its anti-diabetic drug, Avandia.

• Merck in the successful defense of Vioxx litigations and in the negotiation of settlements related to similar cases.

• Mylan Laboratories in the refinancing of its existing secured credit facility with a new $2.5 billion senior secured credit facility.

• OSI Pharmaceuticals in its $4 billion acquisition by Astellas Pharma (Japan).

• PBM Holdings in its $808 million acquisition by Perrigo Company.

• Pfizer:
  • in the dismissal of 166 cases in a multidistrict litigation in Massachusetts brought by plaintiffs alleging injuries related to their use of the anti-epilepsy medicine, Neurontin;

  • in an appellate victory in a statewide class action in Pennsylvania brought by consumers seeking economic damages for Neurontin prescriptions they allegedly paid for because of “off-label” marketing;

  • in the successful defense of Lipitor litigation in jurisdictions throughout the country since 2001;

  • in litigation regarding injuries allegedly caused by Prempro, its hormone replacement drug;

  • on tax aspects of its $68 billion acquisition of Wyeth;

  • in its acquisition of Ferrosan’s consumer health care business, which includes dietary supplements and lifestyle products, from Altor 2003 Fund GP Limited;

  • in its acquisition of a 40 percent stake in Laboratório Teuto Brasileiro S/A, a leading Brazilian developer, manufacturer and marketer of generic pharmaceutical products; and

  • in patent matters.

• Schering-Plough on tax matters regarding its $41 billion acquisition by Merck.

• Frederick S. Schiff, the former chief financial officer of Bristol-Myers Squibb, in connection with a two-count criminal indictment on charges of securities fraud and conspiracy in federal court and in a complaint filed by the SEC. In April 2010, the U.S. Court of Appeals for the Third Circuit affirmed a district court ruling that contemplates the dismissal of all criminal charges against Schiff.

• Valeant Pharmaceuticals (formerly ICN Pharmaceuticals) in:
  • a settlement regarding excessive attorneys fees resulting from the dismissal of a shareholder derivative litigation;

  • its $3.5 billion merger with Biovail (Canada); and

  • its $1.5 billion Rule 144A/Regulation S high-yield offering of senior notes in two tranches.

• various pharmaceutical companies, including Abbott Laboratories, Endo Pharmaceuticals, Regeneron Pharmaceuticals and Taro Pharmaceutical Industries, in licensing and other agreements.

• Watson Pharmaceuticals with the antitrust aspects of its $1.75 billion acquisition of Arrow Group; and with the antitrust aspects of its $92.5 million acquisition of the U.S. rights to the Crinone and Priocheve progesterone gel product line from Columbia Laboratories.

Medical Devices and Supplies

• Advanced Medical Optics in its $2.8 billion acquisition by Abbott Laboratories.

• Covidien (Ireland) in connection with the tax aspects of its $2.6 billion acquisition of ev3.

• Dade Behring with the antitrust aspects of its $7 billion acquisition via a tender offer by Siemens Medical Solutions Group, a subsidiary of Siemens.

• DENTSPLY International in its $1.8 billion acquisition of Astra Tech.

• Guidant in its $27 billion acquisition by Boston Scientific.

• Kinetic Concepts:
  • in its $6.3 billion acquisition by a consortium of funds advised by Apax Partners, together with controlled affiliates of the Canada Pension Plan Investment Board and the Public Sector Pension Investment Board;

  • in its $1.7 billion acquisition of LifeCell;

  • in certain "deep-dive" patent analyses relating to medical device technology; and

  • in response to a federal investigation of certain Medicare reimbursement matters.

• Medtronic USA in litigation involving its AneuRx Stent Graft System, a medical device used in the treatment of abdominal aortic aneurysms; and in response to federal investigations of sales and marketing practices.

• Micrus Endovascular in its $480 million acquisition by Johnson & Johnson.

• St. Jude Medical in a $1.2 billion offering of senior notes and a $450 million offering of senior notes.

• Stryker Corporation:
  • in its $1.5 billion acquisition of the neurovascular business of Boston Scientific Corporation;

  • in connection with ongoing FCPA investigations by the DOJ and SEC of several companies in the medical device industry regarding those companies’ sales practices and relationships with government health care providers in a number of countries; and

  • in a $1.6 billion offering of common stock and concurrent $2.5 billion offering of senior notes.

Biotechnology

• Amgen in the dismissal of putative nationwide Racketeer Influenced and Corrupt Organizations Act (RICO) and consumer protection class actions (coordinated as a multidistrict litigation) in connection with claims regarding non-FDA-approved uses of Amgen’s Epogen and Aranesp anemia medications.

