The main patent for semaglutide – the active ingredient of Ozempic – filed on 03/20/2006, expired on 03/20/2026, in strict compliance with article 40, caput, of the Brazilian Industrial Property Law No. 9,279/96 (LPI), which sets a 20-year term of protection for invention patents, counted from the filing date. Although the Brazilian Patent and Trademark Office (INPI) took more than a decade to grant the patent, the administrative delay did not allow any extension of the exclusivity period.
Seeking to circumvent this scenario, Novo Nordisk filed a lawsuit requesting acknowledgment of INPI’s delay and an extension of the patent terms for Ozempic and Rybelsus. The case reached the Superior Court of Justice (STJ) through Special Appeal No. 2,240,025/DF, where the Fourth Panel, in light of the Federal Supreme Court’s decision in Direct Action of Unconstitutionality (ADI) No. 5,529/DF, denied the request for extension and consolidated the understanding that, in the absence of a statute establishing objective criteria for “case-specific adjustments”, the Judiciary cannot act as a positive legislator to lengthen patent terms.
The STJ reaffirmed three key pillars for intellectual property: (i) the strict temporariness of patents, with a maximum term of 20 years counted from the filing date, with no possibility of judicial extension based solely on INPI’s delay; (ii) the centrality of the social function of industrial property, especially with respect to pharmaceutical products, where the prolongation of exclusivity directly affects competition, the right to health, and access to medicines; and (iii) the existence of specific compensatory mechanisms, such as the right to damages for unauthorized exploitation of the invention as from the publication of the application, as set forth in article 44 of the LPI, which refutes the argument that the patent holder would be left unprotected during the administrative proceedings.
With the expiration of the main semaglutide patent, Novo Nordisk’s exclusivity becomes limited to any ancillary patents (such as new formulations, delivery devices, or specific manufacturing processes) and to regulatory and trademark rights, with the “Ozempic” mark remaining protected as a distinctive sign within the scope of industrial property. In other words, the molecule itself enters the public domain, but the use of distinctive signs and the exploitation of any improvements may still confer a competitive advantage on the original holder.
From a market and public policy perspective, the expiration of the semaglutide patent creates room for the entry of new companies and different types of products (biosimilars and synthetic analogues), which remain subject to stringent regulatory review by Anvisa, given the technical complexity of the molecule. Competition tends to reduce prices and increase access in the medium term, with potential effects as well on the debate regarding the incorporation of these treatments into the Brazilian Unified Health System (SUS).
From the standpoint of intellectual property, the Ozempic case marks a turning point: it confirms the primacy of temporal predictability, legal certainty, and the social function over claims for individualized extensions of monopolies in pharmaceuticals with high economic and public health impact. At the same time, it underscores the need for more sophisticated and diversified IP strategies – which do not rely on expectations of judicial extensions – and for an ongoing institutional effort to reduce backlog and improve the efficiency of the patent system in Brazil.
By: Vanessa Pereira Oliveira Soares
Intellectual Property | CPDMA Team