MEXICO Law and Practice Contributed by: Heidi Lindner and Humberto Vega, Arochi & Lindner
5. Relief Available for Patent Infringement 5.1 Preliminary Injunctive Relief Guarantee and Duration
utable to the IMPI and resulting in a period of more than five years between the filing date in Mexico and the granting of the patent – is demonstrated, a CTC must be granted. Regarding the applicant’s identity, the LFPPI specifies that the CTC can only be requested by the patentee. 4.2 Paediatric Extensions No special provision is stipulated in the Mexican legal framework in regard to paediatric extensions. This does not mean there is no protection for pae ‑ diatric medications; there is simply no patent exten ‑ sion mechanism specifically designated for them as in other jurisdictions. 4.3 Paediatric-Use Marketing Authorisations Mexico does not have a specific regulatory path ‑ way equivalent to the EU’s Paediatric-Use Marketing Authorisations (PUMAs). Paediatric-specific formula ‑ tions, strengths, or presentations of already author ‑ ised medicines, even those without patent or SPC protection, must follow COFEPRIS’s standard market ‑ ing authorisation process, as no dedicated paediatric procedure, incentive scheme, or special protection regime applies. In practice, paediatric-use marketing authorisations are possible, but they are granted through the general marketing authorisation route and require submission of appropriate paediatric data. Mexico also does not offer any particular or extended data protection for clinical evidence generated to support paediatric indi ‑ cations. As a result, there is no distinct authorisation category or exclusivity mechanism tailored to medi ‑ No special provision is stipulated in the Mexican legal framework in regard to orphan medicines extensions. This does not mean there is no protection for this kind of medication; there is simply no patent exten ‑ sion mechanism specifically designated for them as in other jurisdictions. cines developed specifically for children. 4.4 Orphan Medicines Extensions
In Mexico, undertakings as to damages are required from patentees in exchange for a preliminary injunc ‑ tion. The patentee must provide a guarantee for any harm that may be caused to the person against whom the injunction is sought. The amount of the guarantee (usually a bond) is generally quantified by the pat ‑ entee; however, the IMPI may require an increased amount in the event that the elements provided by the applicant from the case file, and statements from the alleged infringer, convince the authority that the amount is insufficient. Regarding the duration of preliminary injunctions, these will subsist for the entire time that the proceed ‑ ing lasts as long as the guarantee remains in force. However, the defendant has the opportunity to either post a counter-guarantee to lift the preliminary injunc ‑ tion or to judicially challenge it. Unfortunately, no one can benefit from an undertaking in respect of damages, apart from the alleged infringer in Mexico. The guarantee provided by the patentee also only serves to compensate the defendant when appropriate. Requirements for a Preliminary Injunction For preliminary injunctions to be enforceable, the fol ‑ lowing are required: • the issuance of a written decision by the IMPI; • personal notification to the alleged infringer of this decision; and • payment of a sufficient guarantee by the applicant to respond to damages that could be caused to the alleged infringer. Preliminary injunctions are enforceable as from ser ‑ vice upon the defendant. The LFPPI stipulates that the person against whom any of these measures have been ordered has a ten-day period to submit observa ‑ tions to the IMPI regarding the measure or the amount of the provided guarantee. This implies that the notifi ‑ cation must be carried out promptly to allow this right
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