Data protection exclusivity for biologics

by Ingrid Ortiz

Mexico still lacks of a specific body of legislation for data protection exclusivity (DPE). But, over the past few years, thorough litigation, based on an interpretation of international treaties (NAFTA & TRIPs) along with the Mexican legislation related to approval of new molecules (new chemical entities, formulations and new indications), means DPE for new chemical entities, formulations and new indications has been obtained.

The five years of protection that has been obtained in some cases results from NAFTA’s provisions establishing that the information submitted to obtain a sanitary authorisation shall be protected at least for five years from the issuance date of the authorisation.

Mexican legislation defines biologics as any substance that has been manufactured by molecular biotechnology; has therapeutic, preventive or rehabilitative effects; is provided in a pharmaceutical form; and is identified as such by its pharmacological activity and physical, chemical and biological properties.

In view of the particularities of biologics, some jurisdictions as Canada, the United States and the European Union have provided longer terms than five years.

While there is no specific regulation on this matter in Mexico, the progress is evident. A few weeks ago the Mexican courts analysed the possibility of having the period of five years (NAFTA) as a minimum for a biologic product, ordering the Mexican Regulatory Agency to consider the case in litigation and the recognition of more than five years of DPE for a biologic product, especially as in that particular case, the applicant submitted evidence for a longer period (12 years) of clinical studies to obtain the corresponding approval.


This precedent is very significant, since for the first time the Mexican courts are contemplating the possibility of having the period of five years (NAFTA) as a minimum period of protection and not as the only established period of protection for clinical data.

We expect that this precedent jointly with the eventual signature of the Trans-Pacific Partnership will have a positive impact in the construction of a DPE-specific regulation in Mexico.

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