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October 7, 2024

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January 28, 2025

The 1ª Specialized Panel of the Federal Court of Appeals for the Second Circuit (TRF-2) in Brazil issued a relevant precedent regarding the interpretation of Article 32 of the Brazilian Patent Statute (BPS – Law # 9.279/96), especially for the life sciences and pharmaceutical research and development industries. For the first time in an invalidity lawsuit, the court confirmed the legality of making restrictive amendments to a patent application claim chart, whether voluntarily or in response to a BPTO (Brazilian Patent and Trademark Office) order, even after a request for examination has been submitted to the BPTO – provided these amendments are included in the patent application as filed. The court has also confirmed that BPTO Ordinance # 93/2003, which regulates this matter, is legal and does not violate any prior legal precedent (namely, Case # 0513584-06.2003.4.02.5101). This precedent is still subject to appeals to the superior courts, but it is relevant, since generic industry often mentions the judgment of Case # 0513584-06.2003.4.02.5101 to argue against the possibility of restrictive amendments after the request for examination. This decision provides greater legal certainty, aligns with what the BPTO has already established on the matter, confirms the provisions of the TRIPS Agreement, and sets the standard for how such cases will be analysed going forward.
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May 9, 2024
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Licks Attorneys Compliance’s Blog provides regular and insightful updates about Ethic and Compliance. The posts are authored by Alexandre Dalmasso, our partner. Licks Attorneys is a top tier Brazilian law firm, specialized in Intellectual Property and recognized for its success handling large and strategic projects in the country.
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