Cross-border intellectual property litigation: a Latin American look with a focus on life sciences and patent enforcement

Anderson Ribeiro
Souto Correa, Brazil
Anderson.ribeiro@soutocorrea.com.br

Aline Ferreira de Carvalho da Silva
Souto Correa, Brazil
aline.ferreira@soutocorrea.com.br

Introduction

Although the Agreement on Trade-Related Aspects of Intellectual Property Rights (the ‘TRIPs Agreement’) was enacted with the promise of minimising barriers to trade by setting comprehensive minimal standards for Intellectual Property (IP) protection and enforcement, the truth is that there are still many gaps that organisations should bridge in order to establish a coherent and efficient cross-border litigation strategy. Indeed, cross-border litigation and enforcement of rights are still challenging in view of the principle of territoriality. This article aims to give some advice on how to design a cross-border litigation strategy in Latin America with a focus on the life sciences industry and patent enforcement. Considering such frame, our analysis will encompass the scenario in Brazil and Mexico (the two biggest economies of the region) and Mercosur (giving the economic links between Brazil and its partners in the group, considering the countries which are full members as of March 2026).

Challenge 1: TRIPs does not mean equal patent protection and prosecution path

Yet the main goal of the TRIPs Agreement was to reduce trade barriers in IP^[1] by the provision of standards and principles for IP protection and enforcement, the level of IP protection may still vary a lot across the same region, which is especially true for Latin America – a large region with lots of inequalities. As TRIPs only set minimal standards, countries are free to provide for TRIPs-plus rules, and sometimes the difference in the rules for IP protection and enforcement between neighbouring countries may even work as a boost for cross-border infringement.

This is particularly true for patents, not only because the international framework does have anything similar to the ‘telle quelle’ rule, but also because the availability of mechanisms such as PCT applications may affect whether some subject matter will be protected by a patent or not. Therefore, in addition to possibly having patents of the same family with a very different scope of protection in view of the principle of independence of patents, organisations may face a situation where a product is protected by a patent in a certain country, but it is not protected in its neighbours. It is no brainer that this fact may lead to parallel imports as well as the launching of similar products by competitors in such neighbouring countries.

This is no hypothetical situation. For instance, while Brazil has been a member of the Patent Cooperation Treaty (PCT) for some decades, its Mercosur partners have been reluctant to accede to such treaty: Uruguay only acceded in 2025, while Argentina and Paraguay are not members. Such differences resulted in many parallel imports into Brazil of drugs that are patented in that country, but not in its neighbours,^[2] even though Brazil has a national exhaustion rule.

Another relevant topic is the backlog in patent offices. Brazil implemented in 2019 a backlog fighting program. However, an updated analysis from Osha Bergman Watanabe & Burton LLP of the patent examination timelines for biopharmaceutical patents indicates that Brazil is taking an average of just over nine years to grant a biopharma patent, considering biopharmaceutical patents granted from January 2020 through November 2025.^[3] This factor has influence on standing to sue in lawsuits claiming infringement, for example, and it worries pharma players especially because the Brazilian Supreme Court ruled in 2021 that patent extensions are unconstitutional.

Aiming to tackle a similar problem, Mexico has not only established fast-track mechanisms, but it also provides for patent extension since the Nexavar case decided by Mexican Supreme Court and the enactment of new statutory rules in view of the United States–Mexico–Canada Agreement (USMCA). After such developments, Mexico now provides for a supplementary protection certificate limited to five years^[4] in case of prosecution delays.

Still, with regard to patent protection and prosecution, the very scope of the patent protection may vary in view of how the local legislation used TRIPs flexibilities. For instance: until 18 March 2026, Argentina severely limited the patentable subject matter for pharmaceuticals, especially polymorphs, dosage regimes and Markush structures.^[5] Such limited scope was the result of guidelines established by the local patent office considering that TRIPs does not establish a standard meaning for novelty and inventiveness and assuming that certain categories of inventions would lack novelty and inventiveness from the outset. That was changed by Joint Ordinance No 01/2026, which fully scrapped Joint Ordinance No 107/2012.^[6]

On the other hand, the other Mercosur countries and Mexico do not have such strict rules, although the Brazilian Patent Office is known to have a heavy hand when analysing pharma patents, possibly as a result of having its examiners trained by the European Patent Office or German Patent and Trade Mark Office (DPMA) examiners. That affects how patents are enforced across multiple jurisdictions – and even if litigation is an option in certain jurisdictions.

On this topic, the availability of preliminary injunctions is a factor that influences whether or not to start a litigation. Litigation in Latin America is known to take considerable time – and obtaining a preliminary injunction may be the key to effectiveness. Although ex parte preliminary injunctions are available in Brazil, that is not true for other countries in the region, which may favour Brazil as a key jurisdiction. Another key point to design litigation strategy is to know whether non-infringement lawsuits are available – and they are in Brazil.

Finally, the possibility of recognition of foreign decisions may be of help. Although patents are a territorial right, it may be useful to use pieces of evidence and documents produced in other jurisdictions. In the Mercosur, the mutual recognition of judicial decisions is established by Las Leñas Protocol.

Challenge 2: The interplay between health regulations and patent protection

Another key factor to be considered in life sciences litigation is the interplay between patent rights and health regulations and how regulations can be used to further patent protection or to make it easier for new entrants to enter the innovator’s market as quickly as possible.

In this sense, while Mexico has seen an increase in the levels of patent protection as a result of USCMA, Brazil has a broad Bolar exemption and Anvisa (local health authority) has been facing a difficult time trying to tackle compound pharmacies that try to act as if they were drug manufacturers. Anvisa has collaborated with the Federal Police on this topic and has been trying to tighten the border measures.

