Commercialization of the gene-edited crop and morality: challenges from the liberal patent law and the strict GMO law in the EU

Abstract

The EU aspires to utilize the economic advantages of gene-editing technology on one hand and ensure human health and environmental safety on the other. Surrounding the fierce debates over emerging gene-edited plant, the current debate focused on the issue of whether the gene-edited crop should be within or outside the GMO law and its implication for innovation. It should not be forgotten that it is also involved in the complex patentability issues pertaining to the legal interpretation of the patent law. The gene-edited crop is governed by GMO regulations due to its potential risk to human health and environmental safety. But it is heavily patented, as patent regulations ignore its potential risk. This article examines the discrepancy of the gene-edited crop between the existing GMO law and the patent law and reveals the challenges to current EU jurisdiction, including the international trade impediment challenge, the patent monopoly challenge, the market confusion challenge, and the agricultural economy suspension challenge. In the end, this article argues that EU GMO regulations should be bridged with a patent system in facing the regulatory challenges from the gene-edited crop.

Keywords:

• gene-edited crop
• GMO
• patent
• EU

1. Introduction

With the population boom, the global demand for the consumption of agricultural products for food and the use of plants as sources of feed are rapidly increasing (Edgerton 2009).¹ To satisfy this increase, new plant-breeding techniques like genetically modified (GM) techniques featuring yield-enhancing traits are used in large-scale areas to improve yield on various plants all over the world, such as crop (Talbot 2014), maize (Chavas, Shi, and Lauer 2014), wheat (Wrree and Sauer 2016), etc. Surely, GM crops alone cannot solve food security problem. The large-scale implementation of GM crops across the globe has environmental, social, and economic consequences. For example, GM crop raised herbicide resistance and cross-pollination concerns (Spring 2011). The expansive use of GM crops threats food sovereignty because the vast majority of GM crops are in a small handful of multinational corporations in certain countries (Tokar 2014).

The acceptance of GMO may become instrumental in solving the major challenges that human being will face throughout the world (Minssen and Nordberg 2015). Evidence have already shown that GM crops could make a significant contribution to a broader food security strategy. The ISAAA Brief No. 42 showed that compared with non-GM cotton, GM cotton increased cotton productivity for famers in India, South Africa and China increases in cotton productivity for resource-poor farmers in India, China, and South Africa of 31 percent, 11 percent, and 9.6 percent, respectively (James 2010). There are other additional gains such as reduced pesticide use for GM-cotton farmers in India and China. Another report from the International Service for the Acquisition of Agri-Biotech Applications in 2015 also showed that the effects of GM crops on farming were overwhelmingly positive: yields increased 9 percent for herbicide-tolerant crops and 25 percent for insect-resistant crops (Paul, Nuccio, and Basu 2018).

In the past decade, the transgenic technique, as the most advanced approach, was supporting the cultivation of GM crops to resolve the challenges of providing adequate food and renewable energy for the growing population (Borsari et al. 2013). However, gene-editing technologies, emerging among them, may offer new solutions. Recently, non-transgenic techniques, such as clustered regularly interspaced short palindromic repeats (CRISPR)-Cas gene editing, have received attention (Godt 2018). Evidence has already shown that the CRISPR-Cas gene-editing system is an efficient gene-editing tool for better crop performance, including improved plant yield, quality, and tolerance to environmental stress (Kim, Apltekin, and Budak 2018; see also Demirci, Zhang, and Unver 2018; see also Liu and Moschou 2018).² Also, research results showed that CRISPR system could be easily established on wheat protoplast and manipulate wheat genome for improved trait (Kim, Apltekin, and Budak 2018). Experts estimate that the gene-edited crop market is expected to see substantial revenue growth over the coming years with the help of the application of this revolutionary technology (Gene-editing market: global industry analysis and forecast 2017–2025).³

However, before the commercialization of the gene-edited crop, it is important to consider how gene-edited crop will be marketed and how gene-edited crop influences society. Before scientific achievements can be marketed, we should ask whether gene editing of plants should fall under GMO legislation. In the EU, GMO legislation was mainly established two decades ago⁴ and focused on monitoring transgenic plants using recombinant nucleic acids (Ricroch, Ammann, and Kuntz 2016). Admittedly, the question of whether the gene-edited crop should be considered GMO or not has drawn much attention from researchers, politicians, and ethicists (Sprink et al. 2016a). Some support the non-application of GMO regulations from the economic perspective, as the de facto ban of CRISPR-Cas plant techniques would drive the global market power outside the EU (Marks and Livingstone 2018).⁵ “If it is decided that a European style GMO regulatory process must be applied to these products it will kill the potential for gene editing to be used to the benefit of European consumers.” (Nuffield Council on Bioethics 2014). Others support the non-application of GMO regulations from the technical perspective, as mutations caused by CRISPR-Cas gene-editing technology are indistinguishable from naturally occurring ones or those produced by conventional breeding.

From a scientific point of view, new plant breed techniques like cisgenic and gene editing should not be subjected to the same GMO regulations that transgenic breeds follow, because EU legislations are outworn since they fail to seize the new bridge between transgenesis and conventional breeding (Sprink et al. 2016a). The scientific community has been pressing regulatory authorities to constrain the definition of GMO in order to encourage the less stringent regulatory regime (Pavone and Martinelli 2015). However, there exist grounded, though controversial, scientific arguments to actually maintain these new plant breed techniques under GMO regime. The Greenpeace opposed the non-application of GMO regulations for the scientific concern that the organism created by gene editing can show “unexpected and unpredictable effects, which can have implications for their food, feed, or environmental safety” (Greenpeace policy brief 2015). Similar to those contradictory scientific arguments, there are good economic arguments and ethical arguments to subject new plant-breeding techniques to GMOs and vice versa, and also good normative reasons to do so. As Pavone and Martinelli observed on the object of cisgenic plants, broader considerations including “economic, political and social values emerge as constitutive elements of the bio-objectification process in which scientists frame and relate to” (Pavone and Martinelli 2015).

It is particularly noteworthy that plant gene-edited patents, which are of paramount importance to the commercialization of the gene-edited crop, also involve some moral considerations related to human health and environmental safety. Both article 53(a) of European Patent Convention (EPC)⁶ and article 6(1) of EU Biotechnology Directive 98/44/EC⁷ regulate that European patents shall not be granted in respect of inventions of the commercial exploitation of which would be contrary to “ordre public” or morality. It has to be decided whether the exploitation of the new plant-breeding techniques in the patent is likely to seriously disadvantage the environment (for example, super weeds, biodiversity destruction) or contrary to the conventionally accepted standards in European culture (Schinek and Schillberg 2016). However, in practice, whether the gene-edited crop falls within the “ordre public” and morality exclusion of patent protection or not has been largely ignored by EU regulators despite that these patents have a major influence on technology innovation, exploitation, and application.⁸ In accommodating the novel biotechnology to the old patent law system, the patent office seems to turn a blind eye to its potential risk. Various patent applications involving new plant-breeding techniques fall outside morality exclusion under article 53(a) of the EPC (G 2/13 (Broccoli II) and G2/12 (Tomatoes II)). In addition, when considering the potential risk of the gene-edited crop to human health and environmental safety, the decision from the GMO legal system has no direct/indirect effect on the decision in the patent law system and vice versa. Although some academics have already noted these two parallel legal frameworks in interpreting and influencing new plant-breeding techniques, they take for granted that different interpretations of terms and regulatory limits for those techniques may exist in different regulatory contexts (Godt 2018; see also Schneider 2011).

