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Christopher Mikson

Christopher M. Mikson M.D.


Chris is a medical doctor, registered patent attorney, and seasoned litigator who advises and represents clients in Food and Drug Administration regulatory matters and complex litigation and transactional matters involving healthcare and the life sciences.

Regulatory: Chris has extensive experience in the regulation of drugs, biologics, human cell and tissue products (HCT/Ps), and medical devices 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 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, biologics, HCT/Ps, 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. 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. In addition to his litigation practice, Chris regularly performs transactional work related to FDA-regulated products, including material and service contracts, licensing agreements, and due diligence of major deals.

Bar admissionsDistrict of ColumbiaNew JerseyPennsylvaniaUnited States Patent and Trademark Office
CourtsSupreme Court of the United StatesUnited States Court of Appeals for the Federal CircuitUnited States Court of Appeals for the Third CircuitUnited States District Court for the District of New JerseyUnited States District Court for the Eastern District of Pennsylvania
  • Jefferson Medical College, MD
    Hobart Amory Hare Honor Medical Society

    University of Pennsylvania, Post Baccalaureate Premedical Program

    Rutgers Law School, JD
    Articles Editor, Rutgers Law Journal

    Rutgers College, BA


LMG Life Sciences recognized Chris as a "Life Sciences Star" since 2018.

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Chris has spoken and written extensively on intellectual property and regulatory issues, including those concerning Hatch-Waxman, biosimilars, and medical devices. He 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.

Civic and Charitable

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 Philadelphia.



+1 215 656 3380
(Work, Philadelphia)
+1 202 799 4000
(Work, Washington, DC)