大学反对自由研究:生物技术的新同床异梦?

Katherine L Record
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摘要

这篇文章探讨了大学反对对基本基因研究和病人护理侵权责任的拟议法定豁免。基因专利允许专利权人阻止基础基因研究,减缓了开发和管理诊断和基因靶向治疗的进展。关于基因专利的优点的争论一直很激烈,最近导致了几项涵盖与乳腺癌和卵巢癌相关的两种基因的所有变异和使用的广泛专利的前所未有的无效。然而,更重要的是(由于该裁决部分被推翻),拟议的侵权责任的法定豁免。美国卫生与公众服务部的遗传、健康和社会秘书咨询委员会(SACGHS)颁布了一项在研究过程中发生的侵权责任豁免规定。这一豁免将促进基础研究,使学术科学家能够不受限制地获取遗传物质。该提案不会改变基因序列的可专利性;它仅仅限制专利权人使用侵权威胁来停止研究。令人惊讶的是,负责促进大学研究发展的大学技术管理人员协会(AUTM)反对这种豁免。AUTM声称,这种豁免会减少私人公司投资大学实验室上游发现的动力,从而减缓研究。然而,这项豁免将起到相反的作用:通过为与任何基因片段相关的研究打开大门,研究豁免将加速基础研究。此外,它不会影响与私营企业的合作:在有可能将基础研究商业化的地方,生物医学公司将继续授权大学的研究成果。因此,AUTM反对拟议的研究豁免的动机是可疑的。它们似乎要么反映了对授予公共资助的大学研究产权背后的目的的误解,要么反映了与行业目标的不适当一致。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
University opposition to unfettered research: a new bedfellow for biotech?

This Article examines university opposition to a proposed statutory exemption to infringement liability for basic genetic research and patient care. Gene patenting has allowed patentees to bar basic genetic research, slowing the progress of developing and administering diagnostics and gene-targeting therapeutics. Debates over the merits of gene patents have been heated, most recently leading to an unprecedented invalidation of several broad patents covering all variations and use of two genes linked to breast and ovarian cancers. More important, however (as this ruling was reversed in part), are proposed statutory exemptions to infringement liability. The Department of Health and Human Services' Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) has promulgated an exemption from liability for infringement that occurs in the course of research. This exemption would promote basic research by granting academic scientists unfettered access to genetic material. The proposal does not alter the patentability of gene sequences; it merely restricts patentees from using infringement threats to stop research. Surprisingly, the Association of University Technology Managers (AUTM), an organization responsible for promoting development of university research, opposes such an exemption. The AUTM alleges that the exemption would slow research by reducing the incentive for private firms to invest in upstream discoveries made in university laboratories. Yet the exemption would do the opposite: by opening the doors to research relating to any gene segment, a research exemption would accelerate basic research. Moreover, it would not affect collaboration with private industry: where there is potential to commercialize basic research, biomedical companies would continue to license the rights to university discoveries. Thus, the AUTM's motivations in opposing the proposed research exemption are suspect. They appear to reflect either a misunderstanding of the purpose behind granting property rights to publicly funded university research, or an improper alignment with industry goals.

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