The GMO law and the patent law, as two important legal systems, regulate the development of gene-editing technology and the commercialization of gene-edited crop. However, facing the morality issue related to human health and environmental safety surrounding gene-editing techniques, these two systems show different attitudes toward the regulatory status of the gene-edited crop: The GMO law adopts a restrictive approach, while the patent law adopts a liberal approach. It inevitably brings this situation that many economic, social, and ethical challenges, particularly when the EU attempts to capture gene-editing technology’s economic advantages while also ensuring human health and environmental safety. This paper illustrates the discrepancy between the GMO law and the patent law regarding plant gene-editing techniques and challenges. Part II explains the development of plant-breeding technology and its application. Part III explores the ethical issues related to plant-breeding techniques. Parts IV and V respectively review EU GMO regulations and patent regulations applied to plant gene-editing techniques. Part VI reveals the tensions between the GMO and patent law systems in terms of plant gene-editing techniques. Part VII discusses the challenges stemming from the discrepancy of two legal systems in the field of the gene-edited crop.

2. Gene-edited crop vs transgenic crop: technical advantages

In the current agricultural industry, economic plant species, such as herbicide-resistant, insect-resistant, or virus-resistant seeds, could develop from either mutagenesis by genetically modification or mutagenesis with parental crossing (Svitashev et al. 2015).⁹ However, some human-induced mutations, such as deliberately crossing specific parent plants to produce offspring and chemical/radiation mutations, remain time-consuming and expensive as they lead to random gene insertions throughout the genome (Schaart et al. 2016). The breeder needed to evaluate and discard many undesirable or harmful traits. With the scientific progress in biotechnology, techniques of genetic modification have evolved over time. One modern approach uses guided nucleases, and the ability to induce breaks in the gene can target a desired DNA-binding domain using targeted mutagenesis tools, such as oligonucleotide-directed mutagenesis (ODM), site-directed nuclease mutagenesis (SDN1) and CRISPR (Globus and Qimron 2018). Another approach to obtain the desired trait is the transgenesis technique that could incorporate the foreign DNA into the host genome. Despite that transgenesis is also based on direct gene transfer methods, it is noteworthy that transgenesis entails the insertion of a foreign DNA into a living organism, while mutagenesis does not. Compared with transgenes originating from non-crossable species, cisgenic plants¹⁰ have been also an object of a similar debate involving the scientific community, The European Food Safety Authority (EFSA), and regulators (Pavone and Martinelli 2015). Cisgenic plants involve only genes from the plant itself or from a crossable species. Considering cisgenic plants without a novel combination of genetic material, it appears to be safe as only the target gene is introduced without linkage drag (Jacobsen and Schouten 2009).¹¹

CRISPR is the DNA sequence found within the genomes of bacteria, which is originally used by bacteria for immune defense (Joseph and Qi 2016). By delivering the CRISPR-associated protein, the cell’s genome can be edited to remove the existing genes or add the new genes at the desired location. Shortly after the demonstration of CRISPR as a gene-editing technology, scientists found it is a useful plant gene-editing tool, which could replace genes that they wished to insert into plant cells (National Academies of Science, Engineering, and Medicine 2016). Various research results reported the application of CRISPR in different plants (Demirci, Zhang, and Unver 2018). In contrast to the previously developed plant-breeding techniques, the CRISPR-Cas gene editing shows many technical advantages. First, the simplicity and accessibility of the CRISPR-Cas gene-editing system could provide a highly effective solution to genetically engineer plants with relatively low cost (Khlestkina and Shumnu 2016). Second, the CRISPR-Cas gene-editing system is a highly efficient and powerful tool to insert, eliminate, and replace a specific gene because of the possibility of the simultaneous introduction of several double-strand breaks (Demirci, Zhang, and Unver 2018). Third, the CRISPR-Cas gene-editing system shows the minimal OFF-target silencing effects, which are particularly important for decreasing the risk of undesirable gene modifications and increasing environmental safety (Paul and Qi 2016).

3. Gene-edited crop vs transgenic crop: less ethical concerns

The ethical concerns of plant genetic modification could be categorized into extrinsic concerns and intrinsic concerns. The unpredictability of technology raises the extrinsic concerns of transmitting alien genes into food and causing a food safety crisis (Bhardwaj 2006). The transgene might escape through pollen or seed distribution. The environmental impact of GM plants is also a major ethical concern. The GM plants may contaminate conventional crops through cross-pollination. This could increase both anti-herbicide resistance of superweeds and antibiotic resistance of disease-causing bacteria in humans (Pascalev 2003). Human intervention, in nature, will potentially overuse natural resources and infringe upon the rights of future generations to exploit the environment. The invasion of GM plants, which might lead to the extermination of certain innocent species, has a major impact on biodiversity (Brown 2006). Food choices are a society’s means to express values in religious and cultural ceremonies. The interference, restriction, or manipulation of food choices may undermine the moral fabric of the community and the very basis of society (Pascalev 2003).

Intrinsic concern relates to the sensibility of people’s view of life, nature, and technology. Ethical concerns still exist even if GM foods are proved to be safe and beneficial. For example, based on the common conservative way of life, ethical objection related to human integrity also constitutes a threat to GM food (Pascalev 2003). GM food offers researchers, enterprises, and governments a powerful instrument to alter the integrity of life and the nature of the evolution cycle. The imbalance of genetic modification technology at the international level shifts food security to food sovereignty (Spring 2011). Most GM food seeds are developed by a small number of transnational enterprises in developed countries, while developing countries are facing severe crisis regarding increased food demand due to population growth (Spring 2011). Therefore, it is morally questionable whether the oligopolistic control of highly profitable GM plant could serve its supposed purpose such as the common good and the benefit of human race.

CRISPR-Cas gene editing has important ethical differences from transgenetic modified techniques. The main distinction is that gene-edited plants do not include foreign DNA. This could be principally equivalent to conventional breeding techniques.¹² Without the need to introduce genes from another species, the CRISPR-Cas gene-editing system could obtain similar changes to the plant gene as natural mutagenesis (Schaart et al. 2016). The conventional ethical concerns for GM plants are raised for those that do not occur naturally by mating and/or natural recombination (Nuffield Council on Bioethics 2016). The results showed that those for ethical concerns raised by CRISPR-Cas plant gene editing are less than transgenic plants from both food safety and ecological perspective.

4. Gene-edited crop constitutes GMO due to concerns over human health and environmental safety

CRISPR gene-editing technique is an attractive choice of the plant-editing tool. Based on the literature reviews, CRISPR system has already successfully used in crop to achieve the improved yield, stress tolerance, and bio-fortification. In 2015, DuPont reported to successfully introduce chlorsulfuron herbicide resistance into soybean (Li et al. 2015) and corn (Svitashev et al. 2015). In 2016, a plant pathologist from Pennsylvania State University used CRISPR to edit the mushroom to have non-brown trait that could increase the mushroom’s visual appeal life (Waltz 2016). Also, research results showed that CRISPR system could easily be established on wheat protoplasts to manipulate wheat genome for improved traits (Kim, Apltekin, and Budak 2018).

