Antibody Patent Evolution

WVU College of Law Research Paper No. 2022-020

IEEE Pulse, This article was published in IEEE Pulse. The version of record is available at: https://pubmed.ncbi.nlm.nih.gov/36301809/, Vol. 13, Issue 5, p. 33-37, 2022

Posted: 3 Nov 2022

See all articles by Theodore Teng

Theodore Teng

Independent

Aaron S. Kesselheim

Brigham and Women's Hospital/Harvard Medical School

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: October 27, 2022

Abstract

Therapeutic antibodies in clinical medicine are become an important focus for the biotechnology industry. In 2021, four of the top six selling prescription drugs were monoclonal antibodies, leading to a reported revenue of over $67 billion dollars. Accordingly, it is no surprise that the patentability rules for antibody patents have become increasingly important to drug companies, health care providers, and consumers alike. In this paper we outline the evolution of antibody patents from broad genus type claims to narrow species type claims. In this paper we explain how the US Patent and Trademark Office (USPTO) has made this shift to catch up with the scientific changes in antibody technology. Additionally, we suggest how the USPTO could use the written description requirement and the reverse Doctrine of Equivalents to correctly limit the scope of antibody patents while still incentivizing the generation of new antibody therapies.

Keywords: therapeutic antibodies, antibody patents, USPTO, pharmaceutical patents, drug patents

JEL Classification: K10

Suggested Citation

Teng, Theodore and Kesselheim, Aaron S. and Tu, Shine (Sean), Antibody Patent Evolution (October 27, 2022). WVU College of Law Research Paper No. 2022-020, IEEE Pulse, This article was published in IEEE Pulse. The version of record is available at: https://pubmed.ncbi.nlm.nih.gov/36301809/, Vol. 13, Issue 5, p. 33-37, 2022, Available at SSRN: https://ssrn.com/abstract=4264899

Theodore Teng

Independent

Aaron S. Kesselheim

Brigham and Women's Hospital/Harvard Medical School ( email )

1620 Tremont St
Suite 3030
Boston, MA 02120
United States
617-278-0930 (Phone)
617-232-8602 (Fax)

HOME PAGE: http://www.PORTALresearch.org

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/

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