December 16, 2021
The Supreme Court, by majority, ruled that the decision of ADI #5529 would have retroactive effects for: (i) pending invalidity lawsuits that had been filed up until April 7, 2021, date of partial granting of the precautionary measure in the process; and/or (ii) patents covering pharmaceutical products and processes as well as equipment and/or materials for use in healthcare, which were granted term extension. After this decision was issued, on May 12, 2021, the BRPTO began to issue office actions 16.3 to adjust patent validity terms.
To the patent owners that were affected by the decision it was granted the opportunity to file a request for review, according to the notice published in BRPTO’s Official Gazette #2633, of June 22, 2021. The BRPTO’s notice in the Official Gazette #2658 indicates that the results of the analysis of such requests will be published by the BRPTO. In the event of a request rejection, an administrative appeal may be filed, pursuant to article 212 of the Brazilian Patent Statute, upon fees’ payment.
The notice provides that the following measures will be taken:
"1 – The patent, which reasons presented in the request for review are considered pertinent, will have its republishing (office action 16.3) canceled.
2 - The patent which request for review requests the apostille of the Letters Patent, aiming at restricting the scope of protection with the exclusion of subject matters relating to pharmaceutical products and processes, as well as equipment and/or materials for use in healthcare, will have the letters patent republished (office action 16.3) with the proper apostille, in accordance with LEGAL OPINION #00047/2021/CGPI/PFE-BRPTO/PGF/AGU.
3 - The request, which reasons presented are not considered relevant, will not be entertained (office action 22.2) and the reasons for the rejection of the review will be presented in an opinion available on the website.
5 – If additional clarifications to those presented in the request for review are necessary, a requirement will be issued (office action 22.5) which must be answered by means of a brief #207".
Regarding patents in the agrochemical sector, referred to in item 2 of the notice, a legal opinion was issued by the Specialized Federal Attorney’s Office of the BRPTO. The understanding therein established concluded that “it is possible to include an apostille for the letters patent at the request of the patentees, preserving the claims regarding subject matters not covered by the exceptions made in the modulation of the effects on the decision rendered by ADI #5529/DF, and with the consequent exclusion of subject matters related to pharmaceutical products and processes, as well as equipment and/or materials for use in healthcare”.
The conclusion of the opinion is anchored in the case law of the Federal Court of Appeals for the 2nd Circuit and in the provisions of the Brazilian Patent Statute, such as articles 41, 47, and 59.
The BRPTO did not disclose in the notice when it will start publishing the results of the requests for review and what were the criteria used for assessment, except for the agrochemical sector case, already addressed.