The status of patenting plants in the Global South

Over the last few decades, the number of patents on plants and plant parts has greatly increased in various parts of the world. Most research, however, has focused exclusively on developed countries — the United States and European Union states in particular — while little is known about the extent to which plants are being patented in other parts of the world. This article aims to fill this information gap by providing an overview of the status of patenting plants in the developing countries and emerging economies of the Global South. The research is based on the analysis of legal provisions, patentability guidelines, court decisions (where they exist) and a sample of patents granted in the countries selected for this study. The findings indicate that despite the flexibilities of the World Trade Organization Trade ‐ Related Aspects of Intellectual Property Rights Agreement regarding the nonpatentability of plants, 60% of the 126 countries in the Global South for which data were available to allow for the patenting of plants or parts thereof, and many such patents have been identified. This situation warrants further reflection and, potentially, review of existing patent laws as developing countries search for ways of responding optimally to the needs of feeding a growing population while adapting to the challenges of climate change.

not oblige the granting of patents in all fields of technology; there was no obligation, in particular, to grant protection to plants or plant varieties.
The TRIPS Agreement, adopted in 1994 as one of the multilateral agreements of the World Trade Organization (WTO, 2017), introduced such an obligation, but it explicitly allowed WTO members to exclude "plants" from patent protection (Article 27.3(b)). It also required members to provide protection for "plant varieties," but left open the option to do so under patents or in the form of a sui generis regime (such as PVP, whether consistent or not with the International Convention for the Protection of New Varieties of Plants (UPOV), or a combination (Article 27.3(b)).
The wording of the facultative exclusion for "plants" under the TRIPS Agreement gives WTO members the possibility of denying patent protection to any plant, whether wild or obtained through conventional breeding methods of crossing and selection, hybridisation, mutagenesis, genetic modification or any other method. As will be discussed below, many national laws enacted by developing countries that are WTO members have provided for a plant-related exclusion from patentability. In some cases such an exclusion has been broadly crafted, but many developing countries have limited the exclusion-as under European law-to "plant varieties." This means that, for instance, a genetically modified plant may be deemed patentable as such.
While the TRIPS Agreement allows WTO members to exclude plants from patentability, a number of FTAs entered into by developing countries with the United States have included, among other "TRIPS-plus" provisions, an obligation to provide for the grant of patents on plants or to make efforts to ensure that such patents are granted. These FTAs have followed three different approaches (Correa, 2014): (1) Some contain a straightforward obligation to provide for the grant of patents on plants, if requests to that end are submitted.
(2) Some include "best effort" or "reasonable endeavour" obligations, which may be interpreted as obliging the parties to make all necessary efforts to implement patent protection for plants.
(3) Some do not specifically refer to the patentability of plants, but nor do they mention plants as subject matter for which an exclusion from patent protection is allowed.
The first approach can be found, for instance, in Article 14.8(2) of the U.S. FTA with Bahrain, which stipulates that " [E]ach Party shall make patents available for plant inventions." The U.S. FTA with Morocco also makes plant patents mandatory: Article 15.9(2) states "Each Party shall make patents available for the following inventions: (a) plants, and (b) animals … ." In these cases, the obligation is likely to be interpreted as extending to parts and components of plants, such as seeds and plant cells.
The second approach is found, for instance, in Article 17.9.2 of the U.S. FTA with Chile, which provides that: Each Party will undertake reasonable efforts, through a transparent and participatory process, to develop and propose legislation within 4 years from the entry into force of this Agreement that makes available patent protection for plants that are new, involve an inventive step, and are capable of industrial application.
While this provision imposes an obligation to make "reasonable efforts" to "develop and propose legislation," and provides for a deadline to that end, the only actual obligation on the government is to put a legislative process in motion. In this regard, Roffe (2004) has interpreted this obligation as follows: " [A]ccording to this obligation, that in practice applies only to Chile, the latter is not obliged to consider plants as a patentable subject matter, but to engage in a process to legislate to that effect." Arguably, the obligation would not be violated if a government found opposition to the introduction of patent protection for plants, or if other conditions were not met (such as lack of capacity to examine their patentability). Although reciprocal in appearance, the provision is irrelevant for the United States, where patent protection for plants was already available at the time the FTA was signed. Chile does not yet seem to have introduced patent protection for plants.
A similar obligation-although less detailed than in the U.S. FTA with Chile-can be found in the US-CAFTA-DR (Dominican Republic-Central America FTA), 8 but in this case the fact that plant patents were already granted in the United States is reflected in the text. Article 15.9(2) reads: Nothing in this Chapter shall be construed to prevent a Party from excluding inventions from patentability as set out in Articles 27.2 and 27.3 of the TRIPS Agreement. Notwithstanding the foregoing, any Party that does not provide patent protection for plants by the date of entry into force of this Agreement shall undertake all reasonable efforts to make such patent protection available. Any Party that provides patent protection for plants or animals on or after the date of entry into force of this Agreement shall maintain such protection.
The third approach is found, for instance, in the U.S. FTAs with Jordan, Singapore and Australia, which allow only the exceptions provided for in Articles 27.2 and 27.3(a) of the TRIPS Agreement, without any reference to plants (or animals). The U.S. FTA with Oman (Article 15.8: Patents) allows for the exclusion of patents in respect of animals, but does not mention plants: 1. Subject to paragraph 2, each Party: (a) shall make patents available for any invention, whether product or process, in all fields of technology, provided that it is new, involves an inventive step, and is capable of industrial application; and (b) confirms that it shall make patents available for any new uses for, or new methods of using, a known product, including new uses and new methods for the treatment of particular medical conditions. 2. Each Party may exclude from patentability: (a) inventions, the prevention within its territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal, or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by law; (b) animals other than microorganisms, and essentially biological processes for the production of animals other than non-biological and microbial processes; and (c) diagnostic, therapeutic, and surgical procedures for the treatment of humans or animals.
A question arises as to whether the obligation to issue patents for "plants" implies the need to extend such protection to "plant varieties." Countries bound by FTAs' obligations in this respect may consider that these are two different categories of subject matter. Article 27.3(b) of the TRIPS Agreement, for instance, as noted above, distinctly refers to them as different subject matter.
FTAs signed with the EU or the European Free Trade Association do not include an obligation to grant or endeavour to grant patents on plants, but to ensure PVP under the standards of UPOV (generally the 1991 Act).
The Trans-Pacific Partnership Agreement, now renamed the Comprehensive and Progressive Agreement for Trans-Pacific Partnership, introduced a new type of obligation in relation to patents on plants, the implications of which still need to be clarified. Article 18.37.4 stipulates that: A Party may also exclude from patentability plants other than microorganisms. However, consistent with paragraph 1 and subject to paragraph 3, each Party confirms that patents are available at least for inventions that are derived from plants.
The concept of "inventions that are derived from plants" was new in FTAs and national patent laws. It is unclear what this phrase was intended to mean. In any case, the second sentence of Article 18.37.4 was suspended in the ongoing negotiations that took place after the withdrawal of the United States (Geist, 2017).