Although the CRISPR-Cas gene-editing technique has proved valuable in plant breeding, the development of CRISPR-Cas technology nevertheless depends on the identification of its regulatory status. The legal interpretation of the classification of gene-edited crop relies on scientific and ethical criteria. The lack of consensus of scientists and ethicists on the regulatory status of gene-edited crop has led to prolonged controversy in the application of EU GMO regulations. The European Council Directive 90/220/EEC of April 23, 1990, on the deliberate release into the environment of GMOs (Directive 90/220) was the first EU GMO regulation. A precautionary principle was established to take protective action before there was a complete scientific proof of a risk when carrying out the deliberate release of GMOs into the environment.¹³ Then, in 2000, the EU overhauled Directive 90/220, which was repealed by the general comprehensive Directive 2001/18/EC on the deliberate release of GMOs into the environment (Council Directive 2001/18).

This new directive clarified GMOs as genetic materials that have been altered in a way that does not occur naturally by mating and/or natural recombination. The ability to distinguish between a GMO plant and non-GMO plant appears to focus on the product. However, the product-based GMO term is interpreted as strictly process-based provisions. Genetic modification is considered to occur at least through the use of recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules, techniques involving the direct introduction into an organism of heritable material prepared outside the organism, and cell fusion or hybridization techniques. Furthermore, in vitro fertilization and natural processes, such as conjugation, transduction, transformation, and polyploidy induction, are not considered to result in genetic modification.

Notwithstanding, the process- and product-related GMO term still leaves the legal uncertainty of the new plant-breeding techniques. Before the adoption of Directive 2001, only conventional breeding techniques through random or undirected gene alterations by mutagenesis or naturally occurring events, such as crossing, were routinely used for plant breeding. Subsequently, new plant-breeding techniques were developed using directed mutagenesis techniques, such as ODM, directed nuclease mutagenesis, or CRISPR-Cas gene editing.¹⁴ Legal interpretations of these new plant-breeding techniques in genGMO legislation are urgently needed for the increasing number of plant products that are being pushed into the market.

Therefore, there is some controversy surrounding whether new plant-breeding techniques, such as CRISPR-Cas gene editing, are to be considered as GMO in the EU (Sprink et al. 2016a). Some scholars have argued that there is no reason to apply GMO regulations to new breeding plants from CRISPR-Cas because they could, in principle, be generated by random mutagenesis or conventional breeding (Huang et al. 2016). Thus, in terms of regulating genetically edited crops, one proposed step is to demonstrate the absence of foreign sequences. New breeding crops must abide by the rules applied to conventional breeding. EFSA has also confirmed that new plant-breeding techniques such as CRISPR-Cas create mutations similar to those introduced by natural or induced mutagenesis (European Food Safety Authority 2015). Accordingly, some countries in the EU have, for instance, that plant gene editing using CRISPR-Cas cannot be considered by GMO. The German authorities judged that plants generated from plant gene editing did not constitute GMO in a canola case in 2012 and a rapeseed oil case in 2015 because gene-edited crops were indistinguishable from plants of conventional mutagenesis (ZBKS 2012).

Other scholars have opposed the exclusion of gene-edited crops from GMO. Answering whether a deliberate change in technique can be distinct from a conventional mutation cannot provide sufficient justification for whether that gene-editing technique produces a GMO or not (Kraemer 2015). Some scholars have argued that the German decisions did not conform to the purpose of Directive 2001/18, as “the risks which stem from the new techniques of ODM and CRISPR-Cas techniques, were, until now, not exhaustively examined, are not necessarily known and as the ODM techniques do not have a long safety record” (Kraemer 2015). In October 2016, the French agricultural union, in conjunction with 8 other parties, requested the annulment of the mutagenesis exclusion from the GMO directive due to the risks involved (United States Department of Agriculture 2016). The French Council of State referred to the European Court of Justice (the CJEU) the question of whether ODM and other site-directed mutagenesis techniques were covered by EU Directive 2001/18 (Judgment in Case C-528/16).

In a preliminary ruling, the Advocate General held the opinion that mutagenesis techniques are exempted from Directive 2001/18, while on 25 July 2018, the CJEU dramatically ruled that organisms obtained through techniques/methods of mutagenesis constitute GMOs within the meaning of that provision. The reason for this overturn was that

excluding organisms obtained by new mutagenesis techniques from the scope of the GMO Directive would compromise the objective pursued by that directive, which is to avoid adverse effects on human health and the environment, and would fail to respect the precautionary principle which that directive seeks to implement. (Judgment in Case C-528/16)

The decision, which means that new plant techniques such as CRISPR-Cas crossover into the realm of genetic engineering, implies that, on one hand, investment in CRISPR-Cas techniques will be limited and, on the other hand, that seeds from CRISPR-Cas techniques will be avoided in the EU market.

5. Gene-edited crop patents ignore moral concerns over human health and environmental safety

In the current debate, much attention has been paid to whether plant gene editing falls within GMO regulations. In fact, there are other concerns related to the regulatory status of gene-editing techniques: for example, the patentability issue, which has a significant impact on technology development and successful commercialization. In the early days of the plant-breeding industry, no property protection was provided to plant variety (Campi 2014). Then, at the end of the nineteenth century, the US granted the first plant patent to provide proper compensation for breeders’ innovation. It was soon criticized for its patentability, the vaguely defined claim, and the public expenditures. When patent protection for plant varieties spreads to Europe, it faced serious objections due to human conflicts of interest (Campi 2014). During the debate to allow patent protection or to create specific rights, European countries eventually established a sui generis system to provide plant variety rights for breeders (Bently and Sherman 2004).¹⁵

Although plant variety is excluded from patents, plant breeders may still seek patent protection or use a broad claim to obtain a product patent (Novartis/Transgenic plant, G 1/98).¹⁶ Article 53 of the EPC states that European patents shall not be granted for plant varieties or essential biological processes for the production of plants. Article 4(2) further states “Inventions which concern plants or animals shall be patentable if the technical feasibility is not confined to a particular plant or animal variety.” This means that if a claim covers two or more varieties, it should be patentable. To clarify, Recital 31 of the Directive provides that “a plant grouping which is characterized by a particular gene (and not its whole gene) is not covered by the protection of new varieties and is therefore not excluded from patentability even if it comprises new varieties of plants” (Directive 98/44/EC). This is also confirmed in the Transgenic plant/Novartis case. The CJEU ruled “a claim that did not specifically relate to plant varieties but to transgenic plants having certain features was allowable in the case of an invention, the technical feasibility of which was not confined to a particular plant variety” (Novartis/Transgenic plant, G 1/98).

