BRAZIL Trends and Developments 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
An Introduction to Life Sciences and Pharma IP Litigation in Brazil 2025 saw certain developments that have bolstered Brazil’s role as a relevant jurisdiction in life sciences and pharma litigation. By reflecting on the milestones achieved in 2025, this article hopes to provide an accurate outlook for trends in the sector in 2026. ADI #5529 The Brazilian patent system has faced significant changes following the landmark Brazilian Supreme Federal Court (STF) decision on Constitutional Chal ‑ lenge (ADI) #5529. This very consequential decision on judicial review led to the revocation of the auto ‑ matic adjustment of patent terms provided in Article 40 of the Brazilian Patent Statute (BPS). Before ADI #5529, applicants in Brazil were assured a minimum ten-year patent protection term (or sev ‑ en years for utility models), counted from the day on which the patent was granted. This mechanism acted as a safety net for applicants against the well- documented patent backlog and pendency issues of the Brazilian Patent and Trademark Office (BRPTO). ADI #5529 removed this safety net. Although the deci ‑ sion had (mostly) prospective effects, patentees in the healthcare industry were hit especially hard. In its decision, the STF included a provision stipulating that it would have retroactive effect for patents covering pharmaceutical products, processes, equipment and materials “for use in healthcare”. That led to a signifi ‑ cant shortening of patent terms for many patents in the healthcare industry (eg, pharmaceuticals).
The immediate response was a wave of litigation. Specifically, pharmaceutical companies started fil ‑ ing lawsuits requesting compensation in the form of term of protection equal to the period lost due to the BRPTO’s inactivity during prosecution. By the end of 2025, more than 70 lawsuits had been filed, seeking compensation for the term of protection reduced due to the BRPTO backlog. The results were a mixed bag. Many preliminary injunctions were granted and later revoked – some lasted over two years, and the initial trial court decisions on the merits denied the com ‑ plaints. However, 2025 saw the first two favourable decisions being rendered in major cases. Although it is still too early to say that the tide has turned, these decisions provide an encouraging sign for prospective Patent Term Adjustment (PTA) plaintiffs. Proposed legislation to ensure adequate patent terms Compensation for losses in the term of protection lawsuits relies on provisions from Statute #9,784/99 (Federal Administrative Proceedings Statute), which establishes deadlines for when administrative pro ‑ ceedings shall be decided. These deadlines are use ‑ ful to ascertain when the administration has taken too long to decide on a given issue. Currently, there are no specific provisions in the BPS or other patent statutes concerning the possibility of term adjustment such as in other jurisdictions. This lack of specific legislative provision is a gap in the law, and the courts are being called upon to fill it in the current lawsuits. However, that gap may be filled in the near future.
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