On March 20, 2026, the patent for semaglutide expires in Brazil, ending Novo Nordisk’s exclusivity over the active ingredient in Ozempic and Wegovy. This date marks the conclusion of a legal dispute that went through the INPI (Brazilian Patent and Trademark Office, or BPTO), the STJ (Superior Court of Justice) and the STF (Supreme Federal Court), bringing to light fundamental questions about the Brazilian patent system. Given its high economic relevance, the case offers a practical study on the laws and regulations governing intellectual property (IP) in Brazil’s pharmaceutical sector, and on the risks of late protection strategies.
Case timeline: from the patent filing at the BPTO to its expiration
The semaglutide patent application was filed with the BPTO in 2006. The grant, however, only came in 2019, after 13 years of administrative processing and technical examination. In the meantime, Novo Nordisk had obtained approval from Anvisa (Brazil’s National Health Surveillance Agency) to market Ozempic in 2018, but without the patent formally granted, the enforcement landscape remained uncertain.
Brazil’s Industrial Property Law (Law No. 9,279/1996) establishes in Article 40 that an invention patent is valid for 20 years from the filing date. Under this rule, semaglutide would be protected until March 2026, meaning only 7 years of effective exclusivity after the grant.
Novo Nordisk argued that the BPTO’s delay consumed a significant portion of the protection term and sought judicial compensation: an extension of the patent until 2038. The claim was unanimously rejected by the 4th Panel of the STJ in December 2025, on the grounds that Brazilian law does not provide for a Patent Term Adjustment mechanism.
Lesson 1: Brazil does not have Patent Term Extension
The STJ’s decision in the semaglutide case was not an isolated surprise. It is consistent with the STF’s ruling in ADI 5,529, which declared unconstitutional the sole paragraph of Article 40 of the Industrial Property Law. That provision guaranteed a minimum validity period of 10 years for invention patents and 7 years for utility model patents, regardless of examination delays.
With the repeal of this rule and the modulation of its effects, it became clear that, in Brazil, patent protection lasts 20 years from the filing date, with no possibility of extension, regardless of how long the BPTO takes to complete its analysis. This reality sets Brazil apart from countries such as the United States, the European Union and Japan, which have formal term extension mechanisms (such as Patent Term Adjustment and Supplementary Protection Certificates).
For companies investing in pharmaceutical innovation, the lesson is that IP strategy planning must account for the fact that the effective exclusivity period in Brazil may be significantly shorter than in other markets, given the absence of mechanisms to compensate for administrative delays. The longer the grant takes, the greater the risk to the return on R&D investment. Accordingly, the use of examination acceleration procedures, such as the PPH (Patent Prosecution Highway), becomes critical to maximizing the period of exclusive commercial exploitation.
Lesson 2: the Bolar exception is a strategic tool, but not a blank check
While Novo Nordisk was disputing the extension of its patent, several laboratories were already positioning themselves to launch generics as soon as protection expired. This was made possible by the Bolar exception.
The name traces back to a U.S. court case in the 1980s. Bolar Pharmaceutical conducted tests using the active ingredient flurazepam, patented by Roche, in order to obtain regulatory approval for a generic to be launched after the patent expired. Although the American court recognized the legitimate purpose of the activity, it held that existing law did not support this use. The case led the U.S. Congress to amend the law to expressly include the exception, and the precedent served as a reference for several countries to adopt similar mechanisms. In Brazil, the rule was introduced by Law No. 10,196/2001, which added Subsection VII to Article 43 of the Industrial Property Law. It is internationally recognized and was validated by a WTO panel under Article 30 of the TRIPS Agreement.
In practice, the Bolar exception allows third parties to use a patented invention during the patent term, solely for the purpose of producing information and data required to obtain marketing authorization. This is what enables laboratories to carry out bioequivalence studies, produce pilot batches and submit regulatory dossiers to Anvisa before the patent expires, so that the generic product is ready to enter the market at the appropriate time.
The limits, however, are strict. The exception covers only regulatory activities. Building commercial inventory, establishing distribution networks, negotiating with pharmacies and running marketing campaigns during the patent term are not covered. Any activity that goes beyond the purpose of obtaining regulatory approval may constitute patent infringement and unfair competition.
The boundary between legitimate regulatory preparation and premature commercial exploitation is assessed on a case-by-case basis by Brazilian courts, based on the purpose and proportionality of the activities involved. For those relying on the Bolar exception, thorough documentation of every step is essential.
Lesson 3: patent expiration does not automatically open the field to competitors
The expiration of the semaglutide patent has made the molecule available for third-party production, but it has not removed all intellectual property barriers. This is a point that many market players underestimate.
- Trademarks and trade dress remain protected. The names Ozempic, Wegovy and Rybelsus remain registered trademarks of Novo Nordisk, with protection that is independent of the patent and can be renewed indefinitely. Any new market entrant must adopt its own brand name and ensure that its visual identity (trade dress) does not create confusion with the original products, under penalty of unfair competition claims.
- Adjacent patents may still be in force. The primary patent has expired, but patents covering specific manufacturing processes, formulations, delivery devices (such as injection pens) and controlled-release technologies may remain active. In the case of oral semaglutide (Rybelsus), the absorption technology (SNAC) has separate protection expected to last until 2031. Entering the market without a thorough analysis of the existing patent portfolio is a risk that can prove costly.
- Regulatory data protection. Law No. 10,603/2002 governs the protection of undisclosed information submitted to regulatory authorities. Companies seeking to register generics must understand these boundaries in order to structure their dossiers independently and avoid legal challenges.
Lesson 4: regulatory timelines dictate “Day One”
The semaglutide case also highlighted the importance of Anvisa in the strategic calculus for market entry. The agency is currently reviewing at least 14 registration applications for semaglutide-based medicines, with plans to grant up to three approvals per semester. This means that, even with the patent already expired, most generics will only reach pharmacies in the second half of 2026 or later.
For companies in the sector, the lesson is that regulatory planning and IP planning cannot operate in silos. The Bolar exception only has practical value if the company uses it early enough so that marketing authorization is either approved or at an advanced stage by the time the patent expires. The concept of a “Day One” launch, widely known in the pharmaceutical industry, depends on this coordination between IP strategy, regulatory preparation and commercial planning.
Lesson 5: Lifecycle Management
The impossibility of extending patent terms in Brazil compels pharmaceutical patent holders to develop complementary protection strategies. Some alternatives include filing patents on improvements and new formulations, protecting the brand as a long-term asset (since trademark registrations can be renewed indefinitely every 10 years), using trade secrets to protect manufacturing know-how, and building patent portfolios that cover different aspects of the technology.
These strategies require planning from the earliest stages of product development, not just when the primary patent’s expiration approaches. The semaglutide case illustrates what happens when protection is concentrated on a single asset: once the term ends, competition moves in quickly.
The importance of specialized legal guidance
The semaglutide case is emblematic, but it is not unique. The same issues, including patent term, Bolar exception limits, adjacent patents, trademarks and unfair competition, apply to any sector where patents and regulatory approvals coexist. Biotechnology, agrochemical, medical device and technology companies face similar scenarios.
Understanding these mechanisms is the first step toward protecting innovation investments and entering new markets with legal certainty. Ricci Intellectual Property has over 35 years of experience in protecting patents, trademarks and other intangible assets, helping companies navigate IP challenges with strategic planning. For more information, visit riccipi.com.br.
