The patent on semaglutide, the active ingredient in Ozempic, is nearing expiration in Brazil, renewing attention to discussions about patent terms and access to medicines.
The Supreme Court of Justice recently decided not to extend the patent’s validity, reinforcing the principle that patent protection must follow the term established under Brazilian law.
The 20-year patent rule
Under Brazilian patent law, invention patents are granted for 20 years from the filing date before the Brazilian Patent and Trademark Office.
In this case, the patent holder argued that administrative delays in the examination process justified an extension. However, Brazilian courts have followed the precedent set by the Brazilian Supreme Court in ADI 5.529, which rejected automatic extensions based on examination delays.
According to the Court, indefinite patent extensions could negatively affect public access to medicines and healthcare costs.
What happens after expiration
Once a patent expires, the protected invention enters the public domain, allowing other pharmaceutical companies to develop alternative versions.
This may lead to:
- the development of generic or similar medicines
- increased market competition
- potential price reductions over time
However, new products must still undergo regulatory approval before reaching the market.
Regulatory considerations
Even after patent expiration, commercialization depends on approval from the Brazilian Health Regulatory Agency.
Currently, compounding of semaglutide is restricted in Brazil, as the substance is registered as a biotechnological product. Any alternative versions must be evaluated and approved through the appropriate regulatory pathway.
Intellectual property implications
The semaglutide case highlights the ongoing debate between patent protection for innovation and broader access to medicines.
While patents play a crucial role in incentivizing pharmaceutical research and development, their expiration allows greater competition and expanded access to treatments.
