
Karla Loranca
IP expert of the Latin America IP SME Helpdesk
In recent years, Mexico has undergone significant transformations in its legal and institutional framework regarding industrial and intellectual property, driven by international commitments such as the United States-Mexico-Canada Agreement (USMCA), as well as national initiatives aimed at modernising and strengthening the protection and enforcement of these rights. However, challenges in implementation, regulatory gaps, and administrative delays have raised concerns among both national and foreign stakeholders. This analysis seeks to look at each relevant aspect, emphasising the negative challenges or controversies that may adversely affect efforts to promote innovation and protect intangible assets in Mexico.
Reform and regulatory challenges of the Federal Law on the Protection of Industrial Property (LFPPI)
Enactment of the LFPPI
The latest version of the LFPPI was published on 1 July 2020 and came into force on 5 November of the same year, coinciding with the entry into force of the USMCA. This law replaced the 1991 Industrial Property Law, aiming to align Mexican legislation with modern standards and international commitments. Among its main innovations are new forms of protection such as geographical indications, changes to the system for non-traditional trade marks, and new mechanisms, obligations, and means to ensure the effective enforcement of industrial property rights.
Absence of regulatory norms and practical guidelines
Notwithstanding the above, as of mid-2025, a much-needed general regulation for the LFPPI is still to be issued. This delay affects many procedures: deadlines, online processes, clarifications regarding temporary extensions, and administrative defence mechanisms.
It is also worth noting that the Mexican Institute of Industrial Property (IMPI), which serves as the first administrative instance for trademarks and patents, has never published guidelines to inform practitioners or the general public about the criteria it applies. While the IMPI does follow specific standards in its decision-making, it is up to the parties involved in proceedings to discover them through practice. This stands in contrast to other offices, such as the EUIPO, which publicly share their examination criteria through freely accessible guidelines.
As a result, applicants and rights holders lack legal certainty regarding the ways and cases in which the law is applicable and how, as well as a uniform interpretation by the authorities responsible for its application.
Also, divergent criteria are observed among examiners at the Mexican Institute of Industrial Property (IMPI), which results in uncertain predictability of decisions. This uncertainty is further compounded by considerable delays in contentious proceedings (invalidity, revocation, infringements), which affect the timely defence of rights.
The industrial sector has repeatedly called for the publication of the regulation to prevent irregular criteria and to strengthen legal certainty.
Substantive changes in patents, trade marks, and designs
Some of the most remarkable changes that the LFPPI introduced in 2020 are the following:
- New grounds for invalidity and revocation, some of which are subject to interpretation due to the absence of secondary regulations (implementing rules). Among these, it is now possible to request the partial invalidity of a trade mark, or to cite, as grounds for invalidity, the claim that a false first-use date was provided.
- Reform of the renewal system and rules relating to the effective use of rights, particularly regarding the actual and effective use of the trade mark.
- Non-traditional trade marks such as olfactory, holographic, and trade dress marks, whose effective protection depends on criteria that are still underdeveloped by the relevant authorities.
- Electronic filing and maintenance: While the digitalised process represents a significant improvement in agility and user convenience, it lacks formal uniformity in several areas due to the absence of official guidelines.
Copyright: reforms, problems, and recent trends
Legislative amendments and reactions in the digital environment
In 2020, Mexico reformed its Federal Copyright Law (LFDA) to align with its obligations under the USMCA, especially Chapter 20 on intellectual property. Key reforms include the adoption of notice-and-takedown procedures and new technological protection measures (Digital Rights Management, or DRM).
However, the implementation of these mechanisms has been controversial, mainly due to concerns expressed by civil society organisations and academics over potential negative effects on freedom of expression (an issue further exacerbated by the reform to the Telecommunications Law, as will be discussed later), as well as the absence of safeguards for legitimate use (fair use or limitations and exceptions). Several of the provisions introduced by this reform have been challenged on the grounds of potential unconstitutionality; these challenges are currently pending before the Supreme Court of Justice of the Nation. Nevertheless, the recent judicial reform in the country has raised growing concerns about the consequences it could have for constitutional oversight (both over the legal norms themselves and over judicial rulings), as will be explored further on.
