This article is contributed by Lea Polito, a 2L at UNH Franklin Pierce School of Law.
CRISPR stands for “clustered regularly interspaced short palindromic repeats.” A form of genome editing technology, CRISPR sequences can be used to identify and target specific sequences of DNA that control the expression of certain genes in an organism’s genome. Cas9, one of the enzymes produced by the CRISPR system, can bind to and cut the CRISPR target sequence, like a form of genetic scissors. As such, the use of CRISPR-Cas9 technology can allow for the insertion of helpful genes and the deletion of harmful genes from a genome. Although the use of CRISPR-Cas9 technology remains highly controversial, especially in the area of human gene therapy, the application of CRISPR-Cas9 technology within the agricultural sector has the potential to alleviate food insecurity through the introduction of favorable genetic traits to plant genomes, such as traits that increase crop yields and pathogen resistance. Globally, the patent landscape of CRISPR technologies is highly fragmented, with the U.S. and China leading in the total number of patent families relating to the CRISPR gene-editing system. According to a study published in Nature, China and the U.S. also lead in the number of plant patent families relating to CRISPR technology as of 2017 (see Fig. 1), with the total number of CRISPR plant patent families decreasing by over 50% when comparing China to the U.S. and to Europe respectively (see Fig. 2e). Unsurprisingly, these trends in CRISPR plant patents mirror the regulatory stance of each country with regards to the ongoing genetically-modified organism (GMO) controversy. While China and the U.S. have regulatory regimes that allow for commercialization of certain gene-edited crops, the EU essentially banned gene-edited crops from the market in a highly-criticized decision by the Court of Justice of the European Union (CJEU) in 2018. Given the unfavorable market for gene-edited crops in the EU, it is likely that the EU will continue to lag behind the U.S. and China in patents granted that relate to CRISPR technology in plants. The country-by-country variation in patent and regulatory regimes poses a challenge in implementing CRISPR technology in areas with high food insecurity. This summer, I had the opportunity to work on a pro-bono project for the African Orphan Crops Consortium (AOCC). The project involved researching patent and regulatory considerations in various African countries, with the goal of compiling our findings into a centralized resource that can be used to inform African plant breeders about relevant patent and regulatory concerns in their respective countries as they research CRISPR technology in crops. While working on the AOCC project, I was surprised to learn that even neighboring African countries had completely opposite regulatory regimes for CRISPR-edited crops, with some having favorable regulations for conducting field trials, and others imposing de facto bans on CRISPR research. The implementation of CRISPR-edited crops in areas of high food insecurity is further complicated by the ongoing dispute between the Broad Institute of Cambridge and UC Berkeley regarding ownership of patent rights for claims pertaining to the use of CRISPR in eukaryotic cells. As long as this dispute continues, the prospect of a joint licensing agreement between the major players in the CRISPR patent landscape that would eliminate patent hurdles for food-insecure countries to research CRISPR technology seems farfetched.
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