There is no patent linkage in Mercosur countries and the work of detecting possible patent infringement consists in following up the publication of market approval certificates in the Official Gazette. Conversely, Mexico has established a cooperation between COFEPRIS (local health authority) and IMPI (Mexican Patent Office) by which COFEPRIS publishes a list of applications for marketing approval requests for generics and biosimilars giving patentees the opportunity to oppose such applications if it considers that a patent right is affected by such applications.^[7]

As for data protection exclusivity concerning tests produced for regulatory purposes, there is no such protection in Mercosur except for data related to agrichemicals. The protection of undisclosed information used for obtaining marketing approval for agrichemicals was the result of an arbitration between Brazil and Argentina where it was discussed whether the Ouro Preto Protocol of the Mercosur Agreement obliged Mercosur members to adopt the same standards for the commercialisation of agrichemicals. Prior to the enactment of Law No 10,603/2002, Brazil did not register generic products based on the confidential information of the innovators alleging that was a trade secret with perpetual protection, which was a practice that differed from the regulatory standards of the other country members.^[8] After the enactment of Law No 10,603/2002, Brazil provides a time-limited protection for undisclosed information used for obtaining marketing approval for agrichemicals when (1) such data is not easily accessible to people who normally deal with the type of information in question, either as a whole or in the specific configuration and assembly of its components; and (2) effective precautions have been taken to maintain their confidentiality by the person legally responsible for their control. The term of protection varies according to the type of product. The protection of undisclosed information used for obtaining marketing approval for drugs for human use was expressly ruled during the discussions of Law No 10,603/2002.

On the other hand, Mexico must provide data protection exclusivity for new chemical entities for a five-year-term, according to Article 20.48 of USCMA, but no specific legislation was enacted on this regard.^[9] The current legal text (Article 168 of the Federal Act for the Protection of Intellectual Property) merely says that some protection should be granted in line with the law or international treaties. That may give rise to litigation as Mexico is not complying with USCMA.

Concerning the backlog of marketing approvals, both COFEPRIS and Anvisa have been putting in place measures to expedite proceedings, and they both are using reliance and recognise each other for this purpose.^[10] Anvisa also allows expedition proceedings for generics when the patent of the innovator is close to expiration. On the other hand, disruptive technologies, such as gene therapies, may face a bumpy road when trying to get market approval, as the Brazilian law on drug registration dates back to the 1970s. Although Anvisa has been doing its best to overcome the gaps in legislation, there is still a long way to go until innovative products have a better regulatory path.

Conclusion: a proposed roadmap

In view of the challenges mentioned above, we propose that anyone considering cross-border litigation in Latin America, whether acting for the innovator or new entrants, should first answer the following questions for each country involved in the litigation:

• Does the scope of the patent differ from other jurisdictions?
• Is the enforcement of the patent affected by imports or products from compounding pharmacies?
• Is the enforcement of the patent affected by backlogs in prosecution?
• Is there a patent term adjustment available?
• Is there patent linkage or data protection exclusivity available?
• Is a preliminary injunction available?
• Is a non-infringement lawsuit possible?
• Is there a prosecution path to expedite marketing approval for generics?
• Is there a prosecution path to expedite marketing approval for innovations?
• Is it possible to use evidence produced in other jurisdictions?

Based on the answers, the litigator may, for instance, coordinate litigation in a country to prevent parallel imports in another, as well as use a preliminary injunction in a country to obtain an agreement covering the entire region.

Notes

^[1] In this sense, please see the preamble of the Agreement, available at https://www.wto.org/english/docs_e/legal_e/27-trips_02_e.htm, accessed 5 May 2026.

^[2] See https://g1.globo.com/saude/noticia/2026/02/10/paraguai-ja-reconheceu-comercio-de-canetas-emagrecedoras-falsas-na-fronteira-entenda-os-riscos.ghtml, accessed 5 May 2026.

^[3] See https://phrma.org/blog/the-time-is-now-to-address-brazils-notorious-patent-backlog, accessed 5 May 2026.

^[4] In this sense, article 126 of the Federal Act for the Protection of Intellectual Property, available at www.gob.mx/cms/uploads/attachment/file/645081/LFPPI.pdf, accessed 5 May 2026.

^[5] The revoked rule is available at www.argentina.gob.ar/normativa/nacional/resoluci%C3%B3n-118-2012-196991/texto, accessed 5 May 2026.

^[6] See further www.argentina.gob.ar/noticias/argentina-moderniza-su-sistema-de-patentes-farmaceuticas-para-garantizar-el-acceso-mejores, accessed 5 May 2026.

^[7] See further www.gob.mx/impi/es/articulos/se-publica-en-el-dof-el-acuerdo-por-el-que-se-dan-a-conocer-disposiciones-relacionadas-con-la-colaboracion-impi-cofepris?idiom=es, accessed 5 May 2026.

^[8] See further https://imagem.camara.leg.br/MostraIntegraImagem.asp?strSiglaProp=MPV&intProp=69&intAnoProp=2002&intParteProp=36#/, accessed 5 May 2026.

^[9] As highlighted by the Mexican Association of the Innovative Pharmaceutical Industry in an article authored by Mariana González Vargas available at https://amiif.org/proteccion-de-datos-clinicos-su-importancia-para-garantizar-el-derecho-de-acceso-a-la-salud/, accessed on 24 March 2026.

^[10] See further www.gov.br/anvisa/pt-br/assuntos/relacoes-internacionais/confianca-regulatoria, accessed 5 May 2026. Anvisa also recognises the work of ANMAT (Argentina’s health authority) for some purposes.