Brief of 42 Professors of Law, Economics, Business, and Medicine as Amici Curiae in Support of the Petition

Supreme Court brief in Teva Pharmaceuticals v. GlaxoSmithKline (2022)

Rutgers Law School Research Paper

WVU College of Law Research Paper No. 2022-015

22 Pages Posted: 11 Aug 2022 Last revised: 21 Nov 2022

See all articles by Michael A. Carrier

Michael A. Carrier

Rutgers Law School

Charles Duan

American University Washington College of Law

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

Date Written: August 10, 2022

Abstract

“Skinny labels” allow generics to reach the market quickly by disclaiming a drug's patented uses.

This brief supporting Teva's cert petition argues that the Federal Circuit’s opinion:

(1) undermines the Hatch-Waxman Act by removing the certainty of the skinny-label route, subjecting all generics to unexpected lawsuits, and

(2) creates a conflict since the Hatch-Waxman Act requires a generic drug to use the same labeling as its patented counterpart but the Federal Circuit now requires editing of the label to avoid inducement.

We also explain the importance of this case, as the significant increase in method-of-use patents could be used against a wide array of generic drugs, threatening consumers with higher payments and adverse health effects.

Keywords: skinny labels, generics, Hatch Waxman, method-of-use patents

JEL Classification: I18, K21, L40, L41, L43, L65, O34, O38

Suggested Citation

Carrier, Michael A. and Duan, Charles and Tu, Shine (Sean), Brief of 42 Professors of Law, Economics, Business, and Medicine as Amici Curiae in Support of the Petition (August 10, 2022). Supreme Court brief in Teva Pharmaceuticals v. GlaxoSmithKline (2022), Rutgers Law School Research Paper, WVU College of Law Research Paper No. 2022-015, Available at SSRN: https://ssrn.com/abstract=4186947 or http://dx.doi.org/10.2139/ssrn.4186947

Michael A. Carrier

Rutgers Law School ( email )

217 North Fifth Street
Camden, NJ 08102-1203
United States
856-225-6380 (Phone)
856-225-6516 (Fax)

Charles Duan (Contact Author)

American University Washington College of Law ( email )

4300 Nebraska Ave NW
Washington, DC 20016
United States

Shine (Sean) Tu

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/

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