Models of Technology Transfer for Genome-Editing Technologies

Abstract

Many of the fundamental inventions of genome editing, including meganucleases, zinc finger nucleases (ZFNs), transcription activator-like effector nucleases (TALENs), and CRISPR, were first made at universities and patented to encourage commercial development. This gave rise to a diversity of technology transfer models but also conflicts among them. Against a broader historical and policy backdrop of university patenting and special challenges concerning research tools, we review the patent estates of genome editing and the diversity of technology transfer models employed to commercialize them, including deposit in the public domain, open access contracts, material transfer agreements, nonexclusive and exclusive licenses, surrogate licenses, and aggregated licenses. Advantages are found in this diversity, allowing experimentation and competition that we characterize as a federalism model of technology transfer. A notable feature of genome editing has been the rise and success of third-party licensing intermediaries. At the same time, the rapid pace of development of genome-editing technology is likely to erode the importance of patent estates and licensing regimes and may mitigate the effect of overly broad patents, giving rise to new substitutes to effectuate commercialization. Expected final online publication date for the Annual Review of Genomics and Human Genetics, Volume 21 is August 31, 2020. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

The Emergence of Genome Editing—Innovation Network Dynamics of Academic Publications, Patents, and Business Activities

“…Knowledge-intensive fields such as genome editing and biotechnology require a broad and strong boundary spanning (interdisciplinary) scientific base; hence, companies will engage in joint R&D efforts with academia ( Akbar et al, 2012 ; Golembiewski et al, 2015b ; Lokko et al, 2018 ). The development of the CRISPR/Cas9 technology clearly benefited from the engagement of academic institutions and individuals in the commercialization of their ideas, as was shown in other areas before ( Etzkowitz, 2012 ; Wu et al, 2018 )—and is likely to be shaped by these in the future ( Graff and Sherkow, 2020 ; Whelan et al, 2020 ). This is visible in our analysis of public–private networks throughout the layers.…”

“…The emergence of genome editing, especially after discovering the CRISPR/Cas9 methodology, resulted in very complex horizontal networks in academia and patents—that reflect also the great diversity of technology transfer models in this technological system ( Graff and Sherkow, 2020 ). Therapeutics and medical solutions are currently the most relevant field for genome editing applications, as our analysis of the patent data and the major company clusters show.…”

“…Patent analysis of specific application areas points toward future increase in technological development ( Gupta et al, 2020 ) and already identified some key players connected to the patent licensing of major scientists involved, including the recent Nobel laureates ( Egelie et al, 2016 ). However, a systemic change is only possible if new potential technologies diffuse from scientific knowledge into the market applications and efficient transfer systems are established ( Geels and Schot, 2010 ; Vandermeulen et al, 2012 ; Graff and Sherkow, 2020 ). Especially when emerging technologies have the potential to change different areas such as agriculture and medicine, the dynamics of the innovation networks from science to business can reach a high level of complexity ( Golembiewski et al, 2015a ).…”

Genome editing and its applications in genetic improvement in aquaculture

“…The aquaculture industry, farmers and scientists should learn from the experiences of patenting new breeds/ verities/lines in agronomic plants 129 and livestock. 130,131 Certainly, it is highly possible that different countries and regions may have different opinions on patenting GE technologies and products generated by GE. 132…”

Governance Choices of Genome Editing Patents

“…The largest divide, perhaps (at least in terms of access and distribution to a given patented technology) is whether the license is exclusive or nonexclusive—that is, whether the technology will be licensed exclusively to a single other entity or broadly licensed among a variety of market participants. But there are, to be sure, various gradations in between ( Graff and Sherkow, 2020 ).…”