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Professor Sean Tu Publishes in Nature Biotechnology

West Virginia College of Law professor  S. Sean Tu recently published a new article in Nature Biotechnology The article, titled& "Biologic patent challenges under the America Invests Act," is co-authored by Professor Tu with Victor L. Van de Wiele and Aaron Kesselheim, both of the Program on Regulation, Therapeutics, and Law at Brigham and Women’s Hospital.  It was published online by the journal on March 15, 2024.

An image with the title of the article, the journal name, and a brief description of the article.

Professor Sean Tu Publishes New Research Letter in JAMA

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.

Professor Sean Tu Publishes New Research Letter in JAMA

West Virginia College of Law professor  S. Sean Tu recently published a new opinion piece in JAMA. The article, titled  "Biologic Patent Thickets and Terminal Disclaimers," is co-authored by Professor Tu with Rachel Goode (Fresenius Kabi USA) and William B. Feldman (Brigham and Women's Hospital).  It was published online by the journal on December 14, 2023.

The article discusses "terminal disclaimers", or stipulations added to patent applications that the follow-on patent will expire at the same time as the original.  Professor Tu analyzed the use and timing of terminal disclaimers in all biologic patents involved in litigation from 2010 to 2023.

Professor Sean Tu Publishes Two New Articles in JAMA

West Virginia University College of Law professor S. Sean Tu recently published two new Research Letters in JAMA.  Both were published online on Nevember 13, 2023 and appear in volume 330, issue 21 of the journal.

"Ancillary Product Patents to Extend Biologic Patent Life" is co-authored with Rachel Goode (Fresenius Kabi USA) and William B. Feldman (Brigham and Women's Hospital). "Inequitable Conduct and Invalidation of Patents Related to Food and Drug Administration–Regulated Products" is co-authored with Carolnie Leadmon (WVU), C. Joseph Ross Daval and Aaron S. Kesselheim (both of Brigham and Women's Hospital).

Professor Sean Tu Publishes New Article in Clinical Pharmacology & Therapeutics

New scholarship by West Virginia University College of Law professor S. Sean Tu appears in Clinical Pharmacology & Therapeutics, a journal published by the American Society for Clinical Pharmacology & Therapeutics.  The article is titled "Preserving Timely Generic Drug Competition with Legislation on “Skinny Labeling”. Professor Tu co-authored the work with Aaron S. Kesselheim of Brigham and Women’s Hospital and Harvard University.

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