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

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 Representative, recently 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 publication of the linkage gazette must be a list of patents for reference medicines provided by the Mexican regulatory agency (COFEPRIS).

  • The way of communication between COFEPRIS and the Patent Office (IMPI) will be through a gazette issued by COFEPRIS in which it will include an active ingredient patent for each reference medicine.

  • It expressly establishes that health authorizations should not be denied when there are formulation or use patents.

In general, the initiatives contradicts 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.

We consider that the proposal has low chances to be approved as presented, however, it could be considered the most recent and new pressure by those against the rule of law, as it has occurred the last 15 years through the various attempts to limit the patent linkage system, but now under the scenario of the expected regulations of the law due by-December of this year, approximately. The battle to have influence in the regulation of the law in connection to patent linkage, already started.

FOR FURTHER INFORMATION ON THE CONTENT OF THIS NEWSLETTER, PLEASE CONTACT:

Alejandro Luna Fandiño

Alejandro Luna Fandiño

Partner

Alejandro Luna joined OLIVARES in 1996 and being made partner in 2005, he has been instrumental to the firm´s IP Litigation, Regulatory and Administrative Litigation practices. He co-chairs the Life Sciences & Pharmaceutical Law industry group and coordinates the Litigation Department.
Armando Arenas

Armando Arenas

Partner

Armando Arenas joined OLIVARES in 2000 and became a partner in January 2017. He has experience working on a range of IP matters, including consulting and litigation on trademark, patent, unfair competition, trade dress protection, and misleading advertising cases before the Mexican Institute of Industrial Property (IMPI), Federal Court of Tax and Administrative Affairs (FCTA), Federal Circuit Courts (FCC) and the Supreme Court of Justice (SCJ) Regulatory Affairs and Public Acquisitions.
Daniel Sánchez

Daniel Sánchez

Partner

Daniel Sanchez joined OLIVARES in 2000 and became a partner in 2011. He is one of the leading intellectual property (IP) and administrative litigators in Mexico and is recognized by industry rankings and publications.
Sergio L. Olivares Sr.

Sergio L. Olivares Sr.

Partner

Sergio L. Olivares Sr. joined OLIVARES in 1987 and today leads the firm with strength and a commitment to transparency, client satisfaction, and personal service. He has been a partner since 1994 and Chairman of the Management Committee since 2009.

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