The Hatch-Waxman Act of 1984 ushered in a new era of affordable medicine, with 90% of all prescriptions today filled with generic drugs. Hatch-Waxman provided an expedited pathway for generic entry and mandated that the FDA publish up-to-date information on patent information related to non-biologic drugs. That publication is known as the Orange Book.
Roughly twenty-five years later, the Biosimilars Act similarly aimed to facilitate the entry of less-expensive versions of biologics, which are more complex drugs made by living systems. Information related to biologics and biosimilars is published in what is known as the Purple Book. Biosimilars, however, have captured less of the biologic market and have reduced prices to a lesser extent than generic non-biologic drugs.
To explore the biosimilars system’s shortcomings, this Article uses the case study of insulin drugs, which are popular biologics. Insulin offers a natural experiment, given that these drugs were originally listed in the Orange Book before moving to the Purple Book, in 2020. Comparing the intellectual property data available for insulin in both books reveals the surprising dearth of patent information disclosed in the Purple Book.
* Arthur J. Goldberg Distinguished Professor of Law, Albert Abramson ‘54 Distinguished Professor of Law Chair, Director of the Center for Innovation (C4i), University of California Law, San Francisco.
** Director, Law & Medicine Initiative, and Senior Research Scholar, Center for Innovation (C4i), University of California Law, San Francisco. We are grateful to Ramy Alsaffar, Sunnie Liu, Maisam Goreish, Oriana Tang, and Tanziuzzaman Sakib for research assistance. We are also tremendously grateful to the Laura and John Arnold Foundation, whose generous grant helped support the research in this area. The title of this Article is derived from the title of the book and television program “Orange Is the New Black.” For similar uses of that title, see Anthony Sabatelli & Cambria Alpha-Cobb, Will Purple Become the New Orange?, 4 Pharm. Patent Analyst 63 (2015); April Abele Isaacson & Yifan Mao, Is Purple the New Orange?, Kilpatrick (Feb. 19, 2021), https://kilpatricktownsend.com/en/Blog/MEMO/2021/2/Drug-to-Biologic-Transition—Is-Purple-The-New-Orange [https://perma.cc/SJQ6-S7MV].
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