Proposal to modify the patent linkage system established in the new IP Law in Mexico

August 19, 2020

One month after being published and before the new Federal Law for the Protection of Industrial Property (new IP Law) enters into force, the Lower Chamber of Congress published two proposals to reform the law and limit the scope of the patent linkage system, as follows:

• Expressly ban the granting of use patents/claims;
• The linkage gazette publication must be a list of patents for reference medicines provided by the Mexican regulatory agency (COFEPRIS);
• Communication between COFEPRIS and the Patent Office (IMPI) will be through a gazette issued by COFEPRIS, which will include an active ingredient patent for each reference medicine; and
• It expressly establishes that health authorizations should not be denied when there are formulation or use patents.

In general, the initiatives contradict the provisions of Article 28 of the Constitution and various articles of the Industrial Property Law. Likewise, the initiative contradicts the patent system itself, as well as the USMCA, which is already in force.

The proposal appears to have low chances of approval as presented. However, it could be considered the most recent and newest pressure by those against the rule of law, which has been occurring over the last 15 years through the various attempts to limit the patent linkage system. The difference now being that the new IP law is set to come into force on November 5, 2020, and the battle to have influence in the regulation of the law in connection to patent linkage has already started.