The Myth of DNA Trade Secrecy

Are DNA sequences subject to trade secrecy protection? At least three decades of scholarship has assumed so even while there is no explicit statutory authority directly on point and very few reported decisions in the area. And yet, an investigation into the elements of trade secrecy law— read in light of rapid advances in DNA and genomic sequencing—suggests the answer is probably, no. Those advances include the rise of cheap, accurate, easy, fast, and readily available DNA sequencing services, including the recent availability of whole human genome sequencing for less than a monthly cell phone bill. This cuts against some of the elements required for trade secret subject matter, namely, whether the sought-to-be protected information is “readily ascertainable” to the public and whether the information derives “independent economic value” from its secrecy. To date, neither caselaw nor scholarly case studies concerning genomic trade secrets have engaged with these advances. Understanding that much genomic data may not be protectable as a trade secret has several practical consequences, including the difficulty of litigating non-trade secret “stolen data” cases in federal fora; variability in enforcing nondisclosure agreements; and diminished remedies for breaches of confidence. More broadly, seeing that technological advances can upend the protectability of information once thought to be a trade secret yields several theoretical insights. It suggests that trade secrets, like some servitudes, can be terminated when faced with changed conditions. It also suggests that several defenses of trade secrecy—ready accessibility, independent derivation, and reverse engineering—are much closer to one another than typically conceived. And it demonstrates, à la the “comedy of the commons,” that work to remove trade secret protection may benefit both the former trade secret holder and the public at large. The omnipresence of next-generation DNA sequencing should spur a serious reexamination of DNA sequences as trade secrets, a belief that courts, policymakers, and scholars should now recognize is largely a myth

Patent Protection for CRISPR: An ELSI Review

The revolutionary gene-editing technology, CRISPR, has raised numerous ethical, legal, and social concerns over its use. The technology is also subject to an increasing patent thicket that raises similar issues concerning patent licensing and research development. This essay reviews several of these challenges that have come to the fore since CRISPR’s development in 2012. In particular, the lucre and complications that have followed the CRISPR patent dispute may affect scientific collaboration among academic research institutions. Relatedly, universities’ adoption of “surrogate licensors” may also hinder downstream research. At the same time, research scientists and their institutions have also used CRISPR patents to ensure that the technology is used in an “ethical” manner. The review of these discussions concludes with several observations about what the CRISPR patent dispute can teach us, generally, about normative science and patents

Patent Protection for Microbial Technologies

Microbial technologies often serve as the basis of fundamental research tools in molecular biology. These present a variety of ethical, legal and social issues concerning their patenting. This commentary presents several case studies of these issues across three major microbiological tools: CRISPR, viral vectors and antimicrobial resistance drugs. It concludes that the development of these technologies—both scienti cally and commercially—depend, in part, on the patent regime available for each, and researchers’ willingness to enforce those patents against others

Patent Law\u27s Reproducibility Paradox

Clinical research faces a reproducibility crisis. Many recent clinical and preclinical studies appear to be irreproducible; their results cannot be verified by outside researchers. This is problematic for not only scientific reasons but legal ones: patents grounded in irreproducible research appear to fail their constitutional bargain of property rights in exchange for working disclosures of inventions. The culprit is likely patent law’s doctrine of enablement. Although the doctrine requires patents to enable others to make and use their claimed inventions, current difficulties in applying the doctrine mitigate or even actively dissuade reproducible data in patents. This Article assesses the difficulties in reconciling these basic goals of scientific research and patent law. More concretely, it provides several examples of irreproducibility in patents on blockbuster drugs — Prempro, Xigris, Plavix, and Avastin — and discusses some of the social costs of the misalignment between good clinical practice and patent doctrine. Ultimately, this analysis illuminates several current debates concerning innovation policy. It strongly suggests that a proper conception of enablement should take into account after-arising evidence. It also sheds light on the true purpose — and limits — of patent disclosure. And lastly, it untangles the doctrines of enablement and utility

Writing Definitions in Rewriting Nature: Lessons from FDA Law

Paul Enríquez’ book Rewriting Nature fits neatly within what has become a cottage industry of legal takes on genome editing. It is also something that many books in this area are not: fun; an entertaining tromp through a wide variety of legal doctrines and how they relate to this new, powerful technology. Enríquez advocates for “the adoption of a (more) uniform definition of genome editing primarily aimed at building a science-based, legal and policy framework to address current and future predicaments within the ambit of genome-editing technologies.” This essay pushes back on this principal claim with a few lessons from another scientifically complex and highly technical area of law: FDA Law. It begins from Enríquez’ premise that what the law needs at this juncture—or, perhaps, any juncture—is definitional congruity and uniformity. Sometimes definitional uniformity is helpful. But while wanting simplicity in an age of seemingly maximum complexity is admirable, maybe, for the law, universal definitions are too blunt of a cut

Administrating Patent Litigation

Recent patent litigation reform efforts have focused on every branch of govemment-Congress, the President, and the federal courts-save the fourth: administrative agencies. Agencies, however, possess a variety of functions in patent litigation: they serve as gatekeepers to litigation in federal court; they provide scientific and technical expertise to patent disputes; they review patent litigation to fulfill their own mandates; and they serve, in several instances, as entirely alternative fora to federal litigation. Understanding administrative agencies\u27 functions in managing or directing, i.e., administrating, patent litigation sheds both descriptive and normative insight on several aspects of patent reform. These include several problems inherent in patent litigation generally, and ways of fixing them that focus less on the identities or characteristics of litigants and more on agencies\u27 (and courts\u27) institutional incentives. This Article synoptically describes the functions of administrative agencies in patent litigation, elucidates several problems with agencies\u27 operation of those functions, and provides several cheap, easy, and politically viable solutions to better administrating patent litigation

Patent Protection for Microbial Technologies

Microbial technologies often serve as the basis of fundamental research tools in molecular biology. These present a variety of ethical, legal and social issues concerning their patenting. This commentary presents several case studies of these issues across three major microbiological tools: CRISPR, viral vectors and antimicrobial resistance drugs. It concludes that the development of these technologies—both scienti cally and commercially—depend, in part, on the patent regime available for each, and researchers’ willingness to enforce those patents against others

Describing Drugs: A Response to Professors Allison and Ouellette

Profs. Allison and Ouellette’s Article, How Courts Adjudicate Patent Definiteness and Disclosure, 65 Duke L.J.609 (2015), on courts’ adjudication of certain patent disputes presents some surprising data: pharmaceutical patents litigated to judgment fare substantially worse on written-description analyses if they are not part of traditional pioneer-generic litigation. This Response engages in several hypotheses for this disparity and examines the cases that make up Allison and Ouellette’s dataset. An analysis of these cases finds that the disparity can be best explained by technological and judicial idiosyncrasies in each case, rather than larger differences among pharmaceutical patent cases. This finding contextualizes the power and limits of large-scale empirical patent scholarship, like Allison and Ouellette’s, and provides of model for how empirical and doctrinal patent scholarship can complement one another