The Brazilian Patent and Trademark Office (INPI) has published DIRPA Ordinance No. 5/2026 in Official Gazette (RPI) No. 2,895, dated June 30, 2026, reinstating the acceptance of requests for priority examination of patent applications classified under IPC H04, which covers technologies relating to electric communication, including telecommunications, communication networks, data transmission, and other information and communication technologies (ICT).

The new measure ends the previous suspension on the filing of such requests while introducing a restricted framework for access to priority examination.

Key Changes

Effective immediately:
• each applicant may file only one priority examination request per calendar month, considering all available priority examination procedures applicable to patent applications classified under IPC H04;
• exceptionally, a second request from the same applicant will be accepted during the month of July;
• under the Patent Prosecution Highway (PPH) program, requests may be filed for applications in which the INPI has already issued a substantive office action (publication code 6.23);
• the monthly limitation does not apply to elderly applicants, applicants with disabilities, applicants suffering from serious illnesses, or startups; and
• the overall annual cap of 3,200 PPH requests remains in force for 2026.

Our team continues to closely monitor developments in INPI practice and is available to assess the impact of the new regulation on patent portfolios and to assist clients in developing examination acceleration strategies aligned with their business objectives.

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.

Polylaminin is a synthetic biological substance developed in the laboratory from a protein naturally produced by the body called laminin, with promising potential for the treatment of acute spinal cord injuries that cause paralysis. Behind this innovation is researcher Tatiana Sampaio, a Brazilian scientist whose research gained significant recognition and who sought national and international protection through the patent system.

In interviews, the researcher revealed that, due to federal funding cuts at the Federal University of Rio de Janeiro (UFRJ), she ended up paying the Brazilian Patent and Trademark Office (INPI) fees out of her own pocket to maintain the patent in Brazil.

Abroad, Tatiana reported that she also received no institutional support and, therefore, was unable to obtain international protection in the claimed territories: the United States and Europe.

However, the problems appear not to have been solely financial. In addition to administrative abandonment for failure to pay annuities in Europe (EP2326667A1), there was a dismissal for failure to submit required documents in a Brazilian application (PI 0704128-4) and abandonment for failure to comply with an office action in the United States (US2011172159A1). As a result, of the four patent applications filed in Brazil and abroad, only one in which the intrepid researcher is listed as inventor remains in force until 2028 (PI 0805852-0) in Brazil.

On the same subject, the Brazilian laboratory Cristália filed two patent applications in Brazil relating to the process of extraction, purification, and polymerization of laminin, which are still pending examination before the INPI (BR11 2025 012354-8 and BR 10 2022 026276-4).

The polylaminin case highlights a structural and very common problem within the Brazilian public system. Without centralized management and experience in IP assets, there is no predictability regarding costs, deadlines, or the duration of protection, whether national or international. As a result, rights are lost and strategic innovations fail to generate economic returns for the public entities that created them, ultimately harming future investment in innovation.

For these reasons, and in order to ensure effective protection of the asset, it is essential to rely on specialized legal counsel with specific experience in patent protection in Brazil and abroad, ensuring an appropriate strategy aligned with the holder’s objectives. Araripe Advogados has been active for over 40 years in the protection of intellectual assets, including patents, combining technical expertise and strategic vision in the management of national and international projects.