Historical context

As you may be already aware, on April 14, 2021 the Brazilian Supreme Court (i) declared the sole paragraph of Article 40 of the Brazilian IP Law (Law No. 9,279/1996) unconstitutional – thereby eliminating the automatic minimum term of ten years from the patent grant date –, and (ii) ruled that pharmaceutical patents should immediately forfeit this 10-year term.

This was the result of a constitutional challenge filed by the Brazilian Chief Prosecutor (ADI 5529).

In addition to patent duration reductions as a direct result of the Supreme Court's ruling and in spite of many successful measures taken by the Brazilian PTO to reduce the patent backlog, there are still patent applications that continue to be subject to quite sizeable delays exclusively due to BPTO’s lack of action.  

In view of the two situations above, more than 70 PTA lawsuits were filed since April 2021.    

Strategic Context

While the success rate of PTA claims remains limited under current case law, these actions can nonetheless carry significant strategic value, particularly if higher courts – such as the Superior Court of Justice (STJ) or, in the longer term, the Supreme Federal Court (STF) – revisit their current interpretation.

It is also worth noting that the Brazilian Congress may still approve legislation to regulate PTA. It is possible that such legislation may provide that only patents subject to a pending PTA lawsuit will be eligible for term adjustment.

Importantly, we do not foresee significant risks for patent holders in pursuing PTA claims on a case-by-case basis, given that the Federal Courts have consistently acknowledged the legal soundness of such discussions.

Moreover, the Brazilian Competition Authority (CADE), in a specific case, expressly ruled that PTA claims are neither baseless nor abusive.

Recommended Actions

For these reasons, we recommend that our clients:

• Review the patents of interest that may have been affected by the Brazilian Supreme Court ruling on ADI 5529 or else by an inordinate amount of time taken by the Brazilian PTO; and 
• Consider filing PTA actions concerning the patents of interest. Please bear in mind that any PTA action regarding patents affected by the Brazilian Supreme Court ruling on ADI 5529 must be filed  before May 14, 2026 due to the applicable Statute of Limitations. 

If you need any help conducting a preliminary review of your patent portfolio to identify patents that may be eligible for PTA claims, we are pleased to assist you.

We would also be pleased to provide a fee proposal to assist with the preparation and filing of these actions.