Life sciences companies of all sizes and from all sectors turn to Paul Hastings’ Life Sciences practice for vital corporate, capital markets, compliance, regulatory, investigations, government defense and litigation support at every stage of growth and each phase of the product lifecycle.

Our destination practice focuses solely on life sciences companies at all stages in their life cycle, combining expansive subject matter command, technical know-how, and former in-house and government experience to deliver business-minded, enforcement-tested guidance to companies and their investors in pharmaceuticals, biotech, rare disease, medical devices, digital health, diagnostics and emerging areas within life sciences.

Life Sciences Transactions

By strategically developing a deep team with broad experience to support each key stage of a life sciences company’s development, Paul Hastings has earned acclaim as a go-to advisor for all life sciences-related corporate matters.

We advise life sciences companies with all aspects of their business activities, from initial start-up advice to exit transactions. Our Emerging Companies & Venture Capital team provides comprehensive legal and strategic support at every stage. The Capital Markets team provides strategic counsel on a variety of capital markets offerings, including domestic, international and cross-border. Our IP licensing and collaboration attorneys combine scientific expertise with legal acumen to help clients protect, commercialize and maximize the value of their innovations. Our M&A lawyers regularly help clients navigate the complex issues most critical to change of control transactions involving life sciences companies. We also counsel life sciences management teams and boards of directors at all stages of growth.

Regulatory and Compliance

Our regulatory and compliance lawyers leverage their experience as senior counsel at the FDA, in-house counsel and executives at pharmaceutical and medical device companies, and leadership roles in private practice to guide clients at all phases of the product life cycle, from discovery, clinical research and FDA approval through commercial launch and post-commercialization compliance.

Life Sciences Regulatory: Our extensive life sciences regulatory experience includes overseeing approval processes for new drugs and biologics; counseling on safety issues, including Risk Evaluation and Mitigation Strategies (REMS); navigating unique regulatory issues raised during the development and marketing of controlled substances; working on the development and commercialization of a broad range of FDA-regulated product types and technologies; and advising medical product companies on engagement with regulators.

Compliance: We also offer training and resources to satisfy regulator compliance program expectations. Our day-to-day compliance advisory work for clients across the industry keeps our finger on the industry pulse, and our deep in-house life sciences experience brings a unique insider’s perspective. Our Life Sciences and Healthcare Consulting Group, a one-of-its-kind life sciences consulting practice, offers a full range of services and works hand in hand with our compliance and investigations lawyers to deliver all needed services “under one roof.”

Investigations, Enforcement, Litigation and Antitrust

Few firms can match Paul Hastings’ breadth of experience. Many of the world’s leading companies in the life sciences industry and beyond have entrusted our team to represent them before global, federal and state prosecutors and regulators on their largest and most challenging cases.

Investigations and Enforcement: Our team is a market leader in U.S. healthcare government investigations, enforcement and litigation. We regularly represent life sciences and healthcare organizations and their executives in connection with government and internal investigations into allegations of potential violations of the federal anti-kickback statute, health care fraud, and the FDCA, HIPAA and FCA. These matters range from conduct surrounding patient support/assistance programs, specialty pharmacy arrangements, clinical trials and investigator-initiated studies, promotional communications to the full range of interactions between manufacturers, prescribers, third-party vendors, patients and payers. We also are a leading authority on voluntary disclosure issues. With a team that includes lawyers with extensive in-house experience as well as former federal and state prosecutors and regulators, we bring firsthand knowledge of the way the government builds cases.

In addition, Paul Hastings has advised on more FCPA settlements than any other firm since 2008 and has had more FCPA monitorships than any other firm since 2004. We represented three of the world’s top 10 pharmaceutical companies in the successful resolution of their DOJ/SEC/FCPA matters and subsequent monitorships. We also have a State Attorneys General Investigations & Enforcement team that leads corporate responses to complex multi- and single-state investigations and enforcement actions.

Intellectual Property Litigation: The Paul Hastings Life Sciences Intellectual Property Practice has a long track record of success in bet-the-company cases in the district courts and groundbreaking victories in Patent Trial and Appeal Board (PTAB) proceedings. Our deep bench of award-winning first-chair attorneys excels at collaborating, providing a one-stop shop for complex IP disputes requiring strategic coordination across multiple forums. We are a go-to firm when the patents or trade secrets protecting a client’s revenue-driving drug products are on the line, having substantial experience in the nuances of Hatch-Waxman and biotech patent litigation.

Antitrust: Our life sciences antitrust team has earned a well-deserved reputation for fast-tracking the approval process for our clients’ most complex and important transactions. With extensive experience in senior roles in the DOJ’s Antitrust Division and the FTC — and in litigation, merger control and cartel matters in the private sector — our lawyers bring unparalleled knowledge and insight to each deal, which enables them to find the shortest and most efficient paths for closing.

Life Sciences and Healthcare Consulting Group

Our first-of-its-kind consulting group has deep experience working both independently and arm-in-arm with our top-tier legal colleagues to design, build, implement and operate effective compliance risk management programs — as well as the organizational constructs and resource models that support those programs across the enterprise. Whether our work together is reactive (i.e., an investigation or government action) or proactive (i.e., borne out of a desire to enhance your risk management program), we have the experience necessary to tailor our approach to your unique needs.

Recognition