Life Sciences

Life sciences companies, ranging from startups to multinational corporations, look to Sheppard Mullin to meet their important legal needs. The firm's experience spans the range of the life sciences, including biotechnology, pharmaceuticals, and medical devices. Our combined legal, business and technical skills enable us to support the intellectual property strategy and development goals of our clients.

We assist clients in this dynamic and developing industry with strategic IP legal issues that range from acquisitions to antitrust, entity formation to enforceability evaluations, licensing to litigation, patents to product liability and trademarks to transfer pricing. In an industry where partnerships and collaboration are on the rise and there is pressure to produce results, we work hand in hand with our clients in their drive to profitability.

We have substantial experience in drafting and negotiating global clinical trial agreements, Contract Research Organization (CRO) and laboratory agreements, manufacturing agreements and the related work orders, budgets and forecasts. In negotiating these agreements, we have been successful in protecting our clients' interests, especially in resolving disputes with manufacturers and CROs without resorting to legal action.

In addition, we have a full service FDA team as part of its Life Sciences practice group. Our attorneys represent manufacturers and distributors of drugs, biologics, medical devices, cosmetics, food, and dietary supplements, as well as other entities whose activities are regulated by the U.S. Food and Drug Administration (FDA), including advertising agencies, clinical investigators, and research organizations. We provide FDA and DEA regulatory counseling to ensure compliance with the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, the Controlled Substances Act, and implementing regulations. Our comprehensive experience includes advising and assisting our clients on all phases of product development and approval; project-specific regulatory counseling; advising on advertising, labeling and marketing issues; responding to formal and informal agency enforcement actions; auditing for GMP and related compliance; transactional work and litigation.

Sheppard Mullin has full-service offices serving the life sciences sector in San Francisco, San Diego/Del Mar Heights, Los Angeles, Orange County, Santa Barbara, New York and Washington DC. Attorneys in these offices work with life sciences companies in every phase of their growth cycle, from formation and financing, mergers and acquisitions, and technology licensing and contracts to defending patents, trademarks and other intellectual property rights. Our team includes attorneys with advanced or technical degrees as well as former in-house counsel of life sciences companies; their backgrounds enable us to better understand our client's business and objectives.

Our life sciences clients can rely on receiving a consistent level of high quality legal work and service from the members of Sheppard Mullin's life sciences team.

Representative Clients