Medical-process patents--monopolizing the delivery of health care.

Patents have helped promote innovation for centuries, but the modern application of patents to the field of medicine raises legal and ethical questions. Patents covering pharmaceutical products and medical research tools are ubiquitous, and many discoveries described by such patents have contributed to the advancement of medical science. At the same time, when patent protection has been too broad, extended beyond the term initially granted, or granted for discoveries that are far from groundbreaking, it has hindered scientific progress and increased costs in the medical marketplace. A wide-ranging debate has emerged over how to balance these competing interests.1-3 This spring, controversy over patent policy resurfaced in a case brought before the Supreme Court, Laboratory Corporation of America (LabCorp) v. Metabolite Laboratories. The case centered on a patent for a method of diagnosing a vitamin deficiency on the basis of the levels of homocysteine in blood. The disputed patent exemplifies the growing effort to claim proprietary rights over medical processes, such as making a diagnosis or treating a condition in a particular way. Medical-process patents threaten to complicate medical practice, increase costs, and restrict access to therapeutic and diagnostic procedures. The American Medical Association (AMA) has declared that this type of patent compromises patients’ access to new procedures.4 Owing to such concerns, nearly 80 countries refuse to grant patents on medical procedures.5,6 U.S. law allows such patents, but in 1996, Congress curtailed the consequences for physicians of certain kinds of medical-process patents.7 Despite this provision, the LabCorp case highlights ongoing concerns about the effect of process patents on health care. medic al processes as intellec tual propert y