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An empirical study of large, human biobanks: intellectual property policies and financial conditions for access

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Jordan, M, Liddicoat, J ORCID: 0000-0001-7370-3936 and Liddell, K 2021 , 'An empirical study of large, human biobanks: intellectual property policies and financial conditions for access' , Journal of Law and the Biosciences, vol. 8, no. 1 , pp. 1-32 , doi: 10.1093/jlb/lsab018.

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Abstract

Biobanks are repositories that collect, store and distribute large quantities of biological samples and associated data (collectively called biobank `material'). Although biobanks have different modes of operation, all face a variety of similar challenges. Some of these challenges, such as donor consent and privacy, have been rigorously debated, but comparatively less attention has been paid to biobanks' intellectual property (IP) practices. IP rights (particularly patents) are integral to the translation of research into clinically relevant outcomes and, therefore, are key features in the business models of many biobanks. As a foundation for such research, commentators have identified five IP clauses of interest: (i) non-obstruction clauses; (ii) march-in clauses; (iii) grant-back clauses; (iv) return-of-results clauses and (v) reach-through clauses (also commonly called `reach-through rights'). In the limited literature that discusses the five clauses, commentators have largely debated their advantages and disadvantages in the abstract. The IP terms that biobanks actually use have not been empirically examined, apart from some small case studies. In particular, no industry-wide evidence exists on three points of biobanks' IP practice: (i) if and how biobanks implement these five types of IP clauses, (ii) whether any norms or standards have emerged, and (iii) whether the norms and standards align with commentators' recommendations for using the five IP clauses. To address these three gaps, the authors conducted a systematic, global survey of the IP clauses used by large, human biobanks. The results indicate that biobanks draft bespoke policies to meet their own needs, and probably do so without knowledge of the gamut of IP terms available. This study also revealed that, in general, biobanks are using IP terms differently from the advice of the commentators. On reviewing the differences, we encourage the use of march-in and grant-back clauses, discourage biobanks from using redundant non-obstruction clauses, and call for more research on return-of-results clauses. We also encourage the use of reach-through clauses to claim royalties (not IP), but only in limited circumstances; for example, where user access fees do not cover a biobanks' operational costs.

Item Type: Article
Authors/Creators:Jordan, M and Liddicoat, J and Liddell, K
Keywords: biobank, intellectual property, access terms
Journal or Publication Title: Journal of Law and the Biosciences
Publisher: Oxford University Press
ISSN: 2053-9711
DOI / ID Number: 10.1093/jlb/lsab018
Copyright Information:

© The Author(s) 2021. Published by Oxford University Press on behalf of Duke University School of Law, Harvard Law School, Oxford University Press, and Stanford Law School. All rights reserved. This is an Open Access article distributed under the terms of the Creative Commons Attribution NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) license,(http://creativecommons.org/licenses/bync-nd/4.0/),which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited.

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