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. In this highly competitive business, you need more than the best and brightest ideas – you need a legal and strategic partner that understands the challenges of securing funding, safeguarding intellectual property, establishing partnerships, bringing new products to market, opening up new revenue streams, and protecting existing product lines.

Lawyers in our life sciences practice are deeply experienced in corporate governance, financing and M&A transactions, collaborations and licensing, regulatory matters, and intellectual property law. As part of our interdisciplinary approach, we also collaborate with attorneys in our patent litigation, products liability, employment and tax practices to protect client interests and to advocate on their behalf.

With a full service team of highly experienced lawyers resident in key life sciences hubs, our team helps clients find the strategic paths that foster growth and minimize risk across all phases of the corporate life cycle. Motivated by the knowledge that the work that we do with you is improving people’s lives, we serve as an extension of your team so you can focus on your core business.

Management teams of all sizes and across a broad spectrum of industries rely on Goodwin for advice and representation in all areas of labor and 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.

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 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.