Inventions in the field of biotechnology are often subject of multiple patentability restrictions in patent laws around the world. The Mexican legal framework is no exception. In Mexico, the Federal Law for the Protection of Industrial Property (FLPIP) includes relevant exclusions from patentability applicable to biotechnology, some of which follow the general provisions in the TRIPS[1] Agreement whereas others specify them with concrete examples of excluded subject-matter.
Below, we will review the admissibility hurdles provided by Mexican patent law to life sciences inventions.
- Ordre public, legality, and morality
The FLPIP sets general grounds for the exclusion from patent protection on the bases of ordre public, legality, and morality. Specifically, the exclusion refers to inventions “which commercial exploitation goes against ordre public or violates any legal provision”, including inventions “which exploitation must be prevented to protect the health or life of humans, animals, or plants, or to avoid serious harm to the environment”.
As it can be noted, the wording of this general clause is in line with that used in article 27.2 of the TRIPS Agreement and 20.36.2 of the USMCA[2], except that the FLPIP further excludes inventions which exploitation is “illegal”.
In other words, in Mexico, no monopoly will be granted over any politically incorrect or illegal invention. Despite the broad language used by the legislator, admitting varying interpretations (that may further change with time, political priorities, even legislative activity), it is worth noting that a similar provision in the former law was scarcely, if at all, used to raise claim objections, and there is no reason to believe that such practice will change with the current FLPIP.
Furthermore, limitations are imposed on the exploitation of inventions that harm health and life, or significantly damage the environment. Underlying this exclusion is a morality principle aiming to ensure that the Mexican State only protects inventions that provide a greater benefit than the environmental or health costs they may signify for humans, animals, and plants. The patent law provides the following non-limitative list of inventions falling within such general clause, some of which involve important bioethical issues and remind of the exclusions from patentability set forth by the European Biotech Directive (Directive 98/44/EC):
a) Human cloning and its products.
b) Procedures for modifying the germinal genetic identity of humans and their products when they involve the possibility of developing a human being.
c) The use of human embryos for industrial or commercial purposes.
d) Procedures for modifying the genetic identity of animals that involve suffering without substantial medical or veterinary benefit for humans or animals, and animals resulting from such procedures.
- Plant varieties, animal breeds, and microorganisms
Plant varieties and animal breeds are excluded from patent protection, except in the case of microorganisms.
In Mexico, plant varieties have a separate protection framework in the form of plant breeder’s rights, so patent protection is not an option for these. Animal breeds are also not eligible, whereas there is no corresponding sui generis protection.
It is important to note that there are no general prohibitions for the protection of plants and animals as such, so, for example, engineered organisms can be protected in Mexico.
Furthermore, microorganisms are patentable. The wording of the exclusion implies that technologies related to plant varieties and animal breeds that qualify as microorganisms, could be patented, such as in the case of isolated cells or in vitro culture. Furthermore, microorganisms per se are not listed as an exclusion so any microorganism can be patented. To that end, it would be necessary to demonstrate technical human intervention, such as purification, isolation, or modification; in other words, the microorganism should be different to those found in nature.
- Essentially biological processes for obtaining plants or animals and their products
The FLPIP excludes essentially biological processes for obtaining plants or animals and the products resulting from these processes.
The criterion being that essentially biological processes may occur without significant human technical intervention, in an attempt to avoid legal monopolies on conventional breeding.
Regarding processes for obtaining plants, although the Mexican Institute of Industrial Property has rejected patents for plants that are produced by marker-assisted breeding and other modern breeding methods, recently there have been Court resolutions affirming that the methods and plants at issue are biotechnological in nature, and cannot be produced spontaneously without human intervention, so they are not excluded from patentability.
- Diagnostic, therapeutic and surgical methods of treatment
Surgical or therapeutic methods for the human or animal body and diagnostic methods applied to them cannot be subject to a patent in Mexico.
Although the prohibition is clear, there are ways to overcome this limitation. For example, ex vivo methods are, in principle, patentable, for which the description must support that the method is or can be carried out outside the human or animal body. Methods that cannot qualify as therapeutic may also be protected.
Furthermore, medical use formats such as EPC2000 and Swiss Style are allowable, and these formats may coexist in a single application. It is important to highlight the absence of a defined criterion of Mexican Examiners, although a favorable bias exists towards EPC2000 claims and specific diseases, rather than therapeutic activities, which should be defined.
- Human body and its parts
The FLPIP excludes the human body in the different stages of its constitution and development, as well as the simple discovery of one of its elements, including the total or partial sequence of a gene.
Genes as found in nature are not patentable and the same applies for the human body. In addition, Mexican law does not regard as “invention” a simple discovery. However, inventions where human intervention can be demonstrated are in principle patentable.
Interestingly, biological material isolated from its natural environment may be subject to a patent, since isolation involves a technical process sufficient to differentiate the material from its natural counterpart.
Underlying these prohibitions are bioethical considerations protecting the dignity and integrity of individuals as well as obstacles against monopolizing natural components of life.
- Conclusion
The majority of life science inventions are susceptible to patentability in Mexico, provided they meet the requirements of novelty, inventive step, and industrial applicability. The exclusions provided by Mexican patent law are in line with international treaties, supported by widespread ethical principles. Despite these exclusions, Mexico represents a permissive country in which most biotechnology and life sciences inventions can be protected by patent, when compared to other jurisdictions in the continent, making it an attractive country for business development and technology transfer. If you are interested to protect an invention in Mexico, we recommend seeking the help of a local patent counsel.
[1] Trade Related Aspects of Intellectual Property Rights.
[2] United States-Mexico-Canada Agreement.
