Patenting medical and surgical techniques: an ethical-legal analysis.
Considerable controversy has recently arisen regarding the patenting of medical and surgical processes in the United States. One such patent, viz. for a "chevron" incision used in ophthalmologic surgery, has especially occasioned heated response including a major, condemnatory ethics policy statement from the American Medical Association as well as federal legislation denying patent protection for most uses of a patented medical or surgical procedure. This article identifies and discusses the major legal, ethical and public policy considerations offered by proponents and opponents of such patents. The existing literature divides up into those who favor such patents essentially without qualification, and those who condemn and wish to outlaw them. We advance a compromise position where administrative and legislative action is called for to provide more specific guidelines regarding the patentability of such processes by the Patent and Trademark Office. Our position, in sum, will be that too much is at stake in this complicated area for either the blanket prohibition, or wholesale, uncritical acceptance, of the patenting of medical and surgical processes or techniques.
Wear
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Department of Medicine, SUNY at Buffalo, Amherst 14260, USA.
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Szczygiel
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McEvoy
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D000574:American Medical Association; D035843:Biomedical Research; D026689:Ethical Analysis; D004992:Ethics, Medical; D006801:Humans; D013677:Medical Laboratory Science / Q000331:legislation & jurisprudence*; D013508:Ophthalmologic Surgical Procedures; D010330:Patents as Topic / Q000331:legislation & jurisprudence*; D011640:Public Policy; D018570:Risk Assessment; D013514:Surgical Procedures, Operative; D014481:United States