MEXICO Law and Practice Contributed by: Heidi Lindner and Humberto Vega, Arochi & Lindner
If the FTO reveals patents that could be an impedi ‑ ment to the development and launch of the product, companies have the option of initiating nullity actions against said patents. However, due to the recent cri ‑ teria of the IMPI and the courts of appeal (upheld by the Mexican Supreme Court), the possibility of initiat ‑ ing nullity actions based on the legal standing that arises from the intention to develop a pharmaceutical product that might infringe a patent, or simply being part of the pharmaceutical industry, is not considered sufficient; it is also necessary to demonstrate direct and real harm caused by the patent in question. These criteria greatly limit the ability of pharmaceutical companies to take concrete actions to clear the way for the development and launch of a generic drug (see 1.1 Claimants/Plaintiffs to an Action ). Other options may include modifying the product to avoid infringement or restricting its therapeutic indi ‑ cations (“carve out”), negotiating licences with patent owners, or even changing the product launch strat ‑ egy. The decision regarding which path to pursue will depend on factors such as the strength of the patents in question, the cost and viability of alternatives, and the strategic importance of the product for the com ‑ pany. 1.12 Experts In Mexico, it is common for the parties to submit expert evidence to support their actions and defenc ‑ es during infringement and invalidation proceedings related to pharmaceutical patents. This evidence usu ‑ ally takes the form of written reports known as expert opinions. These opinions are of crucial importance in the analysis of the merits of the matter since they pro ‑ vide essential guidance to IMPI expert officials when issuing their technical opinions, which form the basis of the final resolution of the case. These opinions are formulated from questions that are given in writing to the expert by the proposing party. It is important to note that the counterparty has the opportunity to add questions to the initial question ‑ naire. This process ensures that the parties can con ‑ tribute to the expert evaluation, thus allowing for a more complete and balanced exploration of the tech ‑ nical issues in dispute.
Although each party can submit its own expert opinion prepared by its own designated expert, these experts have the responsibility to maintain scientific objec ‑ tivity by focusing on the relevant technical aspects. When the opinions of the parties’ experts are essen ‑ tially contradictory, however, the IMPI may appoint an independent third-party expert who will render their own impartial opinion. The period for the IMPI to designate a third-party expert in a disagreement cannot exceed 15 business days, unless there are justifiable circumstances that prevent the timely designation of the expert. 1.13 Use of Experiments In Mexico, there is no specific mechanism dedicated exclusively to the submission of experimental results as evidence in patent infringement or invalidation proceedings. However, it is common and feasible for parties to introduce these results as part of their documentary evidence. In order to guarantee their probative value, the said experimental results must be reinforced with other types of complementary evi ‑ dence, such as expert evidence. This combination of experimental and expert evidence contributes signifi ‑ cantly to the soundness and credibility of the argu ‑ ments submitted to the IMPI or court. 1.14 Discovery/Disclosure In Mexico, it is not common for the plaintiff or the peti ‑ tioner to disclose information about their product, its manufacturing process, or even commercial informa ‑ tion. Although the IMPI may request this information, the requested party may oppose its delivery through the interposition of a means of defence, such as the Amparo trial, especially if the information is confiden ‑ tial or sensitive, or if it could be considered directly self-incriminating. However, it is important to point out an exception in the case of process patents, especially when the bur ‑ den of proof is shifted to the alleged infringer. In these cases, the alleged infringer can submit diagrams, logs, and other documents on a confidential basis, and can even offer an inspection visit to the production plant so that the inspector can verify the process used.
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