New technologies derived from biological sciences, particularly those related with genetically modified organisms (GMOs), have generated ethical concerns in Patent Offices worldwide. As Mexico is not an exception, there is no doubt that some modifications to its Industrial Property Law in order to establish an ethical framework for the patentability of these new emerging technologies must be briefly carried out.
So far, the Mexican Industrial Property Law (MIPL) allows the patentability of a wide range of inventions in the genetic field, comprising processes and products, as far as they comply with the general requirements of novelty, inventive step, industrial applicability and also sufficiency in the specification and reproducibility (utility and enablement).
As an example of the above, the following subject matter could be considered as patentable:
- Genes or partial DNA sequences.
- Proteins codified by said genes and their role in the organism.
- Vectors for the transference of genes.
- Microorganisms, cells, and genetically modified plants and non-human animals.
- Processes for creating GMOs.
- The use of genetic sequences or proteins for diagnosing diseases or predisposition to disease.
- Medicaments based on the knowledge derived from the proteins and their biological activity.
Thus, a claim belonging to a biotechnology related invention may comprise:
Products: peptides and proteins; antibodies (including monoclonal); genes; DNA and RNA sequences (promoters, enhancers, oligonucleotides, anti-sense sequences, plasmids, etc.); pharmaceutical products derived thereof.
Biological material: classic microorganisms (bacteria, yeasts, algae, virus, phages); human and animal cell lines; plant cell lines; GM non-human animals and GM plants.
Processes: for preparing proteins, genes, DNA or RNA molecules, microorganisms, cell lines, pharmaceutical products, or processes for producing products by fermentation.
However, even if the above matter may satisfy the patentability requirements stated by law, the ethical aspect of the same would still have to be evaluated.
Within the MIPL, Article 4 is the only one related with the patentability and ethics of inventions. Said article 4 reads as follows in translation:
A patent, registration or authorization shall not be granted, nor shall publication be given in the Gazette to any of the legal figures or institutions that regulate this Law, when the contents or form may be contrary to public order, morality or good practices, or they violate any legal provision.
As the recitation of Article 4 is not quite clear and concise, the terms "morality" and "good practices" may be interpreted in many different ways, thus leaving to the criterion of the Mexican Institute of Industrial Property (MIIP) the patentability of this type of inventions.
During the last years, the MIIP, through the biotechnology substantive examination section, has been carefully studying and discussing how to handle this subject matter, whereby in the case of new emerging biotechnology related inventions, the Mexican authorities will consider and evaluate the following:
- Animal suffering: It should be considered if the genetic animal modification provokes suffering with or without medical utility for the human kind or animals. In case that there is not any medical benefit, the process and the animal obtained there from will not be patentable. <
- The environmental impact or risk. It should be evaluated in light of the specification if there is a negative impact of the claimed product or process, and in case of a potential damage to the environment, as the case may be, genetic contamination, it will be considered as a non patentable invention.
- The utility of the invention for humanity.
According to the above and to the general ethical principles adopted around the world, the following matter is not considered as patentable by our authorities:
- Human being cloning processes;
- Processes for modifying the germinal genetic identity of a human being; and
- The use of human embryos for commercial or industrial purposes.
In addition to the above, it is important to remind that Article 16 of the MIPL lists those inventions also excluded from patentability:
- Essentially biological processes for the production, reproduction and propagation of plants and animals (that is, mere breeding processes).
- Biologic and genetic materials such as they are found in nature (that is, only those materials in which no human intervention may be claimed).
- Animal races (that is, those obtained by breeding, which means that transgenic animals are patentable).
- The human body and the living parts constituting the same.
- Plant varieties. (However, a new law for the protection of breeders' rights is presently in existence, under which all types of plant varieties can be protected).
As the Mexican Institute of Industrial Property (MIIP) is trying to standardize the criteria on biotechnology patent applications, those related to transgenic plants and some related to transgenic animals are and will continue being examined, however, patent applications concerning cloning procedures will not be liberated to examination until the Mexican Authorities reach a final handling criterion for said applications.
Nevertheless, it is believed that the MIIP will finally agree with the European criteria, which are reflected in Articles 53, 52, and 83 and Rules 23 c(a), e(2,3), 27 (1)(e,f) of the European Patent Convention (EPC/CPE). These Articles and Rules refer to patentable matter, animal suffering, human benefit, morality and environmental risks as set forth in above paragraphs.
In view of the above, it can be concluded that there are no precise rules to accurately ascertain the conditions that patent applications for biotechnological emerging products or processes must be met in order to comply with the Mexican Law and practice. The above paragraphs simply show a general view of the Mexican legislation on this type of applications in order to permit the applicant to make the better decision.
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.