Charles Duan* Download a PDF version of this article here. Recently, state governments have begun to claim a copyright interest in their official published codes of law, in particular arguing that ancillary materials such as annotations to the statutory text are subject to state-held copyright protection because those materials are not binding commands that carry the force of law. Litigation… read more
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.
By Daniel M. Lifton* Download a PDF version of this article here. Introduction I. An Overview of Trademark Law as a Species of Competition Policy II. Trademark Infringement Liability A. The Likelihood of Confusion Test B. Expansion of Trademark Liability Over Time III. Problems Posed by Trademark&srquo;s Unitary Liability Regime A. Presumes Harm for All Forms of Confusion B. Does… read more
By Sarah Sue Landau* Download a PDF version of this article here. Introduction I. The History of Copyright and “the Copyright Bargain” II. Trademark Protection III. The Problem IV. Solutions A. Proposal #1: Amend the Lanham Act in order to impose a time limit on marks whose copyrights have expired B. Proposal #2: Allow the Characters to Fall Into the… read more
Our Spring 2020 issue, Volume 9, Issue 2, is comprised of five individual pieces that explore significant, current themes in intellectual property and entertainment law, ranging from providing guidance from practice and experience, to questioning the very underlying legal framework of trademark law. In fact, each piece in this issue is focused on one of the fundamental areas of intellectual… read more
By Justin F. McNaughton, Esq., Ryan Kairalla, Esq., Leslie José Zigel, Esq., and Armando Christian Perez* Download an English PDF version of this article here. Download a Spanish PDF version of this article here An exclusive interview about the article with Messrs. McNaughton, Kairalla, and Zigel can be found here. I’ve worked so hard on crafting my sound and my… read more