Patentees frequently wonder why they should list their recently granted patents in Mexico's Linkage Gazette if their protected pharmaceutical product has not even reached clinical trial stage.

If a patentee has conducted sufficient research to obtain publications and a patent out of a new and innovative technology that has shown promising pharmaceutical activity, but then they run out of funding to take their discovery forward, a competitor could come across the investigation and decide to run a clinical trial on it, without letting the patentee know.

The local health authority, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), requires proof of patent non-infringement when an applicant applies for a marketing authorisation (MA). The applicant can provide such proof by:

  • showing that they own a patent;
  • showing that they have a licence; or
  • simply by declaring under oath that they have complied with the non-infringement requirement.

Even though Mexico follows strict national and international scientific, ethical and regulatory principles to conduct clinical studies in accordance with the General Health Law, enabled by COFEPRIS, there is a gap in the Mexican legislation when it comes to IP protection, specifically patent protection, while applying to conduct clinical trials.

To conduct a clinical trial, unlike for an MA application, COFEPRIS does not require proof from the applicant that third-party IP rights are not being infringed. In fact, the Bolar exemption – which, among other things, enables the import of patent-protected active chemical ingredients to conduct tests during the last three years of patent protection – seems to be the only mechanism that directly links patent protection with clinical testing. In its wider interpretation, the Bolar exemption does not really provide true protection against unauthorised third parties using a patented technology to apply for a clinical trial.

An early listing of a granted patent in the Linkage Gazette – specifically, during the pre-clinical trial (and pre-marketing phase) – might be the only mechanism to gain an extra layer of protection if unauthorised third parties apply to conduct clinical trials on a patented technology in Mexico. Such a listing provides more visibility of the granted right. It also benefits the applicant in the following ways:

  • It allows the applicant to comply with article 167 bis of the Regulations of Health Supplies in advance. This is one of the requirements to request an MA in Mexico. Therefore, by the time the clinical trials are initiated or finished, the patent will already be listed in the Gazette.
  • It may serve as an implicit proof that the invention is being worked or exploited in Mexico if an unauthorised third party applies to obtain a compulsory licence (such a licence can be requested by a third party to exploit an invention if it is not being worked by the owner after a three-year post-grant period has elapsed).
  • The listing in the Gazette does not need to be renewed and there are no fees involved in keeping it listed during the patent's term.

For further information on this topic please contact Soledad Betanzos-Lara at Becerril, Coca & Becerril SC by telephone (+52 55 5263 8730) or email ([email protected]). The Becerril, Coca & Becerril SC website can be accessed at