Update on the term of protection of patents affected by the Supreme Court decision (ADI #5529)

February 10, 2022

Update on the term of protection of patents affected by the Supreme Court decision (ADI #5529)

(BRPTO's gazette of February 8, 2022)

The BRPTO published on February 8, a notice in its Official Gazette #2666 providing guidelines on the review of patent terms for patents claiming subject matter going beyond pharmaceutical arts and/or medical products/equipment for use in humans affected by the 2021 Supreme Court decision (ADI #5529).

As detailed in our client alert from May 18, 2021, the sole paragraph of article 40 of the Brazilian Patent Statute (Statute #9,279/1996) was declared unconstitutional with no retroactive effects (ex nunc) by a majority of 9 votes, having Justices Luis Roberto Barroso and Luiz Fux (Chief-Justice) presented dissenting opinions. This means that all patents granted with a 10-year term of protection from grant remained valid, with two exceptions, for which retroactive effects were applied (ex tunc): i) patents with pending invalidity lawsuits grounded on the unconstitutionality of the Sole Paragraph of Article 40 and lodged until April 7, 2021; and ii) patents granted under the now unconstitutional Sole Paragraph covering pharmaceutical products and processes and equipment and materials “for use in healthcare”.

Due to the distinct ADI #5529 retroactive effects on patent terms for pharmaceuticals and medical equipment arts, and nonretroactively for all other technologies, the BRPTO decided to allow Letters patent covering subject-matters beyond the scope of the pharmaceutical field and/or medical products/equipment for use in humans to have two distinct terms of protection:

  • 20 (twenty) years, counted from the filing date: term of protection for subject matters related to pharmaceuticals and medical products/equipment, for use in humans.
  • 10 (ten) years from the grant date: term of protection for subject matters not related to the pharmaceutical field.

Said Letters Patent will have the following annotation:

“The term of protection for pharmaceuticals and medical products/equipment, for use in humans, is 20 (twenty) years, counted from the patent filing date, under the conditions provided by law. Patent granted according to ADI #5529.”

The annotation will be published under code 16.3 in the BRPTO's Official Gazette, as follows:

“Term of protection: 10 years counted from mm/dd/yyyy, under the conditions provided by law. Patent granted in accordance with ADI #5529/DF, with annotation of the term of protection for subject matter related to pharmaceutical products and processes, and equipment and/or materials for medical use in humans”

Additionally, according to the BRPTO's notice, the technical coordination of the patent division will prepare an internal document justifying said annotation. This document will not be automatically available but may be requested via the BRPTO's website communication channel.

For the mentioned annotated patents, the patent annuity fees will correspond to their longest term of protection and only the extinction of the longest term of protection will be notified in the BRPTO's Official Gazette.

The notice is available at the BRPTO's website, and the original version (in Portuguese) can be downloaded here, and its English version here. In case you wish further information on the notice, please contact us at patents@lickslegal.com. We will be glad to assist you.