A 'Method of Use' to Prevent Generic and Biosimilar Market Entry

New England Journal of Medicine, Vol. 388, p. 483-485

WVU College of Law Research Paper No. 2023-009

Posted: 8 May 2023

See all articles by S. Sean Tu

S. Sean Tu

West Virginia University College of Law; Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital; Georgetown University - The O'Neill Institute for National and Global Health Law

Ameet Sarpatwari

Harvard Medical School; Brigham and Women's Hospital

Date Written: Febraury 2023

Abstract

Brand drug manufacturers use large numbers of patents directed towards the same products creating "patent thickets" to delay or deter generic drug entry. In this Perspective, Dr. Tu and Dr. Sarpatwari show that over the past two decades drug companies have been increasing the intensity of patenting. Additionally, the authors show that many of these patent thickets are comprised of less innovated "method of use" patents.


This article was published in the New England Journal of Medicine at https://www.nejm.org/doi/full/10.1056/NEJMp2216020

Keywords: patent law, patent thicket, pharmaceutical patents, generic drugs, method of use patents

JEL Classification: K00, K10, K23

Suggested Citation

Tu, Shine (Sean) and Sarpatwari, Ameet, A 'Method of Use' to Prevent Generic and Biosimilar Market Entry (Febraury 2023). New England Journal of Medicine, Vol. 388, p. 483-485, WVU College of Law Research Paper No. 2023-009, Available at SSRN: https://ssrn.com/abstract=4439334

Shine (Sean) Tu (Contact Author)

West Virginia University College of Law ( email )

101 Law School Drive
Morgantown, WV West Virginia 26506
United States

HOME PAGE: http://https://www.law.wvu.edu/faculty-staff/faculty/s-sean-tu

Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital ( email )

1620 Tremont St.
Suite 3012
Boston, MA 02120
United States

HOME PAGE: http://https://www.portalresearch.org/sean-tu.html

Georgetown University - The O'Neill Institute for National and Global Health Law ( email )

600 New Jersey Avenue, NW
Washington, DC 20001
United States

HOME PAGE: http://https://oneill.law.georgetown.edu/experts/s-sean-tu/

Ameet Sarpatwari

Harvard Medical School ( email )

25 Shattuck St
Boston, MA 02115
United States

Brigham and Women's Hospital ( email )

Boston, MA 02115
United States

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