Christopher Mikson is a partner in Washington DC, where he serves as leader of Mayer Brown's FDA Regulatory practice and co-leader of the Health Care practice. With his unique combination of training and experience as a physician, registered patent attorney, and trial lawyer, he focuses his practice on FDA regulatory matters and complex litigation and transactional matters involving health care and the life sciences. LMG Life Sciences recognized Chris as a "Life Sciences Star" in 2018 and 2019.
Regulatory – Chris has extensive experience in the regulation of drugs, biologics, medical devices, and human cell and tissue products (HCT/Ps) by FDA and other federal and state agencies. He has counseled and represented clients in regulatory matters across all stages of the product life cycle from research and development to nonclinical testing, clinical trials, premarket clearance and approval, manufacturing and distribution compliance, and post market surveillance and reporting, including a broad range of agency proceedings such as Orange Book listing disputes, comments during rulemaking, citizen petitions, establishment inspections, responses to agency letters, and enforcement actions. Chris has completed FDA’s Clinical Investigator Training and NIH’s Clinical Research Training, affording him a unique multi-disciplinary understanding of current and evolving regulatory conditions as well as state-of-the-art science and technology that are critical to the design, conduct, and ultimate success of clinical trials for small molecule drugs, biological drugs, human cell and tissue products, and medical devices.
Litigation and Transactional – Chris has comprehensive experience in a broad range of complex litigation matters. He has represented some of the world's largest pharmaceutical, medical device, consumer product, and technology companies in patent infringement, trade secret, false advertising, and product liability litigation throughout the country. Chris focuses his litigation practice on FDA regulatory disputes and cases where FDA regulation intersects with other areas of the law such as product liability and intellectual property, including Hatch-Waxman and biosimilar cases. He is currently defending the publisher of a drug compendium in a Lanham Act case in federal court involving the listing of certain drugs currently legal for sale based on FDA’s Drug Efficacy Study Implementation (DESI) program. In addition to his litigation practice, Chris regularly performs transactional work related to FDA-regulated products, including preclinical testing and clinical trial agreements, contract research and manufacturing agreements, ingredient and component supply contracts, licensing agreements, and due diligence of major deals.
Chris is a Fellow of the American College of Legal Medicine, a member of the American Medical Association, Food and Drug Law Institute, American Intellectual Property Law Association, and Life Sciences Pennsylvania, and a former trustee of the Pennsylvania Medical Society. He has spoken and written extensively on intellectual property and regulatory issues, including those concerning Hatch-Waxman, biosimilars, and medical devices. Chris has taught patent and FDA law at the University of Pennsylvania, and regularly provides training on drug and device regulation for new hires at FDA as well as major drug and device companies.
Chris has long served as a pro bono lawyer with the Support Center for Child Advocates, providing legal representation and social service advocacy for abused and neglected children in his adopted home town of Philadelphia.
Jefferson Medical College, MD
University of Pennsylvania, Post-Baccalaureate Premedical Program
Rutgers School of Law - Camden, JDArticles Editor, Rutgers Law Journal
Rutgers College, BA
- District of Columbia
- New Jersey
- US Supreme Court
- US Court of Appeals for the Federal Circuit
- US Court of Appeals for the Third Circuit
- US District Court for the District of New Jersey
- US District Court for the Eastern District of Pennsylvania
- US Patent and Trademark Office