{"id":27318,"date":"2026-04-15T08:13:56","date_gmt":"2026-04-15T14:13:56","guid":{"rendered":"https:\/\/basham.com.mx\/?p=27318"},"modified":"2026-04-15T08:13:57","modified_gmt":"2026-04-15T14:13:57","slug":"patent-term-extension-for-regulatory-approval-mexicos-outstanding-obligation-under-the-usmca","status":"publish","type":"post","link":"https:\/\/basham.com.mx\/en\/patent-term-extension-for-regulatory-approval-mexicos-outstanding-obligation-under-the-usmca\/","title":{"rendered":"Patent Term Extension for Regulatory Approval: Mexico\u2019s Outstanding Obligation under the USMCA"},"content":{"rendered":"

April 15, 2026<\/p>\n\n\n\n

\"\"<\/figure>\n\n\n\n

For decades, many of the world\u2019s leading economies\u2014such as the United States, Canada, and the European Union\u2014have recognized that in highly regulated sectors such as pharmaceuticals, patents face a structural limitation: when the State requires prior regulatory approval before a product associated with a patent may be commercialized, the patent holder loses part of the time during which it may exploit the patent. This loss results from a legitimate state decision aimed at protecting public health, but it has a direct impact on the effective duration of the exclusive patent right. Accordingly, these jurisdictions have developed specific mechanisms to compensate for this impairment and to preserve incentives for innovation.<\/p>\n\n\n\n

Mexico, by contrast, lacked an equivalent mechanism for many years and only recently sought to introduce one in order to comply with the obligations assumed under the United States\u2013Mexico\u2013Canada Agreement (USMCA), nearly six years after the treaty entered into force. The amendment to the Federal Law for the Protection of Industrial Property (Ley Federal de Protecci\u00f3n a la Propiedad Industrial, LFPPI), published on April 3, 2026, incorporated Article 136 Bis<\/em>, which establishes a mechanism for compensating the term of a patent for reductions caused by the corresponding regulatory approval procedure. However, in our view, the design adopted in this provision entails significant risks and leaves unresolved essential issues that affect legal certainty for regulated parties and the protection of industrial property rights.<\/p>\n\n\n\n

Article 20.46 of the USMCA is clear: when market access for a pharmaceutical product depends on regulatory approval, States must provide effective mechanisms to compensate for the reduction in the exploitation of the associated patent. The logic is straightforward: if the State imposes a legal barrier to the exercise of the right, it must recognize and correct its effects on the actual duration of the exclusive right.[1]<\/a><\/p>\n\n\n\n

In international practice, these mechanisms are based on objective criteria, such as fixed dates within the regulatory process and predetermined formulas to identify the actual temporal impact on the exploitation of the patent resulting from the obligation to comply with regulatory requirements prior to commercialization. As a general rule, they do not depend on assessing potential delays attributable to the regulatory authority. In other words, irrespective of whether a delay attributable to the regulatory authority exists, what is calculated is the reduction in the effective patent term deriving from the very design of the legal regime.<\/p>\n\n\n\n

The Mexican implementation departs from this logic by conditioning compensation on the existence of an \u201cunreasonable delay\u201d attributable to the health regulatory authority\u2014a concept that is neither contemplated nor defined in Article 20.46 of the USMCA nor in the LFPPI itself\u2014thus introducing an uncertain and discretionary threshold for accessing the benefit of this mechanism.<\/p>\n\n\n\n

Moreover, the reform weakens the role of the Mexican Institute of Industrial Property (IMPI) as the specialized patent authority by transferring to the regulatory authority (COFEPRIS) decision-making powers regarding the eligibility for, and duration of, the adjustment, and by leaving to its discretion the request for the \u201csupplementary certificate.\u201d While technical coordination between the health regulatory authority and the authority responsible for industrial property is undoubtedly necessary, this does not justify transferring to the regulatory authority the power to determine adjustments to patent term. In our opinion, such determinations should fall within the competence of the authority responsible for industrial property, without prejudice to the regulatory authority providing the technical information necessary regarding the regulatory approval process.<\/p>\n\n\n\n

