Published on June 02, 2026.
IMPI – Cofepris Linkage System: What Is It About?
Within the complex ecosystem of Mexico’s pharmaceutical industry, the relationship between intellectual property and sanitary regulation has undergone a significant transformation following the reform to the Federal Law for the Protection of Industrial Property (LFPPI), published in April 2026. But what exactly is the IMPI – Cofepris Linkage System, and how does it impact businesses?
The Bridge Between Patents and Public Health
This system serves as the coordination mechanism between the Mexican Institute of Industrial Property (IMPI) and the Federal Commission for the Protection against Sanitary Risks (Cofepris). Its primary objective is to prevent the infringement of industrial property rights when granting sanitary registrations for pharmaceuticals.
Under the new reform, IMPI is required to publish, at least semiannually, a list of active patents related to inventions that may be used in allopathic medicines. This level of transparency enables the health authority to rely on accurate technical information before authorizing the commercialization of a product.
Compensation for Delays: The Supplementary Certificate
One of the most relevant additions introduced in 2026 is Article 136 Bis, which establishes a mechanism to adjust patent terms. If Cofepris incurs an “unreasonable delay” in granting a sanitary registration, it may determine a compensatory period:
- This compensatory period may not exceed five years.
- IMPI will issue a supplementary certificate to adjust the term of the original patent.
- This certificate will take effect on the day following the expiration of the initial patent.
Why Is This Important for Your Company?
This system not only protects innovation but also provides legal certainty. By reducing ambiguity in timelines and strengthening inter-institutional coordination, it fosters a more stable investment environment for technological development in Mexico.
Do You Need Guidance to Protect Your Pharmaceutical Assets or Manage Supplementary Certificates?
At Merida IP, we are intellectual property attorneys ready to guide you through compliance with this new regulatory framework. Ensure the validity of your rights and optimize your legal processes with our support.
Contact us today!
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