Academic Medical Centers as Innovation Ecosystems: Evolution of Industry Partnership Models Beyond the Bayh–Dole Act

Abstract

Innovation ecosystems tied to academic medical centers (AMCs) are inextricably linked to policy, practices, and infrastructure resulting from the Bayh-Dole Act in 1980. Bayh-Dole smoothed the way to patenting and licensing new drugs and, to some degree, medical devices and diagnostic reagents. Property rights under Bayh-Dole provided significant incentive for industry investments in clinical trials, clinical validation, and industrial scale-up of products that advanced health care. Bayh-Dole amplified private investment in biotechnology drug development and, from the authors' perspective, did not significantly interfere with the ability of AMCs to produce excellent peer-reviewed science. In today's policy environment, it is increasingly difficult to patent and license products based on the laws of nature-as the scope of patentability has been narrowed by case law and development of a suitable clinical and business case for the technology is increasingly a gating consideration for licensees. Consequently, fewer academic patents are commercially valuable. The role of technology transfer organizations in engaging industry partners has thus become increasingly complex. The partnering toolbox and organizational mandate for commercialization must evolve toward novel collaborative models that exploit opportunities for future patent creation (early drug discovery), data exchange (precision medicine using big data), cohort assembly (clinical trials), and decision rule validation (clinical trials). These inputs contribute to intellectual property rights, and their clinical exploitation manifests the commercialization of translational science. New collaboration models between AMCs and industry must be established to leverage the assets within AMCs that industry partners deem valuable.

Modernize the academic medical center through innovation career pathways

“…Prior to 1980, the government owned patents resulting from federally funded projects and policy required non-exclusive licensing; thus, there was little incentive for the private sector to make significant investments in clinical trials or the development of novel clinical technologies taking place at AMCs. However, the Bayh-Dole Act shifted the management of resulting research assets to the awardee institution; this gave rise to technology transfer offices within AMCs and provided significant financial incentive for private industry to invest in the translation of scientific discoveries from AMCs into frontline health solutions (Silva & Ramos, 2018). The Bayh-Dole Act is the impetus for healthcare innovation as we know it today, and from this perspective, innovation within AMCs should be viewed as both a strategic driver of institutional value, as well as a societal imperative to ensure that federally funded research projects translate to frontline care improvements.…”

Plastic Surgeons as Medical Directors: A Natural Transition into Medical Leadership

“…Medical advancements in the forms of research and technological innovation are the driving forces behind improving the way medicine is practiced throughout the world. 33 While many ideas with the potential to change medicine are generated by innovative minds, most remain a concept and never come to fruition. Many of these innovative thinkers lack the capital or infrastructure to conduct research or develop products.…”

The valorization of non-patent intellectual property in academic medical centers

“…In the early 2000’s, AMC innovations included some notable vaccines, specifically those preventing human papilloma virus (HPV) and rotavirus infections. Silva and Ramos ( 2018 ) suggest that vaccines originating from AMCs may be the logical result of the vast amount of host-pathogen knowledge generated by decades-long basic and translational studies, borne from single investigators scientific programs in AMCs; activities not frequently pursued by commercial interests (AAUP 2014 ), rather than from the presence of technology transfer offices. Again, it is notable that the top academic inventors were small in number and worked collaboratively in one center.…”

“…With notable exceptions, AMCs have typically not excelled in advancing commercial products. Indeed, the Association of University Technology Managers often notes gaps between research expenditures and commercialization success metrics such as licensing revenue and businesses creation (Silva and Ramos 2018 ).…”