Mitochondrial Replacement Therapy and the Regulation of Reproductive Genetic Technologies in the United States

By: Bob Zhao

The ability to alter the genes of future generations no longer belongs in the realm of science fiction. The genetic modification capabilities of modern science are advancing rapidly. Mitochondrial replacement therapy (MRT) represents the first crossing of the germline barrier in humans, and as of February 2015, it is the first procedure of its kind to be legalized in the Western world. How Congress decides to regulate MRT will influence future regulation of all genetic manipulation technologies. This brief argues that the current patchwork regulatory framework established in the United States is insufficient to deal with the complex issues MRT presents. As such, the creation of a new regulatory agency specifically focused on the oversight of reproductive and genetic biotechnologies may be necessary to balance the goals of ensuring the safety of research participants, promoting public debate, and stimulating continued scientific progress.

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Cite: 15 Duke L. & Tech. Rev. 121

Flying Under the Radar: Low-Altitude Local Drone Use and the Reentry of Property Rights

By: Kenneth Maher

The characteristics and capabilities of civilian drones have proliferated in recent years, giving rise to a burgeoning industry. The popular media and academic literature have predominantly focused on privacy concerns, devoting considerably less attention to the regulatory challenges created by the new technology. Congress instructed the FAA to integrate drones into the National Airspace System in 2012, but rulemaking delays and a moratorium on commercial uses hampered the industry and withheld benefits from the public.

Final regulations are now in place, but the new rules revive legal uncertainty over the constitutional limits of federal authority and the ambiguous vertical bounds of private property rights. Low-altitude local drone use is one of the most promising aspects of the technology, and lies at the outer edge of federal authority. Much of the current debate gets key questions exactly backwards. Under current Supreme Court precedent, the proper legal question is not whether federal airspace authority can extend lower to govern virtually all drone use, but whether drone use pushes private property rights in airspace higher, limiting federal authority. Therefore, this Issue Brief joins the scholarly criticism of FAA efforts to date and calls for a greater focus on clear property rights.

Copyright Severability: The Hurdle Between 3D-Printing and Mass Crowdsourced Innovation

By: Alan Fu

3D-printing is gradually becoming widely accessible to the population, and with accessibility come enthusiasm, participation, and ingenuity. Its continued development reflects a potential surge in technological advancement, bestowing on any person with a computer and the right software the ability to design and create. So far, the utilitarian benefits of designs such as blueprints, schematics, and CAD files have always been safeguarded from copyright over-protection through the doctrine of copyright severability. However, the doctrine is applied inconsistently across different circuits and different factual scenarios. This inconsistency can chill innovation by making it impossible to distinguish aesthetic designs protected by copyright from functional designs that are not. Thus, copyright severability does not do enough to protect innovation as 3D-printing begins to make product design more accessible to the general public. A more suitable solution may lie in the abstraction-filtration-comparison test from the software context of copyright infringement.

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Cite: 15 Duke L. & Tech. Rev. 84