MEXICO Trends and Developments Contributed by: Carlos Perez de la Sierra and Ciara Cleary, Calderón & De La Sierra
Generally, to prove legal standing in civil law proceedings, the plaintiff must show that a fact or set of facts is capable of harming or affecting the exercise of their rights. Being a defendant in a patent infringement action is sufficient to show legal standing to counterclaim and seek to invalidate the patent. However, in the absence of an infringement action, the simple fact of being a pharmaceutical company is no longer sufficient to prove legal standing. During previous years, for pharmaceutical pat - ents, a third party could establish standing by showing that it conducted industrial or com - mercial activities in the pharmaceutical industry. Unfortunately, this is no longer sufficient and more detailed evidence is now required. Accord - ing to a decision by the IP Branch of the Federal Tribunal, in the absence of an infringement action, third parties had only the following two options to prove legal standing to institute invalidation pro - ceedings against a pharmaceutical patent: • As a first option, a third party can assert that it has legal standing if it has filed a request for market approval of a product covered by the relevant patent with the regulatory author - ity, the Federal Commission for Protection Against Sanitary Risks ( Comisión Federal para la Protección contra Riesgos Sanitarios , or COFEPRIS), which entails a tacit admission that the product for which approval is being sought would infringe on the patent. • A second option occurs if a third party has applied for market approval for a pharmaceu - tical product and the regulatory authority has objected on the grounds of potential infringe - ment of a patent under the Linkage System. This entails that the Mexican Patent Office has provided relevant information drawing attention to the potential infringement. This
option does not therefore entail an admission of infringement on the part of the third party. The decision by the IP Branch of the Federal Tribunal was recently confirmed, albeit with a minor yet relevant difference on how to demon - strate sufficient legal standing. In the wording of the decision, Justice Farjat failed to list specific circumstances which could be used to demon - strate legal standing, leaving third parties free to come up with appropriate arguments and evi - dence to demonstrate how the relevant patent prevents them from exercising earlier rights. This method, which diverges from the two options originally provided by the IP Branch of the Tribu - nal, consists of the third party demonstrating the development or sale of an asset which may be in conflict with the claimed subject matter of the patent. This has proved successful and can be considered a third option for an interested third party wishing to pursue an invalidation action. In any case, because of the considerations offered in the decision by the Supreme Court of Justice, legal standing is to be analysed on a case-by-case basis, albeit it is no longer valid to assert legal standing based on the condition of being a pharmaceutical company. The challenges surrounding the inclusion of process patents in the Mexican Linkage System As is well known, the manufacturing process plays an essential role in the development of biologics. The manufacturing processes for such biologics involve many steps, such as cell line develop - ment, cell culturing conditions, bio-reactor con - ditions, purification, and quality control testing. These processes are sensitive to change and any modification in one or more of these complex steps runs the risk of changing the quality and/or quantity of the final biologic product. Thus, it is no
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