In addition, with the development of breeding techniques, the term “essential biological process” became vague and problematic (European Patent Office (EPO)-EBA G1/08 (Tomatoes I) and G2/07 (Broccoli I)).¹⁷ The intention of the literal arrangements is to confine conventional breeding techniques based on selection and hybridization to the patentability exemption. The primary question is the degree of technical intervention to satisfy non-essential biological processes (Trade-Related Aspects of Intellectual Property Rights).¹⁸ In the Lubrizol/Hybrid plants case, the CJEU stated that human intervention alone means that the process is not a purely biological process, rather than serving as a sufficient criterion for it is not being essentially biological (Lubrizol/Hybrid plant). The specific arrangement of the process for the preparation of hybrid plants represents an essential modification of known biological and classical breeders’ processes. Thus, this specific arrangement shows important technological characteristics that should not be considered as essentially biological.

The subsequent question is whether introducing a technical step in the procedure can avoid essential biological processes and therefore be eligible for the patent? Article 2(2) of Biotechnology Directive 98/44/EC confirms “a process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection.” However, The Technical Broad of Appeal (TBA) views that Article 2(2) is somewhat self-contradictory because crossing and selection, which are classified as entirely natural phenomena, would not occur without human intervention (Sommer 2008). In the Broccoli case, the following questions have been referred to the EBA:

whether a non-microbiological process for the production of plants which contained the steps of crossing and selecting plants escaped the exclusion of Article 53(b) merely because it contained, as a further step or as part of any of the steps of crossing and selection, an additional feature of a technical nature. (Plant Bioscience/Broccoli)

The CJEU eventually ruled in the Broccoli case that the technique step that serves to enable or assist crossing or selection does not escape the exclusion of Article 53(b) EPC (G 0002/07). However, if a process introduces a trait into the genome or modifies a trait in the genome of the plant produced, this process is not covered by the patentability exclusion under Article 53(b) EPC. This means that regardless of whether the process contains techniques/method mutagenesis or natural mutagenesis, it is considered a non-essential biological process outside the patentability exclusion.

The remaining question involves the patentability of plant varieties produced by non-essential biological processes. On the basis of the ban on double protection, because plant variety is already protected by the plant variety right, the CJEU ruled that the GM origin of a plant did not make any difference to the conventional origin plant variety, which fell within the exclusion from patentability in Article 53(b) EPC in the Transgenic plant/Novartis case. The Administrative Council of the EPO further clarified “patents shall not be granted in respect of plants and animals exclusively obtained by means of essentially biological process (Decision of the Administrative Council 2017).” However, this interpretation still leaves many outstanding issues: what does the term “exclusively” means? Is the term “plants” equal to “plant variety”?

Although Article 53(b) constitutes a challenge to the gene-editing plant patent, plant variety produced by the CRISPR-Cas gene-editing technique has to be considered in the framework of Article 53(a) EPC. The exclusion in Article 53(a) EPC asks whether a claim covers something immoral or contrary to ordre public. However, neither the definition of “ordre public” nor the benchmark of morality was provided by this provision. Indeed, morality is “an exceedingly complex standard to implement as a criterion of patentability” (Gitter 2001). To manage the increasing applications of biotechnology patents, the EPO had established two standards: one is the “abhorrence” standard, and the other is the “unacceptability” standard. Correspondingly, there are two methodologies relevant to the moral standard: the “balancing exercise” approach followed by the “unacceptability” standard and the “rebuttable presumption” approach followed by the “abhorrence” standard. According to Amanda Warren Jones, this distinction is significant because “under the ‘balancing exercise’ all of the issues considered to form part of the reason why the invention is patentable or not: whereas the ‘rebuttable presumption’ approach identifies a single issue upon which the decision rests” (Jones 2008).

The first instance of adapting the “abhorrence” standard is the Lubrizol/Hybrid plants case. The Opposition Division held that “an invention will be excluded from patent protection only where the public in general would regard the invention as so abhorrent that the grant of a patent would be inconceivable.” In reference to the benefit, the invention of hybrid transgenic plants might present a solution to the food crisis. To deny patent protection and leave this technology unprotected is to risk it being unexploited, which is contrary to the public interest. Another standard of “unacceptability” is referred to in the Plant Genetic Systems case. In this case, the TBA applied utilitarian analysis through weighing benefits against disadvantages. The Opposition Division of the EPO indicated that the possibility of GM plants disturbing the ecological balance “has no bearing on whether a patent is granted or not.” Furthermore, this represented uncertainty in relation to the morality assessment of new plant-breeding techniques. Regardless of the approaches used, patent protection for plant genetically engineered techniques is allowed under Article 53(a) EPC.

6. The tensions between the GMO law and the patent law

Technologies as well as legislative measures, social practices, and public policies do not emerge from a vacuum. The diverse actors – inventors, consumers, farmers, multi-corporation, and government – continually interact in the patent law system and the GMO law system. Admittedly, the GMO law and the patent law serve different stakeholders’ interests, imply different power relationships and strategy. The EU patent law system shows a deliberate support to the agricultural corporation. Regardless of the fact that farmers and consumer associations oppose the patentability of inventions regarding plants for the fear that these patents make the food supply chain increasingly concentrate and dependent on large agricultural companies (Minssen and Nordberg 2015), the EPO allows companies to patent common plants just by describing a characteristic. This helps multinational corporations/agrochemical giants to award themselves the rights to plants that are bred by farmers over centuries (Leroux 2017). Moreover, under the political pressure, the members of expert group on biotechnology patents, providing advice to the European Commission on the patent law in the field of genetic engineering, even include no representatives from farmers’ organization (Godt 2016).

Compared with the patent system, GMO system shifts from an industry-driven policy towards a more consumer-sensitive policy. To adapt the policy to the preferences of consumers, the regulative approach to GMOs is based on input from various Non-Governmental Organizations (NGOs) termed the “precautionary principle” (Skogstad 2003). The EU farmers also oppose the approval of GMO for the fear that their conventional product would be threatened by competition from lower-priced GM products (Tagliabue 2017). To gain the political and electoral consensus of organic food producers and retailers, the optimal response of politicians may be to lobby for a disadvantage in GM adoption (Tagliabue 2017). Representing the farmers, the consumers, and the organic food industry, EU was widely recognized as ideologically suppress GM crops (Masip et al. 2013).

From the above, we can conclude that the GMO law and the patent law inevitably interconnected in relation to the regulatory status of plant gene editing in the EU. This interconnection appears to be amicable: the patent system is intended to foster technological innovation and economic progress (Campi 2014)¹⁹, while the GMO law serves to protect public safety and welfare by assessing the risk and safety, and by deciding how the technology should be exploited. However, the differences between what they pursue and who they reveal show that tension between the patent law and the GMO law cannot be avoided.

