MEXICO Law and Practice Contributed by: Heidi Lindner and Humberto Vega, Arochi & Lindner
• consider the seriousness of the alleged infringe ‑ ment and the nature and scope of the requested preliminary injunction. In the request for a preliminary injunction, the affected patent owner – in addition to providing proof of own ‑ ership of the right allegedly affected and a sufficient guarantee to respond to the damages that may be caused to the defendant should there be a wrong ‑ ful granting of the preliminary injunction – must also prove any of the following presumptions: • the existence of a violation of their right; • the imminent violation of their right; • the possibility of suffering irreparable damage; and • a well-founded fear that evidence will be destroyed, hidden, lost or altered. As noted above, the main requirement to request a preliminary injunction is proof of ownership of a valid industrial property right that has been affected. A pending application or a translation does not provide the right to request preliminary injunctions. Quia timet relief A request for a preliminary injunction can be filed immediately after the respective patent is granted. Regarding quia timet relief, it is important to point out that this will be granted as long as it is demonstrat ‑ ed that the violation of the patent right is imminent, there is the possibility of suffering irreparable damage, or there is a well-founded fear that evidence will be destroyed, hidden, lost or altered. The following are some examples of acts that may constitute an imminent threat of infringement of phar ‑ maceutical patents, giving rise to quia timet relief. • The publication of studies or research results that suggest the unauthorised use of a patented for ‑ mula or procedure. • The issuance of import permits by a regulatory authority regarding substances or products cov ‑ ered by a patent. • Advertisements or promotions of pharmaceutical products that indicate the use of technology or a formula protected by a patent without the consent of the owner.
• Conducting R&D activities that suspiciously imitate or replicate a patented formula or method, sug ‑ gesting future infringement. In patent litigation related to life sciences cases, there are no special considerations for granting preliminary injunctions; it is enough to prove ownership of the patent that is the basis of the action, as well as dem ‑ onstrate any of the requirements indicated above. Notification and Response In Mexico, the alleged infringer must personally be notified of the preliminary injunction. Although in prin ‑ ciple notification must be carried out immediately, this is subject to the IMPI’s workload. Once the alleged infringer is notified of the preliminary injunction, they have ten business days to respond and to submit the relevant evidence to either demonstrate the inadmis ‑ sibility of the measures or disagree with the amount of the guarantee provided by the plaintiff. The IMPI usually takes the alleged infringer’s response to the preliminary injunction seriously. Thus, the prelimi ‑ nary injunction may be modified or reversed, and the amount of the guarantee may be re-evaluated, based on what is proved and argued in the alleged infringer’s response. Given the possibility that preliminary injunctions may be taken against them, pharmaceutical companies of generic drugs, biosimilar drugs and medical devices must be prepared to demonstrate non-violation of patents (freedom-to-operate – FTO) and have docu ‑ mentation that serves to preliminarily reject the plain ‑ tiff’s claim. Likewise, they must be aware that they have the possibility of lifting the preliminary injunctions by granting a counter-guarantee, demonstrating the appearance of good law, and demonstrating that the impact they would suffer from the measures is more significant than the applicant would suffer if the pre ‑ liminary injunctions were lifted. Finally, protective letters/orders are not considered in the Mexican legal system. 1.4 Structure of Main Proceedings on Infringement/Validity In Mexico, infringement and nullity proceedings are carried out independently but in parallel. Thus, in an
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