PROTECTION OF PLANT INVENTIONS IN MEXICO

INTRODUCTION

The development of biotechnology, in particular genetic engineering, has made possible to design and, subsequently, create new plant varieties instead of using traditional techniques, such as crossing and selection. While it is possible that the well-known crossing or selection techniques cannot qualify for patent protection, new plant varieties created by genetic engineering can increase the likelihood that new plant varieties meet the requirements of novelty and inventive activity. Some advantages of the new plants are the following:

• improved resistance to drought or other adverse climate conditions;

• lower nutrient requirements;

• seed-resistance to certain pests, which would reduce the use of and the expenditure on pesticides, and which would also mean less environmental impact;

• increased photosynthetic performance;

• improved quality of agricultural products;

• food with greater nutritional characteristics than those of natural species.

However, when new plants are created, some disadvantages may arise:

• loss of biodiversity;

• displacement of genes to conventional crops or related wild varieties that pollinate by wind, insects, birds, etc.;

• reduced antibiotic efficiency: by making plants resistant to pests, resistance to diseases and viruses is indirectly generated;

• increased chemical contamination, for example, with herbicide tolerant plants, farmers might feel free to use larger amounts of herbicides to get rid of other species;

• increased insecticidal abilities threaten the existence of species, for example that of the monarch butterfly.

These and other relevant issues, along with the moral and ethical dimension of the protection and commercialization of biotechnological inventions, have become topics of debate in several forums. Nevertheless, this should not hinder the advancement of science, specifically the field of biotechnology. It is in our hands to establish a strong and suitable legal framework that maintains an equilibrium between the benefits and side effects of new plant-related creations, while protecting at the same time the rights of innovators in this matter.

INTERNATIONAL LEGAL FRAMEWORK FOR PATENTING PLANTS IN MEXICO

Now then, in view of the interrelationship between plant patents and plant varieties protection, it should be clarified to the innovators which would be the appropriate way of protecting their creations. This means which of the two would be the best option for them, which requirements must be complied with, and what is the scope of protection in each case. The following table can help to see the differences between both legal forms.

The main international legal framework considered for patenting plants in Mexico includes the following:

• Paris Convention

The Convention of the Paris Union for the Protection of Industrial Property of 1883 (CPU), is an instrument that harmonizes intellectual property rights worldwide, and of which Mexico is a party.

The Paris Convention does not regulate the exclusions of patentable matter. However, Article 1, Section 3 states that:

Industrial property shall be understood in the broadest sense and shall apply not only to industry and commerce proper, but likewise to agricultural and extractive industries and to all manufactured or natural products, for example, wines, grain, tobacco leaf, fruit, cattle, minerals, mineral waters, beer, flowers, and flour.

• TRIPS (Trade Related Aspects of Intellectual Property Rights)

Section 5 of Part II of the TRIPS Agreement is dedicated to Patents. This section stipulates that countries must grant patents for inventions (of products and processes) in all fields of technology, provided that the inventions are new, involve an inventive activity, and are susceptible of industrial application.

The TRIPS Agreement in Article 27 paragraph 3.b) states that Members may also exclude from patentability:

• • • • plants and animals except microorganisms, and

      • essentially biological procedures for the production of plants or animals, other than non-biological or microbiological procedures.

However, Members shall provide for the protection of plant varieties either by patents, by means of an effective sui generis system or by a combination thereof.

“Sui generis system”

It is known that plant varieties have a specific protection system established by the International Convention for the Protection of New Varieties of Plants, signed in Paris on December 2, 1961, successively amended in 1972, in 1978 and in 1991. This Agreement creates the Paris Union on Plant Varieties (UPOV) and obliges signatory States to protect plant varieties. Thus, on the basis of the 1978 Act of this Agreement, in October of 1996, the Federal Plant Variety Law in Mexico entered into force granting a breeder’s right to those who obtain a plant variety, provided that it meets the novelty, distinction, homogeneity, and stability requirements.

Wild/natural species that were not improved by man are excluded from protection. The rights are granted to varieties that are new, distinct, uniform/homogeneous, and stable.

The scope of the term “Plant” in the context of TRIPS has been extended to include protection of plants, algae, and mushrooms; bacteria and viruses are not included within this scope, however.

• USMCA (United States-Mexico-Canada Agreement)

The recent Agreement between United States, Mexico, and Canada includes in its Article 20.F.1 the considerations for patent the subject matter regarding plants. It states that:

1. Subject to paragraphs 3 and 4, each Party shall make patents available for any invention, whether a product or process, in all fields of technology, provided that the invention is new, involves an inventive step, and is capable of industrial application.

2. Subject to paragraphs 3 and 4 and consistent with paragraph 1, each Party confirms that patents are available for inventions claimed as at least one of the following: new uses of a known product, new methods of using a known product, or new processes of using a known product.

3. A Party may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect public order or morality, including to protect human, animal, or plant life or health or to avoid serious prejudice to nature or the environment, provided that such exclusion is not made merely because the exploitation is prohibited by its law. A Party may also exclude from patentability:

1. 1. diagnostic, therapeutic, and surgical methods for the treatment of humans or animals;

1. 2. animals other than microorganisms, and essentially biological processes for the production of plants or animals, other than non-biological and microbiological processes.

4. 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.

MEXICAN PRACTICE

In Mexico, plant protection could be requested via a patent according to the Mexican Legislation of 1991, and via a plant variety based on the Plant Varieties Law based on UPOV 1978 which was established in 1996 for the protection of plant varieties.

