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West Virginia College of Law professor  S. Sean Tu recently published a new opinion piece in JAMA. The article, titled  "Patents on Risk Evaluation and Mitigation Strategies for Prescription Drugs and Generic Competition," is co-authored by Professor Tu with Ameet Sarpatwari, PhD, Sajeev Kohli, and Aaron S. Kesselheim, MD, JD, MPH, all of the Program on Regulation, Therapeutics, and Law at Brigham and Women’s Hospital.  It was published online by the journal on February 22, 2024.

The article discusses the impact of patents held by manufacturers on risk evaluation and mitigation strategies or "REMS."  REMS may be required by the FDA to mitigate risks associated with certain prescription drugs.  Professor Tu and co-authors discuss the prevalence of REMS patents and their effect on delaying generic competition.

West Virginia University College of Law professor  S. Sean Tu recently published a new Research Letter in JAMA. The article, titled "Changes in the Number of Continuation Patents on Drugs Approved by the FDA", is the result of a comprehensive study of all drug patents from 2000-2015.  Professor Tu and co-authors examine the frequency of continuation patents on brand-name drugs and how they contribute to the creation of patent thickets. Professor Tu co-authored this new work with Aaron S. Kesselheim, and William B. Feldman of Brigham and Women’s Hospital in Boston, Massachusetts, and with Kathrine Wetherbee of Duke University. It was published online by the journal on August 1, 2023.

Professor Tu has also been interviewed by media outlets on this topic following the article's publication: 

West Virginia University College of Law professor  S. Sean Tu recently published a new article in Nature Biotechnology. The article, titled  "The prevalence of drug patent term extensions in the United States, 2000–2018," analyzes the impact of patent term extension (PTE) on drug market exclusivity.  Professor Tu co-authored with work with Victor L. Van de Wiele, Aaron S. Kesselheim, and  Sarosh Nagar, all of whom are affiliated with Brigham and Women’s Hospital in Boston, Massachusetts, It was published online by the journal on July 14, 2023.

Find more of Professor Tu's scholarship on  SSRN.

West Virginia College of Law professor S. Sean Tu recently published new scholarship in Chest, the journal of the American College of Chest Physicians. The article is titled "Patenting strategies on inhaler delivery devices." Professor Tu co-authored the article with Brandon J. Demkowicz, Aaron S. Kesselheim, M.D., J.D., M.P.H. and William B. Feldman, M.D., D.Phil., M.P.H., colleagues at the Program On Regulation, Therapeutics, And Law (PORTAL) at Harvard Medical School, and Michael A. Carrier, J.D. of Rutgers Law School.  

The article pre-print was published online on February 25, 2023 and will subsequently appear in volume 163 of the journal later in 2023.

West Virginia Unviversity College of Law Professor Sean Tu will receive a research grant from the National Institute of Health Care Management in 2023-2024. NIHCM awards grants to those who initiate work that will "advance evidence on a broad range of factors that contribute to rising health care costs and ongoing health care disparities."

Professor Tu's project is called "Improving Competitive Drug Markets by Reviewing Patents." He will be joined on the project by Aaron S. Kesselheim of Harvard University and Victor van de Wiele of the University of Cambridge.