Navigating Cross-Border Patent Litigation in Latin America’s Life Sciences Sector: Insights from Brazil, Mexico, and Mercosur

Answer first: Despite the TRIPs Agreement’s aim to harmonize intellectual property protection, significant disparities persist across Latin America, complicating cross-border patent litigation in the life sciences industry. This analysis examines Brazil, Mexico, and Mercosur member states, highlighting challenges such as patent sco…

Litigation context for IP teams

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) was designed to reduce trade barriers by establishing minimum standards for intellectual property (IP) protection and enforcement globally. However, in Latin America, significant gaps remain that complicate the design and execution of coherent cross-border litigation strategies, particularly in the life sciences sector and patent enforcement.

This article focuses on the legal landscape in Brazil and Mexico—the region’s two largest economies—and the Mercosur trade bloc, which includes Brazil and its full member partners as of March 2026. The analysis underscores how territoriality principles and divergent national implementations of TRIPs influence patent protection and enforcement across borders.

Key takeaways for cross-border patent litigation Latin America

• Confirm how the development affects litigation ownership, enforcement, licensing, or portfolio records.
• Separate confirmed facts from legal interpretation before advising business teams.
• Map deadlines, affected assets, contracts, and evidence files to the responsible internal owner.
• Use the issue as a prompt for monitoring, filing strategy, dispute preparation, or member education.

Practical analysis

While TRIPs sets baseline standards, Latin American countries often adopt TRIPs-plus provisions or interpret flexibilities differently, resulting in uneven IP protection. This disparity can inadvertently encourage cross-border infringement, especially in patent law where no international ‘telle quelle’ rule exists. For example, Patent Cooperation Treaty (PCT) membership varies: Brazil has been a PCT member for decades, but Uruguay only joined in 2025, and Argentina and Paraguay remain outside the treaty. Consequently, drugs patented in Brazil but not in neighboring countries have led to parallel imports despite Brazil’s national exhaustion rule.

Patent office backlogs further complicate enforcement. Brazil’s 2019 backlog reduction program has yet to significantly shorten examination times. Data from Osha Bergman Watanabe & Burton LLP shows Brazil averages over nine years to grant biopharmaceutical patents (2020–2025). This delay affects litigation standing and concerns pharmaceutical companies, especially after the Brazilian Supreme Court ruled patent term extensions unconstitutional in 2021.

Mexico has addressed similar challenges by implementing fast-track patent examination procedures and allowing patent term extensions following the Nexavar case and provisions under the United States–Mexico–Canada Agreement (USMCA). Mexico now offers supplementary protection certificates for up to five years to compensate for prosecution delays.

Patentable subject matter also varies. Until March 18, 2026, Argentina restricted patent eligibility for pharmaceuticals, excluding polymorphs, dosage regimes, and Markush structures based on local patent office guidelines interpreting TRIPs flexibilities. This changed with Joint Ordinance No 01/2026, which replaced the prior restrictive ordinance. In contrast, Mercosur partners and Mexico maintain broader patentability criteria, though Brazil’s patent office is known for rigorous scrutiny of pharmaceutical patents, influenced by training from European and German patent offices.

The availability of preliminary injunctions is critical in Latin American patent litigation due to typically lengthy proceedings. Brazil permits ex parte preliminary injunctions, enhancing its attractiveness as a forum, whereas other countries in the region do not. Additionally, Brazil allows non-infringement lawsuits, offering strategic options unavailable elsewhere.

Recognition of foreign judicial decisions can aid cross-border enforcement. Within Mercosur, the Las Leñas Protocol facilitates mutual recognition of judicial decisions, enabling the use of evidence and documents from other jurisdictions despite patents being territorial rights.

Regulatory frameworks intersect significantly with patent rights in life sciences litigation. Mexico’s patent protections have strengthened under USMCA, while Brazil maintains a broad Bolar exemption. Brazil’s health authority, Anvisa, collaborates with federal police to combat compound pharmacies operating as drug manufacturers and has intensified border controls.

Mercosur countries lack patent linkage mechanisms; patent infringement detection relies on monitoring marketing approval publications in official gazettes. Conversely, Mexico’s COFEPRIS and Mexican Patent Office cooperate to publish generic and biosimilar marketing approval applications, allowing patentees to oppose those potentially infringing patents.

Data protection exclusivity also diverges. Mercosur offers such protection only for agrichemicals, following arbitration between Brazil and Argentina that harmonized standards under the Ouro Preto Protocol. Brazil’s Law No 10,603/2002 grants time-limited protection for undisclosed information used in agrichemical marketing approvals, contingent on confidentiality and inaccessibility criteria. However, no analogous protection exists for pharmaceuticals.

Mexico is obligated under USMCA to provide five years of data protection exclusivity for new chemical entities, but has yet to enact specific legislation, creating potential for litigation over compliance.

Both COFEPRIS and Anvisa have implemented measures to expedite marketing approval processes, including mutual reliance and recognition. Anvisa expedites generic approvals nearing patent expiry. Nonetheless, innovative therapies like gene therapies face regulatory hurdles due to outdated Brazilian drug registration laws dating to the 1970s.

Given these complexities, stakeholders contemplating cross-border litigation in Latin America should carefully evaluate each country’s patent scope, enforcement tools, regulatory environment, and procedural timelines. Understanding these factors is essential to crafting effective strategies for protecting and enforcing life sciences patents across the region.

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