Quarterly Journal Volume 52, Issue 4 December 2024

The Biologics Price Competition and Innovation Act of 2009 (the BPCIA) created a twelve-year period of exclusive rights for investors who secure FDA approval for biologic products.  This exclusive right is intended to, and does in practice serve the same function as a patent. The U.S. Constitution authorizes grants of exclusive rights only to inventors of inventions, not to investors in regulatory approvals. This understanding of the Constitution is consistent with received English legal tradition, with policies of colonial governments, and with centuries of judicial interpretation of the Constitution. It is also consistent with the well-established principle that affirmative limitations on an enumerated power (such as the limitations in the Intellectual Property Clause) cannot be circumvented by resort to another enumerated power, especially the Commerce Clause. There is no constitutional source of authority for the BPCIA’s grant of exclusive rights without regard to the presence of an invention, and the BPCIA’s exclusivity provisions are unconstitutional. BPCIA Exclusivity was intended to respond to shortcomings in the patent laws which affect all users of the patent system. Those shortcomings must be addressed within the context of the patent laws, not by giving one industry its own unconstitutional alternative to the patent system.

Trademark law’s motivation for affording rights to a distinct mark centers around consumer protection and maintaining company reputation. The genericide doctrine was developed to further trademark law’s purpose. A mark that suffers from Genericide is found to have fallen from its distinct pedestal into the public domain in the consuming public’s eyes. This Note contends that the Genericide doctrine has not kept pace with the economic and social realities of the current age. Specifically, the doctrine does not consider marks that may be “too big to fail.” Mirroring the economic concept of “too big to fail” banks, trademarks of the same distinction are marks which have spread beyond source-identifiers and have rooted themselves within various economic and social spheres. Allowing these marks to “fail,” or be found generic, creates overwhelming costs in the face of slim benefits. Think Google, Kleenex, or Band-Aid. The loss of one of their marks would wound both the company and consumers. Analyzing Genericide through the law and economics lens and walking through court’s evaluation of Genericide claims highlights an inherent acknowledgment in common law of “too big to fail” marks. Some courts and scholars argue that narrowing the Genericide principle harms consumers and economic efficiency by taking from the public domain. This line of thinking is mistaken because it ignores the multifaceted nature of “too big to fail” marks: these marks serve as both source and product identifiers depending on the setting. Considering the Internet’s and social media’s effect on public perception and brand identity, this Note proposes a purgatory period for “too big to fail” marks facing Genericide. If a company can prove most consumers understand their mark to signify source in a purchase setting irrespective of social use, then the mark should remain intact.

This Note examines the issues around proving biometric privacy harms in federal courts under state biometric laws such as the Illinois Biometric Information Privacy Act (BIPA). Article III standing problems arise for plaintiffs trying to bring BIPA violations into federal courts. By discussing the benefits and problems with existing U.S. biometric privacy enforcement mechanism, this Note argues for a new way for courts to interpret biometric privacy harm based on existing doctrines in common law and trade secret.

The issue of permissible repair versus impermissible reconstruction is one that has concerned the courts from the early days of the United States and into the modern day. An initial standard of permissible repair focusing mostly on the replacement of temporary parts was established by a series of cases throughout the 19th and early 20th centuries. However, this standard changed dramatically in 1961 with the holding in Aro that impermissible reconstruction was limited solely to “true reconstruction” of the patented combination and anything short of that was merely repair. Since then, despite seeming simple on its face, the Aro standard has led to the development of multiple standards for evaluating whether a given action is permissible repair or impermissible reconstruction, with the applicable standard varying depending on the nature of the patented combination at issue. These multiple standards have increased uncertainty in this area of the law. To remedy this, the courts should adopt a new singular standard based on whether an action impermissibly extends the lifespan of a patented combination or merely allows the owner to make full use of the already extant lifespan. When evaluating this, the courts should take inspiration from Aktiebolag and its balancing test, with specific factors including the useful life of the replaced part compared to the whole combination, as well the importance of the part to the operation of the combination as a whole.