Describing Drugs: a Response to Professors Allison and Ouellette

In their article, How Courts Adjudicate Patent Definiteness and Disclosure, John R. Allison and Lisa Larrimore Ouellette present a comprehensive study—thirty years’ worth of cases—of federal courts’ application of patent law’s written-description, definiteness, and enablement requirements. Using their own hand-coded dataset, Allison and Ouellette measure a number of interesting disparities in courts’ application of the two doctrines across various industries and technologies. But one of their results is simply shocking: the massive disparity in how courts apply patent law’s written-description requirement in pharmaceutical cases. In Allison and Ouellette’s study, pharmaceutical patents litigated as part of generic drug manufacturers’ Abbreviated New Drug Applications (ANDAs) before the U.S. Food and Drug Administration (FDA) fare no worse on courts’ written-description analyses than a control, industrial/business goods and services patents. But pharmaceutical