Mexican Supreme Court ruled on the required legal standing to question marketing authorizations in violation of patents and health law regulations

January 1, 2014

By the end of the 2013, the Mexican Supreme Court published a landmark decision that now is public available that certainly will impact the legal framework of the Pharmaceutical Industry in Mexico.

Fact pattern of the case. A pharmaceutical company developed an innovator biologic medicine.   The Regulatory Agency in charge of granting the marketing authorizations in Mexico (COFEPRIS) granted a generic company an approval for the same product as bioequivalent of the innovator biologic product.

The innovator company filed a Constitutional Action (Amparo suit) contesting, inter alia, the following: i) That COFEPRIS never called the innovator to the generic approval proceeding in violation of the civil right of due process of law; ii) that COFEPRIS never responded certain legal and factual issues raised by the innovator during the generic approval proceeding; iii) That the generic approval was granted in violation of the Health Law and Regulations as the generic product never showed the required tests such as clinical trials and in-vitro studies.

The District Court in charge of reviewing this Constitutional Action at the first stage mainly dismissed all plaintiff’s argumentation. Both, the innovator and the generic company appealed the District Court´s decision. Due to the relevance of the case, the appeals were turned to the Mexican Supreme Court.

 

The Supreme Court addressed many legal issues relevant for the decision; however, to be concise, we will refer in this newsletter to only some of them, as follows: i) although, it was not the main issue subject of analysis, the Supreme Court states that a patent holder has a subjective right that is transformed in proper legal standing to questioning any proceeding that may violate its exclusive rights; and ii) in absence of a subjective right such as a patent, based on the human right conferred in the Mexican Constitution to healthcare a pharmaceutical company having a valid marketing authorization for an innovative medicine has the proper legal standing to questioning and request COFEPRIS the issuance of an approval for a bioequivalent product only if it fully complies with all the applicable law and regulations, otherwise the healthcare right provided in the Mexican Constitution would be jeopardized.

Although, this Supreme Court precedent did not order COFEPRIS to cancel the generic approval and also established that COFEPRIS was not bound to call the innovator to the generic´s approval proceeding, it is a valuable and positive case law which confirms that patent holders have the legal standing to question marketing authorizations that may violate the exclusive rights but also based on the human right to health recognized in the Mexican Constitution, a pharmaceutical company as part of the health system, in order to prevent health risks is entitled to question and request COFEPRIS to observe all the applicable rules and regulations for an approval of a medicine.