INPI Publishes an Update on the Terms of Patent Protection for Pharmaceutical and Non-Pharmaceutical Claims.

Summary:

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

The expiry date of a patent in Brazil is 20 years from filing of the patent application, which cannot be less than 10 years from the patent grant. Therefore, if a patent application takes 12 years to be granted, its term of protection will be 22 years

INPI Publishes an Update on the Terms of Patent Protection for Pharmaceutical and Non-Pharmaceutical Claims.

PATENTS

SUPPLEMENTARY PROTECTION CERTIFICATE (SPC) – ACTIVE INGREDIENT NOT SPECIFICALLY COVERED BY A PATENT

CA Paris, October 15, 2021, Royalty Pharma Collection Trust v. INPI (docket no. 17/04327)

The Paris Court of Appeal upheld the denial by the French Industrial Property Office (INPI) of an application for a supplementary protection certificate on the grounds that the product was not protected by the basic patent in force: the applicant had not shown that on the basic patent’s filing or priority date, a person skilled in the art would be able to specifically identify the product.

According to Article 3(a) of Regulation (EC) No 469/2009, the product for which an SPC is requested must be protected by a “basic patent in force.” And according to CJEU case law, it is not enough for the product, namely the medicine’s active ingredient, to be implicitly included in the formula claimed by the patent, it must be (i) “necessarily” and (ii) “specifically” covered by the claims.

As previously said  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.