The General Attorney’s Office (PGR) has filled a Constitutional Challenge (ADI 5529) against the sole paragraph of article 40 of Law No. 9.279/96 (Brazilian IP Law – LPI), which guarantees patents the minimum protection term of 10 years counted from their grants. The judgement was scheduled originally on April 7th, 2021, however, it was postponed to April 14th, 2021.
Nonetheless, Supreme Court Justice Dias Toffoli partially granted the preliminary injunction relief that had been requested by the General Attorney’s Office on February 24th, 2021, suspending the rule under debate. However, the Justice decided that the rule still applies to patents already granted and still in force due to the application of the sole paragraph, except for pharmaceutical and medical device patents granted with the term extension. The Justice justified the suspension of such patents based on the COVID-19 pandemic.
In other words, for patents related to pharmaceutical products and processes, and equipment and/or materials for the health use, the rule is fully suspended, even for granted patents currently valid, due to the sole paragraph. For other fields of application, however, the rule is also suspended for pending patent applications, but the decision will not affect patents already deferred and/or granted.
This does not mean, however, that all pharmaceutical patents granted under the sole paragraph are already suspended, as those that were filed less than 20 years ago remain in force, that is, there was no term compensation based on the single paragraph.
The decision can be reversed or confirmed at the Collegiate judgment, which will begin on April 14th. In case it is reversed, all decisions (administrative or judicial) issued based on this injunction during its validity, will be reformed and, thus, the rule will be restored normally. If the decision is upheld, the content of the preliminary decision will be confirmed definitively, so (i) all patent applications pending before the Brazilian Patent and Trademark Office – INPI will only be able to generate patents with 20-year terms from their filing dates; and (ii) patents related to pharmaceutical products and processes, and to equipment and/or materials for the health use granted with the application of the sole paragraph that were filed more than 20 years ago will be extinguished.
There is also the possibility that the Court may decide towards an alternative vote, which considers the rule unconstitutional, but does not make specific restrictions to the pharmaceutical sector, as this possibility would go against what is established in TRIPs Agreement. Since the position of the other Supreme Court Justices is still unknown, it is too soon to speculate on the outcome of the final judgment to come.
Finally, it is important to highlight that there is a possibility of an appeal against the decision that granted the injunction and its revocation before the start of the trial.
