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.
Find more of Professor Tu's scholarship on SSRN.