MEXICO Law and Practice Contributed by: Heidi Lindner and Humberto Vega, Arochi & Lindner
1. Life Sciences and Pharma/ Biopharma Patent Litigation 1.1 Claimants/Plaintiffs to an Action
may still request that the IMPI initiate the procedure ex officio, in which case the authority may consider the information provided. 1.2 Defendants/Other Parties to an Action Concerning infringement requests in the field of life sciences and pharmaceuticals in Mexico, the defend ‑ ants mainly tend to be the manufacturers and distribu ‑ tors of the pharmaceutical products in question. Likewise, it is common for patent owners to take legal action against the regulatory authority, specifi ‑ cally against the Federal Commission for Protection Against Sanitary Risks ( Comisión Federal para la Pro- tección contra Riesgos Sanitarios , or COFEPRIS), by requesting the invalidation of marketing authorisa ‑ tions, arguing a violation of the linkage system to the detriment of their patent rights. It is important to clarify that infringement proceedings for patent violations are commonly processed in the first instance before the IMPI, which acts as a conten ‑ tious authority and decides upon such proceedings. 1.3 Preliminary Injunction Proceedings The LFPPI allows the possibility to file for a prelimi ‑ nary injunction at the request of a party and without a prior hearing of the alleged infringer. Thus, requests for preliminary injunctions in Mexico will always be ex parte. The IMPI is the authority which grants prelimi ‑ nary injunctions. Requirements to Grant Preliminary Injunctions In order to decide whether to grant preliminary injunc ‑ tions, the IMPI must do the following: • analyse the appearance of the good right (fumus boni iuris) principle (which means that the plain ‑ tiff has minimum legal basis for bringing a further legal action) and non-contravention of public order provisions; • assess whether the periculum in mora principle has been met (which means that the authority must assess if any delay in granting the preliminary injunction could harm the plaintiff’s rights); • verify that the preliminary injunction does not affect the general interest; and
In Mexico, the parties to an infringement proceeding are the affected owner or owners of the patent as the plaintiff, and the alleged infringer as the defendant. In the case of co-owners of patent rights, unless there is an agreement to the contrary duly recorded before the Mexican Institute of Industrial Property ( Instituto Mexicano de la Propiedad Industrial , or IMPI), they must act jointly. They may also appoint one of the owners as a common representative. In terms of the Federal Law for the Protection of Industrial Property ( Ley Federal de Protección a la Propiedad Industrial , or LFPPI), licensees – whether exclusive or non-exclusive – have the right to exercise the necessary actions in defence of the patent that is the subject of the licence, including the proceedings of infringement, unless otherwise expressly stated in the licence agreement. In the case of sublicensees, they can only take actions in defence of the patent if said right has been expressly agreed in the subli ‑ cence. For licensees of a patent – whether exclusive or non- exclusive – to initiate an infringement proceeding, the licence must be duly registered before the IMPI. The IMPI and the Specialised Chamber on Intellectual Property Matters ( Sala Especializada en Materia de Propiedad Intelectual , or SEPI) of the Federal Court of Administrative Justice ( Tribunal Federal de Justicia Administrativa , or TFJA) have established that in order to have legal standing to file an administrative dec ‑ laration of invalidation of a patent, the plaintiff must demonstrate that the patent at hand causes real and direct damage (actual harm). For both authorities, it is not enough to be part of the life sciences and pharma ‑ ceutical market or industry to request the invalidation of a patent. This criterion has been confirmed by the Mexican Supreme Court of Justice. However, the Supreme Court has also clarified that, although a party lacking sufficient legal standing can ‑ not formally file a nullity action against a patent, it
128 CHAMBERS.COM
Powered by FlippingBook