First, the innovation-oriented patent law system tends to grant property rights to private companies and enterprises, while the safety-oriented GMO law system tends to limit risking technology for public interest. The different interests which the patent law system and the GMO law system represent highlight different explanations and limits, such as an “essentially biological process” in patent law and “techniques/methods of mutagenesis” in the GMO law. Under the patent law, because both techniques/methods of mutagenesis and natural mutagenesis are outside the patentability exclusion of essentially biological processes, skillful claim-drafting could overcome the hurdles of plant variety patentability exclusion to obtain patent protection as much as possible. The term “essentially biological process” is narrowly interpreted. As long as the process includes human intervention, which is not a natural phenomenon, such as crossing or selection, the plant-breeding process can be granted a patent (Blakeney 2012).²⁰ Some conventional breeding methods, such as hybridization, are also patentable, as the specific arrangement of the steps shows important technological characteristics. Moreover, on the basis of the CJEU rulings, the patent claim that does not confine itself only to one particular plant variety will escape the plant variety exclusion under article 53(a) (Len Ben 2006). The plants resulted from the emerging genetic engineering techniques, such as CRISPR-Cas, will not only be granted plant variety rights but will also contain an invention protected by a patent since these techniques could be applied in more than a plant variety.

In contrast to those of the liberal patent law regime, EU regulations are quite restrictive in their GMO law regime, which can be largely attributed to public awareness of safety regarding GM foods (Corneio et al. 2014).²¹ Its highly rigid regulations distinguish technical/method mutagenesis from natural mutagenesis, thus categorizing plant gene editing as GMO. This implies that it is uneconomical to develop plant gene-editing techniques, as it is nearly impossible to obtain authorization to cultivate GMOs (Marks and Livingstone 2018). Considering the risk of releasing new GMOs, and to ensure that all new GMO foods are fully tested and labeled, the CJEU, in a recent case, clarified that crops and other products produced using ODM or CRISPR-Cas are to be subject to the same regulatory oversight as GMOs created by traditional transgenic approaches (Offord 2018). The European Seed Association (ESA) pessimistically described the situation as follows: “it is now likely that much of the potential of these innovative methods will be lost for Europe, with significant negative economic and environmental consequences. That strikes a serious blow to European agriculture and plant science” (Byrne 2018). Therefore, food safety and security take precedence over agricultural innovation when classifying plant gene-editing techniques under the GMO law regime, while the opposite is true in the patent law regime.

Second, the GMO law system uses the precaution principle to limit genetically engineered foods for public food and environmental safety, while the patent law system ignores or denies potential risks and grants patents to genetically engineered techniques for technological innovation. Under the GMO law regime, the precautionary principle is the basic rule that allows the government to impose restrictions on otherwise legitimate commercial activities if there is a risk, even if not yet a scientifically demonstrated risk, of environmental damage (Nuffield Council on Bioethics 1999). The precautionary principle requires regulators to give absolute priority to avoiding harm to consumers and the environment (Nuffield Council on Bioethics 2012). In GMO regulations, the principle of precaution is properly invoked to guard against the low probability that harm will be caused. However, under the patent law regime, the precaution principle seems to be introduced to prevent uncertain food safety issues and possible environmental threats. The CJEU ruled that as long as no conclusive evidence has been provided that the exploitation of the claimed subjective matter is likely to harm the environment, a GMO patent claim should not be rejected (Plant Genetic System). Risks such as transforming crops into weeds, spreading herbicide-resistant genes to other plants, and damaging the ecosystem are possible and are unpredicted, undesired, and destructive. Thus, new plant-breeding techniques, including transgenic, ODM, and CRISPR-Cas gene editing, are consistent with the patentability requirement in keeping with morality or public order.

Third, the GMO law system uses a process-based approach in regulating the plant gene-editing technique, while the patent law system uses a product-based approach. To accommodate new genetic engineering techniques within the existing GMO law framework for GMOs, EU regulations are interpreted as being strictly process-based: they do not “look at the final result of the process, the organism, but rather at the way in which this final result is obtained.” (Sprink et al. 2016b). The recent CJEU ruling confirmed that even the mutations obtained by the new techniques of directed mutagenesis are similar to spontaneous or randomly introduced mutations and unintentional mutations in nature, and plant varieties obtained using mutagenesis techniques/methods come within the scope of GMO Directives (Judgment in Case C-528/16). In contrast, the patent system focuses on the final product. If the product claimed is the same as a prior product, it is not patentable even though the process applied is different from a prior art process (G 2/13 (Broccoli II) and G2/12 (Tomatoes II)). Conversely, if the product claim is different from a prior art product, the claimed product is patentable even though it was made using the same process.

Fourth, the patent law system uses a “patent first, ask questions later” approach to leave the question to the GMO law system, while the GMO law system lags behind the patent law system. The patent regime, on one hand, ignores or denies sufficiently substantiated food and environmental risks and, on the other hand, claims its inadequacies in carrying out risk assessment and emphasizes that risk assessment should be the duty of other regulatory authorities (Plant Genetic System). Admittedly, it is the duty of GMO regulation to assess the hazards stemming from the exploitation of a given technology. The patent authority recognizes its inability to carry out comprehensive and time-consuming risk-testing and evaluation, but the results of such tests and assessments are usually not available to the patent authority during the prosecution of a case. When the risk and safety assessment by the competent authorities has not been performed or been completed, the patent law decides patentability, which has a major public impact.

7. Challenges to the EU, which wants to exploit gene-editing technology’s economic advantages as well as ensure human health and environmental safety

Since the result of gene-editing research might be applied in the commercial world, both patent and GMO regulatory considerations, which are of paramount importance, should be identified and evaluated equally. Ironically, when facing the same human health and environmental risk posed by the gene-edited crop, GMO regulations rigidly restrict the gene-edited crop, while the patent regulation liberally allows gene-editing patents to accelerate its exploitation. The division between the patent law system and the GMO law system will hardly balance the interests between the right holders and the public in the field of the gene-edited crop. Nevertheless, it is difficult to conclude all challenges posed by the gene-edited crop in the EU. Further research is needed, in particular, on interactions regarding new breeding plant patents, seed markets, farmers’ rights, and regulatory approval for the gene-edited crop. We propose at least four lines of consideration that might structure future studies on this issue.

7.1. International trade challenge

With regard to the agricultural industry, rigid GMO regulations negatively impact the gene-editing plant trade between the EU and other countries. Forceful GMO regulations limit the free market and restrict consumer choices. The US Department of Agriculture (USDA)²² had already stated that there are no plans to regulate the gene-edited crop. As of March 2018, the gene-edited crops have not been under regulatory oversight as transgenic plants in the US.²³ In contrast, the CJEU ruling of July 2018 considered the gene-edited crop to be within the scope of GMO regulations in the EU. Transatlantic differences between the US and EU in the gene-edited crop regulations will create trade tensions. For example, US food exporters, who are eager to sell gene-edited crops, will complain about the EU’s strict approval and labeling process. The boom in the gene-edited crop in the US will inevitably bring tremendous pressure on the EU. To meet consumer demands and preferences, to some extent, the EU must keep pace with the US by developing liberal regulatory policies for the gene-edited crop.

