Licensing and Innovation in Genetics and Genomics

描述（由申请人提供）：社会历史上受益于研究型大学和联邦机构，如美国国立卫生研究院通过研究成果的自由和公开交流的创新能力。然而，近年来，一个越来越常见的传播研究成果的机制是通过机构与产业之间或研究人员之间的合同协议。这种新的交换模式将研究视为一种知识产权，而不是一种知识共享，因为它具有真实的或被认为是一种收入来源的潜力。这个学术资本主义的新时代（Slaughter & Leslie，1997）在研究文献中受到越来越多的关注。一些人认为，它有助于创新向市场的扩散，学术专利和大学-行业合作伙伴关系的急剧增加以及重组DNA，紫杉醇和顺铂等成功案例就是证明。另一些人则表示担心，契约性的、增加收入的交换模式会破坏科学事业，并可能减缓创新的传播。教师和机构利益冲突的案例经常被引用为证据，获得专利和许可技术用于研究目的的挑战的故事也是如此。本研究旨在实证研究学术资本主义对创新扩散的影响，在一个震中的辩论-典型的基本遗传/基因组技术的独家许可。使用多个合同交易数据，包括来自SEC文件和其他跟踪大学和联邦生物技术许可协议的专业公司的数据，本研究的具体目的是： 1.识别并记录学术和联邦许可实践（即，专利权、使用领域、分许可和通过条款及相关实践达到的范围）向产业提供遗传/基因组诊断、治疗和研究工具技术。 2.检验一个理论模型，该模型分析了专利授权的排他性、技术来源以及技术创新潜力对创新扩散、后续研究和后续专利申请这两个指标的偶然性影响。 迄今为止，还没有进行过关于专利许可对创新的影响的国家研究。然而，确定学术和联邦许可做法的性质及其对后续创新扩散的影响是促进公共卫生的核心。这项研究有助于为政策和实践提供信息，以最好地管理和促进遗传/基因组创新的传播。

DESCRIPTION (provided by applicant): Society has historically benefited from the innovative capacity of research universities and federal agencies such as the NIH via the free and open exchange of research findings. In recent years, however, an increasingly common mechanism by which research is disseminated is via contractual agreements between institutions and industry or among researchers themselves. This new exchange model treats research as an intellectual property rather than an intellectual commons given its real or perceived potential as a source of revenue. This new era of academic capitalism (Slaughter & Leslie, 1997) is receiving growing attention in the research literature. Some have argued that it has aided the diffusion of innovation to the marketplace as evidenced by a steep increase in academic patenting and university-industry partnerships as well as success stories such as Recombinant DNA, Taxol, and Cisplatin. Others have expressed concern that a contractual, revenue enhancement model of exchange undermines the science enterprise and may slow the diffusion of innovation. Case examples of faculty and institutional conflicts of interest are often cited as evidence as are stories of access challenges to obtaining patented and licensed technologies for research purposes. This study seeks to empirically investigate the effects of academic capitalism on innovation diffusion at one epicenter of the debate - the exclusive licensing of typically basic genetic/genomic technologies. Using multisource contract deal data including from SEC documents and other specialized firms that track university and federal biotechnology licensing agreements, the specific aims of this study are: 1. To identify and to document academic and federal licensing practices (i.e., exclusivity, fields of use, sublicensing and reach through provisions, and related practices) to industry for genetic/genomic diagnostic, therapeutic, and research tool technologies. 2. To test a theoretical model of the effect of licensing exclusivity, technology source, and the contingency effect of technology innovation potential on two measures of innovation diffusion, follow-on research and follow-on patenting. To date, no national study of licensing exclusivity effects on innovation has been conducted. Yet, identifying the nature of academic and federal licensing practices as well as its effects on follow-on innovation diffusion is central to the advancement of public health. This study can help to inform policy and practice around how to best manage and to facilitate the diffusion of genetic/genomic innovations.