Life Sciences and Pharma IP 2026

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

Licks Attorneys Av. Oscar Niemeyer, 2000 9th floor, Aqwa Corporate Rio de Janeiro, RJ Brazil 20220-297 Tel: +55 21 3550 3700 Fax: +55 21 3956 9444 Email: info@lickslegal.com Web: lickslegal.com

1. Life Sciences and Pharma/ Biopharma Patent Litigation 1.1 Claimants/Plaintiffs to an Action Infringement

Nullity Unlike infringement lawsuits, nullity actions may be initiated before a federal court by a wide array of par ‑ ties. According to Article 56 of the BPS, any person with a legitimate interest may file for a patent’s nullity. Historically, case law construes this “legitimate inter ‑ est” quite broadly to encompass any person poten ‑ tially affected by a patent’s existence. Statute also provides that the BRPTO itself is a legitimate party to request a patent’s nullity before a federal court. That said, patent nullity may also be argued as a means of defence within a patent infringement lawsuit (per Article 56, Section 1 of the BPS and the Supe ‑ rior Court of Justice’s ruling in Motion for Clarification on Appeal #1,332,417/SP). When used as a defence, a finding of patent nullity will produce effects strictly between the parties engaged in litigation (inter partes effects), whereas a verdict issued in an independent nullity lawsuit will remove the existence of the patent for any party (erga omnes effects). Moreover, when an independent nullity lawsuit is filed, the BPS requires the participation of the BRPTO in that lawsuit, as it is the federal agency in charge of ana ‑ lysing patent applications. In these proceedings, the BRPTO is not necessarily compelled to act in defence of the patent. Rather, the BRPTO will assess the nullity allegations and provide an opinion on whether the pat ‑ ent should be declared valid, invalid or partially invalid (ie, undergo amendments to restrict claim scope and satisfy patentability requirements).

An action for infringement may be filed before a state court by any party with a legitimate interest in the sub ‑ ject matter of the lawsuit, according to Article 17 of the Brazilian Code of Civil Procedure (CPC). In life sciences infringement suits, the interested parties who take part in an infringement action are the patentee (or other parties authorised to act on the patentee’s behalf – eg, a licensee) and the entity accused of infringement. Unlike other jurisdictions (eg, the United States), the Brazilian Patent Statute (BPS) does not provide specific guidance on the joint ownership of patents. Therefore, the Civil Code’s general rules of joint own ‑ ership apply to intellectual property, including patents. In this sense, unless otherwise specified by contract, co-owners are cleared to act in defence of the patent independently of each other. In turn, Article 61 of the BPS allows patentees to grant authorisation towards licensees to act independently in defence of the patent, even without the participation of the actual patent owner. However, Article 62 of the BPS requires such licence contract to be recorded with the Brazilian Patent and Trademark Office (BRP ‑ TO) in order to produce effects against third parties.

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