A hidden technological assumption in patent law: The case of gene patents and the disclosure requirement

• Date: 01 November 2019
• DOI: http://doi.org/10.1111/jwip.12130
• Published date: 01 November 2019
• Author: Or Cohen‐Sasson

© 2019 The Authors. The Journal of World Intellectual Property © 2019 John Wiley & Sons Ltd

J World Intellect Prop. 2019;22:272–288.272

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wileyonlinelibrary.com/journal/jwip

DOI: 10.1111/jwip.12130

ORIGINAL ARTICLE

A hidden technological assumption in patent law:

The case of gene patents and the disclosure

requirement

Or Cohen‐Sasson

The Buchmann Faculty of Law, Tel‐Aviv

University, Tel‐Aviv, Israel

Correspondence

Or Cohen‐Sasson, The Zvi Meitar Center,

Faculty of Law, Tel‐Aviv University, Ramat

Aviv, 6997801 Tel‐Aviv, Israel.

Email: cohensasson@mail.tau.ac.il

Abstract

The disclosurerequirement in patent lawis designed to reveal

knowledge regarding a patented invention to allow proper

understanding and utilization of that invention. The conten-

tion offered here is the presence of an inherent incompat-

ibility between the disclosure requirement and genetic

inventions. Genetic inventions are highly contingent on big

genetic statistical data (GSD), which is gathered during the

commercial phase of a genetic invention. GSD are essential

for various purposes, which at least some should be satisfied

by the disclosure. However, since GSD can be gathered only

at the postapplication period, GSD are not disclosed through

the disclosure requirement. Therefore, there is a disclosure‐

genetics incompatibility. This incompatibility prevents patent

law from fully accomplishing its intendedpurpose. The origins

of this incompatibility can be traced to the structure of the

disclosure requirement, a consequence of a hidden techno-

logical assumption in patent law regarding the very percep-

tion of what is an invention. Patent law perceives all

inventions as fully revealed objects and not as semirevealed

objects. That creates a difficulty that may be more pervasive

than for genetics alone. Thus, acknowledging this technolo-

gical assumption facilitates the introduction of an insight

regarding thefully revealed/semirevealed spectrum regarding

inventions in other, nongenetic technological fields.

KEYWORDS

data, gene patents, genetic resources, genomics, patents

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INTRODUCTION

The disclosure requirement in patent law is designated to reveal knowledge regarding a patented invention to allow

proper understanding and utilization of the invention.

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I argue that there is an inherent incompatibility between

patent law’s disclosure requirement and genetic inventions, an incompatibility which prevents patent law from fully

accomplishing its desired objectives. The incompatibility’s origins lay in the architecture of the disclosure

requirement; this architecture is the outcome of a hidden assumption in patent law regarding the very idea of what

comprises an invention. Considering this technological assumption, it seems that the problem is more general and

not limited to genetics. In light of the exposure of the technological assumption, I offer an insight regarding fully

revealed and semirevealed environments.

The following illustration should help clarify the presented argument. When BRCA genetic testing was first

marketed, Variants of Uncertain Significance (VUS)—genes’versions whose correlation with cancer is unknown—

were found in 10–15% of the cases. As more patients were tested, more genetic statistical data (GSD) were

collected. With a proprietary database of about 14,000 variants, the rate of VUS dramatically plunged to 2.5%

(Bellcross, 2014; Chen & Parmigiani, 2007; Sluiter & Van Rensburg, 2011, p. 211). The patent rights granted Myriad

the exclusive right to gather these data (Simon, 2011, pp. 1310–1311). Other genetic laboratories that do not hold

GSD are unable to use the invention in the same way, certainly not effectively, even after the patent expires or has

been invalidated. Considering these facts, it is not surprising that Myriad dominated the market even after the

patent period. The vast database Myriad has retrieved, owing to the patent monopoly, enables it to understand and

utilize the very same genetic invention differently than others (Begley, 2016; Myriad Genetics, 2017; Ray, 2013).

The cited case reflects a more profound incompatibility between the disclosure requirement and genetic

inventions. Disclosure is a means to disseminate adequate knowledge for properly understanding and utilizing an

invention. Society pays for this precious knowledge with exclusive rights. However, unfortunately, as shown in the

case of Myriad, the disclosure does not satisfy its objective. In fact, patent law assists the patentee to conceal

pertinent knowledge from the public. Hence, the question remains: does patent law truly serve society when

applied to gene patents? Does patent law deliver on its promises?

The current study focuses on American patent law and examines whether the disclosure requirement reveals

adequate knowledge regarding a patented genetic invention. The study refers to and scrutinizes the literature,

principles, and practices in the field of genetics, especially regarding GSD. Integrating knowledge from the field of

genetics allows this study to offer a more nuanced, accurate, and reality‐based portrayal. Furthermore, the study

harnesses the theories behind the disclosure requirement to conclude whether gene patents allow the absence of

specific knowledge required for proper disclosure.

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THE DISCLOSURE REQUIREMENT: HISTORY, THEORY, AND POLICY

This section presents historical and theoretical aspects of the disclosure requirement to lay the foundation for

subsequent discussion regarding patent disclosure. I describe the disclosure requirement and its doctrines in

American patent law, focusing on its objectives. I address the primary justifications of the disclosure requirement as

an obligation that is part of the social bargain and that is also based on economic efficiency perspectives. Tracing

the essence of the disclosure requirement allows us to address the incompatibility between genetic inventions

and the disclosure requirement, to be presented in Section 3.

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Historical background: The patent system as an evolving system

In this section, I briefly sketch the history of the disclosure requirement and emphasize the evolutionary progress

it has undergone from the 17thcentury until today.I rely mostly on secondarysources and focus on theUnited States.

COHEN‐SASSON

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