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West Virginia College of Law professor S. Sean Tu recently published new scholarship in the New England Journal of Medicine. The article is titled Leveraging Old Hepatitis C Therapies. Professor Tu co-authored the article with Shyamasundaran Kottilil, M.B., B.S., Ph.D. (University of Maryland School of Medicine), and T. Joseph Mattingly II, Pharm.D., M.B.A., Ph.D (University of Utah College of Pharmacy). It was published online by the journal on December 28, 2024 and subsequently in print in volume 392 on January 2, 2025.

Find more of Professor Tu's scholarship on SSRN.

West Virginia College of Law professor S. Sean Tu recently published new scholarship in the Journal of Law and the Biosciences. The article is titled "Accelerating biosimilar market access: the case for allowing earlier standing". Professor Tu's co-authors are: Rachel Goode and Matthew Turner of Fresenius Kabi Biopharma, and Victor Van de Wiele, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital. The article was published online by the journal on January 3, 2025 and subsequently in print in volume 12, issue 1 of the journal.

From the abstract:

West Virginia College of Law professor S. Sean Tu recently published new scholarship in the Journal of Law, Medicine & Ethics. The article is titled "Use of Public Research and Manufacturing Enterprises to Lower Prescription Drug Prices and Increase Innovation ". Professor Tu's co-authors are: Alex Moss, Public Interest Patent Law Institute and Dana Brown, The Democracy Collaborative. The article was published online by the journal on December 16, 2024 and subsequently in print in volume 52, issue 3 of the journal.

From the abstract:

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: