Medical Process Patents - Monopolizing the Delivery of Health Care
Aaron S. Kesselheim
Brigham and Women's Hospital/Harvard Medical School; Harvard University - Edmond J. Safra Center for Ethics
Michelle M. Mello
Harvard University - Department of Health Policy & Management
New England Journal of Medicine, Vol. 355, pp. 2036-2041, 2006
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, O31Accepted Paper Series
Date posted: November 9, 2006
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