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Title:Patent Law’s Reproducibility Paradox
Author(s):Sherkow, Jacob S.
Subject(s):patent
science
reproducibility
drugs
pharmaceuticals
enablement
utility
intellectual property
clinical tests
Abstract: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.
Issue Date:2017-01-19
Publisher:Duke University Law Journal
Citation Info:Jacob S. Sherkow, Patent Law's Reproducibility Paradox, 66 Duke L.J. 845 (2017)
Genre:Article
Type:Text
Language:English
URI:http://hdl.handle.net/2142/110297
Date Available in IDEALS:2021-08-11


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