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.

From the abstract:

Professor Sean Tu Publishes New Research Letter in JAMA

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: 

Professor Sean Tu Publishes Article in JAMA on Patent Claims before SCOTUS in Amgen v. Sanofi

West Virginia College of Law professor  S. Sean Tu recently published new opinion piece in JAMA. The article, titled  "Broad Patent Claims Come Before the Supreme Court in Amgen v Sanofi," is co-authored by Professor Tu with researchers at Program On Regulation, Therapeutics, And Law (PORTAL) at Harvard Medical School where Professor Tu is a visiting professor.  It was published online by the journal on March 27, 2023.

The article discusses patent claims raised in Amgen v. Sanofi, a case currently before the Supreme Court. Professor Tu previously contributed to an amicus brief filed in the case: Brief of Intellectual Property Law Professors and Scholars as Amici Curiae in Support of the Respondents.