Lab-grown meats are ready to be sold in United States markets. However, the meat product needs approval from regulators such as the Food and Drug Administration (“FDA”) and the United States Department of Agriculture (“USDA”). The regulation approval process takes a significant amount of time. This approval period will cut into the lab-grown meat producers’ patent time, rendering a period of the patent ineffective.
This Comment analyzes the effect of, and possible changes to, our current laws on the emerging lab-grown meat market. To look at this problem, this Comment compares FDA and USDA regulations, analyzes the Hatch-Waxman Act, and looks at what individual states have done in response to lab-grown meats. The current federal plan is to establish a joint regulation of the industry by the FDA and the USDA through a memorandum of understanding. However, this Comment shows that the FDA is better suited to handle the regulatory side of the process because of its current experience in regulating other genetically modified organisms and experience with the Hatch-Waxman Act. This Comment also explores the idea that Hatch-Waxman may need to be modified by Congress to adequately incorporate patent extensions to lab-grown meat producers. By incorporating the ideas in this Comment, the federal government will be able to effectively and efficiently handle this emerging market from a regulatory perspective, and lab-grown meat patent holders will not be negatively impacted as they wait for approval from regulatory authorities.
Sean A. Grafton,
Welcome to the World of Tomorrow: An Exploration of Cell-Based Meats and How the FDA and USDA May Protect Intellectual Property Rights,
Cath. U. J. L. & Tech
Available at: https://scholarship.law.edu/jlt/vol28/iss2/8