Mexico: Biological Patents In Mexico

With the present Mexican Patent Law, which entered into effect on October, 1994, we may say that although in the biological field there are some specific exceptions, it is possible to consider that practically all types of these inventions are susceptible of patentability in Mexico.

Said exceptions are basically represented by the following non-patentable inventions according to Article 16 of said Law:

a) Essentially biological processes for the production, reproduction and propagation of plants and animals (Breeders' rights).

b) Naturally occurring biological and genetic material.

c) Animal races.

d) The human body and the living parts constituting the same.

e) Plant varieties.

However, taking into consideration that the above provisions do not refer to processes involving molecular biology, genetic engineering and the like, it may be concluded that any invention related to said processes is susceptible of patentability in our country.

It is important to point out that those patents which are related or refer to living organisms can be defined as biological patents. However, the purpose of having a patent of a living organism or organic matter is directly related with the biotechnology, which may be defined as the group of techniques which object is the industrial exploitation of the microorganisms, animal cells, vegetables and components thereof, it is to say, the industrial exploitation of the living organisms and in general of the organic matter, or as defined by the Office of Technology Assessment (OTA), the group of techniques using living organisms (or a part of them) for manufacturing or modifying products, to enhance plants or animals, or to develop microorganisms for specific uses. With the above in mind, it would be more appropriate to refer to a biological patent as a biotechnological patent.

Nowadays, the strategic role of the biotechnology in the innovation and development in the industry is extremely important. The development of the bioindustry (the evolution of the molecular biology and the biochemistry research) allows to locate the biotechnology as a great group of biological technologies in the core of the markets war, with a potential of markets without limits and having a wide application in areas such as Health Sector, Pharmaceutical, Littering of Animals, Manufacturing of Anticontaminant Products and Minerals Extraction among others.

At the present time, there are four sectors wherein the modern biotechnology can be applied, namely:

1.- Techniques for the tissue and cell cultures.

2.- Biotechnological processes.

3.- Techniques which apply the microbiology for the selection and culture of cells and microorganisms.

4.- Techniques for manipulation, modification and transference of genetic materials (genetic engineering)

Moreover, the biotechnology allows a new domain of the biological processes and their industrial applications.

Thus, different categories of biological patents (assisted by the modern biotechnology: the molecular biology) could be then stated.

ACTIVITY AREAS OF THE BIOTECHNOLOGY

a-) Patents in the chemical area (ethanol, ketone, butyl alcohol, organic acids, enzymes, biopolymers).

b-) Patents in the pharmaceutical area (antibiotics, diagnostic agents (antibodies, enzymes), enzyme inhibitors, steroids, vaccines).

c-) Patents in the energy area (ethanol, methane (biogas), biomass).

d.- Patents in the food area (starting cultures, alcoholic beverages, functional modification of proteins, additives (antioxidants, colorants, flavors), aminoacids and vitamins, starches and pectines, toxins elimination).

e-) Patents in the agricultural area (veterinary vaccines, ensilage and compost, microbial plaguicides, rhyzobia and other nitrogen fixators, mycorrhiza, tissue and cell cultures, phyto hormones).

f-) Patents in the mining area, (biolixiviation, oil recovery, exploitation of metals).

g-) Patents in the services area (water purification, effluents treatment, waste handling and using).

As it can be seen from the above, it is completely clear that the biotechnology, because of its importance, is and must be considered within the "new technologies" which have lately originated a real revolution or breakthrough of the known technological strategies until now.

Now then, due to the importance of the biotechnology-related inventions and knowing that for the inventors it is also extremely important to protect said inventions in strategic and specific countries in accordance with their interests, it can be stated that in addition to those provisions provided for by Article 16 of the Law, there is not any other restriction applicable in Mexico for the patentability of inventions in the biotechnological field. In other words, any biotechnological invention not falling within the express prohibitions of said Article 16 of the Law can be considered as susceptible of patentability in Mexico.

Nevertheless, it is important to stress that similarly to a mechanical invention or a method for obtaining chemical compounds, the biotechnological patents must also comply with the requirements of novelty, inventive activity (non obviousness) and industrial application (utility), since these patents will be of course subject to a substantive examination through which the Examiners will determine, in accordance with the Mexican law and criteria used for this type of inventions, the patentability of the same.

In order to be considered as patentable, an invention must not be obvious and must be novel, which in the scientific and technological development means a great accumulation of knowledge, whereby in order that something new can be produced (an idea, a process), a multidisciplinary synthesis permitting to overcome the previous knowledge must occur.

In the case of the biotechnology, said synthesis is present because the accelerated development has been possible due to the accumulation of knowledge in different disciplines (microbiology, genetics, molecular biology) as well as to the transference of knowledge between different disciplines, which phenomena are conjugated with important economical potentialities in very competitive sectors by tradition, such as the pharmaceutical sector, in which the biotechnology already assumes a strategic role.

The above is mentioned in view of the fact that the criteria for determining the patentability of a mechanical or chemical invention are not exactly the same as those used for determining the patentability of biotechnological inventions, since the complexity of these inventions, due to the different disciplines intervening in a new biotechnological innovation as well as the vertiginous development thereof, requires that the analysis of the matter claimed in the inventions during the substantive examination be really exhaustive. This fact is indeed understandable if the problems an Examiner faces to determine the novelty and inventive activity (non obviousness) of a biotechnological patent are considered, since said concepts in most cases are closely related with the prior art and are differentiated simply by a very subtle limit.

As to the industrial application (utility) requirement, and only as a comment to be taken into account, it is to be noted that Article 12-IV of the Mexican patent law states that, in order to have industrial application, an invention must be capable of being used in any branch of the economical activity. In the biotechnological patents, and particularly in the case of the genetic engineering, sometimes this requirement cannot be easily demonstrated because the technological innovations do not possess a direct industrial application and it permits that the Mexican Examiners argue based on the concept that an invention, to have utility, must set forth and claim an invention which can be operative for at least a purpose set forth in the patent application. However, such argumentation may be refuted saying that in order to satisfy the utility requirement, an invention need not be unerringly effective in its operation, since all what is required is usefulness in some instances. This is the reason why biotechnological patents may contain a considerable degree of speculation regarding uses of the basic discovery, provided that said speculation does not go too far so as to constitute an indication of fully inoperative embodiments.

Thus, the two following recommendations for filing a biotechnological patent application in Mexico should be taken into consideration:

a.-) When a biotechnological patent application is to be drafted, it is extremely important to try to distinguish the novelty and non obviousness of the matter to be claimed in connection with the prior art, as well as to point out the branch of the economical activity where the invention is to be used.

b.-) The biotechnological patent application must contain the necessary information about the obtainment of the microorganism, genetic techniques, morphology, antibiotics resistance, growing, vitamins etc., which are the conditions or requirements contained in the Budapest Treaty for the International Recognition of the Deposit of Microorganisms in Patent Matters.

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.

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