Pharmaceuticals

Companies regulated by the Food and Drug Administration (FDA) know that expertise and practical advice are critical to the bottom line. Goodwin’s experienced FDA practice, a key component of the firm’s Technology & Life Sciences team, provides strategic counseling and skillful advocacy to companies subject to the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and related federal and state laws. 

Succeeding in the life sciences industry is as much about strategy and execution as it is about research and development. And with the breakneck pace of technology disrupting industries on a global scale, Goodwin’s depth of experience not only in the life sciences space, but also in collaboration with our technology, healthcare, real estate and private equity lawyers, makes our team exceptionally suited to address whatever the future brings. We partner with clients to embrace the promise and potential of innovation to make a profound and lasting impact.

Goodwin’s fully integrated, globally recognized destination life sciences practice is dedicated to serving the needs of innovators and investors working collaboratively to improve patients' lives. Our team of more than 150 lawyers is devoted to life sciences companies across the entire company lifecycle, and team members are strategically located across the major life sciences hubs in the U.S., Europe and Asia.

Litigation in the pharmaceutical and biotechnology industry can be particularly complex, requiring counsel that is as well versed across scientific disciplines as it is in the law. Goodwin has made servicing the needs of the pharmaceutical and biotechnology industries a strategic priority for more than two decades, and we have one of the largest and most active life sciences practices in the United States. Our IP litigation team is among the most experienced in the country, successfully representing both brand and generic companies in Hatch-Waxman litigation. Our portfolio of clients includes some of the largest innovator and generic companies in the world, and we have represented our clients in patent cases involving some of the world’s biggest blockbuster drugs.

Our firm is also a leader in the emerging field of biologics and biosimilars litigation. Our lawyers were involved in the legislative process that resulted in the Biologics Price Competition and Innovation Act (BPCIA), and our work counseling clients as they advance their biologic and biosimilar development programs has been a natural outgrowth of our extensive work on behalf of the pharmaceutical industry. Clients consistently praise our blog, BigMoleculeWatch.com, for its timely and relevant posts on biosimilar-related litigation, legislation and regulatory developments. In addition, our team authored Guide to Biosimilars Litigation and Regulation in the U.S., 2019-2020 ed., a first of its kind publication that explores the BPCIA.

Management teams of all sizes and across a broad spectrum of industries rely on Goodwin for advice and representation in all areas of employment law. We provide practical advice to employers on hiring and disciplinary practices, compensation, workplace violence, privacy concerns, issues arising under the Family and Medical Leave Act, loyalty issues, and protection of employer good will and proprietary information via restrictions on post-employment competition.

Our lawyers have extensive employment litigation experience involving all significant employment law issues, including reasonable accommodation of disabilities; sexual harassment; discrimination claims arising out of reductions in force; individual disparate treatment claims; wrongful discharge/public policy claims; employment contract and employee benefits claims; wage and hour disputes; and enforcement of noncompetition obligations.

Clients rely on our experienced attorneys and science advisors to help them make sound business decisions.

Lawyers in our patent opinions and counseling practice provide strategic advice to domestic and international companies. We work closely with clients to determine offensive and defensive patent strategies. Issues we routinely address include patent infringement, invalidity, unenforceability, licensing and freedom to operate.

Goodwin's appellate litigators have briefed and argued hundreds of high stakes appeals, securing victories for clients in federal and state appellate courts throughout the United States. Lawyers in our Appellate Litigation practice are experts at working cooperatively as part of a team — alongside trial counsel and subject-matter experts — to preserve and present the best possible case on appeal and maximize our clients’ chances for success.

Our work begins well before a case goes on appeal: preparing dispositive motions in trial court; preserving error for appellate review; handling post-verdict motions practice; and even initiating litigation, to set aside arbitrary decisions by administrative agencies or to enjoin unconstitutional or invalid laws on legal grounds. Members of the practice have argued more than twenty cases before the U.S. Supreme Court and have briefed scores of others.

When a company is faced with a securities class action or shareholder derivative litigation, they need a partner who understands what is at stake and can think outside the box to achieve resolution. Goodwin’s deep experience, creative thinking and tenacity has led to our involvement in precedent-setting securities cases in courts across the country. The results we achieve are best of breed and have helped shape the law nationally, including outright dismissals of billions of dollars in putative class action and shareholder derivative claims. Our cases range from defending high tech and biotech companies in class action securities fraud litigation brought following restatements of earnings or the release of bad business news, to resolving shareholder derivative challenges, to multibillion dollar mergers and acquisitions.

Pharmaceutical companies need experienced counsel to protect their regulatory interests. Goodwin’s Administrative Law and FDA Litigation practice provides counsel, representation and strategic advice that covers all aspects of our clients’ interactions with the Food and Drug Administration. Our lawyers regularly advise clients on regulatory issues, engage with the FDA and other federal and state agencies through Citizen Petitions, comments, meetings and other petitioning, and represent drug manufacturers in Administrative Procedure Act challenges. 

As businesses today face an increasingly sophisticated threat environment compounded by aggressive regulatory enforcement, companies need a partner who can help mitigate risk and respond to the unthinkable. Our top ranked Data + Privacy + Cybersecurity practice is one of the longest-standing of any Am Law 50 firm. Our practice is fully integrated and leverages the firm's core strengths, with the group's lawyers coming from our technology, financial institutions, licensing, litigation, regulatory and appellate practices. Our unique approach, focusing on client needs and value, enables us to engage specialists whose experience is framed by a holistic understanding of clients' greatest risks in this threatening environment.