Admittedly, governments may be motivated to adopt liberal policies to recognize that multinational corporations may seek access to alternative national markets. During the diffusion of the gene-edited crop, patent protection will be prominent. The patent proprietors and their licensees who invested a great deal in the field of the gene-edited crop will put pressure on the EU regulators to remove the strict GMO regulations on the gene-edited crop. In fact, as the liberal EU patent system allows the patentability of inventions related to the gene-edited crop, proprietors, and its licensees will rush to exploit the gene-edited crop patents. The first CRISPR patent dispute is an example of how companies are pushing both within and outside the EU market. In November 2014, Atlas Venture, along with Caribou, founded by the Doudna team, collaboratively established Intellia to exclusively use the CRISPR-Cas9 platform. Intellia announced a licensing agreement with Regeneron Pharmaceuticals, Inc. Based on the terms of the agreement, Regeneron will pay a US$75 million upfront fee, as well as milestone and royalty, for exclusive discovery and development of CRISPR-based products against up to 10 targets (Summerfield 2016). Another giant Dupont also entered a strategic alliance with Caribou in October 2015 for CRISPR-Cas tool applications in plants (Gruchkin 2016; see also Akst 2017). In March 2017, the EPO granted the first CRISPR patent to the University of California, the University of Vienna and Emmanuelle Charpentier. Because of their great economic potential, CRISPR were licensed even before the patent was officially granted. In 2015, a Swiss-based company founded by Emmanuelle Charpentier-licensed CRISPR to the US-based companies Vertex Pharmaceuticals Inc. and to Bayer.²⁴

Therefore, the EU’s narrow interpretation of the gene-edited crop as GMO is likely to be a hindrance to the trade in the gene-edited crop. Other countries, such as the US who have no supervision of the gene-edited crop, might believe Europe had misapplied the risk assessments and misused the scientific evidence. The application of GMO regulations to the gene-edited crop would constitute a disguised restriction on trade, which was in violation of Article 2.2, Article 2.3, and Article 5.5 under Agreement of Sanitary and Phytosanitary Measures (SPS).²⁵ There is a previous similar case involving transgenic plants. In 2003, the US, Argentina, and Canada, which represented 96 percent of the world’s acreage of GM crops or transgenic crops, initiated a dispute settlement proceeding to the World Trade Organization (WTO) to claim access to the European agricultural market for their transgenic products (Thomison 2007). Through the WTO’s dispute settlement mechanisms, the WTO panel eventually issued its interim report. The panel identified that the European Communities had applied a general de facto moratorium on the approval of transgenic products between June 1999 and August 2003.²⁶ The moratorium did, however, represent an “undue delay” within the meaning of Article 8 and Annex C of the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement).²⁷ In the end, the dispute settlement body adopted the panel reports and the European Community had to make changes to its GMO legislation.

7.2. Patent monopoly challenge

In the field of the gene-edited crop, patents may empower inventors to control immoral practices and may ultimately benefit narrow commercial interests rather than the public interest. The pursuit of goals and interests and the exercise of rights all entail risks that involve and affect the public. The monopoly control of the patent means control of the food supply and food security. Since patents do often act as the gatekeepers to access to new varieties of GM foods such as gene-edited crops, patent control over this new source of food, to some extent, performs some functions of GMO regulation (Torrance 2007). Therefore, within the triangle of patent regulation, GMO regulation, and the market, the liberal procedures for patent approval and the restrictive procedures for pre-market GMO approval might enlarge patent rights from laboratory/bench (basic research) to public/bedside (industrial application). The restrictive GMO regulations might reduce the number of patent licenses, and then further condense the technology in the hands of the patent right holder. However, the pursuit of commercial interests and the exercise of patent rights all entail responsibilities that include public health and environmental safety being understood with equal care. One case in point is the patent linkage system of pharmaceutical. Aiming at balancing patent protection and generic entry, it requires generic marketing approval applicants to list patents that cover the drug. With information about what patent cover drug product, the patentee could file an infringement suit to prohibit drug marketing approval and generic drug companies can quickly take appropriate actions and make better decisions (Baker 2008). Theoretically, patent linkage system might promote research and development by giving patent holders more certainty over their rights on one hand, while promote medical accession and public health by giving generic manufacturers more information over their freedom on the other hand (Ellis 2019).

Indeed, there are growing concerns over monopoly control of gene-editing conflicting starkly with the rationales of human health and environmental safety. There is a culture shift in biotechnology in academic research institutions from a pure basic research to profit-maximizing commercialization. The example of terminator technology illustrates fears about the abuse of monopoly control over food supplies. Terminator technology introduces a “suicide gene” into the plant which could prevent the organism from reproducing once it has yielded its agricultural product (Sutton 2004). A fear of monopoly control over GM crops has arisen because companies employing terminator technology would be able to control the use and unauthorized perpetuation of their GM crops. The monopoly control offered by a terminator patent on GM crops has been deemed as a threat to agricultural food security (Torrance 2007).

It appears no one is waiting, and no one wants to lose the venture capitalists, even though CRISPR technology does not draw a specific map for future profitability (Greenberg 2016). CRISPR begins at the bench of a basic science laboratory at a molecular level and still must overcome many obstacles before being used in the plant-breeding and food market. Nonetheless, investors continue to flood CRISPR with money. All of this demonstrates that patents interact with the agricultural community and influence the trend of plant-breeding research. This probably presents an underlying and underestimated aspect of patents; they comprise not only a dynamic, two-way relationship between inventors and the patent office but also among the trends and priorities of the scientific community, agricultural industry, food system, and society. Patent holders could publicly refuse to enforce patents, impose price control or require access conditions. With the trend of open innovation, relevant bodies and companies should consider the desirability of securing coordinated group licensing free of charge in order to promote the public interest in having a safe, sufficient food supply. One model of creating a non-profit humanitarian patent pool in the form of a single licensing authority is the humanitarian Golden Rice project. Six key patent holders reached an agreement to license-free to alleviate chronic vitamin deficiency in developing countries (Overwalle et al. 2006).

7.3. Market confusion challenge

Plants obtained using CRISPR-Cas techniques cannot be easily distinguished from plants that are mutated naturally, as both share identical characteristics. It is hard for the public to distinguish different mutation, such as induced mutation by CRISPR, cisgenesis, or chemical/physical techniques, since genetic analysis is necessary for both such plants and consumers might feel confused with these. Initially, spontaneous random mutations achieved through propagation and selection. Later, X-rays and radium turn spontaneous mutations to induced mutations (Songstad et al. 2017). Now, using CRISPR can simultaneously create direct induced mutations. Mutagenesis has evolved from spontaneous mutation, induced mutation using chemical and physical mutagenic agents to directed mutation through CRISPR technology. For the public, it is hard to distinguish induced mutation by CRISPR from spontaneous mutation or chemical/physical induced mutagenic since genetic analysis is necessary for both such plants (Songstad et al. 2017).

One of the reasons for including the gene-edited crop within the scope of GMO law is that the traceability and labeling of the GMO products could guarantee consumers right to know whether products contain any gene-edited crop. In the circumstance when gene-edited crop is exempted from GMO regulation, consumers would not be able to actively choose gene-edited free products that are important to their health (Lilian and Froydis 2017). Providing information vital to consumer protection is an important factor in the debate concerning “methodology” approach in EU vs “substantial equivalence of the product” approach in the US. Theoretically, the traceability and labeling of GMO products could, to some extent, help consumer to distinguish gene-edited crop. Therefore, one way that consumers would be able to assess the risk and make a decision of whether to purchase a GMO is through the mandatory labeling. However, the technical differences between different plant-breeding techniques are likely beyond the recognition of most consumers. The research shows that the nuanced differences between CRISPR, transgenic, cisgenic, and intragenic are possibly even more confusing for consumers than the differences between traditional and GM techniques (Lusk, McFadden, and Wilson 2018).