This is compounded by a conceptual confusion arising from references to \u201cregulatory approval of patents,\u201d when in fact regulatory approvals apply to products, which may be linked to one or more patents. The regulation also fails to clearly define which patents qualify, how many patents may be compensated per product, who may initiate the procedure, or how the compensable period should be calculated, among other fundamental issues, and merely establishes that compensation is capped at five years.<\/p>\n\n\n\n

Although some of these deficiencies might be addressed through the regulations to the LFPPI or amendments to health legislation, in our view many of them should have been resolved directly in the LFPPI itself. Moreover, even with such reforms, several structural problems would remain, as the design is based on flawed conceptual assumptions, inappropriately allocates powers among authorities, and generates legal uncertainty. In this context, we consider that the obligation assumed by Mexico under the USMCA has not yet been adequately fulfilled, and that the correct application of this mechanism will likely have to be determined, ultimately, through judicial proceedings.<\/p>\n\n\n\n

Finally, it should be noted that the USMCA will be subject to an upcoming review and that the extent of Mexico\u2019s compliance with the obligations assumed under that treaty will be assessed, which could impact mechanisms such as the one analyzed herein.<\/p>\n\n\n\n

Should you require any additional information on this matter, please feel free to contact us.<\/p>\n\n\n\n

Sincerely,<\/p>\n\n\n\n

Adolfo Athi\u00e9 Cervantes<\/strong><\/p>\n\n\n\n

aathie@basham.com.mx<\/a><\/p>\n\n\n\n

Mariana Gonz\u00e1lez Vargas<\/strong><\/p>\n\n\n\n

mgonzalezv@basham.com.mx<\/a><\/p>\n\n\n\n

Erika Rodr\u00edguez Kushelevich<\/strong><\/p>\n\n\n\n

erodriguez@basham.com.mx<\/a><\/p>\n\n\n\n

\n\n\n\n

[1]<\/strong><\/em><\/a> In a sense, the Supreme Court of Justice of the Nation outlined precisely the principle that patents must enjoy a real and effective term of protection in its decision issued in Amparo en Revisi\u00f3n (AR) 257\/2020, decided on October 14, 2020, from which the adjustment of patent terms (PTA) in Mexico originates.<\/em><\/p>\n\n\n\n

<\/p>","protected":false},"excerpt":{"rendered":"

April 15, 2026 For decades, many of the world\u2019s leading economies\u2014such as the United States, Canada, and the European Union\u2014have recognized that in highly regulated sectors such as pharmaceuticals, patents face a structural limitation: when the State requires prior regulatory approval before a product associated with a patent may be commercialized, the patent holder loses […]<\/p>","protected":false},"author":19,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_crdt_document":"","footnotes":""},"categories":[1],"tags":[],"class_list":["post-27318","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/basham.com.mx\/en\/wp-json\/wp\/v2\/posts\/27318","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/basham.com.mx\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/basham.com.mx\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/basham.com.mx\/en\/wp-json\/wp\/v2\/users\/19"}],"replies":[{"embeddable":true,"href":"https:\/\/basham.com.mx\/en\/wp-json\/wp\/v2\/comments?post=27318"}],"version-history":[{"count":1,"href":"https:\/\/basham.com.mx\/en\/wp-json\/wp\/v2\/posts\/27318\/revisions"}],"predecessor-version":[{"id":27320,"href":"https:\/\/basham.com.mx\/en\/wp-json\/wp\/v2\/posts\/27318\/revisions\/27320"}],"wp:attachment":[{"href":"https:\/\/basham.com.mx\/en\/wp-json\/wp\/v2\/media?parent=27318"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/basham.com.mx\/en\/wp-json\/wp\/v2\/categories?post=27318"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/basham.com.mx\/en\/wp-json\/wp\/v2\/tags?post=27318"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}