The development of CRISPR depends, in part, on the patents-past, present, and future-covering it. As for the past, the origins of the CRISPR patent landscape predate its use as a gene editing technology. Fundamental patents covering CRISPR-Cas9 as a genomic editing system did not first arise until 2012; they sparked the now canonical dispute between the University of California and the Broad Institute. The present dispute has not stopped widespread licensing of critical patents, however, bringing with it an explosion of research from both academic and commercial sectors. Whether this broad availability will persist in the future remains uncertain. The ease and reliability of CRISPR threatens many future patents as being ''obvious.'' Nor is it clear how academic scientists and technology transfer offices will respond to the patent dispute. Like the technology itself, the future of the CRISPR patent landscape depends on researchers and their institutions.
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.
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