The Mexican industrial property law (IPL) is under revision at the Mexican Senate. There are two law initiatives proposed by different senators that will have to be studied, but one of them is more likely to prevail because it has the support of the Mexican Institute of Industrial Property (IMPI) and intends to substitute entirely the current law.
Beyond other objectives of the comprehensive IPL proposal, including implementation of the USMCA provisions, one of the most significant changes intended under the proposed initiative relates to an update in the eligibility criteria of biotechnology-related inventions, as described below.
Revisiting morals and ordre public objections
Article 27 section 2 of the Agreement on the Trade-Related Aspects of Intellectual Property rights (TRIPS), provides a general right to Member states of the World Trade Organization (WTO) to exclude from patentability inventions, under certain conditions, to protect “ordre public or morality”.
The current Mexican IPL implements these provisions of the treaty under its Article 4, with a general reference to prohibit the grant of patents that are contrary to ordre public, morals or good customs.
However, the proposed IPL includes an equivalent Article 12 which changes the current standard for the narrower term “scientific ethics” instead of the more general term “morals”.
The proposed law further clarifies the “scientific ethics” perspective in the proposed Article 49 that deals specifically with non-eligible inventions. The article refers specifically to human beings, by specifying that the following fields shall not be patentable in Mexico if approved:
- cloning and derivative products of cloning procedures in humans
- modification of the germinal genetic identity of human beings and its products
- the use of human embryos for industrial or commercial purposes
Regarding animals, the proposed law restricts patentability of these same actions but only if they “imply suffering to the animals without substantial veterinary or medical usefulness for mankind or animals”.
In practice, IMPI examiners object patentability of inventions under Article 4 for technologies such as stem-cells under the broad Article 4 provisions of the current Mexican IPL, particularly when there is manipulation of embryos but the support for their decisions is vague. With the proposed law, although there would be technologies that could clearly be excluded from patentability, it would also be clearer for applicants what may be eligible or not, including the use of animals for research if there is a substantial veterinary or medical usefulness.
A twist in the ineligible subject matter
Article 27 section 3 of TRIPS, further provides another general right to WTO Member states to exclude from patentability diagnostic, therapeutic and surgical methods for the treatment of humans or animals, as well as plants, animals and essentially biological processes for the production of plants or animals, other than non-biological and microbiological processes. The current Mexican IPL mimics these exclusions in its Articles 16 and 19.
The proposed law under study at the Mexican Senate in its Article 49, that relates to eligibility of inventions for patents, includes clarification in several aspects of biotechnology-related inventions.
Regarding the isolation of microorganisms or genes, the proposed law clarifies that these will be eligible “as such”, when obtained through a technical procedure, which is the current IMPI criterion for interpreting the current provisions of the IPL.
In connection with the human body, the Mexican IPL currently in force prohibits patentability of the “human body and the parts thereof”. In the proposed Article 49 under study at the Senate, the word “parts” is eliminated from the prohibition. This would therefore leave open the possibility of patenting organs through new techniques, provided that they do not fall into the exceptions of manipulation of the germinal identity of human embryos.
The proposed law keeps consistency in the perspective of human related materials, by also prohibiting patenting of the human body in any stage of its constitution or development.
Regarding the protection of genetic material, the proposed law only makes non-eligible the mere discovery of partial or total sequences of genes, thus making necessary to describe a use or industrial applicability of the invention in order to make genes eligible subject matter.
Finally, the proposed law, in the same article, clarifies eligibility of plant-related inventions.
In the current prohibition of patenting “essentially biological processes for obtaining plants” the term “plants” is changed for “vegetables” and a specific definition of the term “essentially biological” is provided. According to the proposed law, essentially biological processes are: “procedures consisting entirely of natural phenomena such as crossing and selection”. The intention of the word “entirely” within the proposed definition is not that clear, but it may be interpreted as a sign that patents covering crossing and selection will only be denied if the steps in the procedure are only cross and selection. Procedures including laboratory techniques might be eligible.
Patentability of microbiological or technical procedures, or the products obtained thereof, shall not be affected by the exclusions in the same article, and will remain consistent with TRIPS.
What to expect
Some inventions might become ineligible under the proposed IPL that is being studied at the Mexican Senate. However, the new law as proposed seems to provide greater certainty regarding eligibility for biotechnology inventions.
The proposed law was announced to be studied as of February 2020. The breadth and complexity of the proposal is large because it includes all industrial property legal tools, and the discussions are likely to last long. However, given the fact that the party in the government has a majority at both chambers in the Mexican congress and IMPI is supporting this law initiative, the fastest that this law might be enacted would be within the same year 2020. However, the law-making process might take longer depending on the political agenda.