Publication Date
3-17-2022
Document Type
Article
Organizational Units
Sturm College of Law
Keywords
Patent, Thickets, Biologics, Drugs, Biosimilars, Canada, United Kingdom, United States
Abstract
Our study seeks to determine whether patent thickets covering biologic drugs are responsible for delayed biosimilar market entry. We compare patent assertions against the same biosimilar drugs across three countries. On average nine to twelves times more patents were asserted against biosimilars in the United States than in Canada and the United Kingdom. Biosimilars also enter the Canadian and UK markets more quickly than they do in the United States following regulatory approval. Later market entry is not a problem when the brand name drug company is asserting high quality patents (i.e. patents covering significant advances). Consequently, we drilled down into the U.S. patent portfolio of one major biologic, Abbvie’s Humira drug, and found that it was made up of roughly 80% non-patentably distinct (duplicative) patents linked together by terminal disclaimers, which is permitted under USPTO rules. In contrast, there were far less non-duplicative European patents that covered Humira.
Patent thickets can allow brand name drug companies to delay biosimilar entry by relying on the high cost of challenging many duplicative patents instead of the quality of their underlying patents. Accordingly, we suggest several policy interventions that may thin these biologic patent thickets.
Publication Statement
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Originally published as Rachel Goode & Bernard Chao, Biological Patent Thickets and Delayed Access to Biosimilars, An American Problem, 9 J.L. & Biosci. 1 (2022).
Recommended Citation
Rachel Goode & Bernard Chao, Biological Patent Thickets and Delayed Access to Biosimilars, An American Problem, 9 J.L. & Biosci. 1 (2022).