Obstet Gynecol. 2002 Nov;100(5 Pt 1):1051-6.
New technologies and the translation of research into clinical medicine are essential to patient care. Those who develop useful drugs, diagnostic and screening tests, and medical technologies have the right to expect a fair return for their efforts and risks. Current interpretations of patent law (particularly regarding gene patenting), however, have the potential to impede both medical advances and patient care. Patenting policies must balance the open exchange and use of information with making the pursuit of such knowledge financially rewarding. The Committee on Ethics and the Committee on Genetics of the American College of Obstetricians and Gynecologists maintain that patents on medical or surgical procedures are ethically unacceptable. Physicians may obtain patents on surgical and diagnostic instruments that they have developed, but such instruments should be made available to others at a fair and reasonable cost. Patents for genes as "compositions of matter" enable patent holders to control future applications of the genes and should not be granted. Patents should be granted only for specified uses or applications of genes or sequences. If composition-of-matter patents on genes continue to be enforceable, such patents on genes with clinical application is should be subject to federal regulation and oversight to ensure availability on reasonable terms for research and clinical use.
新技术以及将研究成果转化为临床医学对患者护理至关重要。那些研发出有用药物、诊断和筛查测试以及医疗技术的人有权期望其付出的努力和承担的风险能得到合理回报。然而,当前对专利法的解释(尤其是关于基因专利)有可能阻碍医学进步和患者护理。专利政策必须在信息的开放交流与使用和让对这类知识的追求获得经济回报之间取得平衡。美国妇产科医师学会伦理委员会和遗传学委员会坚持认为,对医疗或外科手术方法授予专利在伦理上是不可接受的。医生可以为他们研发的外科和诊断器械获得专利,但此类器械应以公平合理的成本提供给他人。将基因作为“物质组合物”授予专利会使专利持有人能够控制基因的未来应用,不应予以批准。仅应为基因或序列的特定用途或应用授予专利。如果对基因的物质组合物专利继续具有可执行性,那么此类具有临床应用的基因专利应受到联邦监管,以确保能以合理条件用于研究和临床使用。