PROTECTION OF PLANTS BY PATENT

The Mexican Industrial Property Law in Article 16 thereof states that inventions that are new, the result of an inventive activity, and susceptible of industrial application, shall be patentable, in the terms of this Law, except:

I.- essentially biological processes for obtaining, reproducing, and propagating plants and animals;

II.- biological and genetic material as found in nature;

III.- animal breeds;

IV.- the human body and the living parts constituting it, and

V.- plant varieties.

For a better understanding of the exceptions of Article 16, it is necessary to define some crucial terms as “essentially biological processes” and “step of a technical nature”.

An essentially biological process for the production of plants encompasses a method which contains or consists of the steps of sexually crossing the whole genomes of plants and of subsequently selecting plants. Such a method would be considered an essentially biological process even if the method also contains a step of a technical nature which serves to enable or assist the performance of the steps of sexually crossing. However, if the method contains an additional step of a technical nature, which by itself introduces a trait into the plant genome or modifies a trait in the genome of the plant produced, so that the introduction or modification of that trait was not the result of the mixing of the genes of the plants chosen for sexual crossing, then the method would not fall under the patentability exception of Article 16.

In a step of a technical nature there is an indispensable human intervention, without which the final result would be different. For example, a process of production and propagation of transgenic plants is a step of a technical nature even if it includes traditional biological stages. A process for the production of plants and animals that includes at least one technical step, which cannot be carried out without the intervention of man and that has a decisive impact on the final result, will not fall within this patentability exception.

For example, if the process contains crossing and selection steps, and an additional stage of a technical nature (genetic engineering) that induces a trait of interest in the genome or modifies the trait in the obtained plant, in such a way that this introduction or modification of the feature of interest is not the result of sexual crossing, both the method and the plant obtained through it would not be excluded and could be patentable.

What can be protected?

1. Genetically modified plants by introduction of exogenous genetic material (transgenic plants);

2. Genetically modified plants by directed genetic modifications without introduction of exogenous genetic material;

3.- Genetic engineering methods for introducing new traits into plants or animals, etc.

What is excluded?

1.- Genetically modified plants by physical or chemical means, due to lack of reproducibility;

2.- Breeding methods for plants or animals which contain steps of crossing and selection;

3.- Marker-assisted breeding of animals or plants, etc.

Examples of patentable claims

1. A glyphosate resistant corn plant that comprises in its inserted genome the 5-enolpiruvil-3-fosfoshikimato synthase gene from SEQ. ID NO. 4.

2. A genetically modified plant comprising the mutated SHS gene of chloroplast.

3. A drought-resistant monocot plant that comprises the FIS gene (SEQ ID NO. 1) of Selaginella.

4. Method of producing a (transgenic) plant having trait X by introducing a vector comprising the sequence of SEQ ID NO: 1.

5. A plant having stably incorporated into its genome the expression cassette of claim 1, wherein said nucleotide sequence is operably linked to a heterologous nucleic acid of interest.

6. Method for the production of plants with character X comprising crossing plants A (transgenic) and B (transgenic), and selecting progeny with Marker X.

7. Use of the nucleic acid of SEQ ID NO: 1 to select a plant having trait X.

A plant variety is not patentable even if it is genetically modified. However, if it is described as a whole plant, it could be patented.

Examples of claims excluded from patentability

1. Method for the production of plants that have trait X that comprises crossing plants A and B, and selecting the progeny that has the marker X.

Method for obtaining glyphosate resistant plants comprising:

1. crossing the plants that contain the characteristic FRI8017 with wild corn plants;

2. reproducing these plants by crossing and selection;

3. propagating resistant plants.

2. Introgression of an X (transgenic) trait into a plant.

Method for providing a Solanum lycopersicum plant with improved yield, said method comprises introducing into the genome of said Solanum lycopersicum plant the SP3D and SP3 gene, or at least the promoter sequence thereof, of Solanum pennelli or another Solanum species selected from the group consisting of Solanum neorickii, Solanum chmielewskii, Solanum chilense, Solanum parviflorum, Solanum pimpinellifolium and Solanum peruvianum.

3. Method for the production of plants having trait X comprising crossing plants A (transgenic) and B (wild), and selecting progeny having marker X.

4. A plant characterized by new genetic markers (without claiming the essentially biological method).

5. Methods for plant breeding comprising the step of embryo rescue.

6. Parts of the plant obtained by an essentially biological method without claiming the method.

CONCLUSION

Plant variety protection —covering specific plant varieties— and plant patents —covering plants at a more generic level— have co-existed for decades in Mexico.

Now, if a process of sexual crossing and selection includes within it an additional step of a technical nature, which by itself introduces a trait into the genome or modifies a trait in the genome 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. This principle applies only where the additional step is performed within the steps of sexually crossing and selection, independently from the number of repetitions.

Otherwise, the exclusion of sexual crossing and selection processes from patentability could be circumvented simply by adding steps which do not properly pertain to the crossing and selection process, being either upstream steps dealing with the preparation of the plant(s) to be crossed or downstream steps dealing with the further treatment of the plant resulting from the crossing and selection process. This will be the case for genetic engineering techniques applied to plants which differ from conventional breeding techniques, as they work primarily through the deliberate insertion and/or modification of one or more genes in a plant.

Janett Lumbreras