Licensing and Innovation in Genetics and Genomics

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:
-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.
-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.