Life Sciences and Pharma IP Litigation 2025

MEXICO Trends and Developments Contributed by: Carlos Perez de la Sierra and Ciara Cleary, Calderón & De La Sierra

• the defendant has easier access to the evi - dence or can easily prove the evidence in the trial. Article 335 of Mexican Patent Law states the fol - lowing: “When the subject matter of the patent is a process for obtaining a product, in the adminis - trative infringement declaration procedure, the alleged infringer must prove that said product was manufactured using a process other than the patented one when: I.- The product obtained by the patented pro - cess is new, or II.- There is a significant probability that the prod - uct was manufactured using the patented pro - cess and the patent holder has not succeeded, despite having tried, in establishing the process actually used.” Thus, Mexican Patent Law does contemplate the problem associated with product patents when debated during infringement actions. However, despite this provision in the law and the avail - ability of a reversal of the burden of proof, pro - cess patents relating to biologics remain one of the more difficult types of infringement cases to litigate. Patent term extensions of pharmaceutical patents: complementary certificates Pharmaceutical patents can often take a while to move through prosecution, particularly due to their complexity. Thus, patent term extensions

have become an attractive option for clients in recent years, particularly for biologic patents which may move slowly through the prosecution system at the Mexican Patent Office. However, patent term extensions filed before 5 November 2020 remain a difficult issue. Such patents are barred from term extension under the former gov - erning law, yet litigation has made them possible (in a few cases). Specifically, when prosecution of the relevant application took more than five years, it was possible to seek a conventional interpre - tation of the Paris Convention together with the so-called “pro-homine” principle, under which a patent term could be adjusted to 17 years from the date of granting (in Mexico), as opposed to the current 20 years from date of filing (priority date). The path to seek the extended term must initiate before the patent expires, and in a best- case scenario, at least two or three years before the original expiration date, to ensure sufficient time to reach the courts and obtain the injunctive remedy preventing the term from expiring before a final decision in the case can be rendered. The injunction then results in a relative win in the case, as it provides the patent holder with an additional term for at least as long as it takes for a final deci - sion in the case to be rendered. On the other hand, the new law clearly outlines how patent term extensions can be obtained for any patent application filed on or after 5 Novem - ber 2020. These are obtained via “complemen - tary certificates”, which can be requested if the time between the filing date and the granting date is more than five years, and the Mexican Patent Office is directly responsible for this delay.

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