The NBER Orange Book Dataset: A user's guide.

This paper introduces a newly digitized, open-access version of the Food and Drug Administration's "Orange Book"-a linkage between approved small-molecule drugs and the patents that protect them. The Orange Book also reports any applicable regulatory exclusivity that prevents competitive entry. We summarize the Orange Book's coverage and discuss the opportunities and challenges associated with using these data for research. Empirical validations against various administrative datasets suggest that Orange Book records are, largely, complete and accurate. We conclude with a specific use case-calculating legal exclusivity periods for drugs-to highlight the types of choices that researchers must make when using this resource.

Déclaration de conflit d'intérêts

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: C. Scott Hemphill reports that he “has at various times served as an expert witness in litigation involving Orange Book-listed patents”. This relationship includes: paid expert testimony. Bhaven Sampat reports that he “has served as a consultant in litigation on issues relating to pharmaceutical patenting and innovation and to the Medicines Patent Pool for work on patents and access to medicines”. This relationship includes: consulting or advisory.