https://orcid.org/0000-0002-9094-0551
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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:
Disclosure statement
No potential conflict of interest was reported by the author.
ORCID
Li Jiang http://orcid.org/0000-0002-9094-0551
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.
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.
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
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.
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.
