Life Sciences Key Contacts Andrea L.C. Reid Partner Boston +1 617 728 7131 David S. Rosenthal Partner New York +1 212 698 3616 Mélanie Thill-Tayara Partner Paris +33 1 57 57 81 04 Translate Page MENU Hatch-Waxman Litigation Digital Health Combining international resources with a boutique focus Innovative leaders in today's competitive life sciences industry rely on Dechert as their strategic adviser to capitalize on business opportunities, handle disputes and resolve challenges through smart, real-world solutions. Dechert is recognized around the globe for successfully navigating the most complex issues confronting life sciences companies from start-ups to multinationals in pharmaceuticals, biotechnology, drug discovery, genomics, diagnostics, medical devices, biosimilars, and digital health as well as the industry s most active investment banks, venture/growth capital firms and research institutions. Our team brings the entrepreneurial energy and technical expertise required to work alongside our clients in their most sophisticated matters.
Cross-border work is our hallmark. With Dechert's global footprint, we collaborate seamlessly to help our clients establish or expand their international presence. Our life sciences team works every day in leading biotech hotbeds in the U.S., UK, Europe, Middle East, Russia and Eastern Europe, and East Asia. Excellence Across the Product Lifecycle Dechert s integrated mix of practice and sector experience provides our life sciences clients with insightful and efficient support throughout the product lifecycle from discovery through development, clinical testing, promotion and sales. We draw on our intellectual property, corporate, securities, litigation, antitrust, international arbitration, international trade, tax, employment and labor lawyers to provide comprehensive transactional, regulatory and dispute resolution services. We are proud to be recognized as a leader in life science legal services. Chambers Global has ranked us among the top legal advisors worldwide for Pharma/Life Sciences (2008-2017 inclusive). We are ranked first for life sciences in France by Chambers Europe (2009-2018) and The Legal 500 placed our firm among the top legal advisors in the Life Sciences/Healthcare sector in France, the U.S. and UK (2016-2018). Innovative leaders in today's competitive life sciences industry rely on Dechert as their strategic adviser to capitalize on business opportunities, handle disputes and resolve challenges through smart, real-world solutions.dechert is recognized around the globe for successfully navigating the most complex issues confronting life sciences companies from start-ups to multinationals in pharmaceuticals, biotechnology, drug discovery, genomics, diagnostics, medical devices, biosimilars, and digital health as well as the industry s most active investment banks, venture/ growth capital firms and research institutions. Our team brings the entrepreneurial energy and technical expertise required to work alongside our clients in their most sophisticated matters.cross-border work is our hallmark. With Dechert's global footprint, we collaborate seamlessly to help our clients establish or EXPERIENCE Ipsen, a global specialty-driven pharmaceutical group, in its $US1.0 billion acquisition of the global oncology assets from Merrimack Pharmaceuticals, including its key marketed product ONIVYDE (irinotecan liposome injection) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. Under the terms of the agreement, Ipsen will gain exclusive commercialization rights for the current and potential future ONIVYDE indications in the U.S., as well as the current licensing agreements with Shire for commercialization rights ex-u.s. and PharmaEngine for Taiwan. The transaction also includes Merrimack s commercial and manufacturing infrastructure, and generic doxorubicin HCl liposome injection. Celgene Corporation, a global biopharmaceutical company, in the acquisition of a 10% stake in Juno Therapeutics, Inc. as part of a 10-year collaboration for the development and commercialization of immunotherapies worth approximately US$1 billion. Winner of LMG Life Sciences Collaboration Deal of the Year award in 2015, this acquisition represents the
largest up-front sum for a biotechnology licensing agreement ever, according to Bloomberg Intelligence. As many analysts have noted, this collaboration has the potential to eradicate many forms of cancer over the next 10 years. Dechert has also represented Celgene in several other domestic and cross-border licensing and M&A transactions, including its collaboration with Jounce Therapeutics for US$2.6 billion (including milestone payments), recognized as "Deal of the Year" in 2017 by the New England Venture Capital Association, as well as its collaboration with Agios Pharmaceuticals for US$1.2 billion (including option exercise and future milestones), and the acquisition of Quanticel Pharmaceuticals as part of its up to US$400 million buy-to-build acquisition. CVS Health, a pharmacy innovation company, in a series of antitrust-sensitive billion dollar deals, including its US$12.7 billion acquisition of Omnicare. A public opposition campaign called for the Federal Trade Commission (FTC) to conduct a full second request investigation, alleging that CVS would dominate pharmacy across channels. After working with the FTC, Dechert showed that the deal would improve patient care and lower costs and that a full second request investigation was not warranted. Dechert also guided CVS Health in its US $1.9 billion acquisition of Target s pharmacy and clinic businesses and served as antitrust counsel to CVS Health