That solves---clarifying criteria to describe traits in patent applications increases the overall amount of patents and collaboration, which immediately solves the current unsustainable IPR system.

Table 11.1 summarizes the strengths and weaknesses of the different IPR systems for plant related inventions. In conclusion, the technical progress, especially the increasing complexity and speed of plant innovation and the dematerialization of GRs, are emphasizing the weaknesses of the current IPR systems. While in the past PBRs and patents were rarely overlapping, now the improved understanding and reproducibility of breeding is blurring the boundaries. Consequently, the number of varieties protected by both PBRs and patents in constantly increasing. With that trend also the unresolved issues at the interface of both systems become more immanent. While the patent thickets and managing access and licensing has not yet a material impact on plant breeding several issues and questions are pressing:

• How to determine an “essential derived variety” and dependency under the PBR system if the technical progress renders the criteria of genetic similarity useless? • How to describe a variety if the phenotype and the related DUS criteria are increasingly volatile as a consequence of climate change and other environmental factors? • What are clear and meaningful criteria to describe native traits in patent applications? • How to increase quality and speed of patent examination for plant related inventions? • How to enable a market and competition for post-patent use of GM traits including access to regulatory data packages? • How to balance the interests of farmers, breeders, and technology holders when it comes to farm-saved-seed of varieties protected by both patents and PBRs? • What is an adequate scope of method claims related to general enabling methods? • How can we foster the sustainable use of plant GRs and ensure an equitable benefit sharing? • What measures can smoothen the interface between patents, PBRs, GRs, and other legislations?

*copyright thing big cite thingy omitted*

The debate about the right balance between protection of and access to plant GRs is not new and can be grouped in two major classes: (i) “Horizontal issues” related to “what should be protectable” are predominantly affecting other breeders; and (ii) “Vertical issues” related to the “scope of rights and exemptions” are predominantly affecting farmers and other down-stream users. These issues have been addressed by (12.1) legislative actions, (12.2) court rulings, and (12.3) by industry solutions. 12.1 Legislative Solutions Most countries accept a co-existence of patents and PBRs without specific adaptations. Consequently, the PBR exemptions for breeding and farm-saved-seed are essentially abolished by patents covering the variety. Only few countries have established plant-specific adjustment in their patent laws (Chap. 4). The EU and Switzerland have taken specific measures to harmonize patent and plant breeders’ rights. The Biotech Directive 98/44 states that between patents and PBRs “harmonisation is necessary to clarify [...] uncertainty” and attempts a harmonization both on the level of protection and the level of rights including farm-saved seed and compulsory cross-license.1 Despite the Court of Justice’s ruling that the 1

Directive 98/44/EC of the European Parliament and the Council of 6 July 1998 on the legal protection of biotechnological inventions. Recital (9) Whereas in certain cases, such as the exclusion from patentability of plant and animal varieties and of essentially biological processes for the production of plants and animals, certain concepts in national laws based upon international patent and plant variety conventions have created uncertainty regarding the protection of biotechnological and certain microbiological inventions; whereas harmonisation is necessary to COPYRIGHT OMITTED

EU Members States are stretching this boundary by implementing provisions in their national patent law which have no basis in the Directive 98/44. Usually, it is argued that such provisions follow the spirit of the Directive. Such derivations include the patent law breeder’s exemption,3 clarifications for products obtained by essentially biological processes,4 and provisions attempting to protect the interest of farmers and breeders (Sect. 4.5). While the Biotech Directive 98/44’s original intent was perceived to strengthen patents on biotech inventions by extending the rights resulting from a patent (Kock 2010a,b), now case law and legislation rather construe the provisions as limitations to the scope of patentability and patent rights.5 Likewise, the process which led to Rule 28(2) EPC and G 3/19 can be seen as establishing new legislation or—at least—secondary legislation (Kock 2020a). By assuming that the process towards Rule 28(2) EPC has been valid, the Enlarged Board of Appeal strengthened the function of the EPO’s Administrative Council “to adopt secondary legislation in accordance with Article 33 EPC.”6 The term “secondary legislation” is commonly used in the context of legislation made by the EU institutions,7 but has rarely been clarify the said uncertainty. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/? uri¼CELEX:31998L0044&from¼EN. Accessed January 28, 2022. 2 Court of Justice of the European Union (CJEU), Case C-428/08 Monsanto Technology LLC v. Cefetra BV et al. [2010] ECR I-06765. Recital 2: “Article 9 of the Directive effects an exhaustive harmonisation of the protection it confers, with the result that it precludes the national patent legislation from offering absolute protection to the patented product as such, regardless of whether it performs its function in the material containing it.” Available at: http://curia.europa.eu/juris/ document/document.jsf;jsessionid¼73E9E73A2594FDFB48BD743876A6FAF4?text¼& docid¼80491&pageIndex¼0&doclang¼EN&mode¼lst&dir¼&occ¼first&part¼1&cid¼1733 5586. Accessed January 28, 2022. 3

This exemption enables breeders to utilize biological material covered by a patent for the purpose of breeding. A license is only required if the resulting new variety still comprises the patented gene and is commercialized. See German Patent Act §11 (2a), Article L613-5-3 French Intellectual Property Code, Dutch Patent Act Article 53b(2), Swiss Patent Act §9e; Agreement on the Unified Patent Court Article 27(c). 4 Commission Notice of 3 November 2016 on certain articles of Directive 98/44/EC of the European Parliament and of the Council on the legal protection of biotechnological inventions (OJ 2016/C 411/03 - 14).

