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Abstract

Some drug companies, brand biologic companies, in particular, have been accused of covering only a single drug with more than eighty patents. These drug patents accumulate to what critics claim as one of the major culprits of high drug prices— “patent thickets.” However, current literature mostly focuses on the substantial patent counts and less on the characteristics and the causes of these patent thickets; but to effectively understand and tackle this issue, more thorough discussions are necessary. This article aims to provide further insight into this issue by analyzing and comparing the U.S. patents that cover top-selling biologics and small-molecule drugs. Results not only confirm the existence of biologic patent thickets—in which two of the three selected top-selling biologics have accumulated more than forty patents— but also show that more patents cover biologics than small-molecule drugs. Based on more in-depth analysis, this article further argues that the so-called “patent thicket” is, in fact, a cooperative effort of two types of patent thickets—Type I and Type II—that should be distinguished due to their differences in nature and the causes that give rise to them. Defined as large numbers of non-overlapping or inventive patents that cover different aspects of the drug, Type I Patent Thickets are formed due to the complex nature of biologics and biosimilars. Type II Patent Thickets, on the other hand, are arguably overlapping or non-inventive patents that are prone to double patenting. They cover the same aspect of the drug and owe their existence to the utilization of terminal disclaimers. The two types of patent thickets jointly contribute to the large number of patents that fend off patent challenges; the stretched year spans of collective patent terms that delay biosimilar entry; and the exorbitant drug prices that harm patients. In order to prevent the negative impacts of patent thickets without completely sacrificing the merits patents themselves provide, this article presents two proposals: one being the election of patents to assert to mitigate the adverse effects of Type II Patent Thickets, and the other being a more transformative reform that would target against both types of patent thickets.

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