b"we're actively moving forward, recogniz- TOOLGEN DETERMINED TO MAKE ITS MARKing the need to make strategic decisions without letting unresolved matters hinder our progress. Toolgen, a South Korean biotechnology company, has entered the CRISPR patent fray, challenging the claims of two prominent research institutions: the Broad Institute of MIT and Harvard, and the University of California, The Race is On Berkeley (UCB). The patent race for CRISPR-Cas9 began in 2012, when two research groups filedToolgen says that it invented the use of CRISPR in eukaryotic cells, such as animal and plant cells, before the their first patent applications for theBroad Institute and UCB. Eukaryotic cells are the basis of most living organisms, and the ability to edit their technology. One group, led by Jennifergenomes is crucial for the applications of CRISPR. Toolgen says that it filed its patent application in October 2012, Doudna at the University of California,while the Broad Institute filed in December 2012, and UCB filed in March 2013. Berkeley (UC Berkeley) and Emmanuelle Charpentier, then at Ume University inYoori Kim, chief legal officer at Toolgen, granted Seed World Canada an interview about the situation (both Sweden, published a paper describingthe Broad Institute and UCB declined to be interviewed, but the former did provide some supplementary the CRISPR-Cas9 system and its applica- information for this story). tions in bacteria. The other group, led by Feng ZhangWe have strong evidence and arguments to support our claims, Kim says. We have been working on this at the Broad Institute of MIT and Harvardtechnology for a long time, and we have made significant contributions to the field of gene editing. We believe (the Broad Institute), published a paperthat we deserve to be recognized and rewarded for our innovation.demonstrating the use of CRISPR-Cas9The CRISPR patent dispute is not only a legal battle, but also a scientific and commercial one. The stakes are high in human and animal cells. Both groups sought to patent the technology in vari- as the technology has enormous implications for the future of medicine, agriculture and biotechnology. The ous countries. outcome of the dispute will affect the access and licensing of CRISPR, as well as the reputation and revenue of Since then, a legal battle has ensuedthe parties involved. over the intellectual property (IP) rightsToolgen, as a small Korean company, may not be as well-known as the Broad Institute and UCB, but it is of CRISPR-Cas9, especially in the United States, where the two groups have beendetermined to make its mark in the history of CRISPR, Kim says.involved in a series of patent interfer- In the United States, the Patent Trial and Appeal Board (PTAB) is currently considering who was first to invent the ence and opposition proceedings beforeCRISPR-Cas9 gene-editing technology. ToolGen argues that it was the first to use the technology in plants and the U.S. Patent and Trademark Office (USPTO). The main issue is whether theanimals. The PTAB named ToolGen the senior party in the proceedings, which means the burden of proof is on Broad Institutes patents are valid, orUCB and the Broad Institute to show they developed CRISPR-Cas9 to practice before ToolGen.whether they are anticipated or obviousIn Australia, the Federal Court found that none of the claims in ToolGens patent application for platform CRISPR in light of the UC Berkeley groups earliertechnologies are valid. In Europe, the EPO Opposition Division has revoked a CRISPR patent held by ToolGen.publications and applications. So far, the USPTO has ruled in favor of the Broad Institute. However, the UC Berkeley group has appealed the deci- WHAT NOTABLE COMPANIES HAVE LICENSED CRISPR-CAS9sions, and the litigation is still ongoing. TO DEVELOP PRODUCTS?A new player, South Koreas Toolgen, has also entered the space, complicating things even more. Corteva Agriscience boasts the largest collection of patents related to CRISPR technology in agriculture globally. The patent situation for CRISPR-Cas9The company possesses non-exclusive global rights to the Broad Institutes CRISPR-Cas9 patents specifically for is also complex and uncertain outsideagricultural purposes. Moreover, Corteva holds exclusive global rights to UC Berkeleys CRISPR-Cas9 technology the United States, where different patentfor major row crops, alongside non-exclusive global rights for all agricultural uses and applications. offices have reached different conclu-sions about the validity and scope ofAdditionally, Corteva has secured a license from ERS Genomics covering agricultural applications in plants. The the patents. For example, in Europe,company also possesses its own patents, including those associated with its CRISPR-Cas waxy corn product. the European Patent Office (EPO) hasThese patents involve collaborations with the Broad Institute of MIT and Harvard, UC Berkeley, and Vilnius granted patents to both groups but hasUniversity, encompassing various facets of CRISPR-Cas9 technology.also revoked some of them due to oppo-sition from third parties. Bayer, BASF and Syngenta all hold non-exclusive rights to the Broad Institutes CRISPR-Cas9 technology for its In China, the China National Intellectualapplication in agriculture. Bayer also possesses non-exclusive rights to ERS Genomics CRISPR-Cas9 technology. Property Administration has granted pat- Bayer has engaged in a collaborative licensing agreement with the startup Pairwise, granting rights to use ents to both groups but has also rejectedCRISPR in corn, soybeans, wheat, cotton and canola.some of them due to lack of novelty. FEBRUARY 2024SEEDWORLD.COM /19"