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Publication Date

3-15-2026

Abstract

It is undeniable that the escalating price of biopharmaceuticals is a critical issue, as high prices limit patients’ access to life-saving medications and strain our healthcare system. Biologics, or large-molecule drugs, which are revolutionizing modern healthcare, are significantly contributing to the escalating cost of prescription drugs. While biologic drugs represent only 2% of all U.S. prescriptions, they comprise close to 50% of net drug spending.

Policymakers have proposed a series of interventions to decrease drug prices that target the patent practices of pharmaceutical firms. Yet due to differences in law, we have a robust source of patenting information for small-molecule drugs and a woefully incomplete source of patenting information for biologics. As a result, policymakers are attempting to solve a problem without understanding the patenting landscape of biologics, which comprises the most expensive segment of the prescription drug market.

To fill this gap, we build the first comprehensive patent database associated with all 515 Food and Drug Administration approved biologics, which comprises over 11,500 patents. We then utilize our novel database to examine the controversial patenting practices of pharmaceutical firms.  We find that both patent thicketing—building a dense web of patents for each drug—and patent evergreening—extending the exclusivity period of a drug by obtaining more patents—are significantly more prevalent with biologics than small-molecule drugs. We also find that patents are more effective at delaying biosimilar entry in the biologic market than generics in the small-molecule market. Finally, we utilize our novel database to evaluate various policy proposals aimed at decreasing patent thickets and provide much needed empirical evidence at how many biological patents these proposals would affect.

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