Life Sciences and Pharma IP 2026

BRAZIL Law and Practice Contributed by: Eduardo Hallak, Juliana Neves, Jorge Tinoco and Lívia Dias, Licks Attorneys

advisable. One of the best ways to ensure that the path is clear before product launch is to conduct a Freedom to Operate (FTO) assessment. Through the FTO, a company may find and examine patents (and applications) that are potentially capable of posing problems to the product’s launch. Entering the market without conducting this precaution may expose the company to an avoidable risk of infringement enforce ‑ ment, including hefty damages and injunctions (both preliminary and final). 1.12 Experts Expert evidence is crucial for the determination of infringement/validity issues. It is exceedingly rare for judges to go against the findings of experts. Considering the highly technical nature of patent dis ‑ putes in life sciences, judges appoint a court expert to act as an independent technical aid. This court expert may be contested by the parties if their expertise is not ideal for the technical discussion (eg, if a chemist is designated to perform an analysis that is best suited for a biologist) or if there is reason to believe that the expert would not be impartial (eg, previous ties to the parties-in-dispute). The parties may also engage their own experts to convey their technical arguments to the court expert. There are two main ways to make effective use of technical experts: • engaging experts to produce their own written reports in support of a party’s claims; or • retaining experts to act as “technical assistants”, to accompany the court expert’s examination, submit technical questions and comment on the court expert’s conclusions. The conducting of expert assessments may vary according to the particulars of the dispute. Usually, infringement discussions involve a detailed in-person examination of the accused product. Conversely, disputes regarding validity seldom require in-person examination, relying instead on the review of technical documents. Expert evidence usually takes the form of a written report containing the expert’s assessment of the sub ‑

ject matter in dispute and a response to the ques ‑ tions posed by the parties. After the expert report is presented, the parties may request clarification and/ or present additional questions. It is exceedingly rare for oral depositions and cross-examinations to occur. On the other hand, when PIs are requested, the pro ‑ duction of expert evidence is the exception, not the rule. When assessing requests for PI, judges tend to rely on documents provided by the parties (eg, tech ‑ nical reports, affidavits from technical experts) con ‑ cerning the technical subject matter. From this cur ‑ sory examination of the pleadings, the judge decides whether to grant or deny the injunction. In recent years, some judges have started to conduct expedited expert assessments to rule on preliminary injunction The presentation of experiments is admissible as evidence under Brazilian Law. This evidence may be presented as a document when produced unilaterally by a party (eg, a patentee conducts their own experi ‑ ments on the infringing product). Experiments may also be carried out during the court expert examina ‑ tion with the participation of all parties. requests, but this is still rare. 1.13 Use of Experiments When experiments are conducted unilaterally, it is common for the other party to contest the methodol ‑ ogy and/or the results attained from the experimenta ‑ tion. When the test is to be carried out by the court expert, litigants often engage in lengthy discussions about the correct methodology for the expert exami ‑ nation. It is also common for the parties’ technical assistants to be present to inspect and intervene dur ‑ ing the experimentation by the court expert. There is no specific procedure to ensure the admis ‑ sibility of expert results. Nevertheless, parties may use best practices to ensure that their experiments are hard to discredit (eg, ensuring that the acquisition/ storage/transportation of tested samples is proper and documented, or providing evidence that the methodology employed is the best available). 1.14 Discovery/Disclosure Discovery proceedings are not allowed under Brazilian law. Under the general rule, the plaintiff bears the bur ‑

23 CHAMBERS.COM

Powered by