Patents, GLP-1, and the Public Interest: A Litmus Test for Health Innovation in Brazil

In less than a week, two conflicting court decisions changed the fate of liraglutide in Brazil: first, the Federal Court granted Novo Nordisk the reinstatement of more than eight years on one of its patents; days later, the TRF-1 suspended the effect in response to an appeal by EMS. This judicial back-and-forth, which directly affects medications for obesity and diabetes, exposes the central dilemma of the Brazilian patent system after ADI 5529: how to reconcile legal certainty for innovation with equitable access to healthcare?

The background: ADI 5529 and the redefinition of the patent system

The 2021 Supreme Federal Court decision in Direct Action of Unconstitutionality 5529 was a landmark in the history of intellectual property in Brazil. The court overturned the rule that allowed the automatic extension of patents when the National Institute of Industrial Property (INPI) took too long to complete the review. Until then, a company whose patent application was analyzed for more than ten years after filing automatically gained an extension of exclusivity. The justification was simple: to prevent government delays from penalizing the rights holder. But in practice, this rule resulted in excessively long monopolies, some lasting more than two decades beyond the ordinary term.

The Supreme Federal Court 's logic was twofold. On the one hand, it recognized that the INPI has structural bottlenecks that impact the analysis of applications, something undeniable given the chronic lack of human resources and the growing complexity of biotechnology and pharmaceuticals. On the other, it concluded that the solution could not be to transfer the cost of this delay to society. Automatic extensions of deadlines, without any analysis of merit, unbalanced the system by creating artificial barriers to competition and access to essential medicines. The court, therefore, established a clear understanding: monopolies must be temporary and predictable, and government inefficiency cannot justify indefinite exclusivity.

However, the Supreme Federal Court (STF) did not close the door to specific adjustments. The decision signaled that, in exceptional circumstances, there could be room for mechanisms to compensate for disproportionate and unjustified delays by the State, provided they are duly justified. In comparative law, this is similar to Patent Term Adjustment (PTA) , a practice in countries like the United States, which adjusts deadlines when administrative delays exceed reasonable limits. This ambiguity has opened the door to new legal disputes, such as the one currently unfolding over Novo Nordisk 's liraglutide .

The Liraglutide Controversy: Decisions in a Few Days, Long-Term Impact

Liraglutide is a molecule that belongs to the same family of GLP-1 agonists that have revolutionized the treatment of obesity and type 2 diabetes. Marketed as Victoza and Saxenda , it has become a cornerstone of the portfolio of Novo Nordisk , a Danish company that now holds a global leadership position in this segment. With the explosion in demand for drugs in this class, any decision involving patents linked to liraglutide has direct effects on pricing, availability, and competition.

On September 4, 2025 , the Federal Court in Brasília granted Novo Nordisk the reinstatement of 8 years, 5 months, and 1 day on one of its patents related to liraglutide, claiming that the INPI (Brazilian Institute of Industrial Property) took more than 13 years to complete the review. The company celebrated the decision as a step toward "legal certainty," ensuring that government delays do not erode the effective exclusivity period. In its official statement, Novo emphasized that the decision was in line with the Supreme Federal Court's own interpretation of ADI 5529, which did not prohibit specific adjustments, only automatic extensions.

However, just three days later, the TRF-1 suspended the effects of the decision through an injunction in response to an appeal by EMS , one of Brazil's largest pharmaceutical companies, which had already launched synthetic versions of liraglutide, such as Olire and Lirux . The court highlighted the risk of harm to competition and patients, emphasizing that extending monopolies at a time of high demand for anti-obesity medications could unduly burden consumers and the SUS itself. This judicial back-and-forth highlights how the line between encouraging innovation and preserving the public interest remains unstable.

The Innovation Dilemma: When Time Is the Enemy of Research

For innovative companies, especially in biotechnology , time is as valuable a resource as capital. Developing a novel molecule can take more than a decade, with investments often exceeding billions of dollars in research, clinical trials, and regulatory oversight. In this scenario, each year of exclusivity is crucial to ensuring the economic return on this effort. When the government delays granting a patent, the window of effective exclusivity is reduced—precisely the phase in which the company can explore the market without direct competition and recoup part of its investments.

The argument of Novo Nordisk and other global companies closely following the case is that Brazil needs to demonstrate predictability and respect for intellectual property rights if it wants to attract research centers and clinical trials. Without mechanisms to compensate for disproportionate delays, the country would reinforce an image of legal uncertainty, scaring away investment in high-tech areas. It's no coincidence that Brazil currently participates in only about 2% of global clinical trials , a low rate for the size of its market and population.

This is where the PTA 's proposal arises: adjusting the term of protection on a case-by-case basis, without reverting to the logic of automatic extension. This measure, while reasonable in theory, requires objective criteria to avoid becoming a loophole that perpetuates artificial monopolies. The challenge is to establish clear parameters: what would be the INPI's tolerable delay limit? Under what conditions could reinstatement be granted? And, above all, how can this protection be reconciled with the urgent need for access to therapies that are already in high demand in public health?

The Access Dilemma: Prices, Competition, and Public Health

On the other side of the scale is the collective interest in ensuring that effective therapies reach as many people as possible. GLP-1 drugs have become symbols of a new therapeutic frontier against obesity and diabetes, but also of a struggle for access. Their high price limits their incorporation into the public system and burdens private health plans. Each additional month of monopoly means billions of reais in potential costs for patients and payers.