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In summary, we can conclude that the international patent regime, as contained in the TRIPS Agreement, allows WTO members to broadly exclude plants from patentability. This policy space, however, is totally or partially limited in many FTAs that contain TRIPS-plus obligations, particularly those with the United States.

| LEGAL PROVISIONS IN NATIONAL LAWS
Establishing the precise status of the patentability of plants, plant materials and related processes in developing countries and emerging economies in the Global South requires, as a first step, the determination of the applicable national legal provisions, including, where appropriate, the provisions of international treaties.
The legal provisions contained in patent laws that may affect the patentability of plants and plant materials may refer to the following matters and relate to associated definitions: • Discoveries, natural materials and traits • Plants

• Plant varieties
• Essentially biological processes and other methods to produce or modify plant varieties or plants • Genes and other plant parts, including promoter DNA sequences, transit peptides, cells and so forth.
As summarised in Table 1 and Figure 1, 9 plants are excluded from patentability in 40% of the 126 countries for which legal information was available in 2018 (Oxfam Novib, 2018). 10 In other words, the majority of these countries have not used the TRIPS flexibility regarding the nonpatentability of plants. Of these countries, 43% exclude the patentability of plant varieties and essentially biological processes to obtain them, as is the case under European law, and would hence allow the granting of patents on plants and their parts and components, including plant cells. To the extent that patented elements are incorporated into plant varieties, the production and commercialisation of the latter (and eventually of the products derived from them) may be controlled by the patent owners, despite the fact that the plant varieties as such might not be patentable. In the other 17% of the countries studied, plant varieties might also eventually be patentable, generally due to the lack of an explicit exclusion. Table 2 summarises the relevant provisions of patent laws in force in the selected countries, that may affect the patentability of plants and plant materials. Table 2, patent laws contain different types of exclusions from patentability relevant to plants and plant materials. Some specifically refer to plants, while others contain more general provisions that may prevent plants or plant materials from being patented (e.g., the exclusion under the Brazilian law of "all or part of living beings"). However, a key issue is how the scope of these exclusions is interpreted. Whether the exclusions are, in administrative or judicial practice, broadly or narrowly interpreted will determine the extent to which access to and use of propagating material may be subjected to patent rights. For instance, a narrow interpretation of an exclusion of "plants" may lead to the possibility of indirectly controlling access to and use (notably for saving and reusing seeds) of The patent laws in the countries shown in Table 2 limit the scope of allowable protection through a negative approach, detailing the matters that can not be considered an invention or patentable. Such lists may include discoveries, naturally occurring genetic materials, plants and/or plant varieties and essentially biological processes for the production of plants. These different categories of exclusions are examined in more detail below.

