The substantive examinations carried out by the Mexican Institute of Industrial Property include assessments of inventions in the fields of biotechnology, chemistry and pharmaceuticals. Such inventions are mainly based on novel compounds or molecular structures, novel uses of known compounds, novel chemical processes and related innovations.

The claims in question often focus on enhanced or unforeseen pharmacological properties, but many applications lack the technical data needed to demonstrate the pharmacological effect of the substance or use in question. This may be because the applicant did not have time to perform the necessary tests while developing the invention or is unable to carry out such tests at the time of application.

Clinical trials are time consuming and require careful planning, but the effectiveness of a novel compound or use depends on them. The results and subsequent analysis largely dictate the commercial feasibility of the compound or use in a given market. Thus, the duration and cost of clinical testing are critical factors in the success of a novel compound or use and in making the resulting product available at a fair price. Including trial results in the patent application facilitates a substantive examination by demonstrating the relevant novel effect that sets the subject of the application apart from closely related known inventions.

Although the inclusion of technical data in a patent application is an important demonstration of the effect of a novel compound or use and can expedite the patenting process, it is not required under the Industrial Property Law or its implementing regulations. However, the institute's examiners sometimes require such data before they will officially recognise the effect in question, maintaining that without such data, the enhanced or unexpected effect is not duly exemplified in the application and the claim is not clearly made out under Article 47(3) of the law and Article 29 of the regulations (which relate to the description of the invention and the claim set, respectively). In particular, examiners commonly require technical data as evidence of a claimed effect to distinguish it from similar effects of structurally related compounds or the therapeutic effect of known compounds. Such objections are based on Articles 12(2) and 17 of the law, which relate to the inventive step requirement in a patent application.

Many applicants are independent inventors with limited financial resources, for whom performing technical tests to collect the necessary data may be difficult or impossible. Despite their solid infrastructure and greater financial backing, even large chemical and pharmaceutical companies may face problems in performing clinical studies. In such cases, inventive step objections must be overcome solely on the basis of the enhanced or unexpected effect.

Unfortunately, it is increasingly common for examiners who are not persuaded of the inventive step in an application to issue unfounded official rulings that there is insufficient support for the patent claim - thus, the inventive step is not officially recognised. In such cases, the patent application may ultimately be refused. This unfair outcome excludes valid and patentable claims and discards many years of hard work and research.

However, in most cases such objections are unjustified. If faced with an official request for supporting data, applicants should be aware that the applicable legislation and implementing regulations do not require them to submit technical information in addition to that disclosed in the application.

Experience suggests that the best course is to indicate to the examiner in charge the difficulty of performing the required tests and the time and money that would be required. If it has no additional technical data to submit, the applicant should ask the examiner to consider the arguments that it has filed in order to prevent the application from being delayed unnecessarily or even rejected.

For further information on this topic please contact Jorge Uscanga at Becerril, Coca & Becerril SC by telephone (+52 55 5263 8730), fax (+52 55 5263 8731) or email ([email protected]).