The presence of domestic competitors, such as EMS, which has already launched liraglutide products with synthetic active ingredients, promises greater competition and more affordable prices. A court decision suspending the entry or continuation of these products directly impacts this dynamic. The risk, according to critics of the timeframe adjustments, is that monopolies will crystallize around molecules whose efficacy has already been widely proven, transforming bureaucratic delays into artificial barriers to access.

Furthermore, there is the issue of the sustainability of the Unified Health System (SUS) . Brazil is a country where the prevalence of obesity and diabetes is growing rapidly, with alarming projections for the coming decades. The incorporation of high-cost medications without generic or biosimilar alternatives compromises already scarce resources, forcing difficult choices in public policy. In this sense, extending exclusivity on medications with significant epidemiological impact is not only a matter of corporate competition, but also of equity and social justice.

Economic and strategic impacts for Brazil of the extension of GLP-1 patent terms

The decisions surrounding liraglutide are not limited to an isolated case. They are closely watched by investors, pharmaceutical companies, and international research centers as signals about the business environment in Brazil. If the country takes a hard line against any form of restructuring, it could send the message that there is no predictability for investors in radical innovation. On the other hand, if it opens the door to broad and poorly regulated extensions, it could undermine its own ability to guarantee universal access to healthcare.

The economic dimension is significant. The Brazilian biotechnology market generated approximately US$27 billion in 2023 and is expected to reach US$69 billion by 2030 , growing at an annual rate of over 14% . The healthcare sector is the main driver of this growth. Court decisions that affect patent dynamics therefore have a direct impact on this trajectory, influencing everything from investor appetite to the internationalization strategies of local startups.

Another strategic aspect is Brazil's insertion into global innovation chains . The country has the potential to be a clinical research hub in Latin America, given its diverse population, robust healthcare system, and scientific capacity. But to achieve this, it needs to offer a clear, predictable, and balanced regulatory environment. The case of liraglutide will be a barometer: if Brazil can reconcile innovation and access, it will strengthen its position. If it leans too heavily toward one side, it risks losing global relevance.

Possible scenarios and their implications

The first scenario is that the suspension granted by the TRF-1 is maintained . In this case, competition continues, with EMS products remaining on the market and putting downward pressure on prices. This outcome favors immediate access, but could be interpreted by multinationals as a sign of hostility to compensatory adjustments, driving away future research investments.

The second scenario involves the validation of the GLP-1 patent reinstatement in higher courts , confirming Novo Nordisk 's thesis that disproportionate delays deserve compensation. In this case, exclusivity would extend for years, delaying the full entry of generics and impacting the cost of treatments. The message to the market would be positive in terms of legal certainty, but negative in terms of access and equity.

A third, more balanced scenario would be an intermediate solution : minor adjustments, subject to transparent criteria and, possibly, access compensation. This model would recognize the need for predictability for investors without ignoring the pressure to expand the reach of medicines. For example, the extension could be accompanied by differentiated pricing programs for the SUS (Unified Health System) or compulsory licensing clauses in health emergency situations.

7. What's really at stake

More than just a dispute between two companies, the liraglutide case sets a precedent that will shape the future of healthcare biotechnology in Brazil. The country must decide whether to establish clear rules for adjusting patent terms or to restrict itself to the broad prohibition established in 2021. This choice is not trivial: it determines the attractiveness of investments in radical innovation and the sustainability of the healthcare system in the face of the incorporation of high-cost therapies.

The decision will also test Brazil's institutional capacity to coordinate its science, technology, and innovation policies with its public health policies. The coexistence of these two interests requires regulatory maturity and strategic vision. It's not about choosing between innovation and access, but about finding mechanisms that guarantee both. International experience shows that this is possible: countries that combine research incentives with active policies to expand access are able not only to attract investment but also to reduce inequalities.

The liraglutide case, therefore, is not just about a molecule or a patent. It's about Brazil's place in the global health biotechnology landscape. We want to be a country that offers predictability and attracts innovation, but also ensures the constitutional right to health. Balancing these objectives is the real challenge.

The controversy over the reinstatement of the liraglutide patent is the first major test of the post-ADI 5529 era . The outcome of the case goes far beyond the dispute between Novo Nordisk and EMS . It will determine whether Brazil has the courage and institutional capacity to design an intellectual property model that values innovation without sacrificing access. The answer lies not only in the courts, but in the coordination of the Judiciary, Executive, Congress, and civil society.

The outcome may be seen in the future as a turning point. If we find balance, we can build an environment where Brazilian startups, large multinationals, and the Unified Health System (SUS) itself thrive side by side. If not, we risk seeing the country trapped between investment flight and the unsustainability of the healthcare system. The history of biotechnology in healthcare in Brazil may be being written now, and the decision on liraglutide will be remembered as one of the pivotal chapters.

At IBIS , we believe that judicial and regulatory decisions like this shape the future of healthcare biotechs in Brazil. We closely monitor each development, producing strategic analyses for companies, institutions, and policymakers. If your organization needs to understand the impacts of this dispute on its innovation projects, access strategies, or global partnerships, contact us. IBIS is ready to support you with intelligence, a network of connections, and an international vision.

by Marcio de Paula

Brazilian Health Innovation Institute - IBIS