New guidelines for acceptance of Pharmaceutical Trademarks

September 16, 2013

The Federal Agency from the Ministry of Health in charge of granting the marketing authorization for pharmaceutical products (COFEPRIS) has released an official communication providing new guidelines for the acceptance of pharmaceutical trademarks (called distinctive names under the health law and regulations).

The official communication had an internal character, namely, it was not addressed to the pharmaceutical companies but to COFEPRIS officers. However, this new set of rules is relevant for applicants, as it may change the current scenario regarding the acceptance of proposed distinctive names during the prosecution of a marketing authorization in Mexico.

Briefly, the COFEPRIS official communication of July 2 2012 provides that distinctive names that correspond to another marketing authorization will be acceptable and can be used for new marketing authorizations in the following two cases:

• When the distinctive name becomes available again due to lack of renewal of the corresponding marketing authorization within the term granted; and
• When the distinctive name has become available since it was changed by the applicant for another name during the prosecution of a marketing authorization, or after it is granted.

In these cases, the same applicant of the cancelled distinctive name may apply for a new marketing authorization, using the same distinctive name, provided also that the marketing authorization corresponds to the same category of products in which the cancelled distinctive name was used in the past.

In the case of third parties applying for the same cancelled distinctive name, there is yet another condition: the use of the distinctive name must have lapsed five years before the application is filed.

It is important to bear in mind that marketing authorizations used to be granted for an unlimited period of time, until amendments in 2008 to the HLR. Since those amendments came into force, marketing authorizations have been granted for renewable, five-year periods.

Marketing authorizations granted before the amendments should have been renewed before February 2010. However, many of them were not renewed within the term granted, which has considerably increased the number of distinctive names corresponding to marketing authorizations that are no longer in force.

It is not yet clear whether COFEPRIS will eventually remove the distinctive names for authorizations that have not been renewed from the database, but this situation is becoming an urgent matter. Even more, if we consider what has been established by the new guidelines. In fact, due to the new treatment for the distinctive names related to non-renewed marketing authorization, it is clear that applicants should be alerted to thefact that distinctive names could be available if all the conditions set forth above are met.

However, how and when this will be duly implemented is yet unknown.

Considering that these rules are meant only for internal purposes, it seems that applicants will not have a clear picture of which distinctive names are available or not. The possibility of getting a clear picture before the prosecution is not likely to be provided by the means COFEPRIS has made available.

Our Firm will follow-up and monitor on the practical implementation of these new guidelines to keep our clients updated on the possible impacts to the members of industry.

In case you require further information about the content of this newsletter, please contact Daniel Sanchez at dsb@olivares.com.mx, Sergio L. Olivares, Jr. at sol@olivares.com.mx or Victor Ramirez at vrl@olivares.com.mx