Recently, the Mexican Federal Court has taken a decision, which has caused two different and opposite opinions between the two most important Pharmaceutical Groups: The Mexican Association of Pharmaceutical Industries and Research (IMIIF) and the National Association of Medicine Manufacturers (ANAFAM), participating as authorities the Mexican Institute of Industrial Property and the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), this last belongs to the Health Ministry.
Before September 19, 2003 there was not a relation or regulation between the protection of a pharmaceutical active ingredient (ai) through a patent (IMPI) and the sanitary register before the Health Ministry to commercialize the product (COFEPRIS).
So, there were a lot of problems because any party could ask for the sanitary register to commercialize a medicine with an active ingredient, which was protected through a patent, even if this party was not the owner of the patent. Currently, there is a relation of both entities named “linkage”.
To solve these problems, the linkage was published in the Federal Official Gazette on September 19, 2003 by adding the Article 167-bis of the Rules of Health Supplies (COFEPRIS) and the Article 47-bis of the Rules of the Mexican Industrial Property Law (IMPI), both in force since September 20, 2003.
The new Article of the Health legislation establishes that the person or entity who asks for a sanitary register to commercialize an allopathic medicine has to file the documentation which proves that this person or entity is the owner of the patent for the active ingredient (ai) issued by the Mexican Patent Office (IMPI) or the licensee with the license of the patent registered at the Mexican Patent Office (IMPI).
The new Article of the Rules of the Mexican Patent Office establishes that the IMPI will publish in its Official Gazette a list of the active ingredients protected by a patent and the duration of such patent.
This list will include the relation between the generic denomination and the pharmaceutical identity of the active ingredient and its nomenclature or form of identification in the patent. This addition does not include the process patents to obtain the active ingredients or formulations.
So, since September 20, 2003 the Mexican Patent Office has publishes these lists. However, the case which forced the Federal Court to take a decision about if the Mexican Patent Office would have to publish only the patents which protect active ingredients or also the medicines which includes various ingredients or compounds including an active ingredient, was started by Novartis.
This company filed a legal instant against the Mexican Patent Office because this last did not publish in the list of the patents, the compound, Ciclosporine, since this active ingredient is under public domain since 1978.
The final decision of the Federal Court is not opened to the public yet, but according to the informative sources, the judges interpreted that the Article 47-bis of the Rules of the Mexican Patent Law is confused and instructs to the Mexican Patent Office to publish not only the patents of active ingredients, but also the patents of compounds which have between their elements an active ingredients.
Currently, all the arguments in favor or against the Federal Court decision defend the different interests of this important industrial sector, but what it is for sure is that such decision create and important preceding which will affect the legal procedures in the future.