(BRPTO’s gazette of May 18, 2021)

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On May 12, 2021, the Supreme Court Justices declared the Sole Paragraph of Article 40 of the Brazilian IP Statute unconstitutional with ex nunc effects by a majority.  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 a list of patents affected by the Supreme Court decision (ADI #5529) and further explanation of the methodology applied to identify the listed patents, supposedly covering pharmaceutical products and processes and equipment and materials “for use in healthcare”, as limited by the Supreme Court decision.

The list contains 3,341 pharma-related patents, which comply with Art. 229-C of the Brazilian IP Statute. These patents will have their term of protection reduced or be declared expired, if applicable.

According to the updated methodology, the following groups will have their term of protection reduced or will be declared expired by applying the general rule of Art. 40:

• 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.

The BRPTO’s official communication goes on to state that patents related to pharmaceutical products and processes and for equipment and materials “for use in healthcare” will be divided into two groups:

Group 1: Patents granted under the provisions of the now unconstitutional Sole Paragraph, which, while having their term of protection reduced, remain valid. These patents will have their Letters patents republished with the updated term of protection (under the provisions of the header of Article 40 of the Brazilian Patent Statute).

Group 2:  Patents granted under the provisions of the now unconstitutional Sole Paragraph, which are no longer valid after having their term of protection reduced. These patents will have their Letters patents republished with the updated term of protection (under the provisions of the header of Article 40 of the Brazilian Patent Statute) and be declared extinct as their term of protection of 20-years counted from the filing date will have already expired.

Additional lists of patents affected by the Supreme Court’s decision will 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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