BRAZIL Law and Practice Contributed by: Eduardo Hallak, Juliana Neves, Jorge Tinoco and Lívia Dias, Licks Attorneys
4. Patent Term Extensions for Pharmaceutical Products
4.4 Orphan Medicines Extensions Brazil does not allow orphan medicine extensions for intellectual property rights.
4.1 Supplementary Protection Certificates Supplementary Protection Certificates (SPCs) are currently not available under Brazilian law. However, there is active ongoing debate and litigation involving the possibility of awarding Patent Term Adjustment (PTA) due to delays by the BRPTO in examining pat ‑ ent applications. Until 2021, patent applicants in Brazil enjoyed a minimum ten-year patent term (counted from date of grant). This mechanism acted as a safeguard for appli ‑ cants against the BRPTO’s notable backlog and delay in examination – a reality that has been mitigated in the last few years. In May 2021, the Federal Supreme Court (STF) declared this safeguard to be incompatible with the Brazilian Constitution and the respective section of the BPS was later revoked by the Congress. The STF’s decision had prospective effects for most patents (ie, the minimum ten-year term would still apply for pat ‑ ents already granted) but made a notable exception for patents relating to technologies used in health ‑ care. Thus, many patents related to pharmaceuticals and medical devices had their terms shortened sig ‑ nificantly. This led to a wave of litigation requesting compensation for the patent term unduly lost due to the BRPTO’s inactivity in means of term of protection equivalent to the loss in protection time. These lawsuits were – and still are – the target of broad legal discussion and media attention. Plenty of rul ‑ ings were handed down to award or deny preliminary injunction requests. After initial negative results for PTA plaintiffs, 2025 saw the first trial court decisions affirming plaintiffs’ requests for term compensation. 4.2 Paediatric Extensions Brazil does not allow paediatric extensions for intel ‑ lectual property rights. 4.3 Paediatric-Use Marketing Authorisations Brazil does not provide specific rules for market authorisations in case of paediatric medicines.
5. Relief Available for Patent Infringement 5.1 Preliminary Injunctive Relief
Preliminary injunctions are available in Brazil and may be requested in the same proceedings in which final relief is sought. If awarded, a PI may remain in force throughout the pendency of the legal proceedings or until a new decision by the trial or appellate court revokes it. To attain a PI, a litigant must demonstrate that three conditions are simultaneously met: • the claimant is likely to succeed in its claims; • there is urgency in the relief (ie, the injunction) being sought, as, without it, the claimant may suf ‑ fer harm or the lawsuit may lose its purpose; and • the party that will be targeted by the injunction may not run the risk of suffering irreversible harm. Although rare, a judge may demand the party seeking the PI to post a bond to ensure that the harm suffered by the other party may be compensated if the injunc ‑ tive relief is later found to have been improper. After a PI is awarded, the relief is enforceable upon publication of the decision granting the injunction. Parties are expected to comply immediately with the injunctive order and may be subject to daily fines for non-compliance. Although very rare, there have been cases in which a PI was substituted in favour of a bond or a peri ‑ odic court deposit based on the sales of the infringing activity. Parties targeted with a PI may file an interlocutory appeal with a specific request to stay the effects of the injunctive relief. To demonstrate that a stay is war ‑ ranted, an accused infringer must show that:
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