Patents, Hidden Novelty, and Food Safety

This Note discusses how federal agency policy results in a lack of access to patent-protected genetically modified organisms (GMOs) for independent food safety testing. The U.S. GMO policy is a combination of biotechnology regulations and biotechnology intellectual property protections. Intellectual property protection for the developers of new organisms has increased as the technology has advanced from manual pollination to genetic modification methods. Initially the only protection available was in the form of trade secrets, but the protection has increased incrementally to now include full utility patent protection. This Note evaluates the interactions between U.S. Patent and Trademark Office (USPTO) GMO policy and Food and Drug Administration (FDA) GMO policy by comparing USPTO and FDA treatment of various human consumption products. GMO food products fall into a narrow “hidden novelty” exception created by the combination of the FDA’s GMO policy and the GMO manufacturers’ use of licensing enabled by utility patent protection. This Note emphasizes the necessity of access to human consumption products for independent safety testing and illustrates this necessity through a comparison to trans fats. Finally, this Note proposes a narrow research exemption to correct the “hidden novelty” exception while leaving patent law precedent undisturbed