Patent Term Extension and the Active Ingredient Problem

Patent Term Extension and the Active Ingredient Problem

Journal article

39 pages

Patent term extension (PTE) is a statutorily-based mechanism to compensate inventors for patent term loss due to regulatory delay during the drug approval process at the United States Food and Drug Administration (FDA). In the context of pharmaceutical products, PTE is only available for the active ingredient of a drug formulation. Case law and interpretation of the relevant statutory text have clearly delineated the boundaries of what qualifies as an active ingredient in a chemical formulation for purposes of PTE. As therapeutics expand beyond simple chemical formulations into cell-based and gene therapy-based formulations, where a chemical compound is not the active ingredient, an interpretation of active ingredient for purposes of PTE is lacking. I term this shortcoming “the active ingredient problem.” In the absence of applicable case law, it has become increasingly important to review FDA guidance and recommendations. Furthermore, the United States Patent and Trademark Office (USPTO) has offered limited indications of how it may interpret active ingredients in these scenarios. Moving forward, it will be essential for inventors to understand how these cutting- edge therapeutics will be protected and how their efforts will be compensated as a result of delays associated with the regulatory approval process. In this paper, I advocate the adoption of “treatment complex protocols” or TCPs, a novel framework for PTE for cellular and gene-based therapeutics. This framework moves away from considerations of an active ingredient and instead embraces the complexities of the production and development of cellular and gene-based therapies. Under this framework, PTE would be granted to a TCP, which is a complete protocol-based description of the inputs, modifications, and outputs required to develop these complex and clinically important therapeutics. Although TCPs are necessarily more complex than determinations of active ingredients for chemically based therapeutics, they have the potential to clarify this increasingly murky, yet clinically relevant, area of the law.

Published in : The NYU Journal of Intellectual Property & Entertainment Law

[New York City, New York] : New York University, 2020.

eng