***link thing omitted***

The five EU legal instruments specifically provided for in the Treaties are: Regulations, Directives, Decisions, Recommendations and Opinions. 212 12 Current Solutions for Issues in Plant IPR Systems used in relation to the EPO’s Implementing Regulations.8 In endorsing a stronger legislative function of the AC the EBA de facto reversed its former decisions G 2/95, G 6/95, and G 1/02, where it was found that “the Administrative Council may not amend the Implementing Regulations in such a way that the effect of an amended Rule would be in conflict with the EPC itself.”9 Other countries have no specific plant or biotechnology related provisions in their national patent laws, other than exemptions which exclude plants from patentability. Legislative initiatives in other countries to follow the EU approach are not known.

12.2 Case Law

The legislator’s declining ability to implement legislative changes in a timely manner is forcing courts increasingly to assume the role of legislators to close legislative “gaps” or adapt a “dynamic interpretation” to interpret or amend legislation to support a revised legislative intent or an evolving technical or societal situation. This is especially problematic, if a new interpretation does not only deviate from the original legislative intent but also conflicts with wording of the law. Cases such as C 428/08, G 3/19, or Myriad led to fundamental changes, sometime turning the former legislative position upside down.10 Increasingly courts and administrative councils, which are usually limited in their role to interpret or implement the law through rules, guidelines, and explanatory notes, de facto take the role of legislators. This bears the risk that countries evolve from the “rule of law” principle to a “rule by law” practice. Changes are rather tactical short-term fixes than strategic, sustainable solutions.

While the speed of technology development is increasing exponentially, the legislator’s ability to respond to the change seems to become increasingly slower. The landscape of political parties becomes more fragmented and finding political consent is often an excruciating process. What this means for the future of legislation and its ability to address the challenges of tomorrow’s needs to be seen. 8 A rare use of the term “secondary legislation” with respect to the Rules is found in the EPO Strategic Plan 2023 (p.57). Available under http://documents.epo.org/projects/babylon/eponet. nsf/0/2217F5B7CC07D47CC125841C00610386/$File/EPO_Strategic_Plan_2023_en.pdf. Accessed February 2, 2022. 9 G 6/95 (Interpretation of Rule 71a(1) EPC), decision of 24.7.1996, OJ EPO 1996, 649 – Reasons under 4. 10Case C-428/08 Monsanto Technology LLC v. Cefetra BV (Fn.2) Article 9 of Directive 98/44/EC literally provides an extension of patent protection. However, the CJEU construed it as a limitation to the scope of protection for DNA related subject matter claims, which thereby become narrower than prior than under the prior patent law.

12.2 Case Law 213

12.3 Private Sector Solutions

The use of private sector solutions to manage complex IP situations (“patent thickets”) in the context of plant related innovations has been reviewed by Kock (2021). It is often alleged that complex IP situations (“patent thickets”) slow innovation by increasing transaction costs and market entry delays (Hall et al. 2017; Graff et al. 2003; Egan et al. 2015; Heller 1998; Shapiro 2001; Godt 2007).

However, patent tickets are not necessarily a hurdle for innovation.11 A 2011 report for the European Commission observes [w]hile patent thickets have achieved prominence on the agenda of both policy-makers and academic researchers, one can still legitimately wonder about the true extent of the problem. Two questions arise when assessing the importance of patent thickets. The first one is how often such thickets actually arise. The second is what the size of the inefficiency associated with patent thickets is likely to be. A 2011 report found that the methodology to map thickets is still “in its infancy” (Regibeau and Rockett 2011) and “the welfare effects of thickets might actually be ambiguous.”

12 It is also still largely uninvestigated whether different types of users have better or poorer access to the solutions in a “thicket,” i.e., whether a thicket impacts the structure of an industry sector. However, the CRISPR/Cas patent landscape is meanwhile broadly recognized as a patent thicket (Sherkow 2015, 2018; Brayne et al. 2016, Egelie et al. 2016). The chilling effect of the legal uncertainty affects especially small and medium enterprises which usually lack the capability to assess and manage patent-related risks. In addition, the potential impact of method claims on products has not been considered so far (Sect. 9.9.4). Strategies to avoid a “tragedy of the anti-commons” (Heller 1998) comprise cross-licenses, patent pools, compulsory licenses or a broad breeder’s exception. Mossoff—based on the “sewing machine war” and the resulting first “patent pool”— concludes, that “patent thickets have long existed” and ”that patent owners have the incentives to resolve the problem of patent thickets—exercising their property and contract rights within the framework of these preexisting private-ordering regimes” (Mossoff 2011). Whether the optimistic view that “patent thickets resolve themselves” applies to all industries and technologies is discussed below (Sect. 15.1). While the International Licensing Platform - Vegetables (ILP) (Sect. 12.3.3.2) is successfully addressing current issues, its ability to address the future challenge of stacked traits is untested. In addition, it is unclear whether a similar model with a narrower territorial focus for field crops will get traction (Sect. 12.3.3.3).

