Life Sciences and Pharma IP 2026

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

A further pathway is open to potential plaintiffs in nullity proceedings. According to Article 51 of the BPS, any party with a legitimate interest may initiate an administrative nullity proceeding (PAN) before the BRPTO within six months after a patent is granted. After this six-month period, parties may only seek the patent’s nullity before the courts. Filing a PAN does not stay the effect of the patent but provides an addi ‑ tional means to seek a patent’s nullity before going to the courts. If a PAN is unsuccessful, the parties may further question the patent’s validity by filing a nullity lawsuit before a federal court. 1.2 Defendants/Other Parties to an Action The BPS designates a wide array of acts as infringing (see 2.1 Infringing Acts for more detail). Due to this, patentees may direct lawsuits at many parties that take place in infringing activity (eg, manufacturers, distributors, importers). In Brazil, the most common target for lawsuits is manufacturers, as these parties have the largest potential for market impact by com ‑ peting directly with patentees. In life sciences cases, another common target is importers of active ingredi ‑ ents covered by Brazilian patents. Another potential target for lawsuits is any party engaging in contributory acts for patent infringement (eg, supplying specialised components for use in pat ‑ ented processes). Under Brazilian law, patent infring ‑ ers (including contributory infringers) may be pros ‑ ecuted through both criminal and civil proceedings. In infringement proceedings, the parties to a law ‑ suit are usually limited to the patent holder and the accused infringer. Article 57 of the BPS provides that the BRPTO must take part in all nullity proceedings, as it is the authority responsible for granting or reject ‑ ing the patent application. However, as stated in 1.1 Claimants/Plaintiffs to an Action , the BRPTO is not bound to defend or attack the patent; it may agree with the arguments of the plaintiff or the defendant. 1.3 Preliminary Injunction Proceedings Under Article 300 of the CPC, litigants may request preliminary injunctions (PI) in patent-related litigation. Such PIs may be granted ex parte or after hearing preliminary arguments from the adverse party.

To attain a PI, a litigant must demonstrate that three conditions are simultaneously met: • the requesting party is likely to succeed in its claims; • there is urgency in the relief (ie, the injunction) being sought, as, without it, the requesting party may suffer harm or the lawsuit may lose its pur ‑ pose; and • the party that will be targeted by the injunction will not run the risk of suffering irreversible harm. Considering that urgency is one of the requirements for a PI to be granted, it is important for the party requesting the PI to act consistently with the alleged urgency. Therefore, if a potential plaintiff is known to have learned of a potentially infringing activity, it would be inconsistent for this party to request urgent relief while also taking too long to file suit, although Brazil ‑ ian Civil Procedural Law does not provide a specific timeframe for requesting it, since the assessment of the urgency depends on the elements of the case. See 5.6 Relevance of Claimant/Plaintiff Conduct to Relief for more detail. Although there is no specific timeframe for request ‑ ing a PI, the earliest a party can file for relief is after the patent has already been granted, as Article 17 of the CPC requires the existence of a legitimate inter ‑ est. In nullity lawsuits, if relief is requested to declare the nullity of a patent, the patent must have already been granted by the BRPTO. Conversely, if a law ‑ suit is brought to declare the nullity of an act by the BRPTO to reject or withdraw a patent, the act must have already been performed before a lawsuit may be initiated. In life sciences infringement cases, PIs are usually awarded if the plaintiff can offer convincing prima facie evidence of the infringing acts. Conversely, in nullity cases, the assessment for granting a PI tends to be more restrictive. Brazilian courts have a nar ‑ row understanding of the possibility of granting PIs aimed to stay patent effects in nullity actions, since the BRPTO’s act is presumed to be valid until it is overruled by a court. Judges usually prefer to hear all the parties and produce expert evidence before ruling on the preliminary injunction request. In other words,

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