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 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

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

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

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

Patent Law’s 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 also 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 hamper 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

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

The Science of Substitution: A Response to Carrier and Minniti

In Biologics: The New Antitrust Frontier, Michael A. Carrier and Carl J. Minniti provide an overview of potential antitrust harms in the newly enacted biologic drug approval and litigation regime, the Biologics Price Competition and Innovation Act (“BPCIA”). Importantly, Carrier and Minniti suggest that the scientific complexity of biologic products has the potential to make some litigation conduct that is typically anticompetitive more or less so, given uncertainties surrounding regulatory approval and patent infringement. This response advances Carrier and Minniti’s thesis, suggesting the authors do not take it far enough for their assessments of reverse payment settlements, submarine patenting, and citizen petition abuse. It also makes use of two important court decisions, Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664 (2017)and Amgen Inc. v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017) decided after Carrier and Minniti’s article went to press. Regardless of whether Carrier and Minniti’s predictions come to pass, their core insight—that scientific complexity can regulate antitrust harms—provides a key area of future exploration for practitioners, scholars, and policy makers alike