73 Am. U. L. Rev. 395 (2024).

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Abstract

Pharmaceutical product hops are anticompetitive maneuvers that often represent a last-ditch effort by brand manufacturers to preserve market share in the face of generic competition. An integral part of product life cycle management strategies, product hops may offer marginal benefits to patients but can substantially increase costs to payers and patients alike. Industry advocates, however, maintain that product hops represent essential follow-on research and development, resulting in the development of novel products that would otherwise never reach the market. 

Is there a middle ground between these two diametrically opposed views? Might certain product hops be considered beneficial, perhaps if they furthered important public health interests? Sometimes product hops arise due to safety concerns raised by the U.S. Food and Drug Administration or pressure from other public health agencies. For instance, a push from Congress and the U.S. Environmental Protection Agency to remove chlorofluorocarbons from all consumer and industrial products resulted in a switch from chlorofluorocarbon to hydrofluoroalkane propellants in respiratory inhalers. In another instance, concerns about the opioid crisis fueled the development of abuse-deterrent formulations of opioids as part of a public health response to the crisis. Despite the public health motivations driving each scenario, I find that some public benefit may have been achieved, but at substantial expense to both payers and patients.

I explore the potential benefits of a “public health product hop” in more detail using the recent approval of over-the-counter versions of intranasal naloxone as a case study. This Article develops a framework for rewarding product hops that provide a meaningful and quantifiable public health benefit. In these instances, time-limited patent incentives may more equitably reward manufacturers for advancing important public health goals while ending regulatory incentives for purely profit-driven product hops.

* Michael S. Sinha, MD, JD, MPH (michael.sinha@slu.edu) Assistant Professor, Center for Health Law Studies, Saint Louis University School of Law (“SLU LAW’).