As shown in
3.1 | Patentability of plants and plant materials: Administrative and court interpretation

| Invention versus discovery
According to the ordinary meaning of the term, a "discovery" is the act, process or circumstance of acquiring knowledge or verifying the existence of something previously unknown or not recognised, or the outcome of such acts or processes, while "invention" is the result of the action of humans on the forces of nature, which necessarily implies a human contribution.
Patent laws generally do not define invention. One notable exception exists in Argentina, where invention is defined as "any human creation that allows the transformation of matter or energy that exists in nature, for its use by man and to meet their specific needs" (Article 4(a) The following shall not be patentable: (b) All biological and genetic material existing in nature or derived therefrom in biological processes associated with animal, plant and human reproduction, including genetic processes applied to the said material that are capable of bringing about the normal, free duplication thereof in the same way as in nature Decree 260/96, Article 6 Plants and animals and essentially biological processes for their production shall not be patentable 3. What are not inventions? The following are not inventions within the meaning of this Act: (c) The mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or nonliving substance occurring in nature (h) A method of agriculture or horticulture (j) Plants and animals in whole or any part thereof other than microorganisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals

South Africa Patents Act Section 25
A patent shall not be granted: (b) For any variety of animal or plant or any essentially biological process for the production of animals or plants, not being a microbiological process or the product of such a process Peru Decision 486 (CAN) Article 15 The following shall not be considered inventions: (a) Discoveries, scientific theories and mathematical methods (b) The entirety or part of living beings as encountered in nature, natural biological processes, biological material existing in nature or which may be isolated, including the genome or germplasm of any natural living being.
an inventive process. A rigorous application of the concept of discovery is likely to lead to the rejection of patent applications relating to natural traits 12 and plants as found in nature.
In most selected countries there is no such explicit definition, and the meaning of invention must be deduced from the provisions of the law. In some cases (such as in Brazil), the law specifies what is not deemed to be an invention as well as the subject matter that, even for inventions, is not patentable. Other countries make a more general reference to what is not patentable. This reflects the flexibility allowed by the TRIPS Agreement, which mandates in Article 27.1 that patents be granted for inventions without defining them, thereby leaving national laws significant leeway to determine what may or may not be deemed patentable, including in the area of plants. Table 2 consider that discoveries are excluded from patent protection. This means, for example, that a wild plant as found in nature may not be considered an invention. Depending on the criteria applied by the patent offices and courts (discussed later in this article), a natural gene found in a plant, even if isolated, may also be deemed nonpatentable, in spite of the identification of its utility for a specific product or process. Similarly, a known plant does not become patentable just because a new property is found (such as use for medicinal purposes). The exclusion of patents on discoveries may be based on the lack of novelty (since they already exist) and/or inventive activity (in a discovery the intellectual activity is not to create but to find).

Most laws indicated in
However, the boundaries between invention and discovery have become blurred in the case of biotechnology, as it uses biological systems and living organisms or their derivatives (such as biochemical compounds) as found in nature for the creation or modification of products or processes for specific uses. Thus, notwithstanding that Article 52(2)(a) of the EPC excludes the patentability of "discoveries," a patent may be granted under European law when a substance found in nature can be characterised by its structure, by its process of obtention or by other criteria, if it is new in the sense that it was not previously available to the public. 13

| Genetic materials
Genes themselves are pre-existing in nature and therefore may be considered as discovered rather than invented.
The same applies-if unmodified-to genetic sequences used in biotechnology, such as those involved in the expression of genes and their regulation, including: promoters (DNA sequences that are operatively linked to a gene or a coding sequence and allow the expression of these, which in turn may lead to the synthesis of a protein); enhancers (DNA sequences that increase the level of expression of a gene in general or under specific conditions);

Uganda
The Industrial Property Act 2014 Article 33 (2) The following shall not be regarded as inventions within the meaning of subsection (1): (a) Discoveries and scientific and mathematical theories (b) Plant or animal varieties or essentially biological processes for the production of plants or animals, other than biological processes and the products of those processes Subject matters not protected as inventions. The following subject matters shall not be protected as inventions: 1. Scientific discoveries or theories, mathematical methods 5. Plant varieties, animal breeds 6. Processes of plant or animal production which are principally of biological nature other than microbiological ones Source: WIPOLex (https://wipolex.wipo.int/en/main/legislation), national laws (translated, as appropriate by authors).
CORREA ET AL.