Moreover, in the context of patent law system, it allows all types of mutagenesis and transgenesis, whether random or induced, as long as it contains human intervention rather than essential biological processes²⁸, whereas GMO regulations distinguish random mutagenesis from technical mutagenesis such as CRISPR-Cas. Random mutagenesis is a conventional breeding that does not abide by GMO regulations, while technical mutagenesis must follow these regulations. This may cause confusion for the consumer and uncertainty in the market. For example, farmers cannot distinguish between infringing plant materials using a patented method by random mutagenesis and by the technique mutagenesis. A potential patent claim puts everyone at risk of infringing.²⁹ One extreme situation is that when field crops are contaminated by a neighbor’s GMO plants, the farmer is unable to distinguish GMO from non-GMO plants but bears the burden of proving he/she did not use a patented material (Preston 2003).

7.4. The agricultural economy suspension challenge

European patent legislators aimed to provide incentives to invest in valuable new biotechnological plant-breeding techniques. As plant breeding is a long-term and costly activity, patents are important for an enterprise to enter into business, for scientists to maintain research funding, and for investors to obtain benefits from investments (Dias and Ortiz 2015). According to the CJEU rulings, the exclusion under Article 53(b) EPC is extremely narrowly explained. Plant products, such as seeds, plant parts, and fruits are, in principle, patentable, even if they result from essential biological processes such as selection and crossing, as long as they include human intervention. The narrow interpretations of EPC pave the way to patenting GM plants and lend support to large agricultural companies. However, the upstream patent law system, aiming to secure incentives for new plant-breeding techniques, encounters challenges from the downstream GMO law system. GMO regulations have focused on market safety assessment and specific labeling requirements for novel plants produced by large-scale investors and patented genetic engineering technology. The slow pace of the approval system for GM crops is putting Europe’s agriculture industry at risk.³⁰ Particularly in light of the recent CJEU decision, the classification of gene-edited crop falling under the GMO Directive means that the gene-edited crop must pass stringent safety tests before entering the market. It is not clear whether EU will suffer the conflict trade between EU and US due to these stringent regulations. It seems very likely that the court’s ruling will Chill research and Europe’s breeders and farmers may lose out in the competition of plant-breeding innovation. As the ESA warned, EU might miss the huge potential and benefits of the gene-edited plant, which might be a blow to the EU agricultural industry (Byrne 2018).

Indeed, based on the transgenic experience, the regulatory approval of suitable gene-edited crops is generally required before the beginning of the field trials and ultimately commercialization (Chandler and Rosenthal 2007). An empirical model has been established to examine the possible effects on national economic welfare through the comparative analysis of EU with other countries that allow transgenic crops (Nielsen and Anderson 2000). The result showed that the domestic and import ban on transgenic crops would reduce the welfare gains from the new technology much more than would be letting consumers express their preferences through the market (Nielsen and Anderson 2000).³¹ In addition, the “develop technology first, patent technology second, limit marketing technology later” approach might be a waste of social resources and goes against social welfare. Under the current collateral patent system and market approval system, patents related to gene editing were granted, but inventions were restricted to be marketed. Patentees’ rights seem to be meaningless since patent right is mainly a defensive right.³² Patents system might fail to encourage innovation and investment. It should be noteworthy here that we do not mean that technology could not just remain at a laboratory level as knowledge advancement, or only technologies with commercial implications have a right to exist. What we argued here is that the linkage between the market approval system and patent-granting system. Human health and environmental safety assessment should initially filter which technologies should be banned or appropriately developed via research, rather than limit the marketing technology after it has been granted a patent.

8. Conclusion

Prospects for the CRISPR-Cas gene-editing technique are truly a revolutionary biotechnological breakthrough for plant breeding. Compared with the transgenic technique, the CRISPR-Cas gene-editing technique shows greater technical merits and fewer ethical concerns. The aggressive dispute regarding whether plant gene editing should fall within GMO regulations has significantly affected the development of plant breeding, food security, and the agricultural industry. However, the classification of plant gene-editing techniques in the GMO law system is not the only relevant issue. Collaterally, the patentability of the plant gene-editing technique in the patent law system should also be considered, although its effects are less immediate and more diffuse. The gene-edited crop needs to be discussed within a much larger societal and political context in the EU: The issue of the GMO law and the patent law and their implication for innovations pertaining to plant science research and food market.

This article observed the tensions between the patent law and the GMO law in the regulatory approach toward the gene-edited crop. The EU has adopted a relatively restrictive approach to applying the GMO law in the gene-edited crop due to human health and environmental safety reasons. By contrast, the EU has allowed gene-edited crop patents regardless of the potential risk to human health and environmental safety. It might be misunderstood that ensuring the lawful exploitation of a given technology disregards patents because the assessment of the hazards stemming from the exploitation of a given technology should be carried out regardless of whether or not it is protected by a patent. Different purposes of different regulatory contexts lead to various interpretations of the term and to different attitudes towards the techniques. Such differences are implied in various interpretations of the term, such as adapting the term of conventional plant breeding in the GMO law vs essential biological processes in the patent law, taking precautions against potential risk in the GMO law vs ignoring potential risk in the patent law, process-based approach in the GMO law vs product-based in the patent law, and stipulating the restrictive and lagging regulation in the GMO law vs liberal and leading regulation in the patent law. Moreover, the outcome of a decision in the patent law system has no direct effect on the GMO law system, and conversely, the ruling of cases on the GMO law system is irrelevant to the patent law system. The frequent disconnect between the GMO law and patent law is a serious problem for the regulator in controlling and promoting plant gene editing.

Should the GMO Law be relaxed or the Patent Law be made more restrictive? It is indeed difficult to build a convincing argument around this point and out of the scope of this article. What this article arguing for is limited to the interconnection between the GMO law and the patent law. Considering the EU’s permissive patent policy and negative GMO policy as well as their differentiation in gene-editing policy with other countries like the US, that the regulatory framework of gene-edited crop in the EU will inevitably face the international trade impediment challenge, the patent monopoly challenge, the market confusion challenge, and the agricultural economy suspension challenge. These challenges pose difficult regulatory challenges for the EU, which wants to exploit gene-editing technology’s economic advantages while simultaneously ensuring human health and environmental safety. Current tensions, including asymmetry interpretations under the patent law and the GMO law and the segregation between the patent law and the GMO law, would ultimately lead to the EU losing the technological economic advantage and failing to protect both human health and environmental safety.

Thus, EU GMO law should be bridged with the patent law when facing regulatory challenges from the gene-edited crop. These challenges might be met by positioning the patent law and the GMO law hand-in-hand rather than side-by-side in dealing with the gene-edited crop. At least, EU regulators should show the same attitudes and keep its policy consistency between the GMO law and the patent law. Particularly both two legal systems have a significant role in gene-edited crop technology, market, and industry and have tremendous influence on companies, consumers, and farmers. The GMO law and the patent law should share the same risk assessment standard when the patent-granting process and the product-approving process examine the gene-edited crops. Rather than they run in opposite directions where the GMO law disapproves the gene-edited crop for protecting the interests of farmers and consumers, while the patent law approves the gene-edited crop patent for the interests of companies and industries.

