In Mexico: Can the Minimum Period of 5 Years Established by NAFTA for Regulatory Data Exclusivity be Extended for Biological Medical Products?
In Mexico, there is no specific body of legislation governing data protection exclusivity (DPE), also known as regulatory exclusivity, for chemical drugs, biological medical products and new indications. The authority responsible for enforcing the regulatory framework for drugs, biological medical products and medical devices, is the Federal Commission for Protection against Sanitary Risks (COFEPRIS), which is part of the Ministry of Health.
In 2012, in an attempt to provide guidance on DPE, COFEPRIS issued internal guidelines that provided a 5 year-term of data protection for new chemical entities only. The guidelines did not address DPE for biological medical products and new indications. Moreover, the reliability and legal value of these guidelines remains uncertain. However, up to now, these internal guidelines have not been challenged or contested by any generic companies.
Based on the interpretation of international treaties (namely, NAFTA and TRIPS), along with the Mexican legislation specifically related to approval of new molecules, innovator companies have successfully obtained regulatory data exclusivity of 5 years through litigation for new chemical entities, formulations and new indications.
Regarding the length of DPE protection, NAFTA states that it should be for at least 5 years. However, for biological medical products, some countries such as United States, Canada, the European Union, among others, grant a greater length of protection of regulatory exclusivity.
Article 222 bis of the Mexican General Health Law defines a “biologic product” as any substance that has been manufactured by molecular biotechnology; has therapeutic, preventive or rehabilitative effects; is provided in a dosage form; and is identified as such by its pharmacological activity and physical, chemical and biological properties.
At the end of 2012, Janssen Cilag (Janssen) requested DPE for a biological medical product. Based on an interpretation of International Treaties, International Comparative Law and Mexican regulations for biological medical product approval, protection beyond the minimum period of 5 years established by NAFTA was requested. This request was ignored by COFEPRIS which was understood as a tacit negative response. As a result of this reaction, at the beginning of 2013, the tacit negative response was challenged before the Federal Court for Tax and Administrative Affairs (FCTA). On November 2014, the FCTA confirmed the denial to grant the protection holding that the minimum period of 5 years established by NAFTA had already expired. The FCTA also concluded that foreign legislation was neither applicable nor mandatory and that the plaintiff failed to prove that considerable efforts were involved in the generation of data and information to prove the safety and efficacy of the biological medical product.
As a result of an appeal, in June 2015, a Federal Circuit Court issued a decision ordering the lower FCTA court to issue a new, accurate decision on the merits, providing certain guidelines as to how to decide the time of protection for clinical data of a biological medical product. In a complying decision issued in July 2015, the FCTA concluded that Janssen had demonstrated that the generation of data and information aimed to prove the safety and efficacy for the biological medical product involved considerable efforts. The FCTA also concluded that COFEPRIS did not accurately analyze the case. As a result, at that point of time, FCTA was unable to assess the applicable provisions in NAFTA, which established a possibility of granting a longer period of protection than the minimum period of 5 years. For this reason, FCTA held that it could not act as an administrative authority. Therefore, it ordered COFEPRIS to issue an accurate decision determining whether to expressly recognize a longer period of protection than the minimum of 5 years established by NAFTA. The FCTA’s decision is awaiting further action by COFEPRIS.
This case is very important because for the first time ever the Mexican courts are contemplating the possibility of having the minimum period of 5 years established by NAFTA as a minimum period of protection and not the only established period of protection for clinical data.
Mauricio Sámano and Ingrid Ortiz also contributed to this article.