About

Life Science Industry Practice

Sheppard Mullin has full-service offices serving the life sciences sector in Palo Alto, San Diego/Del Mar, Los Angeles, San Francisco, Orange County, Santa Barbara, New York, Washington DC and Shanghai, China. Attorneys in these offices work with life sciences companies in every phase of their growth cycle. Our team includes lawyers with advanced or technical degrees as well as former in-house counsel of life sciences companies; their backgrounds enable us to better understand our clients' business and objectives.

We assist clients in this industry with strategic 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 collaborations are on the rise and there is pressure to produce results, we work hand-in-hand with our clients in their drive for success and profitability.

Formation and Organization

The starting point for any life sciences business is the choice of the legal entity or entities within a structure in which to operate the enterprise. Sheppard Mullin has structured, organized and documented all types of legal entities in California, Delaware and other states and foreign countries, working with clients ranging from single, inexperienced entrepreneurs to veteran managers, venture capitalists and strategic investors, as well as domestic and international company owners.

Intellectual Property

We assist in the creation, structuring and negotiation of intellectual property transactions that are so crucial to the success of most life sciences companies. Whether it is the acquisition or licensing of technology, the protection, development and capitalization of intellectual property assets, or the creation of a strategic partnership, we have the experience, relationships, and resources available to bring value to our clients throughout the transaction. Our patent attorneys are highly skilled in the strategic planning of patent portfolios, including meshing the focus of the portfolio with competitive intelligence and a company’s business plan. They provide “out-of-the-box” thinking related to complex and novel situations.

Clinical Trials

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.

FDA Regulatory

We represent manufacturers and distributors of drugs and medical devices in FDA rulemaking proceedings and in enforcement proceedings brought by the U.S. on behalf of the FDA. We advise advertising agencies, clinical investigators, research organizations and other non-manufacturers on compliance with the Federal Food and Drug and Cosmetics Act. We also assist companies regulated under the Prescription Drug Marketing Act, including advice on sampling, product distribution and return, reimportation and wholesaler registration requirements and requirements for storage and handling of prescription drugs.

Healthcare Regulatory

We advise and represent pharmaceutical manufacturers, device manufacturers, hospitals, and other health care providers, as they manage the risks and optimize the opportunities posed by Medicare and Medicaid programs. We advise clients with respect to reimbursement issues pertaining to all aspects of the Medicare program, including the Part D prescription drug benefit. We also advise pharmaceutical manufacturers with respect to their reporting and payment obligations under the Medicaid Drug Rebate program.

We routinely counsel these clients regarding compliance with the privacy standards promulgated under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). We have assisted in our clients’ efforts to obtain amendments to, or clarifications of, these regulations. We also counsel our clients on state laws affecting the privacy of certain types of medical records, including genetic information and pharmacy records. In addition, we regularly provide advice on the interaction between state law and the federal regulations governing health information privacy.

Fraud and abuse in the drug and device fields is also an area in which we counsel clients. Lastly, we help clients address the California statute requiring pharmaceutical manufacturers, device companies and drug distributors to post their Comprehensive Compliance Plans on their websites.

Labor and Employment

Because life sciences companies operate daily under strict government regulation, the risk of a wrongful termination suit in violation of public policy is greater than with most companies. As easy as it is for an employee to raise one of these claims, it is equally as easy for management to miss the fact that the claim is coming. Because discussions regarding operating procedures, protocols and test results are so common in the life sciences workplace, managers may not realize that the discussion can create a higher risk of employment litigation.

Real Estate

We work with life sciences companies in the siting, permitting, developing, financing of new research and manufacturing facilities, as well as developing, leasing and acquiring R&D and laboratory facilities.

Litigation

We have an outstanding litigation practice, particularly in areas of significance to life science companies. First and foremost, we are trial lawyers, who resolve matters of importance to our clients in the courtroom when settlement is not beneficial. We protect patents, trademarks and associated rights. We have special expertise in the interplay between patent, regulatory and antitrust laws in the Hatch Waxman context, e.g., In re Taxol Antitrust Litigation which we handled successfully for our client. Our clients turn to us to sort out complex rights issues to resolve collaboration, consortium and joint venture disputes. We protect from trade secrets theft. We defend against, and manage, product liability matters. And we litigate licensing disputes related to patent rights and other intellectual property as well as handle international arbitrations for life sciences companies.