Document Type

Article

Publication Date

2024

Abstract

The Food and Drug Administration (“FDA”) and U.S. Patent and Trademark Office (“USPTO”) play complementary roles in driving pharmaceutical innovation. Yet, for the most part, the agencies conduct their affairs without regard for one another. Recent calls for a “whole of government” approach to reduce this departmentalism have led to only modest initiatives. Collectively, the FDA and USPTO have announced mandates that they have no intention of enforcing; conducted cross- training in topics that their employees will most likely never use; and resisted proposed legislation that would formalize their relationship.

Current agency intransigence represents a lost opportunity to further the goals of the Hatch–Waxman Act: encouraging the labors that lead to pharmaceutical innovation, while also distributing the fruits of those labors to the public through low-cost, generic medications. At a minimum, agency cooperation could lead to consistent and accurate terminology. The FDA and USPTO should coordinate their policies toward adjusting patent terms to account for regulatory delays. They should also act jointly to enhance the Orange Book, an FDA publication that in part acts as a clearinghouse for pharmaceutical patents. The USPTO should issue patents along the lines of the inventive categories identified with the Hatch–Waxman Act. For its part, the FDA ought to take advantage of USPTO resources to maintain the integrity of the Orange Book by striving toward accurate patent listings.

The FDA’s anomalous “use code” practice deserves reconsideration. The FDA does not assess the scope of patents claiming methods of medical treatment based on the instrument the USPTO granted. Rather, it relies upon brand-name drug companies to characterize these patents using 250 characters or less. Use codes defy foundational patent law principles and have been prone to abuse. This dubious approach to complex legal texts approved by a peer agency should be modified or abolished.

The FDA and USPTO are also well-positioned to consider the idiosyncratic and possibly unbalanced practices of pharmaceutical patent enforcement. During these cases, which for the most part arise in just 2 of the 94 federal districts in the United States, generic drug companies must explain at the outset why they don’t infringe— even though the patent proprietor bears the burden of proving infringement. Congress also afforded brand-name drug companies the ability to sue a dozen or more generic drug companies in one courtroom at one time, for no other reason than that they allegedly infringe the same patent. These and other litigation practices bear reassessment.

Finally, the USPTO routinely issues patents with dozens or hundreds of claims. It also issues multiple patents covering the same drug. Such prolix USPTO work product has resulted in coping strategies by courts, which must encourage or cajole patent proprietors into choosing just a few of these claims to be subject to adjudication. That so many pharmaceutical patent claims remain unadjudicated breeds uncertainty, particularly with respect to FDA administration of regulatory exclusivities. These issues should be addressed through changes to agency practice or to the wording of the Hatch–Waxman Act.

Publication Citation

Arizona Law Review, Vol. 66, Issue 4, Pp. 1021-1065.

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