There is growing recognition in the seed industry, politics, and academics that for plant innovations an emphasis on “exclusivity” is not desirable. Several initiatives attempt to evolve the use of plant related patents from exclusivity to inclusivity and 11Despite complex patent thickets smartphones still exist. Would we have better smartphones if the patent system were more “open”? Defining a “but-for” situation is intrinsically difficult and the conclusion that weaker patents enable more innovation is difficult to verify with hard data. 12Regibeau and Rockett (2011), p. 16. 214 12 Current Solutions for Issues in Plant IPR Systems openness (Van Overwalle 2015, 2017). Especially the debate on patents on native traits in Europe led to solutions such as European Seed Association’s database PINTO (Sect. 12.3.1) 13 and the International Licensing Platform - Vegetables (ILP; Sect. 12.3.3.2) which improved transparency and access. In principle, the solutions can be grouped in five models:

1. “Transparency pledges” attempt to avoid “innocent” infringement by creating transparency which varieties are protected by patents. The PINTO database (Sect. 12.3.1) is a prominent example. 2. “Patent pools” (Brufani 2011) deal with complex innovations by creating a “one stop shop” which enables collective licensing for a reasonable price (Lerner and Tirole 2002; Farrell et al. 2007). They “clear” patent thickets with pro-competitive effects.14 Patent pools of a larger size (i) have in general a simple royalty sharing mechanism based on quantity (i.e., number of patents) rather than quality, i.e., value of the innovation15 (ii) do not allow to in-license only a sub-selection of the technologies (ii) consist of a rather small and homogenous group of patentees. Patent pools are not always seen positively, especially when it comes to their effect on stifling innovation as they may reduce the incentive innovate (Vermeulen 2013). Patent pools also require careful anti-trust consideration and usually regulatory clearance (Rodriguez 2010). For plant innovations, no holistic patent pool has been developed yet, although there has been an attempt to establish a patent pool for CRISPR-Cas916 and the joint initiative of Corteva and The Broad Institute (Sect. 12.3.2) may qualify as a “mini-pool.”

13The 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 January 29, 2022. 14Guidelines on the application of Article 101 of the Treaty on the Functioning of the European Union to technology transfer agreements (2014/C 89/03) “TT-Guidelines.” Available at: https://eurlex.europa.eu/legal-content/EN/TXT/PDF/?uri¼CELEX:52014XC0328(01)&from¼EN. Accessed February 2, 2022. See para. 245. “Technology pools can produce pro-competitive effects, in particular by reducing transaction costs and by setting a limit on cumulative royalties to avoid double marginalisation. The creation of a pool allows for one-stop licensing of the technologies covered by the pool. This is particularly important in sectors where intellectual property rights are prevalent and licences need to be obtained from a significant number of licensors in order to operate on the market” (Underlining added). Similarly, the TT-Guidelines include references that reflect the relevance of this economic framework in the context of standard setting. See at para. 245:

“[T]here is no inherent link between technology pools and standards, but the technologies in the pool often support, in whole or in part, a de facto or de jure industry standard.” 15Various methods for royalty sharing are available, including (i) Patent Points: The sharing is based on patent use. Revenues are allocated to each country in which there is coverage and then shared according to a point system based on patents owned or (ii) Equal Sharing: Royalties are allocated among the patent owners in equal parts or (iii) Mixed methods. Combination of Patent Points and Equal Sharing (iv) Enforcement Premium. If an enforcement component is included, additional revenues can be allocated to Patent Owners that make patents available for enforcement. 16MPEGLA suggested a CRISPR patent pool in 2019. The initiative has not yet gotten any visible traction. See https://www.mpegla.com/crispr/initiative/; https://www.mpegla.com/wp-content/ 12.3 Private Sector Solutions 215 3. “Patent clearing houses” facilitate access to collections of patented technologies. They usually work with standard agreements and terms and have no mechanism to deal with stacking. Clearing houses are therefore less an approach to manage patent tickets than to pragmatically establish FRAND terms.17 The international Licensing Platform—Vegetables (ILP) (Sect. 12.3.3.2) is an example for a clearing house.18 4. “Licensing Pledges” are declarations to grant licenses, which can be made in various forms, e.g., by declarations at the patent offices.19 Several seed companies have made “licensing pledges” through e-licensing and other instruments (see Sect. 12.3.4). 5. “Open-Source Models” 20 have been primarily developed for software related innovations where copyright is established automatically without the need for any registration. There have been attempts to establish open-source models for plant related innovations by obligations not to patent (Sect. 12.3.5). The most relevant models for plant related innovations and their impact are now discussed.