in its joint venture with Cardinal Health, forming the largest generic drug sourcing entity in the U.S. The work of Dechert s antitrust/competition team on the CVS Health/Target transaction received a LMG Life Sciences M&A impact deal of the Year award (2016). The underwriters, led by Citigroup Global Markets Inc. and Jefferies LLC, in the initial public offering and cross-border listing of French radiopharmaceutical company Advanced Accelerator Applications S.A. (AAA) on NASDAQ. AAA was seeking to advance the molecular nuclear therapy branch of its business, to heighten its corporate profile and to diversify its investor base by gaining access to the U.S. capital markets. AAA accomplished these goals by capitalizing on the positive results from the pivotal Phase 3 trial for its novel lead therapeutic candidate, Lutathera, for the treatment of patients with positive midgut neuroendocrine tumors to conduct a successful US$86.5 million initial public offering of American Depositary Shares and listing on the NASDAQ Global Select Market. AAA s IPO priced within its anticipated range despite uneven market conditions. AAA s U.S. IPO not only enabled AAA to access U.S. investors, but AAA used a portion of the proceeds of the offering to establish a permanent Lutathera manufacturing facility in Millburn, New Jersey; further establishing a favorable profile for future capital raising transactions in the U.S. Johnson & Johnson (J&J) and its affiliate Ethicon, a medical equipment developer within the J&J family of companies, in its strategic collaboration with Google, working with the Life Sciences team on advancing surgical robotics to benefit surgeons, patients and health care systems. The companies will bring together capabilities, intellectual property and expertise to create an innovative robotic-assisted surgical platform capable of integrating advanced technologies with the goal of improving health care delivery in the operating room. The companies seek to develop new robotic tools and capabilities for surgeons and operating room professionals that integrate best-in-class medical device technology with leading-edge robotic systems, imaging and data analytics. Dechert s work on this collaboration received a LMG Life Sciences Collaboration Deal of the Year award (2015). Bristol-Myers Squibb (BMS), a global biopharmaceutical company, in an important victory by securing the reversal by the Pennsylvania Supreme Court of a lower court s US$28 million
judgment against BMS for violating Pennsylvania s Unfair Trade Practices and Consumer Protection Law. The decision was significant as at least 26 other states had filed similar lawsuits citing unfair and deceptive practices by pharmaceutical companies. Endo Pharmaceuticals, a global specialty pharmaceutical company, in the Federal Trade Commission s (FTC) first litigation challenge to a patent settlement agreement including a no authorized generic provision. The Dechert team developed a litigation strategy that included a legal challenge to the agency s statutory authority to file federal court litigation and to seek disgorgement. The result was a settlement of all of Endo s litigation with the FTC on favorable terms, requiring no admission of wrongdoing, no monetary payment and prohibitions consistent with Endo s current approach to patent settlements. Also represented Endo in a series of related Hatch-Waxman patent infringement actions filed against seven generic companies regarding its OPANA ER tablets, which at its peak, was Endo s second highest-selling product with US$300 million in annual sales. The Dechert team prevailed in a five-week trial in New York against seven generic companies, and later, secured Federal Circuit affirmance of its hard-fought patent trial victory, so that none of the generic versions of OPANA ER involved can come to market before Endo s patents expire in 2023. Dechert also prevailed in two separate patent trials in the District of Delaware with respect to an additional patent that Endo exclusively licensed from Mallinckrodt. The cases are currently on appeal, and the defendants are enjoined from selling their generic products through 2029. Pfizer, a global biopharmaceutical company, in multiple pharmaceutical mass torts pending in various courts around the U.S. The Reglan litigation is one of the largest coordinated pharmaceutical mass torts in the country, with more than 2,000 cases pending in Philadelphia County alone. Reglan, and its generic counterpart, metoclopramide, is commonly used to treat intractable gastroesophageal reflux disease and diabetic gastroparesis. Dechert plays a key strategic role for Pfizer, advising on legal issues including preemption and innovator liability the potential liability of brand pharmaceutical manufacturers for injuries allegedly sustained by plaintiffs who took only the generic version of the drug made by another manufacturer and coordinating efforts to resolve all Reglan/metoclopramide claims pending against Wyeth in Philadelphia and elsewhere. Dechert also represents Pfizer in separate multidistrict litigations in state and federal courts concerning birth defects in infants allegedly caused by the mothers use of the antidepressant Zoloft. In 2009, when we took over Pfizer s defense in a mass-tort litigation concerning hormone therapy, more than 1,500 cases were pending in Pennsylvania alone; the last case in Philadelphia was settled in 2014. Nimbus Apollo, Inc., a biotherapeutics company that develops drugs to treat non-alcoholic steatohepatitis, in developing and implementing a drug discovery patent strategy and, later, a focused patent strategy protecting the lead drug candidate in human clinical trials. Subsequently, the company was acquired by Gilead Sciences for US$1.2 billion. In 2016, Dechert was honored by the Financial Times in the "Legal Expertise" category entitled " Enabling Clients to Innovate" for the innovative IP strategy work done on behalf of the drug discoverer to underpin the deal with Gilead. LIFECYCLE MANAGEMENT
