Governance Choices of Genome Editing Patents

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.NHGRI T32HG009496Ope