INPI issues update on protection terms for patents covering pharma and non-pharma claimed matter

On 8 February 2022 the National Institute of Industrial Property (INPI) published a notice in the Official Gazette 2666 detailing new rules for updating the patent term of applications comprising pharmaceutical claimed matter and non-pharmaceutical subject matter. These were affected by a Brazilian Supreme Court decision (ADI 5529) that ruled in favour of the unconstitutionality of Article 40 of the Industrial Property Law (Law 9.279/96).

As previously reported, before this decision the patent expiry date in Brazil was 20 years from filing and could not be less than 10 years after a grant. Since the decision, as a rule, patents are no longer issued with a minimum term of 10 years from grant.

Nevertheless, based on the Supreme Court’s final ruling, the INPI currently applies the following reasoning:

• ex nunc effect: all patents granted from the date of the decision (ie, April 2021) will be valid for 20 years from the filing date; and
• ex tunc effect: minimum term protection will still apply to patents related to pharmaceutical products and processes, as well as health equipment and/or materials granted under the now unconstitutional Article 40.

Considering this, the INPI has since clarified that patents covering pharma and non-pharma related matter will be subject to two distinct terms of protection, more specifically:

• 20 years from the filing date for patents related to pharmaceutical products or medical products/equipment for use in humans; and
• 10 years from grant for patents not related to pharmaceutical subject matter.

The corresponding letter patents will be issued with 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.

This annotation will be justified by the technical coordination of the patent division in an internal document available upon request, and will be subject to publication in the INPI’s Official Gazette under Code 16.3 with the following wording:

Rectification ref. RPI xxx, from aa/bb/cccc. Term of Protection: 10 years from grant date aa/bb/cccc, 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.

Given that minimum patent-term protection is no longer possible, or at least is limited to very specific cases, it is recommended that Brazilian applicants review their portfolios to ascertain which cases could be affected and check pending applications where existing fast-track routes might apply.