Piracy, enforcement, and judicial challenges
Mexico continues to be ranked as one of the countries with the highest rates of copyright infringement worldwide, particularly in the audiovisual, literary, and software sectors. Notably, and despite the international obligations Mexico has undertaken in this field (mainly through the signing of the USMCA), the following problems persist:
- Lack of capacity and resources (and will) for effective investigations and judicial proceedings against digital and physical piracy.
- Limited cooperation between customs, tax, and law enforcement authorities.
- The absence of up-to-date public statistics on seizures and final judgments makes it challenging to monitor and evaluate public policy.
Pharmaceutical Linkage and Regulatory Data Protection: Key T-MEC (USMCA) Pending Issues
Requirements set in the USMCA
The USMCA requires Mexico to adopt mechanisms such as Patent Linkage since 2003, when the previous North American Free Trade Agreement (NAFTA) was still in force, as well as at least five years of test data exclusivity (Regulatory Data Exclusivity). This translates into protection for the safety and efficacy data submitted for obtaining marketing authorisations for medicines.
However, these legal requirements have faced a troubled implementation in practice, primarily due to a couple of challenges during their rollout.
Challenges in implementation
Among the main challenges that Mexico has found with the implementation of the USMCA requirements in this topic, the transition period and regulatory gaps are to be highlighted.
About the first one, the deadline for complying with regulatory data protection (Article 20.48 of the USMCA) expired on 1 July 2025. As of today, Mexico has not published guidelines or developed the regulatory framework necessary to guarantee data exclusivity.
Regarding regulatory gaps, questions persist regarding the duration and scope of protection, the applicable periods (five or eight years), and the criteria for biological and biosimilar medicines.
This lack of clarity discourages pharmaceutical companies from investing in local research and development, since there are no guarantees that they will obtain exclusive protection for their clinical data.
Additionally, the mechanism linking IMPI (the Mexican Institute of Industrial Property) and COFEPRIS (the regulatory agency for health) remains a subject of debate, as in practice, the patent linkage system is still not fully operational.
Challenges involving the Office of the Attorney General and the IMPI
The Mexican Office of the Attorney General has not published updated reports on investigations, prosecutions, or rulings related to intellectual property rights violations since 2022, to the detriment of transparency and accountability.
As for the Mexican Institute of Industrial Property (IMPI), it has made efforts in raising awareness through campaigns and by increasing its presence at trade fairs, customs points, and digital platforms. However, it lacks sufficient capacity to carry out field investigations and coordinated actions with public security authorities.
These factors negatively affect Mexico’s image as a secure destination for investment in knowledge-intensive or technology-based sectors.
Restrictions on Parallel Imports, competition, and shortages
Amendments to the Federal Law on the Protection of Industrial Property (LFPPI) and its implications for the Mexican market.
Due to obligations established by the USMCA, since 2020, the LFPPI restricts parallel imports of goods protected by patents, permitting them only for trade marks (Article 61, Section XII). This represents a significant difference compared to the previous law and with international practices in regions such as the European Union, where there is more flexibility.
Eliminating parallel imports of patented medicines and products can affect competition and raise prices of certain goods, making it harder for consumers to access more affordable options. Such restrictions effectively limit third parties from importing legitimate products purchased in other markets.
This has been criticised as a regression by international competition regulators, organisations, and access-to-medicines advocates, who argue that the balance between intellectual property protection and the public interest should be reconsidered. These concerns are particularly pressing given the severe medicine shortage that Mexico has experienced in recent years.
Medicine shortage in Mexico
Since 2019, Mexico has faced a persistent shortage of medicines, exacerbated by the implementation of new policies that were officially aimed at combating corruption, as well as by changes to the public procurement model. The dismantling of the traditional purchasing system, the abolition of Seguro Popular (universal healthcare clinics), and the centralisation of procurement in the Ministry of Finance led to delays, disorganisation, and logistical failures, seriously affecting supply, particularly of oncology drugs and treatments for chronic diseases. The combination of poorly planned administrative decisions, the COVID-19 pandemic, and the inexperience of new officials deepened the crisis between 2020 and 2023, impacting millions of patients.
