(BRPTO’s gazette of June 1, 2021)

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On May 12, 2021, the Supreme Court Justices, by a majority, declared the Sole Paragraph of Article 40 of the Brazilian IP Statute unconstitutional with ex nunc effects.  This means that all patents granted with a 10-year term of protection from grant before the publication of the final hearing minutes will remain valid, with two exceptions, for which retroactive effects will be applied (ex tunc):

• Patents with pending invalidity lawsuits grounded on the unconstitutionality of the Sole Paragraph of Article 40 and lodged until April 7, 2021; and
• Patents granted under the now unconstitutional Sole Paragraph covering pharmaceutical products and processes and equipment and materials “for use in healthcare.”

On May 18, 2021, in an official communication published in the Official Gazette #2628, the BRPTO provided the first list of patents officially affected by the Supreme Court decision (ADI #5529). The list contained 3,341 pharma-related patents, which complied with Art. 229-C of the Brazilian IP Statute and had their term of protection reduced or were immediately declared expired. You may find more information about it here.

On June 1, 2021, in a new official communication published in the Official Gazette #2630, the BRPTO provided a second list of patents officially affected by the Supreme Court decision (ADI #5529). According to the WIPO, the list contains 2,114 patents related to medical technologies, which will also have their term of protection reduced or be declared expired, if applicable.

According to the methodology made available by the BRPTO, the following groups shall have their term of protection reduced or will be declared expired by applying the general rule of Art. 40 ex tunc:

• Patents sent to ANVISA for prior approval, complying with Art. 229-C of the Brazilian IP Statute;
• Patents having at least one of the following IPCs: A61B, A61C, A61D, A61F, A61G, A61H, A61J, A61L, A61M, A61N, or H05G, which are IPCs related to medical technologies according to WIPO;
• Patents having at least one of the following IPCs: A61K/6, C12Q/1, G01N/33, G16H;
• Patents with a judicial decision notified by the BRPTO (code #19.1);
• Certificates of addition related to those patents covering pharmaceutical products and processes and equipment and materials “for use in healthcare” mentioned in the Supreme Court decision.

Additional lists of patents affected by the Supreme Court’s decision might be provided in forthcoming BRPTO gazettes.

You can download a copy of the BRPTO’s original communication here. For additional information, please contact info@lickslegal.com.

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