Ozempic is a registered trademark for a periodically administered injectable medication containing semaglutide, a GLP-1 analog developed by the Danish company Novo Nordisk.
Originally created for the treatment of type 2 diabetes, the product gained global prominence due to its weight-loss effects, becoming one of the most commercially successful drugs in the recent pharmaceutical industry.
Behind this success lies a central element: the patent. It is what grants the holder the exclusive right to commercially exploit the invention for a limited period – a mechanism essential to support the high investments required for research, development, and regulatory approval.
In Brazil, patent protection is governed by the Industrial Property Law (Law No. 9,279/96), which establishes a 20-year term counted from the filing date. In the case of semaglutide, the application was filed in 2006 before the Brazilian Patent and Trademark Office (BPTO), but the patent was only granted approximately 13 years later (PI 0607762-5), and its term expires today (March 20, 2026).
This fact is not merely administrative. In practice, it means that a significant portion of the protection term was consumed while the patent holder was still awaiting governmental examination, without being able to fully exercise its market exclusivity.
Faced with this scenario, Novo Nordisk filed a lawsuit seeking restoration of the patent term, arguing that the excessive delay undermined the economic return on its investment.
However, the legal landscape had changed significantly. In 2021, the Federal Supreme Court (STF), when ruling on ADI 5,529, declared unconstitutional the provision that guaranteed a minimum patent term following grant. As a result, the main mechanism that had previously mitigated the effects of BPTO delays was eliminated.
Based on this precedent, the Superior Court of Justice (STJ) rejected Novo Nordisk’s claim, holding that there is no legal basis for extending or restoring patent terms in Brazil, even in cases of significant administrative delay.
At first glance, this conclusion may appear positive, particularly from the perspective of access to medicines. With the patent expiring within the standard term, the market opens to competitors and, potentially, to lower prices. However, this view must be approached with caution, as it does not fully capture the broader economic effects of the decision.
The pharmaceutical industry operates with long development cycles, high research costs, and strong dependence on regulatory predictability. In this context, a patent is not merely a formal right, but the primary mechanism for recovering investment.
When the system allows a substantial portion of the protection term to be consumed by government delays, without any automatic compensation, the practical result is a reduction in the formal exclusivity period and, consequently, in the expected return on investment.
Some argue that the legal system provides compensatory mechanisms that may mitigate this loss, and that the patent holder could seek damages from third parties who exploited the invention since the publication of the application, as well as from the State, based on civil liability due to excessive delay in examination.
However, these mechanisms are far from being an equivalent solution. Damages do not replace market exclusivity, do not prevent the early entry of competitors, and depend on complex evidentiary procedures, often subject to uncertainty and lengthy timelines before effective recovery. Moreover, once the market has adjusted to the presence of multiple players, the loss of competitive position tends to be irreversible, even if financial compensation is eventually obtained.
The most relevant effect, therefore, lies not only in the resolution of this specific case, but in the signal it sends to the market. By consolidating the understanding that patent term extensions are not available in Brazil, even in the face of significant BPTO delays, the system becomes perceived as less predictable and less protective of innovation investments. In a highly globalized sector, this perception directly influences strategic decisions about where to invest, where to launch new products, and where to concentrate research and development efforts.
Thus, a paradox emerges. In the short term, there may be increased competition and potential price reductions. In the long term, however, an environment with lower legal certainty and weaker patent protection tends to discourage investment, which may negatively impact the introduction of new technologies and treatments in the country.
The Ozempic case therefore demonstrates that Intellectual Property is not merely a technical or bureaucratic issue. It is a central element in the dynamics of innovation and in economic decision-making. By ruling out the possibility of restoring patent terms, Brazil reinforces the urgency of improving the efficiency of patent examination.
This progress, however, depends directly on structural investments in the BPTO, which, although a federal agency, does not have full financial autonomy and remains dependent on budgetary transfers from the federal government.