After nine years of linkage regulation in Mexico, on July 31, 2012, for the first time, the Mexican Patent Office (IMPI) included in the Linkage Gazette formulation patents in accordance to the 2010 ruling of the Mexican Supreme Court. For more information on the linkage regulation and its development, please visit our web site www.olivares.com.mx
The formulation patents listed in this latest edition of the gazette are those for which the inclusion was requested and that IMPI had opportunity to review and prepare the corresponding listing prior to the deadline for the update of the linkage gazette due for the last day of July, 2012.
It is expected that IMPI will issue an extraordinary Gazette in two months to review and include, if suitable, formulation patents which inclusion was requested prior to July 2012. Thereafter, every six months (which is the term established in the Linkage Regulation for the update of the gazette) formulation patents covering allopathic medicines with an identified compound and corresponding INN that are not processes can be included through petitions before IMPI, instead of litigation as had occurred since the enactment of the Linkage Regulation.
Use patents are not included in the gazette and will require litigation to be listed and to obtain the preventive protection consisting in avoid the granting of marketing authorization to non-authorized parties. The reason for this exclusion may be based on the consideration that the Supreme Court decision is limited to formulation patents. The note of criticism would be that IMPI divided the linkage gazette in two parts, one for compound patents and one for formulations; we consider that there is no reason for that division and may be a cause of an undue compliance with the linkage regulation.
Olivares & Cía. is proud to had been at the forefront of the litigation and lobby proceedings which forced IMPI to change its previous criteria, in favor of R&D in the pharmaceutical area. We will continue to advise companies in order to obtain the best protection available for their IP asset.