Thinning Biologics Patent Thickets

For decades, pharmaceutical manufacturers have employed strategies to protect their drug monopolies, preventing the entry of competitors and maintaining high drug prices. One of the strategies pharmaceutical manufacturers, particularly biologics manufacturers, have used to maintain market exclusivity and thwart competition has been patent thickets.&nbsp; <br><br>Biologics patent thickets are created when manufacturers accumulate many patents-sometimes in the hundreds-on one drug product. Patent thickets serve two purposes. First, they provide extended patent exclusivity for the biologic, delaying the possibility of biosimilar competition. Second, they raise the transaction costs for prospective biosimilar entrants, as the associated patent infringement litigation is expensive and it can be difficult to determine if biosimilar competitors would be infringing on any of the numerous patents in the thicket. As a result, patent thickets maintain high drug prices, raise barriers for patient access, and increase healthcare spending. Further, patent thickets may have unintended consequences on pharmaceutical innovation, preventing and incremental innovation in biologics.&nbsp;<br><br>Lawmakers and advocates have called for interventions to stem the frequency of patent thickets in the pharmaceutical market. Yet several barriers have impeded efforts to dismantle patent thickets through litigation or to deter their development through reforms. In particular, the regulatory dynamics within the pharmaceutical industry, especially related to the US Food and Drug Administration (FDA), change how the incentives of patent exclusivity work&nbsp;compared to other industries. These regulatory challenges both highlight the underlying problem encouraging patent thickets and point to solutions to promote access to medicines and biosimilar competition. <br><br>This Article engages with the existing FDA regulatory incentives and dynamics to frame the debate surrounding biologics patent thickets, focusing on the goals of promoting access to medicines and biosimilar competition. It illustrates why biologics patent thickets are a problem, characterizing the suboptimal regulatory, innovation, and public health incentives present in the current system, and identifies the legal, regulatory, and practical barriers impeding potential and proposed reforms. This Article then presents potential solutions to address biologics patent thickets and recommends a change to the rights granted by FDA approval – requiring manufacturers permit biosimilar competition after the end of their regulatory exclusivities. Such a solution could accelerate biosimilar competition, promote access to affordable medications, and recalibrate the current innovation and patent incentives for biologics.