{"id":13081,"date":"2026-07-01T10:00:51","date_gmt":"2026-07-01T08:00:51","guid":{"rendered":"https:\/\/blogip.garrigues.com\/?p=13081"},"modified":"2026-07-01T11:37:59","modified_gmt":"2026-07-01T09:37:59","slug":"pathways-to-extend-the-term-of-pharmaceutical-patents-in-mexico","status":"publish","type":"post","link":"https:\/\/blogip.garrigues.com\/en\/patents-trade-secrets\/pathways-to-extend-the-term-of-pharmaceutical-patents-in-mexico","title":{"rendered":"Pathways to Extend the Term of Pharmaceutical Patents in Mexico"},"content":{"rendered":"

A combination of regulatory developments and recent judicial criteria have opened different avenues to adjust the duration of exclusivity periods.<\/strong><\/p>\n

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In recent years, substantial changes have been made to the Intellectual Property System in Mexico, creating the possibility of modifying the term of patents related to pharmaceutical products. In this entry, we analyze three relevant legal mechanisms.<\/p>\n

Patent Term Adjustments for IMPI Delays under NAFTA Rules<\/strong><\/p>\n

When the North American Free Trade Agreement (NAFTA) was signed, each member country was allowed to choose between two ways of calculating patent duration:
\n(i) a period of at least 20 years from the filing date, or (ii) a period of 17 years from the grant date.\u00a0 Article 1709 also established that each party could extend the term of protection to compensate for delays arising from approval procedures.<\/p>\n

Although Mexican domestic legislation only implemented the 20-year term from the filing date, without considering compensation for delays, this position of the Mexican State was challenged in Court. \u00a0In 2020, Bayer obtained a favorable ruling before the Supreme Court of Justice, achieving a patent term adjustment for the patent claiming the active ingredient sorafenib.<\/p>\n

This decision has led various companies in the pharmaceutical sector to initiate similar proceedings, requesting term adjustments from the Mexican Institute of Industrial Property (IMPI) for patents prosecuted while NAFTA was in force. These requests are typically rejected but can be overturned through litigation.<\/p>\n

Patent Term Adjustments for IMPI Delays under the Federal Law for the Protection of Industrial Property (LFPPI).<\/strong><\/p>\n

In 2020, a new Federal Law for the Protection of Industrial Property entered into force in Mexico. This law includes a chapter on Supplementary Certificates, establishing that if there are unreasonable delays directly attributable to IMPI -resulting in a period exceeding five years between the filing of a patent application and its grant- the patent term may be adjusted.<\/p>\n

Delays are not considered unreasonable if they arise from the applicant\u2019s response time to IMPI office actions, the formal examination period, appeal or challenge procedures, or force majeure events.<\/p>\n

Patent Term Extensions for Regulatory Delays<\/strong><\/p>\n

The United States\u2013Mexico\u2013Canada Agreement (USMCA) introduced an obligation for member states to establish mechanisms to compensate patent terms for pharmaceutical products when unreasonable delays occur in granting marketing authorizations required for commercialization.<\/p>\n

This obligation was recently implemented in Mexico through amendments to the Health Supplies Regulations, with the following key points:<\/p>\n