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transcription terminator sequences (sequence-based elements that define the end of a transcriptional unit, such as a gene) and localisation signals (amino acid sequences that target proteins for import into the nucleus).
Nonetheless, these sequences have often been the subject of patent applications. 14 Many countries have allowed the patenting of genes and nucleotide sequences, based on the argument that by isolating them there would be no appropriation of a natural product.
For instance, in accordance with the EU Directive 98/44/EC on the legal protection of biotechnological inventions and the practice and jurisprudence of the European Patent Office, patents on isolated genes are admissible and may be granted. The USPTO has also granted thousands of patents based on the artificial differentiation between "natural" and "isolated" genes, although in Association for Molecular Pathology v. Myriad Genetics (2013) the U.S. Supreme Court ruled that naturally occurring DNA, even if claimed as isolated, is not a valid patentable subject matter. However, as noted below, the court considered that complementary DNA (cDNA; a form of DNA artificially synthesised used in genetic engineering to produce gene clones) was patentable.
The patentability of genetic material is specifically addressed by Brazil's patent law, which is very precise in stipulating that "all or part of natural living beings and biological materials found in nature, even if isolated therefrom, including the genome or germplasm of any natural living being" are not patentable. This means, inter alia, that a natural trait would not be patentable in Brazil, even if a gene is claimed as "isolated." Although similar provisions do not exist in other selected countries, expert opinion obtained for the study reported in this article holds that the same solution would apply in Argentina, Peru, Uganda and Vietnam. In Vietnam, for instance, a natural plant genetic trait can be considered as a discovery and cannot be patented in accordance with Article 59 of the industrial property law. In Peru, an isolated gene, even if not characterised before, is not considered to be an invention (Decision 486, Article 15(b)).
However, in China, a gene or a DNA fragment per se and the process to obtain it might be patented if the gene or DNA fragment is unknown as prior art and can be accurately characterised and exploited industrially (Li & Cai, 2014).
In India, although the patentability of isolated genes would be excluded if the law were strictly interpreted, according to available studies, such as Ravi (2013) Technology LLC and Ors v. Nuziveedu Seeds Ltd and Ors, 2018). In response, the defendants filed a counter-claim for the revocation of the plaintiff's patent (Shiva, 2019;Trivedi & Beniwal, 2019). The High Court of New Delhi observed that: The conclusion that the court draws therefore, is that transgenic plants with the integrated Bt. Trait, produced by hybridization (that qualifies as an "essentially biological process" as concluded above) are excluded from patentability within the purview of section 3(j), and Monsanto cannot assert patent rights over the gene that has thus been integrated into the generations of transgenic plants (Monsanto Technology LLC and Ors v. Nuziveedu Seeds Ltd and Ors, 2018).
On January 8, 2019, however, the Supreme Court overturned the Delhi High Court decision arguing that the division bench should have confined itself to the question of whether the injunction granted by the single judge was justified or unjustified in the facts and circumstances of the case. The Supreme Court has directed that the issue of patentability will be determined by the Single Judge Bench of the High Court after hearing expert evidence.
In South Africa, patent 2010/01012 filed by Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences (2010), covers a crop height regulatory gene from Arabidopsis thaliana, "expression and regulatory sequences thereof and uses thereof," which can be used to regulate the "plant height, volume, tiller, yield, flower organ size, or seed size of crops." It is important to note that in South Africa patents are granted without prior substantive examination, under a depository system. Hence, there is no ex ante analysis of patentability and the validity of deposited patents is determined by courts after a legal challenge has been made.
The nonpatentability of genetic material is generally limited to natural, unmodified material. 16 DNA constructs, gene promoters, transit peptides 17 and other components designed to genetically modify a plant may be patentable in most countries as long as the modified sequences meet the requirements of novelty, inventive step and industrial application.
Significantly, the protection granted on some of these elements may extend to any cell or plant incorporating them.
In India, for instance, patent 257711 (2013) covers "a nucleic acid sequence having promoter activity when introduced into plant cells" (claim 1), which is described as "strong, constitutive plant promoters … which remain strong and constitutive under biotic and/or abiotic stress conditions." This patent also claims "transgenic cells and organisms, especially plant cell and plants comprising the claimed promoters and methods for expressing nucleic acid sequences in cells and organisms using them." In Uganda, several patents have been identified that also protect a genetic "event" and the modified cells, seeds and plants. For instance, patent AP 2872 (2014) (2010), the Brazilian Supreme Court considered the patentability of a plant DNA sequence (transit zone), a chimeric gene and a vector for the transformation of plants. It discussed whether the claimed matters could be deemed a "chemical substance" and admitted, as a matter of principle, the patentability of products obtained through biotechnological processes.
As mentioned above, a particularly problematic situation may arise when patent claims cover not only plant materials but the products derived from processing plants or their parts. Several examples were found in the sampled patents where the claimed protection extends to food or feed. For example, Monsanto's patent CN 101321873 B (granted in China in 2013) covers "corn meal prepared from" protected corn seed (claim 40) and "a processed product of the seed … wherein said product is a feed, flour, meal or partially purified protein composition" (claim 42). Brazilian patent PI 0610654-4 (2017) covers Monsanto's event M0N89788 for genetically modified soybean and any product derived from it, including food, meal and oil. In Argentina, AR049130 A1, filed by Agrinomics LLC (2005), claims genetically modified plants with increased oil content, including seeds, meal and food. Similarly, the Uganda patent AP 2872 (2014), already mentioned, covers a commodity product derived from a plant, plant cell or seed of soybean modified by event MON87708.

