Market demand for life sciences products and services continues to grow. At the same time, the industry is in a period of tremendous flux. Health care reform is creating new pricing and payor pressures, federal and state regulators and law-enforcement officials are increasing their scrutiny, and drug companies are facing challenging pipelines. Activity is shifting to emerging markets, and outsourcing is becoming an increasingly important cog in the research development and supply chain.
In this fast-paced climate, clients need legal counsel with global experience, integrated services and deep familiarity with the history, challenges and opportunities that make up this dynamic industry. With lawyers practicing across the United States and Europe, and in cooperation with MWE China Law Offices, the life sciences team at McDermott provides effective, coordinated counsel on legal issues facing clients worldwide.
Combined with lawyers from the top-ranked health law practice, our industry team is a collaborative group composed from critical legal areas vital to a life sciences company including regulatory, transactional, intellectual property, litigation and tax.
A number of our lawyers have in-house experience at leading life sciences companies, and others have served in senior positions in government agencies such as the US FDA, Federal Trade Commission (FTC), Department of Health and Human Services (HHS) and Department of Justice (DOJ). We regularly represent clients before international agencies such as the European Commission Directorate General for Competition, EU Member State and Chinese enforcement authorities, and in courts throughout the United States, Europe and China.
We counsel issuers and underwriters across a wide spectrum of capital market transactions across the life sciences industry and globally, including initial public offerings, Regulation A+ Offerings, private placements, registered underwritten offerings, Rule 144A/regulations offerings, high-yield debt and more creative hybrid instruments involving multiple issuers. In conjunction with the Firm’s experienced securities lawyers, we provide guidance on compliance, corporate governance and responsibility, Securities and Exchange Commission (SEC) defense, and related issues arising out of mergers, acquisitions, tender and exchange offers, proxy solicitations and private investments in public entities (PIPEs).
MWE China Law Offices’ Life Sciences Group provides fully integrated, multidisciplinary legal services to the life sciences industry. MWE China Law represent some of the world’s largest pharmaceutical and medical device companies, as well as startups, academic medical research centers, universities, investment banking and venture capital firms. The group’s lawyers have established relationships with the China Food and Drug Administration (SFDA), and regularly provide legal guidance to in-house counsel in areas such as intellectual property, corporate and finance, products regulation, reimbursement, environmental law, product liability, tax, antitrust and international trade.
Hatch-Waxman/ANDA litigation requires lawyers with a solid knowledge of the law and an in-depth understanding of the technologies that underlie pharmaceutical products. Our intellectual property litigators have represented clients in Hatch-Waxman/ANDA litigation involving some of the world’s best-selling drugs. We advise clients at every step, from developing US Patent and Trademark Office (USPTO) and FDA strategies, to compliance with ANDA Paragraph IV certification requirements. We take a proactive approach to preventing and minimizing litigation risks; however, when disputes arise we defend our clients’ interests aggressively before judges and juries, and negotiate effective settlements in line with businesses’ long-term goals.
McDermott’s trial, white collar and securities defense lawyers represent emerging and established biotechnology, pharmaceutical and medical-product companies in “bet the company” litigation. Our team includes lawyers with experience in class actions, product liability, consumer fraud, data privacy, US FDA compliance, Federal Corrupt Practice Act (FCPA), false claims and qui tam disputes, and pharmaceutical marketing and pricing disputes. We regularly lead multi-district, multi-plaintiff litigation and work with scientific experts to prepare opinions and testimony. We also advise clients facing federal and state regulatory and law-enforcement investigations, including representation before the FDA, Drug Enforcement Administration and the Federal Trade Commission.
McDermott’s tax lawyers represent life sciences companies on tax-free and taxable acquisitions of other businesses, joint ventures with unrelated businesses and foreign affiliates, spin-offs and restructuring existing operations to eliminate tax inefficiencies. We also provide tax counsel on day-to-day operations such as in-licensing and out-licensing of intangibles, product sales and other transactions with foreign affiliates, repatriation of earnings from foreign affiliates, and employee compensation and benefits. Our tax litigators represent life sciences companies in controversies at the administrative level and in the courts. Proactively, we work with clients to present their views on tax legislation and regulation to relevant government officials.