Unconstitutionality of the linkage regulation
Every six months the Mexican Patent Office (IMPI) publishes an updated version of the “Linkage Gazette”, a list of valid patents covering pharmaceutical products which are alphabetically listed according to the generic name of the patented product. In order to avoid the infringement of valid patents, the Mexican Regulatory Agency (COFEPRIS) is bound to observe the “Linkage Gazette” prior approving the granting of a new marketing authorization.
Through the public information provided by the Regulatory Agency in Mexico (COFEPRIS) in their official website, a pharmaceutical company that developed an innovator medicine comprising a valid combination patent detected an application for a marketing authorization filed by a generic company.
Olivares advised the pharmaceutical company to file a Constitutional Actionagainst COFEPRIS, contesting the imminent violation of a patent listed in the Linkage Gazette by the granting of a marketing authorization for a generic medicine, essentially claiming the following: i) violation of the patent titleholder’s Industrial Property rights if the Linkage System was not observed by COFEPRIS and ii) the lack of opportunity for the titleholder to be heard during the prosecution of the marketing authorization application and to have knowledge about the contents of the generic’s application.
At the first stage the District Court dismissed the case under the consideration that the pharmaceutical company did not suffer any damage and therefore lacked of legal standing to file said action, since the generic’s marketing authorization application was only a prospect and no violation can occur until its approval.
We appealed the District Court’s decision arguing that the main rationale of the Linkage Regulation is essentially preventive; therefore, the prior approval of a marketing authorization was not required to assure and claim the due application of the Linkage Regulation in benefit of the IP rights.
The Circuit Court overturned the District Court’s decision and ruled that the pharmaceutical company had the proper legal standing to request to COFEPRIS to observe the valid patents listed in the “Linkage Gazette” as established by the Linkage Regulation.
Moreover, the Circuit Court declared as unconstitutional article 167bis of the Linkage Regulation, as it does not provide the right of the titleholder of a patent to be heard during the prosecution of the marketing authorization application. This is the first case in Mexico wherein a provision of the Linkage Regulation is declared unconstitutional on behalf of the patent holder.
Legally speaking, article 167bis of the Linkage Regulation cannot be further applied in damage of this pharmaceutical company that won the Constitutional Action even in different cases, this would mean that derived from this decision, as from now on, the pharmaceutical company is entitled to intervene in every marketing authorization application proceeding filed by third parties.