During 2003, three changes in law or regulations were enacted or passed the legislature that have an impact on patent practice in Mexico. They were the Law on Sustainable Forest Development, the Regulations on Health Substances, both of which have come into force, and an amendment to the patent statute which has not yet come into effect.

The Law on Sustainable Forest Development includes provisions to protect indigenous resources similar to those that have been enacted in other countries. Under this law, which is rather vaguely written, it appears that a patent can be held to be invalid if it involves the use of a “forestal biological resource” and the patent fails to acknowledge the rights of the indigenous community on the property, knowledge or use of a local variety used in the patented invention. Additionally, gathering, assembling, collecting or using forestal biological resources with a view to using such resources in research or biotechnology requires the consent of the Ministry of the Environment and Natural Resources which will only be granted after prior, explicit, informed consent in writing has been granted by the proprietor or possessor of the land where the forestal biological resource in question is located.

The amendment to the Regulations on Health Substances provides that when an applicant for marketing approval of a drug other than the patent holder or its licensee submits a request for marketing approval, the health authorities must request an opinion of the Mexican Patent Office as to whether that drug is the subject of a patent. The patent office has ten days within which to respond. If it does not, it is to be assumed that there is no relevant patent. If a patent is reported to the health authorities, no marketing authorization shall be granted unless the patent is within the last three years of its term. In such a case, authorization may be given for tests and experimental production although the final marketing approval will be effective only after the patent has expired. In a related development, the patent regulations have been amended to require publication of a list of Mexican patents relating to pharmaceutical products indicating not only the patent in question but also the generic name and the pharmaceutical identity of the active material.

As noted above, a change to the Mexican Patent Law was adopted by the legislature but has not yet come into effect. This amends Mexican law relating to compulsory licensing of patents and specifically provides for the grant of compulsory licenses in cases where Mexico is suffering from “serious diseases requiring attention on a priority basis as determined by the General Health Board”. In such cases, applications for compulsory licenses will be made to the patent office with the Ministry of Health setting the conditions relating to production, quality, field of application of the license and determining whether the applicant for the compulsory license has the necessary technical ability.