S. Sean Tu, PhD, JD

S. Sean Tu, PhD, JD

Professor of Law, University of Alabama

Sean Tu is a research collaborator with PORTAL and Professor of Law at the University of Alabama, where he is a nationally recognized expert on patent law and drug law. He is also a Scholar at Georgetown’s O’Neill Institute for National and Global Health Law. A prolific scholar with over fifty publications, his work has appeared in top journals including the New England Journal of Medicine, Journal of the American Medical Association, Nature Biotechnology, and Stanford Technology Law Review, among others.

Tu has co-authored several amicus briefs, one of which was cited by the US Supreme Court, and is co-author of casebooks on biotechnology and intellectual property law. The National Institutes of Health Care Management awarded him a grant to study the intersection between patent law and drug pricing. In 2021–2022, he was a visiting professor at Harvard Medical School. He has also worked as an expert witness in patent law cases, helped start a company focused on patent prosecution analytics, and co-founded a small biotechnology company focused on cancer cell biology.

Tu holds degrees in chemistry and microbiology from the University of Florida and a JD from the University of Chicago, where he was a research assistant for Judge Richard Posner. He received his doctorate in pharmacology from Cornell University and completed a postdoctoral fellowship at the La Jolla Institute for Allergy and Immunology. Prior to joining the University of Alabama, he was a faculty member at the West Virginia University College of Law, where he served two years as Associate Dean for Faculty Research and Development. Before his academic appointments, he was an associate at Foley & Lardner LLP, where he prosecuted pharmaceutical patents.

Featured Work

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Differential Legal Protections for Biologics vs Small-Molecule Drugs in the US

Wouters OJ, Vogel M, Feldman WB, Beall RF, Kesselheim AS, Tu SS - JAMA

  • Innovation Incentives and Competition
  • Price, Value, and Access
  • Regulation and Clinical Evidence
The authors explore whether there is empirical justification for the greater legal protections given to biologics over small-molecule drugs in the US. Across development times, clinical trial success rates, research and development costs, patent protection, market exclusivity periods, revenues, and treatment costs, no no evidence supporting differential treatment was found, suggesting that US law overly rewards the development of biologics relative to small-molecule drugs.
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Clearing Dense Drug-Patent Thickets

Chao B, Whalen R, Kesselheim AS, Tu SS - New England Journal of Medicine

  • Innovation Incentives and Competition
Two proposed patent reforms, the USPTO terminal disclaimer rule and a bipartisan bill to address patent thickets, could significantly reduce patent thickets on biologic and small molecule products. For two products, adalimumab (Humira), and lenalidomide (Revlimid), the USPTO rule would reduce each product’s thicket by 43% and 70%, respectively, while the legislationw would making only 25 of 105 Humira patents and 12 of 30 Revlimid patents enforceable.
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Five-Year Sales for Newly Marketed Prescription Drugs with and Without Initial Orphan Drug Act Designation

Tu SS, Nagar SN, Kesselheim AS, Lu Z, Rome BN - JAMA

  • Innovation Incentives and Competition
Drugs initially approved for orphan indications generated five‑year revenues comparable to non‑orphan drugs, undermining claims that orphan incentives primarily support commercially marginal products. These findings suggest that current orphan drug incentives may over‑reward manufacturers without clear justification.
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