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12.3.1 Voluntary Patent Transparency: The PINTO Database The PINTO database21 of the European Seed Association (ESA) discloses the patent status of many varieties approved for marketing in the EU. In September 2021, it shows 1021 varieties approved for marketing in the EU which are covered by one or uploads/IAM-article-July-5-2019.pdf. Accessed February 2, 2022. Also reviewed in Neville (2020). 17FRAND ¼ fair, reasonable, and non-discriminatory terms, denote a voluntary licensing commitment that standards organizations often request from the owner of an intellectual property right (usually a patent) that is, or may become, essential to practice a technical standard. Available at: https://en.wikipedia.org/wiki/Reasonable_and_non-discriminatory_licensing. Accessed February 2, 2022. 18An overview of collaborative licensing models in the genetics space can be found in “Gene Patents and Collaborative Licensing Models. Patent Pools, Clearinghouses, Open Source Models and Liability Regimes, Edited by G. van Overwalle, Cambridge: Cambridge University Press (2009). 19German term “Lizenzbereitschaftserklärung.” 20Kloppenburg assesses various Open-Source models in detail. Kloppenburg (2010), pp. 367–388. Available under: file:///C:/Users/micha/Downloads/ Impeding_Dispossession_Enabling_Repossession_Biolo.pdf. Accessed February 2, 2022. 21The Patent Information and Transparency On-line (“PINTO”) data base of the European Seed Association enables transparency which commercial plant varieties are covered by patents. Access under: http://pinto.euroseeds.eu/About/Home. Accessed February 2, 2022. 216 12 Current Solutions for Issues in Plant IPR Systems more patents (Sect. 1.6—Table 1.4). This is still a small number in comparison to the more than 60,000 varieties which are listed on the EU Common Catalogue.22

12.3.2 Patent Pools Corteva and the Broad Institute under the headlines of “democratic CRISPR Licensing” and “open innovation” announced to “join forces to enable democratic CRISPR licensing in agriculture” “to jointly provide non-exclusive licenses to CRISPR- Cas9 intellectual property under their respective control for use in commercial agricultural research and product development. Such foundational intellectual property (IP) for CRISPR-Cas9 technology will be freely available to universities and nonprofit organizations for academic research” (The Broad Inst. 2017). Corteva alleges that it “intends to enable others wanting to develop agricultural products using CRISPR through access to intellectual property, technology capabilities, infrastructure and scientific expertise” (Corteva 2018, 2021). The license seems to include several patent families and patents and patent applications from several parties including The Broad Inst., MIT, Harvard University, Rockefeller University, Editas Medicine, Inc., Iowa State University, Tokyo University, New York University, NY Genome Center, Vilnius University, University of California, University of Vienna, CARIBOU Biosciences, and Pioneer Hi-Bred International, Inc. In principle such collective licensing could be seen as a patent pool. However, some typical elements for patent pools are missing and it is unclear whether the terms and conditions are compatible with the antitrust requirements for patent pools.23 The stated ambition to “enable others” and create openness seems to be only partially realized to date. While licenses to the CRISPR-Cas technology “are freely available to universities and nonprofit organizations for academic research” (The Broad Inst. 2017), licenses for a commercial use are only available under non-disclosed terms. Assuming that the terms are similar to the publicly available redacted version of a Cas-license agreement between The Broad Institute and the company Editas24 these conditions would likely not meet the 22The catalogues (status January 4, 2020) list about 28.760 agricultural and 28.800 vegetable species. Plant variety catalogues, databases & information systems: https://ec.europa.eu/food/ plant/plant_propagation_material/plant_variety_catalogues_databases_en. Catalogue for vegetable species: https://ec.europa.eu/food/sites/food/files/plant/docs/plant-variety-catalogues_vegetablespecies.pdf. Catalogue for agricultural species: https://ec.europa.eu/food/sites/food/files/plant/ docs/plant-variety-catalogues_agricultural-plant-species.pdf. Accessed February 2, 2022. 23While the joint license agreement of Corteva and the Broad institute is not public, it is likely that it is similar to the publicly accessible terms of the Broad license to Editas (Fn. 24). Problematic are the missing limitation to essential patents, the lack of equal treatment of licensees, the lack of transparency of conditions, the extension of royalties to products not covered by the patents, penalties for patent challenges, etc. 24Licenses to Editas including the right to grant sublicenses for the field of Agriculture: Amended and Restated Cas9-I License Agreement by and between PRESIDENT AND FELLOWS OF

