Medical Process Patents - Monopolizing the Delivery of Health Care

New England Journal of Medicine, Vol. 355, pp. 2036-2041, 2006

Posted: 9 Nov 2006

See all articles by Aaron S. Kesselheim

Aaron S. Kesselheim

Brigham and Women's Hospital/Harvard Medical School

Michelle M. Mello

Stanford Law School; Department of Medicine

Abstract

Medical process patents, which protect intellectual property in medical and surgical procedures, threaten to complicate medical practice, increase health care costs, and restrict access to therapeutic and diagnostic modalities. Few countries allow such patents, but they have been granted in the U.S. in increasing numbers. Proponents of medical process patents note their value in encouraging medical innovation, while the American Medical Association and others object that conditioning access to advancements in care modalities on payment of a licensing fee conflicts with physicians' professional ethical obligations. A case recently heard by the Supreme Court, Laboratory Corporation of America (LabCorp) v. Metabolite, illustrates the legal and policy challenges raised by the expansion of proprietary rights over everyday medical practices such as making a diagnosis or treating a patient in a particular way. The LabCorp case centered on an effort to patent the "process" of reading an assay for homocysteine levels and inferring, based on the test result, that a patient had a vitamin deficiency. The Supreme Court's decision in the case leaves unresolved important questions about the scope of patentability of medical processes and the effects that patent law will have on the science and practice of medicine. In this article, we review the law of medical process patents and the policy issues that counsel against expansion of intellectual property rights in this area. Please contact the authors for an electronic reprint.

Keywords: patents, medical, process, intellectual property

JEL Classification: I18, O34, O31

Suggested Citation

Kesselheim, Aaron S. and Mello, Michelle M., Medical Process Patents - Monopolizing the Delivery of Health Care. New England Journal of Medicine, Vol. 355, pp. 2036-2041, 2006 , Available at SSRN: https://ssrn.com/abstract=943749

Aaron S. Kesselheim (Contact Author)

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

Michelle M. Mello

Stanford Law School ( email )

559 Nathan Abbott Way
Stanford, CA 94305-8610
United States
650-725-3894 (Phone)

HOME PAGE: http://https://law.stanford.edu/directory/michelle-m-mello/

Department of Medicine ( email )

Center for Health Policy / PCOR
Encina Commons
Stanford, CA 94305
United States

HOME PAGE: http://https://profiles.stanford.edu/michelle-mello?tab=bio

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