faculty scholarship BLOG 

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 College of Law professor S. Sean Tu recently published a new opinion piece in JAMA. The article, titled  "Free Speech Challenges to the Inflation Reduction Act," is co-authored by Professor Tu with Rebecca Tushnet of Harvard Law School.  It was published online by the journal on August 29, 2023.

The article discusses the First Amendment free speech claims raised by drug manufacturers in lawsuits brought after the passage of the Inflation Reduction Act of 2022.  The IRA attempts to lower prescription drug prices, insurance premiums, and out-of-pocket costs for patients. 

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 College of Law professor  S. Sean Tu recently published new opinion piece in JAMA. The article, titled  "Recent Patent Reform Bills and Their Implications for Prescription Drugs," 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 January 13, 2023.

The article discusses three bills expected to be re-introduced in Congress this session with implication for intellectual property law: the Patent Eligibility Restoration Act of 2022 (S. 4734), the Interagency Patent Coordination and Improvement Act of 2022 (S. 4430), and the Patent Examination and Quality Improvement Act of 2022 (S. 4704). 

West Virginia College of Law professor  S. Sean Tu recently published new scholarship in JAMA. The article, titled  "Manufacturer Revenue on Inhalers After Expiration of Primary Patents, 2000-2021," 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 January 3, 2023.

Find more of Professor Tu's scholarship on  SSRN.