• Applera in the $6.7 billion sale of the outstanding shares of its Applied Biosystems Group to Invitrogen; and in connection with the $1.3 billion spin-off of its diagnostics and medical testing business, Celera Group, into a separate publicly traded company.

• Baxter International in securing summary judgment in a putative class action premised on allegations that certain forward-looking statements were false and misleading, and in an Employee Retirement Income Security Act (ERISA) action in which the plaintiff alleged that Baxter’s stock was an imprudent investment for Baxter’s 401(k) participants.

• Biogen in its $14 billion business combination with IDEC Pharmaceuticals.

• BioVeris in its $600 million acquisition by Roche Holding (Switzerland).

• Eppendorf (Germany) in its $110 million going-private acquisition of New Brunswick Scientific.

• Genentech regarding patent litigation and counseling.

• Gilead Sciences in its $11 billion acquisition of Pharmasset; and in its $3.7 billion offering of senior unsecured notes in four ranches.

• MDS in the $650 million sale of its analytical technologies division to Danaher.

Hospitals, Service Providers and Related Organizations

• CIGNA in its $1.5 billion acquisition of Great-West Healthcare; and in an alliance with Humana for the joint distribution of Medicare Advantage policies issued by Humana’s insurance company and HMO subsidiaries to employer group customers.

• Community Health Systems and three of its affiliated hospitals in connection with a federal False Claims Act action pending in the U.S. District Court for the District of New Mexico; and in certain other matters in state and federal courts.

• Express Scripts in its $29.1 billion acquisition of Medco Health Solutions; its $4.7 billion acquisition of WellPoint’s NextRx subsidiaries; and in a $4.1 billion Rule144A/Regulation S offering by its subsidiary.

• Genesis HealthCare in the $2.4 billion acquisition of the majority of its real estate assets by Health Care REIT.

• Getronics in its reorganization and divestiture of its North American outsourcing business; and in a successful arbitration award in connection with a dispute over the sale of its North American operation.

• HCP, a real estate investment trust (REIT) specializing in health care facilities, in its $6.1 billion acquisition of the senior living facilities of HCR ManorCare and in its financing of the transaction; and in its $2.4 billion offering of senior unsecured notes.

• Horizon Health in the dismissal before the U.S. Court of Appeals for the Ninth Circuit of a qui tam action brought under the federal False Claims Act.

• Iowa Health System in compliance and regulatory advice and counseling.

• McKesson in:
  • its $2.2 billion acquisition of US Oncology;

  • its $1.7 billion offering of notes in three tranches; and

  • connection with related patent litigation and counseling.

• Nationwide Health Properties, a REIT specializing in health care facilities, in its $7.4 billion acquisition by Ventas.

• Sutter Health Systems and its Summit Medical Center in an appeal before the U.S. Court of Appeals for the Ninth Circuit, which affirmed a federal court dismissal of a qui tam action.

Financial Services

• Banc of America Securities, J.P. Morgan Securities, Morgan Stanley and Greenwich Capital Markets as joint bookrunning managers in a $3 billion offering of notes by Abbott Laboratories.

• Fortress-Drawbridge Special Opportunities Fund in connection with pharmaceutical financing transactions and strategic investments in pharmaceutical and medical device companies.

• Goldman Sachs as financial advisor to, among others:
  • Emergency Medical Services Corporation in its $3.2 billion acquisition by Clayton, Dubilier & Rice;

  • Medarex in its $2.1 billion acquisition by Bristol-Myers Squibb Company; and

  • Millennium Pharmaceuticals in its $8.8 billion acquisition via a tender offer by Takeda Pharmaceutical (Japan).

• Greenhill Capital Partners as financial advisor to: Roche Holding (Switzerland) in a $46.8 billion bid via a tender offer for the remaining shares of Genentech that Roche did not already own; and the committee of independent directors of Alcon in the approximately $28 billion sale of an additional 52.2 percent stake in Alcon to Novartis from Nestle.

• J.P. Morgan Securities, Goldman Sachs, Merrill Lynch, Pierce, Fenner & Smith and Banc of America Securities as financial advisors to Pfizer in its $68 billion acquisition of Wyeth.

• Nomura as financial advisor to Grifols (Spain) in its $3.4 billion acquisition of Talecris Biotherapeutics.

• Renaissance Securities (Cyprus) and UBS as joint global coordinators in the $400 million Regulation S initial public offering of ordinary shares of Open Joint Stock Company Protek.