| Plants, cells, seeds and other components
As indicated in applications also claim seeds 18 alone or with other subject matter. If allowed, such claims would lead to a de facto protection of the resulting plants, and also make the prohibition of granting patents on plants irrelevant.
For instance, in the patent application AR011036 A1, the main invention relates to a purified nucleic acid sequence encoding a fungicidal polypeptide of the alfalfa plant (AlsAFP1 or AlfAFP2) which, when expressed in a plant, confers resistance to fungal pathogens. A recombinant plant cell, including a polynucleotide (a DNA sequence) encoding an alfalfa antifungal polypeptide, is also claimed as part of the invention. This cell can be selected from apple, alfalfa, barley, broccoli, cabbage, canola, carrot, citrus, corn, cotton, garlic, oats, onion, pea, peanut, pepper, potato, rice, rye, sorghum, soybean, strawberry, sugar beet, sugar cane, tomato, turf and wheat. The claimed plant cell can lead to a complete individual and, if a patent were to be granted, would indirectly permit control over the use and commercialisation of any plant of these crops incorporating the modified cell.
In Monsanto Technology LLC v. Instituto Nacional de la Propiedad Industrial s/denegatoria de patente (2015)

| Plant varieties
Patent laws in some of the selected countries (China, South Africa and Vietnam) and many other countries in the Global South have followed the approach of the EPC and provide that plant varieties (rather than plants) are not patentable. This exclusion is clearly narrower than that applicable to "plants" as it would allow for the patentability of transgenic plants, including their parts and components such as genetic constructs, cells and seeds.
In Argentina and Brazil, the cumulative protection of plant varieties by patents and PVP is banned. These countries are parties to the UPOV Convention, as amended in 1978, 19 which prohibits such cumulative protection.
Brazil's PVP law (Article 2) clarifies that: The

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Methods of producing plants are often presented as "use claims," but these may also be subject to objections Office, n.d., a).
As mentioned above, if patents on processes to produce a plant are accepted, the product obtained with such processes may be protected as well, on the basis of an extension-mandated by Article 28.1(b) of the TRIPS Agreement-of the protection accorded to the process to the product directly obtained with it. 25 The experts' opinion and analysis of legislation show that in many of the selected countries there is uncertainty regarding whether such extension should be allowed in the case of methods of obtaining plants or plant varieties. In India, for instance, it has been noted that the statute is not very clear whether the replication of a plant arising from a patented process would result in an infringement of the patent. In Vietnam, the protection conferred on a process would extend to a product directly obtained with that process (Article 124.1.c of the IP law). In Uganda and Peru, it is considered that the extension may not occur if the product is a plant or plant variety.

| Patentability requirements
Patents are generally granted after a substantive examination 26 to determine whether the patentability standards (novelty, inventive step or nonobviousness, and industrial applicability or utility) have been met. Patent offices also check the sufficiency of disclosure and whether the claims in the patent application are sufficiently clear and concise. Importantly, WTO members have policy space to define not only what an invention is but also how the patentability standards are interpreted and applied.
In the case of biotechnological products and processes, for instance, key issues are whether a substance that exists in nature may be considered "novel," and whether prior knowledge of gene coding sequences or protein amino acid sequences is destructive of the novelty of the other.
Similarly, the standard of inventive activity or nonobviousness can be applied more or less rigorously depending on the policy adopted by patent offices and courts. A large number of techniques in biotechnology, molecular biology or biochemistry are widely known and used in practice, and are the basis of many technological innovations.
Many biotechnological developments that use elements of the art should therefore not be patentable if examined under a rigorous standard of inventive activity or nonobviousness.
For example, the technology of recombinant DNA has allowed the construction of new DNA molecules by rearranging or combining different genetic elements-defined DNA sequences that have a biological function, such as promoter or polyadenylation site. The function of each element is determined solely by its sequence, and not by the elements with which it is combined in a DNA construct. Therefore, once a genetic element is within the state of the art, its function within a recombinant DNA construct will be evident. The combination of different known genetic elements can result in a new DNA molecule, designed to fulfil a particular function when found in the appropriate cellular environment. However, if the purpose or function of the DNA construction results from the simple addition of the individual functions of each genetic element previously described, the developed constructeven if novel-will not generate an advance over the state of the art and, being evident to a person normally skilled in the art, will lack inventive activity.
A situation of particular interest, from the perspective of patent laws and access and benefit-sharing regimes, arises when a claimed plant-related invention has been obtained on the basis of digitised genetic information (Bagley, 2016;Halewood et al., 2018). This is made possible by what is termed the "dematerialisation of genetic resources" (Bhatti, 2013). For instance, patent 284831 granted in India in 2017 to SweTree Technologies AB covers a method of producing a transgenic woody plant that "pertains to a novel and extensive analytical platform for selecting genes with a possible commercial phenotype from a large group of candidate genes identified using tools in bioinformatics, data from EST sequencing and DNA array." 27 In principle, whether a claimed plant-related invention has been obtained by using physical materials or digitised information-for instance through gene editing using the CRISPR-Cas9 technique 28 -would not affect its eligibility for patent protection, provided that the patentability requirements were met. However, patents based on the use of that technique may become harder to obtain due to objections regarding inventive step, as knowledge of the gene-editing technique has been widely disseminated. It is to be noted that a key patent on CRISPR-Cas9 was revoked (due to flaws in the application's procedure) by the European Patent Office in January 2018 (Houldsworth, 2018;Tottie, Skoglösa, & Hoffmann, 2018). mentioned above, objections based on lack of clarity of claims have been raised. For instance, some claims do not refer to a particular genetic sequence, but to a type of sequence or functional element such as "a DNA molecule encoding a transit peptide to chloroplasts," "a DNA molecule terminator of transcription" or "a DNA molecule encoding a glyphosate-tolerant EPSPS." 34 If a protein or DNA sequence is defined on the basis of a "class, type or function," it is possible that new elements or variants of it will fall within the scope of the claims made, even if these are not yet known or included in the description of the invention. The patent may thus cover technical developments the patentee has not conceived, and block further research and development. The biological elements claimed in this way may then be challenged for lack of clear and concise description.
A very common problem in patent applications related to biotechnological inventions is the definition of genetic elements on the basis of a percentage of identity or sequence similarity. 35 Generally, the identity or similarity between two biological sequences allows for the inference of a certain level of homology between them, and in practice is used to find new elements that may have the same biological function. However, it cannot be guaranteed that the two sequences will have the same biological function. For example, the change of a single amino acid can cause the loss of the biological function of a protein (although at the same time that protein maintains a high degree of similarity with another enzyme of known biological function). The Brazilian and Argentine guidelines for the examination of biotechnological patents mentioned above specifically address the issue of claims covering sequences characterised as having a similarity with other sequences.
They consider such claims as not acceptable due to insufficient disclosure, and require a precise definition of all claimed sequences and information showing that they have the same disclosed function (Resolución INPI (Argentina) P283, 25-9-2015INPI, para 1); Resolution INPI (Brazil) No. 44, 2015, para 6.2). In Consejo Superior de Investigaciones Científicas v. INPI (2003) the court of appeal considered that the invention, as claimed, was not reproducible and that the applicant had not satisfied the disclosure requirement despite the observation made by the patent office during the examination process. In the case mentioned above regarding Monsanto's INTACTA technology, an additional argument for the invalidity of the patent was the insufficient disclosure of the invention (SOJA, 2018).
Functional claims, that is, claims that disclose what an invention does rather than what an invention (structurally) is, are another problem often found in plant-related patents. Examples include Monsanto's patent CN 101321873 B (2013) which claims, inter alia, "a transgenic corn seed comprising more than 4000 ppm lysine" (claim 38); and Monsanto's patent 279135 granted in India in 2017 covering a method "of producing a soybean plant comprising a linolenic acid content of less than about 6% of total seed fatty acids by weight and an oleic acid content of about 55% to about 80% of total seed fatty acids by weight" (claim 1). When functional claims are accepted, any plants that perform as described will be covered, granting the patent owner broad control over varieties that are unknown to them or are later developed by third parties.

