The Pick-and-Shovel Play: Bioethics for Gene-Editing Vector Patents

56 Pages Posted: 28 Nov 2018 Last revised: 28 Jul 2019

See all articles by Jacob S. Sherkow

Jacob S. Sherkow

New York Law School; Center for Advanced Studies in Biomedical Innovation Law

Christopher Thomas Scott

Baylor University - Center for Medical Ethics and Health Policy

Date Written: June 27, 2019

Abstract

Concerns over patent protection covering new forms of gene-editing have largely focused on the intellectual property covering the editing mechanism itself, most notably CRISPR (clustered regularly interspaced short palindromic repeats), but also ZFNs (zinc finger nucleases) and TALENs (transcription activator-like effector nucleases). Some of the most important technical advances in these areas, however, relate not to these technologies themselves but to vectors — the means for introducing the gene-editing machinery into human cells. In this Article, we discuss the implications of one intellectual property strategy used by some commercial developers of gene- editing vectors: a divided strategy of keeping some of the most significant information about vectors secret while patenting, cryptically, other aspects. We liken this to the business strategy of a “pick- and-shovel play”: using secrecy as informational arbitrage to sell gene-editing’s necessary equipment. Such a strategy raises specific ethical and safety issues pertaining to many gene therapy interventions, namely, the uncertainty of risk, a reliance on insufficient preclinical evidence, the detriment of patient–physician decision-making, and increases in monetary costs. At the same time, these bioethical issues seem to illuminate the importance of patents’ disclosure function to, perhaps surprisingly, consumers, users, and standards developers.

Keywords: Patent, Gene-Editing, IP, CRISPR, ZFN, TALEN, Vector, Cell, Secret, Pick-and-Shovel, Arbitrage, Equipment, Ethics, Bioethics, Gene Therapy, Risk, Preclinical, Informed Consent, Drug Cost, Drug Price, Price, Cost, Disclosure, Consumer, Standards, SEPs, SSO

JEL Classification: K11, K19, K39, O34, K00

Suggested Citation

Sherkow, Jacob S. and Scott, Christopher Thomas, The Pick-and-Shovel Play: Bioethics for Gene-Editing Vector Patents (June 27, 2019). North Carolina Law Review, 2019, vol. 97, pp. 1497–1552. Available at SSRN: https://ssrn.com/abstract=3277536

Jacob S. Sherkow (Contact Author)

New York Law School ( email )

185 West Broadway
New York, NY 10013
United States
212.431.2355 (Phone)

HOME PAGE: http://www.nyls.edu/faculty/faculty-profiles/faculty_profiles/jacob-s-sherkow/

Center for Advanced Studies in Biomedical Innovation Law ( email )

Studiestraede 6
Studiestrade 6
Copenhagen, DK-1455
Denmark

HOME PAGE: http://jura.ku.dk/cebil/staff/

Christopher Thomas Scott

Baylor University - Center for Medical Ethics and Health Policy

1 Baylor Plaza, Suite 310D
Houston, TX 77030
United States

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