New guidelines for data protection in Mexico are “good news” for innovators and brands, say Hedwig Lindner and Manuel Morante.
Clinical data is protected in Mexico under Article 1711 of the North American Free Trade Agreement (NAFTA) (in force since January 1, 1994), and Article 39.3 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) (in force since January 1, 1995). However, there is no consensus as to whether NAFTA embraces the concept of data exclusivity.
Legal framework
After NAFTA entered into force, the Mexican Congress amended the Industrial Property Law by adding Article 86 bis, which states: “The information required by special laws to determine the safety and efficacy of pharmaceutical and agricultural products that make use of new chemical components shall be protected under the terms of the international agreements to which Mexico is a ratifying party.”
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data protection, TRIPS, COFEPRIS, pharmaceuticals
