On December 6, the Board of Directors (DICOL) of the Brazilian Food & Drug Agency (ANVISA) passed new regulations accepting an exemption to allow generics and branded generics (also called “similar” drugs) to remove patented uses from their labels – i.e., skinny labeling. The change will come into effect 60 days after the amended text…
Brazil’s president published, on September 27, Decree No. 11,715/2023 which institutes the “National Strategy for the Development of the Economic-Industrial Health Complex”. This decree aims at directing public and private investments towards the health and innovation sectors to reduce the Public Health System’s (SUS) vulnerability and increase access to medicines. It aims to do this…
The BRPTO published on September 14 an invitation for interested parties to comment on a proposal to review the provisions of the Brazilian IP Statute regarding two relevant timeframes for patent owners filing applications in Brazil. The first concerns the term for requesting examination (currently 36 months from filing, per Section 33), and the second…
Judges deciding patent matters in Brazil usually have none to limited technical background. In view of the complexity of patent cases, it is often that we see judges appointing a court examiner, as defined by law: “the judge will be assisted by a court expert whenever the proof of the fact depends on technical or…
The Brazilian Patent Statute (Federal Law #9,279/96) establishes that foreign applicants must appoint and maintain a representative in Brazil for each patent application filed with the Brazilian Patent and Trademark Office (BRPTO). Only through a patent agent—be it a person or a legal entity—can a foreign application file and prosecute an application. In November 2020,…
On July 14, a Brazilian Congressman Mr. Alexis Fonteyne presented a Patent Bill proposing key amendments to the Patent Statute (Law No. 9,279 of 1996). The proposal represents an important development for the IP community, especially when it comes to patent term compensation, which may become statutory if the bill is approved (click here for an English…
