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dc.contributor.authorJordan, Matthewen
dc.contributor.authorLiddicoat, Johnen
dc.contributor.authorLiddell, Kathleenen
dc.date.accessioned2021-04-29T23:30:17Z
dc.date.available2021-04-29T23:30:17Z
dc.date.issued2021-01en
dc.identifier.issn2053-9711
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/321744
dc.description.abstractBiobanks 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.
dc.description.sponsorshipThis work was supported, in part, by a Novo Nordisk Foundation grant for a scientifically independent Collaborative Research Programme in Biomedical Innovation Law (grant agreement number NNF17SA0027784).
dc.format.mediumElectronic-eCollectionen
dc.languageengen
dc.publisherOxford University Press (OUP)
dc.rightsAll rights reserved
dc.titleAn empirical study of large, human biobanks: intellectual property policies and financial conditions for access.en
dc.typeArticle
prism.issueIdentifier1en
prism.publicationDate2021en
prism.publicationNameJournal of law and the biosciencesen
prism.startingPagelsab018
prism.volume8en
dc.identifier.doi10.17863/CAM.68867
dcterms.dateAccepted2021-04-26en
rioxxterms.versionofrecord10.1093/jlb/lsab018en
rioxxterms.versionAM
rioxxterms.licenseref.urihttp://www.rioxx.net/licenses/all-rights-reserveden
rioxxterms.licenseref.startdate2021-01en
dc.contributor.orcidLiddicoat, John [0000-0001-7370-3936]
dc.identifier.eissn2053-9711
rioxxterms.typeJournal Article/Reviewen
pubs.funder-project-idNovo Nordisk Foundation (via University of Copenhagen) (NNF17SA0027784)
cam.orpheus.counter10*
rioxxterms.freetoread.startdate2024-04-29


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