Currently (July 2025), the shortage continues in the public sector, with constant reports of unfilled prescriptions at IMSS and ISSSTE (public) hospitals. Contributing factors include changes in procurement strategy, distribution problems, debts with pharmaceutical companies, the annulment of recent tenders, and global issues such as dependence on foreign-sourced raw materials and rising input costs. Although the government has claimed to have invested in mega-storage projects and the promotion of incentives for local production, these measures have not yet stabilised supply or eliminated uncertainty for millions of Mexicans, especially vulnerable patients and people living in marginalised areas.
The restriction on parallel imports of medicines further worsens the shortage. If the official supplier fails to deliver, and importing authorised drugs through other channels is not allowed, hospitals and pharmacies in Mexico remain entirely dependent on the official supply. In contrast to countries where parallel imports have acted as a vital safety valve during supply crises and contributed to moderating prices, Mexico’s exclusion of this practice limits competition and flexibility to address shortages. Thus, Mexican policy fosters the persistence or even aggravation of the shortage in the face of logistical failures, regulatory problems, or unilateral decisions by patent-holding companies.
Artificial Intelligence and Intellectual Property
Throughout 2024 and 2025, legislative proposals and debates have emerged to address the protection and regulation of works generated by artificial intelligence (AI). There is still no specific law or official guidelines that establish whether works automatically generated by AI can be protected under copyright, nor who would hold the rights to such works.
By mid-2025, reports circulated regarding a Supreme Court of Justice of the Nation (SCJN) decision concerning copyright protection for works created with AI. It was speculated that the Court had ruled that this type of work was not eligible for protection. However, days later, the Court issued a statement urging the public to await the publication of the definitive judgment and not to speculate about the decision or content.
Both the emerging legislative debate and the Supreme Court’s forthcoming ruling are being closely watched by the technology industry, by authors, and by traditional rights holders.
Findings and Recommendations
The recent landscape of industrial and intellectual property in Mexico reflects a period of significant legal modernisation, but also of substantial regulatory and operational challenges. Reforms aligned with the USMCA and other international commitments have raised the standards of protection and created legal frameworks comparable to those of advanced economies. However, the persistence of regulatory gaps, particularly due to the absence of implementing regulations and clear guidelines, adds legal uncertainty that can complicate decision-making and investment planning, especially for those looking to introduce new products, technologies, or business models.
For SMEs and potential European investors, it is crucial to understand that, although Mexico offers a large and dynamic market, there are still risks associated with rights enforcement, administrative response times, and a lack of judicial predictability, the latter, now exacerbated by recent reforms to the judiciary. Legal uncertainty regarding the interpretation and application of the law can affect both the registration and defence of intangible assets. At the same time, the recent loss of autonomy by regulatory bodies increases the risk that decisions may be influenced more by political factors than by technical criteria.
Those considering expanding, launching production, or exporting to Mexico are advised to carry out a thorough risk analysis that considers both legal changes and the real-world capacity for protection and enforcement of intellectual property rights. It is essential to establish strong relationships with specialised local firms, invest in preventive legal advice, and maintain ongoing monitoring of regulatory developments, especially in sensitive sectors like pharmaceuticals, technology, and innovative goods.
European and SMP SMEs should consider diversification strategies that involve multiple forms of protection (trade marks, patents, copyright), as well as the use of alternative dispute resolution mechanisms and active monitoring of their rights before Mexican authorities. Additionally, in sectors such as pharmaceuticals, evaluating the feasibility of partnerships with domestic firms and local production models may help mitigate risks stemming from restrictions on parallel imports and the regulatory volatility surrounding supply chains.
In conclusion, Mexico presents significant opportunities, but the current regulatory and political environment demands a proactive, informed, and adaptable approach. The key will be to anticipate and integrate into commercial and legal strategy not only the possibility of unforeseen regulatory changes, but also the need to strengthen partnerships and enforcement capabilities to ensure long-term competitiveness and viability in the Mexican market.
- Publication date
- 31 July 2025
- Author
- European Innovation Council and SMEs Executive Agency