The Linkage System in Mexico: an Overview of Challenges and Implementation

With NAFTA being focused on broader intellectual property rights, the fact that there were no explicit provisions for regulating a linkage system is discussed. The uncertainty that existed prior to the linkage system is explored, whereby the regulatory authority (COFEPRIS) would issue marketing authorisations without verifying anything related to patent rights, and patent holders had to defend their rights against infringement before courts.

Mexico’s linkage system was created on September 2003 by the amendment of Article 167, Section IV of the Health Inputs Regulation, and by the inclusion of Article 167 bis of the Health Inputs Regulation and Article 47 bis of the Industrial Property Law Regulation.

The specific provisions of these articles are discussed, regarding key aspects such as:

Initially, the linkage system only considered patents that protected a molecule per se, rather than product patents. This interpretation changed following legal actions initiated by patent holders, arguing that there are different types of product patents. In 2010 the National Supreme Court confirmed this criterion, and this is discussed at length.

The main obligations here relate to Article 20.50, and the requirements imposed on the parties are examined in detail. Of relevance is that this provision recognised product patents and approved method of use.

There is a specific rule for Mexico contained in Annex 20-A. This states that, as an alternative, Mexico may instead maintain a system other than judicial proceedings that makes conditional (based on patent-related information submitted to the marketing approval authority by a patent holder or the applicant for marketing approval, or based on direct co-ordination between the marketing approval authority and the patent office) the issuance of marketing approval to any third person seeking to market a pharmaceutical product as subject to a patent claiming that product, unless by consent or acquiescence of the patent holder.

Mexico’s obligations under this alternative system are enumerated here.

Inclusion of second-use patents is still a problem and must occur via legal actions. A further challenge lies in the implementation of a system for notifying the patent holder when another party has submitted a marketing authorisation application.