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Agreement. While clear definitions of that concept do not seem to exist in the selected countries, in some cases a very elastic interpretation has allowed for the grant of patents on methods that are ordinarily used in conventional breeding, such as hybridisation.
Only a few of the selected countries have adopted guidelines for the examination of biotechnological inventions, including plants. These guidelines address some important issues relating to patentability, in particular, the admissibility of claims based on the similarity of sequences, as it is not sufficient to prove that all claimed sequences have the same disclosed function. Noncompliance with the sufficiency of disclosure requirement has been one argument often articulated by patent offices or courts to deny the patentability of materials for the genetic modification of plants.
The situation in the selected countries can be summarised as follows: Argentina does not allow patents on plants and plant varieties as such, nor on essentially biological processes to produce plants. Patents on genetic constructs and their components have been granted, however. The patentability guidelines in force and some jurisprudence point to a rather rigorous application of the patentability requirements regarding inventive step and sufficiency of disclosure, and to the exclusion of patents over plant varieties.
Brazil has adopted legislation with some unique provisions limiting the patentability of biological materials. The cumulative protection of plant varieties by patents and breeders' rights is excluded. Despite this, several patents have been granted in relation to methods for the genetic transformation of plants that, in practice, may allow the right owners to control the commercialisation of plant varieties and derived products. The judiciary has found that such patents do not violate the prohibition regarding the cumulative protection of plant varieties.
China is one of many developing countries that exclude patents only on plant varieties, not on plants. However, patents may protect not only genetic constructs to modify plants, but also the modified cells and plants, and the products obtained from them, such as food and feed. Despite the exclusion of plant varieties, in practice this broad coverage gives the patent owner legal tools to control the production and commercialisation of plant varieties that incorporate patented components.
India has incorporated a broad exclusion from patentability in its law, which bans the protection of plants, seeds, plant varieties and essentially biological processes for their production. Patent office guidelines point toward rigorous implementation, but a number of patents have been identified that would suggest some flexibility in the way these requirements are applied. The High Court decision in Monsanto Technology LLC and Ors vs. Nuziveedu Seeds Ltd. and Ors (2018) clarified some aspects of the legislation, notably the nonpatentability of essential biological processes and the products exclusively obtained with them, and that a claim over a nucleic sequence which is introgressed and hybridised into a transgenic plant falls under the exclusions of Section 3(j) of the Patents Act. This decision has, however, been recently overturned by the Supreme Court.
South Africa is a very peculiar case as patents are registered without substantive examination. The patent law follows the European approach, thereby allowing in principle for patents on plants and their parts and components.
South Africa is one of the few African countries where planting of GMOs is admitted. No case law seems to exist on the scope or conditions of patentability in this field.
Peru is bound to apply the industrial property regime of the Andean Community, which prescribes exclusions from patentability regarding biological materials including the "entirety or part of living beings." Several decisions by the Peruvian patent office suggest a rigorous enforcement of these limitations.
Uganda follows the European approach, in which only plant varieties and essentially biological processes for their production are not patentable. Patents have been granted with broad coverage, including cells, seeds and the products obtained with planted material. Although Uganda has only recently adopted the Genetic Engineering Regulatory Bill 2018 to allow the introduction of GMOs in the country, several patents covering genetic constructs have been identified.
Vietnam has also aligned itself with the European approach. The sampled patents show several cases of patents covering DNA, modified cells and plants, methods to detect genetic events, and even a "cropping system for managing weed growth" (Monsanto's patent 1-0014994-000). Although the available sample is insufficient to make an assessment, the patent office seems to apply flexible standards regarding patentability in this field.
In summary, analysis shows considerable diversity in legal status regarding the patentability of plants in the countries of the Global South in general, and in the selected countries in particular. While 40% of the developing countries and emerging economies for which information is available have used the flexibility accorded by the TRIPS Agreement not to patent plants, most have admitted plant patents by deliberate choice (notably those following the European approach which excludes only plant varieties) or by allowing the patentability of plant parts and components, such as nucleic sequences, that indirectly but effectively confer on patent owners exclusive rights to control the production and commercialisation of plant varieties that incorporate such parts, and eventually the products obtained from them, such as food and feed.
This legal situation, together with the substantial number of patents that have been identified in the selected countries, warrants further research and debate on its implications for access to and use of seeds and breeding materials for both farmers and breeders in the Global South. Public debate on plant patents is, for example, a constant practice in Europe, where the patent laws of some countries now include more and broader exemptions for farmers and breeders than in the majority of developing countries. These countries should be encouraged to review their legislation and learn from the examples of others that, consistent with the TRIPS Agreement, have narrowed down the scope of patentability or of the exclusive rights conferred in this field. To feed a growing world population and optimally adapt to the challenges of climate change, developing countries may opt for a patent system that facilitates rather than restricts access to the building blocks of life.

