In summary, Data Protection comprises a sui generis intellectual property right related to the clinical data of pharmaceutical or agrochemical products. Clinical data, the information used to demonstrate that a product is safe and effective to be administered, is guarded against unfair use or blocked for third parties who may depend on it during a regulatory approval process.
Data protection is considered by the Trade-Related Intellectual Property (TRIPS) Agreement, the document which sets the basic provisions governing intellectual property matters amongst members of the World Trade Organization, under a nondisclosure approach. Parties are required to avoid the disclosure of the data or protect it against an unfair commercial use (Article 39, paragraph 3, of the TRIPS Agreement).
TRIPS Agreement: The basic provisions for data protection
Although the TRIPS Agreement establishes the basic provisions for data protection, multilateral treaties may require a higher level of protection. For Mexico, the North American Free Trade Agreement (NAFTA) further required it to protect the data by blocking third parties which may rely on it during the regulatory approval process.
During the period when NAFTA was in force, 1994 – 2020, Mexico did not explicitly establish a procedure in its national law for obtaining data protection. It is assumed that these rights were automatically conceded whenever an innovative marketing approval was approved. In addition, interested firms could also obtain these rights through judiciary or administrative proceedings. Upon a favorable decision from the Mexican judiciary or Administrative Court, the Mexican Regulatory Authority was forced to acknowledge this protection and block potential third parties marketing approvals.
In 2018 The Mexican Regulatory Authority replied to a public inquiry on the data protection given from 2013 until 2018. The response shows that data protection was linked either to marketing approvals or new indications.
NAFTA has been updated to the United States Mexico Canada (USMCA) Agreement
Now, the NAFTA has been updated to the United States Mexico Canada (USMCA) Agreement and though some elements have been kept from the NAFTA, it establishes new rules for data protection; for example, data protection for agrochemical products is now granted for 10 years. Interested firms must consider these amendments when seeking to obtain data protection in Mexico.
According to the USMCA final provisions, Mexico may take up to five years to implement the obligations in regard to data protection; however, this does not seem to be a hindrance for interested firms as the agreements are currently in force.
Data protection remains a supplementary mechanism through which innovative firms may obtain the exclusivity of their products. There is previous data of its acknowledgment in the country, and, although it may take some time to incorporate it into the national law, interested firms could benefit without waiting for the amendments.Read More