The Industrial Property Law is currently under revision at the Senate. Two legal initiatives proposed by different senators 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 aims to entirely substitute the current law.
Among the objectives of the revised proposal, which include the implementation of the US-Mexico-Canada Agreement, is updating the eligibility criteria of biotechnology-related inventions.
Revisiting morals and ordre public objections
Article 27(2) of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) provides World Trade Organisation (WTO) member states a general right, under certain conditions, to deny patentability to protect "ordre public or morality".
Article 4 of the existing Industrial Property Law implements these TRIPS provisions, with a general reference to the prohibition on granting patents that are contrary to ordre public, morals or good customs.
However, the revised proposal includes an equivalent Article 12 which replaces the more general term 'morals' with the narrower term 'scientific ethics'.
The proposal further clarifies the 'scientific ethics' perspective in the proposed Article 49 that deals specifically with ineligible inventions. The article refers specifically to human beings and specifies that the following fields will not be patentable in Mexico if approved:
- cloning and derivative products of cloning procedures in humans;
- the modification of the germinal genetic identity of human beings and its products; and
- the use of human embryos for industrial or commercial purposes.
The proposal restricts patentability of these same actions in animals, but only if they "imply suffering to the animals without substantial veterinary or medical usefulness for mankind or animals".
In practice, IMPI examiners object to the patentability of inventions for technologies such as stem cell research under the broad Article 4 provisions of the current Industrial Property Law, particularly any inventions that involve the manipulation of embryos, but the evidence for this position is vague. Under the proposed amendments, although there would be technologies that could clearly be excluded from patentability, what is eligible would also be clearer for applicants, including the use of animals for research if there is a substantial veterinary or medical usefulness.
Ineligible subject matter
Article 27(3) of TRIPS provides WTO member states another general right to exclude from patentability diagnostic, therapeutic and surgical methods for treating humans or animals, as well as plants, animals and essentially biological processes for producing plants or animals, other than non-biological and microbiological processes. Articles 16 and 19 of the current Industrial Property Law follows these exclusions.
Article 49 of the proposal relates to the eligibility of inventions for patents and clarifies several aspects of biotechnology-related inventions.
Regarding the isolation of microorganisms or genes, the proposal clarifies that they will be eligible "as such", when obtained through a technical procedure, which is the current IMPI criterion for interpreting the current Industrial Property Law.
In connection with the human body, the existing Industrial Property Law prohibits patentability of the "human body and the parts thereof"; however, under Article 49 of the proposal, the word 'parts' is eliminated from this prohibition. The proposal would therefore leave open the possibility of patenting organs through new techniques, provided that they do not fall under the exceptions relating to the manipulation of the germinal identity of human embryos.
The proposal maintains a consistent perspective on human-related materials by also prohibiting patenting of the human body at any stage of its constitution or development.
With regard to the protection of genetic material, only the discovery of partial or total sequences of genes are ineligible under the proposal. A description of an invention's use or industrial applicability is thus essential in order to make genes eligible subject matter. The proposal also clarifies the eligibility of plant-related inventions.
Regarding the current prohibition on patenting "essentially biological processes for obtaining plants", the proposal changes the term 'plants' to 'vegetation' and provides a specific definition of the term 'essentially biological'. Further, the proposal considers essentially biological processes to be "procedures consisting entirely of natural phenomena such as crossing and selection". However, the meaning of the word 'entirely' in the revised definition is unclear – it may be interpreted as a sign that patents covering crossing and selection will be denied only if the steps in the procedure are crossing and selection. Procedures including laboratory techniques might be eligible.
The patentability of microbiological or technical procedures, or the products obtained thereof, will 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 revised Industrial Property Law before the Senate. However, the new law as proposed seems to provide greater certainty regarding the eligibility for biotechnology inventions.
The proposal was expected to be examined in February 2020. The proposal is broard and complex because it includes all industrial property legal tools, and the discussions are likely to last a long time. However, given the fact that the party in government has a majority in both chambers in the Mexican congress and the IMPI is supporting this initiative, the revised law may come into force in 2020, though the law-making process might take longer depending on the political agenda.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.