ACKNOWLEDGEMENTS
We would like to thank the following experts for their valuable inputs and contributions to previous versions of this improved amino acid content, having integrated in its genome a recombinant DNA construct that transcribes an RNA oriented in the opposite direction of the reading frame that suppresses the production of a protein in a catabolic pathway of amino acids, wherein the recombinant DNA comprises a seed-specific promoter operably linked to a DNA that is transcribed into said RNA, and wherein said seeds have a high amino acid content as compared with the seeds of the progeny of control corn plants, where the production of said protein has not been suppressed." This example deals with genetically modified corn plants with a recombinant DNA construct that suppresses the expression of the enzyme lysine-ketoglutarate reductase, which consequently allows a greater accumulation of the amino acid lysine in the transgenic maize plant. 19 Article 2(1) of UPOV 1978: "Each member State of the Union may recognise the right of the breeder provided for in this Convention by the grant either of a special title of protection or of a patent. Nevertheless, a member State of the Union whose national law admits of protection under both these forms may provide only one of them for one and the same botanical genus or species." 20 An example of a patent application (filed in Argentina) covering such a process is AR063688 A1. Claim 1 reads: "A method of plant breeding consisting in: delineating at least one haplotype window comprising at least two haplotypes within the genome of a plant; associating each of said at least two haplotypes with at least one numerical value related to one or more phenotypic traits; and make a decision about plant breeding based on at least one numerical value." In this case, a classic plant breeding method is claimed, which consists of the selection of parental plants with two or more haplotypes each associated with a phenotypic character of interest, to then cross the parental plants and achieve a progeny with a desired phenotypic improvement. 21 For instance, in Decision G2/07 concerning the "Method for the selective increase of anti-carcinogenic glycosinolates in Brassica species" (application 99915886.8), the Board of Appeals of the European Patent Office stated that:"1. A non-microbiological process for the production of plants that contains or consists of the steps of sexually crossing all the genomes of plants and then the selection of such plants is, in principle, excluded from patentability as being 'essentially biological'2. This type of process does not escape the exclusion that Article 53 (b) EPC makes by the fact of containing, as a step or as part of any of the crossing and selection steps, a step of a technical nature that serves to allow or help the realisation of the stages of sexual crossing of all the genome of the plants or later wing selection of plants." 22 Claims 23 and 24 of the patent on "Hybrid Corn Plant And Seed" read: "23. Method for producing a PP59302-derived maize plant, comprising: a) crossing a hybrid maize PP59302 plant with a second maize plant and harvesting the resultant maize seed, wherein representative seed of PP59302 has been deposited under ATCC Accession Number PTA-7428; and, b) growing said resultant maize seed to produce a PP59302-derived maize plant. 24. A method for developing a maize plant in a plant breeding programme using plant breeding techniques comprising employing a maize plant, or its part, as a source of plant breeding material comprising using the maize plant, or its part, of claim 2 as a source of breeding material." 23 Patent 284578 (granted in 2017) covering a "method of introgressing at least one brilliant white curd allele into a cauliflower plant" (claim 1); patent 291357 (2018) protecting a "method of introgressing an allele into a soybean plant." 24 In accordance to the EPO Guidelines for Examination, a "use" claim in a form such as "the use of substance X as an insecticide" is regarded as equivalent to a "process" claim of the form "a process of killing insects using substance X," see para 4.16, available at: https://www.epo.org/law-practice/legal-texts/html/guidelines/e/f_iv_4_16.htm. 25 The European Commission has taken the view that EU legislators' intention when adopting Directive 98/44/EC was to exclude from patentability products (plants/animals and plant/animal parts) obtained by means of essentially biological processes, thereby dismissing the possibility of extending the protection conferred on processes to the products themselves (see European Commission, 2016). 26 In the case of South Africa patents are registered without substantive examination. For this reason, analysis of the patents registered there does not permit an assessment of the impact of the patentability standards regarding the protection of plants. No case law relating to the matter has been identified.
27 Patent grant number 28483. Application 3752/DELNP/2009, PCT PCT/SE2007/050939. From abstract: "The present invention pertains to a novel and extensive analytical platform for selecting genes with a possible commercial phenotype from a large group of candidate genes identified using tools in bioinformatics, data from EST sequencing and DNA array. The analytical platform is concentrated on analyses of growth behaviour based on a combination of multiple criteria. The invention provides a method for producing a transgenic plant by changing the expression of one or more genes selected from a group of genes which fulfil said criteria." 28 This technique is often referred to as "molecular scissors" as it allows DNA to be easily cut and pasted to alter genomes.
It is increasingly seen as a complement to traditional plant breeding strategies (see, e.g., Webb, 2018).
CORREA ET AL.

