The exclusion from patentability of treatment methods is not an exclusive topic belonging to a particular legislation, but a generalized topic shared by several legislations around the world. The Mexican legislation is not an exception. The current Mexican Industrial Property Law (MIPL), in its Article 19 Section VII, clearly indicates that surgical, therapeutic and diagnosis methods applicable to the human body and those related to animals are considered to be non-patentable inventions.
Based on the above regulation, it is very common that the Mexican authorities of the Mexican Institute of Industrial Property (IMPI, by its initials in Spanish), during the substantive examination of patent applications, reject any claim which shows evidence that its contents could be related with the methods expressly excluded from patentability by the Mexican legislation,. Hence, in order to determine if a claimed method really infringes Section VII of said Article 19 of the MIPL, it is essential to carry out a very deep analysis of a patent application. Otherwise, there will always be a permanent risk that a truly important and useful development cannot be protected.
For this reason, some aspects of general interest are exposed in the following lines that may result highly useful when trying to establish a set of criteria that helps to determine what should be understood by surgical, therapeutic and diagnosis methods, to then state if the matter of a specific invention should be considered or not within the provisions of said Article 19 of the MIPL.
Although it is known that different definitions exist about what should be understood as therapeutic treatment method, it can be considered that a therapeutic treatment method is that which implies the cure of a pathological condition or dysfunction of the human or animal body, by the alleviation, elimination, or reduction of its symptoms, and/or by taking measures to prevent spreading or catching any disease. It is worth to mention that especially when the cure, palliation and prophylaxis are carried out or assisted by means of surgery, the analysis of the application becomes extremely complex.
Based on the above definition, it is the opinion of the authors that it would be perfectly valid to establish that treatment methods not having a therapeutic end should be considered patentable. Cosmetic methods, methods related with cattle productivity, and testing methods applicable to the control of processes, among others, are clear examples.
However, it is very important to stress that if the method to be protected includes at least a feature that might characterize it as a therapeutic treatment method, it would not be patentable. For instance, even if the final result of this method is not therapeutic, but it is obtained with the direct or indirect action of a process or action that consists in curing, and eliminating symptoms, or in rehabilitating from, or preventing the spread of a pathological condition or any other dysfunction, said method would be considered as therapeutic. and therefore would not be patentable.
In other words, a method to improve meat production, wool, or any other product from cattle, for example, should be normally considered as patentable. However, if said improvement results from the administration of a medicament or a vaccination, which administration promotes the cure or prevention of a disease, the method should be considered as therapeutic. Even if this condition is not described in the patent application, it is evident that the effect or result improvement - observed is present when the health of the animal is improved or maintained.
The case of cosmetic methods also is very special. There is not a defined border between what should be considered as cosmetic and/or therapeutic. Therefore, it is necessary to first analyze if the object of the invention can be clearly differentiated from a pathological state according to the state of the art. Then, if the method is related with a condition or pathological state, it must be determined, if it implies to alleviate the symptoms, to eliminate the causes, or to prevent said condition. If that is the case, then the method would not be patentable.
Methods making reference to acne, loss of hair, obesity, or halitosis, could be claimed as having a cosmetic and/or aesthetic purpose. It is clear that they improve personal appearance. However, it is important to bear in mind that as the final result or objective of many of these methods is obtained by means of a curative, preventive or palliative action, this feature gives them a therapeutic character.
Additionally, it is of utmost importance to determine how the method is working and to assess its effect performance level in a clear and precise manner.
If the cause of the problem is eliminated when the level of performance of the effect is superficial and merely affects the subject appearance one cannot say that a disease is being cured or prevented. Thus, the result could be considered as cosmetic, and therefore, patentable under the provisions of the MIPL. A good example are corporal mass reducing methods, which supply temporary and superficial effects, through the use of creams and soaps, but in no way eliminate or prevent the fat accumulation at a cellular level.
Another example of this type of patentable methods comprises a skin tanning method, which consists in making that a determined quantity of light, with a particular wave length, directly falls on the skin of a subject, with the only effect to stimulate the natural process of melanocites' melanin production to get the skin tanned. In this particular case, the artificial light substitutes the wave length of the solar light, without modifying the natural function of the cell. Thus, this method is not conferred with any therapeutic feature.
Surgical treatment methods are defined as those directed to the cure or palliation of a disease by means of instrumental procedures of invasive nature which are carried out within the corporal space of an organism. In order to determine if a method is surgical and that therefore falls under the provisions of Article 19 Section VII of the MIPL, it must be considered that "surgical" refers to the nature of the treatment and not only to the purpose thereof. This means that any method in which at least one of its steps makes reference to an invasive procedure on the corporal space of an organism would have to be, in principle, excluded from protection, even if its object is not therapeutic.
A laser depilation cosmetic method, which is based on an invasive procedure consisting in destroying the cells of the pilous follicle by laser radiation, could be perhaps the most illustrative example. This method, even though not having a therapeutic purpose, would have to be however, necessarily considered a surgical method because it is an invasive procedure.
Diagnosis methods can be defined as a series of steps through which it is possible to identify a pathological condition or a dysfunction within an organism. Summarizing, diagnosis methods can be divided in two types: 1) the analysis method and 2) the diagnosis method.
The analysis methods, which can be carried out in vivo or in vitro, are those that generate intermediate results. These results do not allow making a decision on the particular course of a therapeutic method.
Now then, according with the provisions of Article 19, Section VII of the MIPL, it is quite evident that in vivo methods do not have any possibility of protection, because they are carried out directly within the organism. On the contrary, methods carried out in vitro are perfectly patentable. The only restriction for these is not to include the step of obtaining a body sample wherein an invasive procedure is required.
Diagnosis methods arrive to the final result by analyzing and interpreting the intermediate results and then comparing them with the standards of each one of the analyzed elements. This allows the application of a specific therapeutic treatment. Consequently, any methods including this stage cannot be considered as patentable.
Methods for determining glucose in blood, exams using X rays, and those useful for determining molecular markers among others, are example of analysis methods. These methods would be indeed patentable if the step of obtaining a body sample and the step of analysis or interpretation of the results are not included.
According to the above, it can be concluded that in order to determine if a treatment method may be susceptible of patentability on the grounds of Article 19, Section VII of the Mexican Industrial Property Law, it is fundamental to carry out a detailed and profound analysis of the matter intended for protection in each particular case, bearing in mind the considerations expressed for the different instances above described.
Noteworthy said considerations will tend to vary in accordance with the development of the state of the art. While more knowledge is acquired, the definitions and the limits applicable to each case will probably be modified and new criteria to delimit when a treatment is therapeutic will be developed.
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.