Dechert s life sciences team represents clients throughout all stages of their products lifecycle, from discovery through development, clinical testing, promotion and sales. As new complexities arise, we draw efficiently on the talents of the firm s intellectual property, corporate, securities, antitrust, international trade, tax, employment and labor and litigation attorneys. FINANCINGS Clients turn to us to capture and structure capital to support the long development and commercialization process, ranging from early-stage venture financings and strategic equity investments to complex public offerings of equity and debt. MERGERS AND ACQUISITIONS Dechert structures successful deals, ensuring speed-to-market execution and protecting our clients interests in all phases of a transaction. Our teams routinely handle domestic and cross-border mergers, acquisitions, divestitures, spin-offs, joint ventures strategic alliances and collaborative arrangements. Mergermarket ranked us among top M&A legal advisors for total volume of M&A deals in the healthcare and life sciences industry in North America (2015 ). LICENSING AND COLLABORATION AGREEMENTS Our lawyers negotiate and structure agreements across the global supply chain to optimize financing, development, manufacturing and distribution for our clients. We recently were ranked among the top law firms for volume and value of Biotech and Pharma licensing agreements for Global, North America and Europe by BioPharmInsight (2015). We also handle the full range of research, development and consulting agreements, venture formation and joint venture agreements, manufacturing and supply agreements, marketing and distribution agreements, and technology transfer arrangements. INTELLECTUAL PROPERTY
Dechert provides clients with comprehensive, long-range strategic advice to help them protect and enhance their IP positions, both to create a competitive advantage and maximize value. Our life sciences IP counseling team works in concert with our transactional IP team on IP-driven commercial transactions, including strategic alliances, co-promotion agreements, discovery and development licenses, co-development arrangements, acquisitions and related due diligence, joint ventures, and exclusive provider and distribution deals. HATCH-WAXMAN Drawing on a high degree of technical and scientific sophistication, our legal team asserts clients intellectual property rights in the face of Hatch-Waxman Act and Abbreviated New Drug Application (ANDA) applications. Branded pharmaceutical leaders rely on our trial lawyers, appellate lawyers and Ph.D.-level subject matter experts to draw on our broad experience in this area to create and execute successful defense strategies. ANTITRUST/COMPETITION Our antitrust lawyers in the U.S. and Europe combine deep antitrust expertise with industry knowledge to help life sciences clients defend litigation, including class actions, and navigate Federal Trade Commission (FTC) and European Commission (EC) investigations into mergers, as well as various aspects of intellectual property and other strategies. Leading life sciences companies have relied on our team to handle litigation challenges and agency investigations involving, among other things, pay for delay settlements, patent listings, alleged sham patent litigation, and claimed abuse of Risk Evaluation and Mitigation Strategy ( REMS) processes. PRODUCT LIABILITY We fiercely defend our clients in product liability and consumer fraud claims of all kinds, drawing on the skills of one of the top product liability practices in the U.S. We are often called upon to handle new strains of product liability suits, such as so-called innovator liability, in which plaintiffs sue name-brand drug makers based on alleged injuries they sustained by taking a generic version of the branded drug that s manufactured by a different company.
COMMERCIAL LITIGATION AND INTERNATIONAL ARBITRATION Clients count on our team s creativity and experience in the courts and various international arbitration regimes to handle disputes arising out of licensing, collaboration, asset purchase, distribution and other agreements. INVESTIGATIONS AND DEFENSE We guide our clients through complex internal investigations, defend them in parallel civil actions and negotiate the most advantageous outcomes for their businesses. Our clients in this arena include corporations, audit committees and senior executives. EMPLOYMENT, BENEFITS AND TAX ISSUES Life sciences clients rely on our cross-functional team for assistance with the full range of employment, benefits and tax issues, both domestic and cross border, relating to corporate transactions, complex disputes and litigation. Related Professionals SAMUEL B. ABRAMS Partner New York T +1 212 641 5684 JOHN E. ALESSI Associate Boston T +1 617 728 7186 ARIF H. ALI Partner Washington, D.C. T +1 202 261 3307 London T +44 20 7184 7557 KURTIS M. ANDERSON PH.D. Patent Agent New York T +1 212 649 8706
JOSEPH W. ARICO PH.D. Patent Agent Boston T +1 617 728 7185 KATHERINE ARMSTRONG Counsel New York T +1 212 698 3624 View All Related Professionals Related Practice Areas Finance Mergers and Acquisitions Antitrust/Competition Intellectual Property Product Liability and Mass Torts Complex Commercial Litigation