PATENT ENFORCEMENT IN BRAZIL’S MEDICAL DEVICE SECTOR
Brazil’s medical device sector has been experiencing significant growth, with imports surpassing US$6bn annually and an estimated 14,000 new product registrations each year. This expansion, fuelled by rising healthcare demand and innovation in diagnostics and therapeutic technologies, has also made the country a hotspot for patent disputes. As more multinational companies enter the Brazilian market, many are discovering that their patented technologies are being used or commercialised without authorisation, often by local entities indifferent to intellectual property (IP) boundaries.
This article explores Brazil’s patent enforcement landscape, focusing on the medical device industry. It delves into litigation structure, validity challenges, claim construction and theories of infringement, offering practical insights into legal risks and strategic considerations for patent holders.
Litigation framework and validity challenges
Patent litigation in Brazil is shaped by a bifurcated system: infringement lawsuits are generally filed in state courts, while actions for patent invalidation must be brought before federal courts, with the Brazilian Patent and Trademark Office (INPI) named as a co-defendant.
For years, there was debate over whether patent invalidity could be raised as a defence in infringement suits heard by state courts. In 2024, Brazil’s Superior Court of Justice settled this matter, ruling that defendants may argue invalidity in this context, even though state courts cannot formally annul a patent. The effect is limited to the specific dispute and serves only as a basis to deny infringement claims, without broader effect on the patent’s legal status.
Jul-Sep 2025 issue
RNA Law