1 May 2015Jurisdiction reportsPablo Fuentes and Alan Hidalgo

The need for experimental evidence

The forms that this experimental evidence can take depend on the technology for which protection is sought, and are almost infinite. To these authors’ knowledge, there is no regulation around the world that restricts to a specific format the manner in which an applicant should submit these experimental tests.

In Mexico, the intellectual property regulation requires only that the applicant has to demonstrate the best mode to carry out the invention, leaving as optional the filing of experimental evidence in cases in which it might be necessary (article 28 of the Mexican Industrial Property Law’s regulations).

However, in practice, this lack of guidance in the law has meant that Mexican examiners seem to have adopted a position that a lack of experimental evidence in a patent application’s specification is equivalent to a lack of inventive activity. In our opinion, that contradicts the definition of inventive activity in Mexican law, which only describes an evaluation of obviousness in light of prior art.

Statistically the most common type of objection issued by Mexican examiners is based on a lack of inventive activity due to the absence of sufficient examples in the specification (even if some examples are present). These objections are normally accompanied by a request for comparative tests between the closest prior art and the claimed invention.

This goes beyond the obligations of applicants according to the law and its regulations. The argument of the examiners is that: “There must be an advantage/improvement of the invention over the prior art, and such an advantage should be credible for the full scope of the claims in light of the experimental evidence showed.”

Arguments pointing out the invalidity of the examiners’ position have proved to be very ineffective in dealing with these types of objections.

"Mexican examiners seem to have adopted a position that a lack of experimental evidence in a patent application’s specification is equivalent to a lack of inventive activity."

Patent applications directed to protecting non-obvious alternative ways of solving the same technical problem already solved by the prior art are almost a taboo theme right now in Mexico. This is because no technical advantage is present in this type of application, despite its possibly complying with the non-obviousness requirement established under Mexican law.

Of course, the aim behind the strict position of the Mexican examiners is to grant very solid Mexican patents. However, it is surprising that the examiners now ask for more technical evidence even if at least one embodiment of the invention was already exemplified, without considering either how expensive and/or time-consuming additional experimental tests can be for the applicant, or the timeframes in which novel investigations inside the pharma and biotech industry develop.

Additional experimental evidence is normally accepted during the prosecution of Mexican applications but only as long as such evidence can be derived from the same experimental protocols described originally in the specification of the application.

In view of the prevailing situation, when Mexico represents an attractive market for the applicant the best thing to do is to include in the original application strong experimental data that attempts to validate as much scope of the potential claims as possible. This could avoid unnecessarily delaying the prosecution of the patent application during the substantive examination stage.

Likewise if, when drafting the original application, it is not possible to include broad experimental evidence, a second desirable step should be at least to try to define in a broad manner a tentative experimental protocol that could be carried out after the filing of the original application, in order to generate the experimental results and file such experimental results upon the request of the Mexican patent office to demonstrate the inventive activity of the patent application.

Pablo Fuentes is patents coordinator at  Becerril, Coca & Becerril. He can be contacted at: pfuentes@bcb.com.mx

Alan Hidalgo is technical engineer at Becerril, Coca & Becerril. He can be contacted at: ahidalgo@bcb.com.mx

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