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.

DIY COVID-19 vaccines raise legal and ethical questions.

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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In September 2020, a detailed report on Heritable Human Genome Editing was published. The report offers a translational pathway for the limited approval of germline editing under certain circumstances and assuming various criteria have been met. In this perspective, three dozen experts from the fields of genome editing, medicine, bioethics, law, and related fields offer their candid reactions to the National Academies/Royal Society report, highlighting areas of support, omissions, disagreements, and priorities moving forward.

The World Health Organization’s recent Report on Human Genome Editing departs from similar reports from other institutions in that it recognizes that ethical assessments of the technology are deeply complex, surprisingly fragile, and subject to practical and political considerations. The WHO report largely recommends that human genome editing, rather than being accepted in some circumstances and banned in others, should be handled with care. The report recommends some oversight mechanisms—such as intellectual property licensing—previously undiscussed or underexplored in sister reports, and it recognizes that others—like international law—may be impractical. This essay explores how the report has shifted global considerations of governing human genome editing to more pragmatic ends.

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There are a variety of governance mechanisms concerning the ownership and use of patents. These include government licenses, compulsory licenses, march-in rights for inventions created with federal funding, government use rights, enforcement restrictions, subject-matter restrictions, and a host of private governance regimes. Each has been discussed in various contexts by scholars and policymakers and some, in some degree, have been employed in different cases at different times. But scholars have yet to explore how each of these choices are subject to—or removed from—democratic control. Assessing the range of democratic implications of these patent governance choices is important in understanding the social and political implications of controversial or wide-ranging technologies because their use has a significant potential to affect the polity. This paper seeks to unpack these concerns for genome editing, such as CRISPR, specifically. Patents covering genome editing make an interesting case because, to date, it appears that the polity is concerned less with certain kinds of access, and more with distribution and limits on the technology’s particular uses, such as human enhancement and certain agricultural and environmental applications. Here, we explore what it means for patents to be democratic or non-democratically governed and, in so doing, identify that patents covering many of the most controversial applications—that is, ones most likely to gain public attention—are effectively controlled by either non- or anti-democratic institutions, namely, private restrictions on licensing. This may be effective—for now—but lawmakers should be wary that such restrictions could rapidly reverse themselves. Meanwhile, other choices, like compulsory licenses, more broadly touch on democratic deliberation but, as currently structured, are aimed poorly for particular applications. Insofar as the public wants, or perhaps deserves, a say in the distribution and limits of these applications, illuminating the ways in which these governance choices intersect—or fail to intersect—with democratic institutions is critical. We offer some concluding thoughts about the nature of patents and their relationship with democratic governance as distributed claims to authority, and suggest areas for scholars and policymakers to pay close attention to as the genome editing patent landscape develops.