Patent Law's Reproducibility Paradox
67 Pages Posted: 22 Feb 2016 Last revised: 23 Jan 2017
Date Written: January 19, 2017
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.
Keywords: patent, science, reproducibility, drugs, pharmaceuticals, enablement, utility, intellectual property, clinical tests
JEL Classification: K11, K19, K39, O34, K00
Suggested Citation: Suggested Citation