Mexico: Utility Issues In Protection Of Biological Inventions In Mexico

By: Oscar M. Becerril

The concept of utility is relatively new in the Mexican legislation on industrial property, since it was for the first time introduced in the 1991 law and was more clearly defined only in the 1994 law. Prior to the 1991 law, the Mexican patent system was extremely defective and the vast majority of the inventions were not considered as patentable, which therefore restricted the possibility of obtaining patents only to the mechanical inventions and to the methods of obtaining chemical compounds.

The new patent law and particularly the 1994 law, however, by allowing patentability to practically all types of inventions, including those pertaining in the biotechnological field, has practically removed from the analysis the patentability issues and, instead, has now introduced the utility issues which are already being used in connection with the examination of patent applications and that no doubt will have relevance in the future as a reason for the invalidation of granted patents in Mexico.

The definition of invention contained in article 15 of the Mexican patent law, by stating that it must be a human creation for use by man in order to satisfy his concrete needs, undoubtedly calls for compliance with a utility requirement which, in order to be satisfied, requires that a significant use of the invention claimed must exist. On the other hand, the conditions for patentability of inventions stated by article 16 of the Mexican patent law, by establishing that an invention, in order to be patentable, must comply with the requirements of novelty, inventive activity (non obviousness) and industrial application, also involves a definite utility requirement if considered in combination with the condition established by article 12-IV of the Mexican patent law which very clearly states that, in order to have industrial application, an invention must be capable of being used in any branch of the economical activity.

The utility issues incorporated in the new Mexican patent law are already inducing the examiners at IMPI to introduce the concept that an invention, to have utility, must set forth and claim an invention which is operative for at least a purpose set forth in the patent application. However, in order to satisfy the utility requirement, the invention need not be unerringly effective in its operation; all what is required is usefulness in some instances.

Also, the distinction between the operative and the operational is to be noted. The utility requirement is fully satisfied if the claimed invention is operative, that is, if it functions for its intended purpose. There is no requirement that the invention be fully operational, in the sense of the existence of a marketable embodiment, although the existence of commercial success is a definite evidence of operability of the invention.

In connection with biotechnology-related inventions, which often involve a considerable degree of speculation regarding uses of the basic discovery, it is important to consider that the old Mexican Patent Office, in connection with inventions patentable at the time, never considered the existence of inoperative embodiments in a claimed invention to be sufficient reason to invalidate the patent, provided that at least one of the embodiments within the scope of the claimed invention was operative and provided that the remaining embodiments could be rendered operative by one skilled in the art with the addition of elements or selection of conditions of operation which do not constitute a new invention in themselves. As this practice has not been changed up to the present time, it is to be concluded that said practice will be also applicable to biotechnology-related inventions which, therefore, may contain a considerable degree of speculation, provided that said speculation does not go too far so as to constitute an indication of fully inoperative embodiments.

On the other hand, the basic discovery of a biotechnology-related invention may be described and claimed without the need of incorporating all the possible uses to which it is susceptible, because an inventor is not charged with a prophetic understanding of the entire field of usefulness of his invention. The basic principle of patents that an inventor is entitled to every use to which the invention is susceptible, whether or not those uses are known to the inventor at the time of the invention, is fully recognized by the Mexican patent system. Therefore, the owner of a patent whose claims are drawn to structure or basic discovery is entitled to exclude others from using anything embodying said structure or basic discovery, even if the use was neither disclosed nor claimed in his patent. Of course that if one discovers a use for said structure or basic discovery which is new, useful and unobvious, he could be entitled to patent such new use, but the claims drawn to such use would be subservient to those in the earlier patent claiming the structure or basic discovery per se.

Also, an inventor does not need to carry out his invention to the highest degree of perfection to be entitled to obtain a patent. There is no requirement in the Mexican patent law that each and every embodiment within a claim be equally useful for each and every contemplated application, that is, all embodiments within the scope of a claim do not need to be equally effective in order to be entitled to patent protection and, moreover, the Mexican law does not consider the economic or commercial value of an invention to be material to the question of utility.

In specific reference to chemical and biotechnology-related inventions, particularly those that claim products for use in the fields of foods and drugs, the utility requirements may be regarded as somewhat more stringent than those applied to other inventions, in the sense that, in order to comply with the utility requirements, some degree of safety must be shown. In other words, a food product or a drug cannot be considered to have a practical application (usefulness) unless it is safe. Therefore, in order to comply with the utility requirement of the Mexican patent law, a certain minimum level of safety must be demonstrated. However, said level of safety has nothing to do with the standards handled by the Direction for the Control of Foods and Drugs of the Mexican government (equivalent to the Food and Drug Administration of the U. S. A. government). Proof of safety may be required by the IMPI only when adequate reasons can be advanced by then examiner for believing that the drug or the food product is unsafe, and the evidence submitted will be accepted if it establishes a reasonable probability of safety. The documentation required by the Direction for the Control of Foods and Drugs would therefore seem to far exceed that necessary to establish utility under the patent law.

Accordingly, it is quite possible to patent a drug or a food product and yet be unable to market the same as such for failing to meet the standards of safety required by said Direction for the Control of Foods and Drugs.

The showing of utility for biotechnology-related inventions must be effected taking into consideration the provisions of non-patentability for certain inventions, contained in article 16 of the law.

When dealing with essentially biological processes for the production, reproduction and propagation of plants and animals, that is, merely breeding processes, the showing of utility is not enough, unless some chemical or genetic methods can be included to carry out the said breeding and the new transgenic plants or animals are proven to have usefulness.

When a use unknown in the prior art for certain biological or genetic material existing as such in nature is found, although the material per se cannot be patented, the new use per se can be made the subject matter of a valid patent, but in this instance the usefulness of said material must be proven by means of working examples or the like in order to satisfy the utility requirements of the law.

The content of this article is intended only to provide general guidelines related to this particular matter. For your specific circumstances, full specialist advice is recommended.

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