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29 For instance the PCT application WO 2004/070020 A2 included the following claim 11: "A method for detecting the presence of a DNA corresponding to DNA of the alfalfa plant J-101 in a sample, characterised in that it comprises: a) placing the sample comprising DNA in contact with a set of primers which, when it is used in a nucleic acid amplification reaction with genomic DNA from the alfalfa event J-101, produces a DNA amplicon comprising SEQ ID No. 1 or SEQ ID No. 2 *; and b) performing a nucleic acid amplification reaction, thereby producing the amplicon; and c) detect the amplicon." 30 This patent covers "a method for identifying transgenic corn plants, comprising:(a) obtaining corn plant cells transformed with a DNA segment comprising a nucleic acid sequence of interest;(b) regenerating a plurality of corn plants or differentiated corn plant parts from the cells without first selecting for the presence of said DNA segment;(c) identifying at least a first transgenic corn plant or transgenic differentiated plant part from the plurality of corn plants or differentiated corn plant parts." 31 See also Brazilian patent PI 0418683-4 (Dow Agrosciences LLC (US), 2016), which covers a method of detecting insectresistant genetically modified cotton. 32 For example, claim 1 of the PCT application WO 2013/012775 A1 reads: "A nucleic acid molecule, preferably isolated, comprising a nucleotide sequence that is unique to the MZDT09Y event, wherein the sequence is selected from the group consisting of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEC ID NO: 4 *, and its complements." The sequences SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4 described in the invention correspond to the binding sequences between the insert and the genome of the plant. 33 However, another point of view is that DNA sequences that bind to a genetic sequence introduced into a plant cell may be used to check if gene insertion has occurred, whether the introduced sequence is retained by the progeny, and whether it is present in the cells of plants produced by a suspected infringer. nucleotide sequence encoding a polypeptide necessary for proper root formation, wherein the polypeptide has an amino acid sequence with at least 70% sequence identity, on the base of the Clustal V alignment method, when compared to a SEQ ID No. 6, 8, 30 or 38; or (b) a complement to the nucleotide sequence, where the complement and the nucleotide sequence consist of the same number of nucleotides and are 100% complementary." In this example, the sequence of the DNA molecule is not specified, nor is the polypeptide sequence. Furthermore, it is stated that the polynucleotide encodes a polypeptide that "has an amino acid sequence with at least 70% sequence identity," which implies that any DNA sequence that codes for any polypeptide with at least 70% identity with the sequences SEQ ID No. 6, 8, 30 or 38, would be achieved by this claim. This includes numerous DNA sequences that have no support in the description of the invention. On the other hand, sequence identity does not necessarily imply that the polypeptides possess the same biological function. Therefore, the polynucleotide thus claimed can include DNA sequences encoding polypeptides that are not involved in root formation or that are not functional, which can lead to the lack of reproducibility of the invention.