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legal requirements for patent pools in the EU and other countries25 which include (a) participation in the pool creation process is open to all interested technology rights owners; (b) sufficient safeguards to ensure that only essential technologies are pooled; (e) the pooled technologies are licensed out to all potential licensees on FRAND terms; and (f) the licensees are free to challenge the validity of the pooled technologies. The Broad-Editas license does not only include a right to terminate the license in case of a patent challenge,26 but also requests royalties for products not covered by a valid patent claim, i.e., “Enabled Product” 27 which are “made, identified, discovered, developed, optimized, characterized, selected, derived from or determined to have utility” by using the licensed technology but are—by definition of the license agreement—outside the scope of the patent. This “reach-through” seems to address a concern that in most countries the ultimate plant resulting from a general genome editing process is outside the scope of any claim covering a general enabling technology (Sect. 4.5 (4) and Sect. 9.9.4).28 The provision may also intend to cover the “workaround” that a trait is discovered using CRISPR-Cas, but then re-established using conventional mutagenesis. It is questionable whether this “reach-through” royalty meets the requirement of FRAND as any third party could use such products without paying a royalty to the patentees. HARVARD COLLEGE, THE BROAD INSTITUTE, INC. and EDITAS MEDICINE, INC., October 29, 2014, Amended and Restated as of December 16, 2016. https://www.sec.gov/ Archives/edgar/data/1650664/000155837017000174/edit-20161117ex992b17c22.htm; CAS9-II LICENSE AGREEMENT by and between THE BROAD INSTITUTE, INC. and EDITAS MEDICINE, INC. December 16, 2016 https://www.sec.gov/Archives/edgar/data/1650664/00015583701 7000174/edit-20161117ex993f74f02.htm. See also CPF1 LICENSE AGREEMENT by and between THE BROAD INSTITUTE, INC. and EDITAS MEDICINE, INC. December 16, 2016: https://www.sec.gov/Archives/edgar/data/1650664/000155837017000174/edit-20161117ex991 6e543d.htm. All accessed February 2, 2022. 25TT-Guidelines (Fn.14), para. 261. 26Amended and Restated Cas9-I License (Fn. 24) See Article 10.2.4. Termination for Patent Challenge.

27License to Editas (Fn. 24) See definition section. Enabled Product” means any product, other than a Licensed Product, which is or incorporates, or which is made, identified, discovered, developed, optimized, characterized, selected, derived from or determined to have utility, in whole or in part, by the use or modification of, (a) any Patent Rights or any technology or invention covered thereby, (b) any Licensed Product or any Institution Technology Transfer Materials, (c) any progeny, modification or derivative of a Licensed Product, or (d) any living or nonliving cell, organism, microorganism (including viruses), plant, plant tissue or plant seed made or modified through use of a Licensed Product or technology covered by the Patent Rights, or any progeny, clone, modification or derivative of such living or nonliving cell, organism, microorganism (including viruses), plant, plant tissue or plant seed.

28The final plant will not comprise any of the Cas-machinery. Further, in most countries the scope of a method claim is limited to “direct products,” i.e., the plant cell directly edited and does not extend to the ultimate plant. See Monsanto Technology LLC v Cargill International SA (Case No: HC06C00585; decision of October 10, 2007) Available at: https://www.casemine.com/judgement/ uk/5a8ff75f60d03e7f57eabda1. Accessed January 29, 2022. 218 12 Current Solutions for Issues in Plant IPR Systems While such clauses may be enforceable under US law under certain circumstance, they may not withstand antitrust review in other legislations.29