Disclosure statement

No potential conflict of interest was reported by the author.

ORCID

Li Jiang http://orcid.org/0000-0002-9094-0551

Additional information

Funding

This project was supported by the Fundamental Research Funds for the Central Universities (22120190125) and was funded by the Jiangsu Philosophy and Social Science Foundation (17ZXC003).

Notes

1 The world population has reached new heights and is expected to keep increasing, reaching a total of 10 billion by the end of this century.

2 CRISPR-Cas gene editing technique has also been found to have the potential for functional plant studies and steering plant development.

3 https://www.persistencemarketresearch.com/market-research/gene-editing-market.asp.

4 https://ec.europa.eu/food/plant/gmo/legislation_en

5 See the Secretary Genera of the ESA, Garlich Von Essen said it is going to be in big trouble to classified CRISPR as a GMO. The Continent would likely fall behind South America, the US and Canada in terms of innovation in the long run.

6 https://www.epo.org/law-practice/legal-texts/epc.html

7 https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX:31998L0044

8 The patent systems direct new plant-breeding research, funding, and investment. Ultimately, the setting of patentability limits and regulatory principles will determine what type of new plant-breeding techniques will develop and whether these new plant-breeding techniques will have historical significance.

9 Mutagenesis refers to any process of generating a genetic mutation, either occur spontaneously or be induced by techniques.

10 Cisgenic plant refers to the genetic modification of a recipient plant with genes are artificially transferred between organisms that could otherwise be conventionally bred.

11 In the progeny’s genome, the desirable characters will always carry the lined undesirable characters. Linkage drag refers to the reduction in fitness in plant breed because deleterious genes always drag along with the beneficial gene during backcrossing.

12 In many cases, the products of gene editing and traditional breeding would be indistinguishable. See Gene editing an ethical review, the report of Nuffield Bioethical Committee. http://nuffieldbioethics.org/ (last visited August 10, 2018)

13 http://www.ilo.org/dyn/cisdoc2/cismain.details?p_lang=en&p_doc_id=60498 (last visited August 10 2018).

14 The first scientific publication of the ODM technique was made in 1999. Patents were applied for and attributed much later. See ACRE, the United Kingdom Advisory Committee on Releases to the Environment: New techniques used in plant breeding. Advice of 18 July 2013,

https://www.gov.uk/government/publications/genetically-modified-organisms-new-plant-growing-methods

15 The international Convention for the Protection of New Varieties of Plants (UPOV) established in 1961 grants property right in new plant varieties. According to a ban on dual protection given by a sui generis plant breeder’s right and patent, plant varieties should be excluded from patentability. For this purpose, the Article 53(b) of EPC precluded plant varieties from patentability.

16 The boarder of two regimes-patents and plant variety rights-excludes plant variety from patentability subject matter because it is eligible for plant variety rights.

17 The drafters of this provision deliberately chose “biological” in opposition to “technical” and “essentially” in contrast to “purely”.

18 Art. 27.3(b) of the TRIPS Agreement provides that states can exclude from patentability essentially biological processes for the production of plants or animals; however, it does not provide any parameter to ascertain which biological processes fall under the category of essentially biological processes.

19 The evolution of patent law system is not strictly determined by scientific and technological progress. The relationship of patent system with scientific and technological progress is non-linear but affected by political factors.

20 If a process of sexual crossing and selection includes within it an additional step of a technical nature, which step by itself introduces a trait into the gene or modifies a trait in the gene of the plant produced, so that the introduction or modification of that trait is not the result of the mixing of the genes of the plants chosen for sexual crossing, then that process leaves the realm of the plant breeding and, consequently, is not excluded from patentability.

21 The survey shows European consumers prefer food that is natural over genetically modified.

22 USDA is one of three federal agencies which regulate products of food and agricultural technology. Together, USDA, the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) have a Coordinated Framework for the Regulation of Biotechnology that ensures these products are safe for the environment and human health. USDA’s regulations focus on protecting plant health; FDA oversees food and feed safety; and EPA regulates the sale, distribution, and testing of pesticides in order to protect human health and the environment. See https://www.cornucopia.org/2018/04/usda-refuses-to-regulate-gene-editing-in-plants/

23 Secretary Perdue Issues USDA statement on Plant Breeding Innovation, Press Release by USDA Press on March 28, 2018. https://www.usda.gov/media/press-releases/2018/03/28/secretary-perdue-issues-usda-statement-plant-breeding-innovation

24 See https://www.prnewswire.com/news-releases/bayer-and-crispr-therapeutics-ag-join-forces-to-discover-develop-and-commercialize-potential-cures-for-serious-genetic-diseases-300195724.html

25 Article 2.2 of the SPS Agreement, which requires that measures be “based on scientific principles and [not be] maintained without sufficient scientific evidence” and that such measures be applied only to the extent necessary to protect human, animal or plant life or health. Article 5.5 of the SPS Agreement prohibits arbitrary or unjustifiable distinctions [in the level of sanitary or phytosanitary protection], if such distinctions result in discrimination or a disguised restriction on international trade. Article 2.3 of the SPS Agreement forbids application of SPS measures in a manner which would constitute a disguised restriction on trade.

26 See https://www.wto.org/english/tratop_e/dispu_e/cases_e/ds291_e.htm

27 SPS agreement is an agreement on how governments can apply food safety and animal and plant health measures sets out the basic rules in the WTO. Article 8 of SPS agreement stated that Members shall observe the provisions of Annex C in the operation of control, inspection and approval procedures, including national systems for approving the use of additives or for establishing tolerances for contaminants in foods, beverages or feedstuffs, and otherwise ensure that their procedures are not inconsistent with the provisions of this Agreement. See https://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm

28 Induced random mutagenesis in today’s practice is not novel; therefore, it usually rejected patent as it involves little technical expertise. However, based on the CJEU ruling, induced random mutagenisis is not rejected by essentially biological process under Article 53(b) EPC.

29 The patent scope in new plant-breeding techniques might extend to material undistinguishable from the patent-protected material.

30 Biotech firms warn EU over pace of GM crop approvals, http://news.agropages.com/News/NewsDetail---5361.htm (last visited August 10, 2018).

31 Welfare gains refers to annual global welfare gains. Based on Nielsen and Anderson’s analysis, the welfare gains are indeed substantial:

introducing GMO rice leads to annual global welfare gains of about 6 billion dollars with the current trade distorting rice policies and almost 15 billion dollars if these policies are liberalized globally. For GMO cotton the impact of eliminating existing trade – distorting policies in the textiles and clothing sector is even more marked: the global welfare gain is less than 2 billion US dollars when introducing GMO cotton varieties in the presence of existing policies and 43 billion US dollars without.

32 Defensive right means that the patent owner has the right to exclude others from making, using, selling, or importing the patented invention.