title: Patent Law's Reproducibility Paradox.
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 also 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 hamper 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.
authors.affiliation: Innovation Center for Law and Technology, New York Law School.
authors.forename: Jacob S
authors.initials: JS
authors.lastname: Sherkow
mesh_terms: D000068258:Bevacizumab; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data; D030881:Disclosure; D004338:Drug Combinations; D055808:Drug Discovery / Q000331:legislation & jurisprudence*; D004966:Estrogens, Conjugated (USP); D006801:Humans; D017258:Medroxyprogesterone Acetate; D010330:Patents as Topic / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data; D000071220:Pharmaceutical Research / Q000331:legislation & jurisprudence*; D011486:Protein C; D011994:Recombinant Proteins; D015203:Reproducibility of Results; D012107:Research Design; D013988:Ticlopidine / Q000031:analogs & derivatives; D014481:United States
chemical_list: D004338:Drug Combinations; D004966:Estrogens, Conjugated (USP); D011486:Protein C; D011994:Recombinant Proteins; D000068258:Bevacizumab; D017258:Medroxyprogesterone Acetate; D013988:Ticlopidine