MEXICO Trends and Developments Contributed by: Carlos Perez de la Sierra and Ciara Cleary, Calderón & De La Sierra
Calderón & De La Sierra Avenida Santa Fe 481 – PH Lomas de Santa Fe 05349 Mexico City Mexico
Tel: +52 55 5047 7500 Email: cps@cyslaw.mx Web: www.cyslaw.mx
The Latest in Mexican Life Sciences and Pharmaceutical Intellectual Property Litigation Biologics research and manufacturing has increased rapidly in the last few decades and shows no sign of slowing down. This recent increase in the development of biologics for therapeutic use has driven substantial growth in the global litigation sector. Naturally, the expand - ing area of biologics has also led to increased interest in the development of biosimilars. While litigation continues for small molecules, cases concerning the complex technologies behind biologics have also begun to creep into the Mexican courts, mainly due to the increased use of biologics and biosimilars in the Mexican market. This is not surprising, given that Mexico represents a large market opportunity for many international companies due to its proximity to the US, particularly for the manufacture and sale of biosimilars. In this article, we explore the lat - est trends and emerging issues shaping life sci - ence litigation in Mexico today. Legal standing to file invalidation actions: third-party invalidation filings have now become more difficult Post-grant invalidation actions are available in Mexico. These are usually filed with the Mexi - can Patent Office, also known as the Mexican
Institute of Industrial Property ( Instituto Mexi- cano de la Propiedad Industrial , or IMPI), to counter a claim for patent infringement initiated by the patentee. A defendant in such a claim has automatic legal standing to start invalidation proceedings against the corresponding patent. However, a third party can also file an invalida - tion action without the presence of an infringe - ment action, provided that they can demonstrate sufficient legal standing. When there is no claim for infringement, the plaintiff will be considered to comply with this legal standing requirement if they can show that they have suffered direct harm as a result of the granting of the patent. In previous years, the simple act of being a com - pany involved in the pharmaceutical field was sufficient to prove legal standing in a pharma - ceutical case. However, this is no longer the case. After considerable debate in the courts, new decisions have made this requirement much stricter, making it much more difficult for a third party to prove legal standing without an infringement action. The Supreme Court of Mexico recently con - firmed legal standing as a valid requirement in a decision resulting from a challenge asserting that the requirement should have been consid - ered to misrepresent constitutional provisions.
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