Pharmaceutical Trademarks: Brazilian Court Holds that Regulatory Process at ANVISA Constitutes Valid Defense in Cancellation Action for Non-use of the

In a landmark decision issued in mid-2016,¹  the Superior Court of Justice – highest Brazilian court for non-constitutional matters – held that the pending regulatory process of a pharmaceutical product before the National Health Surveillance Agency (ANVISA) constitutes a valid defense in a cancellation action for non-use of the mark at the Brazilian Patent and Trademark Office (BPTO). 

The case relates to an oral contraceptive named “MINESSE”, whose trademark registration was granted by the BPTO on July 2, 1996 and served as basis for an opposition against an application for trademark “GINESSE”. 

In response to the opposition, the applicant of trademark “GINESSE “brought a cancellation action for non-use of the mark against the registration for trademark “MINESSE”.

In its response, the owner of trademark “MINESSE conceded that the mark was not used within the 5-year period of investigation, but justified the non-use arguing that the product registration had not yet been granted by ANVISA.

Besides, the company has shown that “MINESSE” is an oral contraceptive manufactured in Ireland. Thus, in order to introduce the product in Brazil, it had to comply with several requirements of the Brazilian regulatory legislation, including sections 12 and 18 of the statute that deals with the registration of pharmaceutical products in the country (Law n° 6.360/76).²  

Given this scenario, the trademark owner defended that the “MINESSE” registration should not be cancelled because the Brazilian IP Act contains a legitimate reason exemption in section143, §1°. This section provides that “the registration shall not be cancelled if the trademark owner justifies the non-use of the mark for legitimate reasons.”

The BPTO agreed with the trademark owner and held that the non-use of the mark was duly justified. Unhappy with the outcome, the other party decided to challenge the BPTO’s decision at the federal courts.

However, the 35th Federal Court of Rio de Janeiro has agreed with the trademark owner and with the BPTO. In a very well-grounded ruling, the judge examined sections 12 and 18 of Law n° 6.360/76, stressing that “the Brazilian legislation regulating the registration of pharmaceutical products applies both to the medications manufactured in Brazil and in other countries.” Thus, according to the trial court, “if the company wishes to use the mark in Brazil, it has no option but complying with the non-IP regulation established by Brazilian law.”

The trial court also observed that “since November 1999, the trademark owner has taken measures to comply with the Brazilian regulatory legislation related to the registration of the product”; and that “before the expiration of the 5-year deadline established by section 143 of the IP Act, the company had finalized all the necessary proceedings.”

At the end, the court concluded that “what matters is that the company has taken effective measures to introduce the product in the Brazilian market within the 5-year investigation period.”

After a new appeal, the Federal Court of Appeals for the 2nd Circuit affirmed the trial court decision. The appellate court agreed with all the arguments used by the trial court and added that “the measures taken before ANVISA should be viewed as in clear contradiction to the notion of trademark abandonment.”

Subsequently, the defeated party filed a special appeal against the decision directed to the Superior Court of Justice in Brasília. The appeal was admitted. However, on the merits, the Superior Court of Justice rejected the same emphasizing that “in the chapter dealing with non-use cancellation actions, the IP Act provides an exemption, mandating that the registration should not be cancelled if the trademark owner justifies the non-use of the mark for legitimate reasons.”

According to the court, “the seeking of regulatory approval for introducing a pharmaceutical product in the market is certainly within the legitimate reasons envisaged by the legal provision under examination.”  

The Superior Court of Justice, therefore, also concluded that the regulatory approval process before ANVISA constitutes a legitimate reason for the non-use of the mark within the 5-year period demanded by the statute.

This ruling is extremely important for the pharmaceutical industry, since it sets relevant guidance as to how the BPTO and lower courts should proceed when deciding similar cases.

The court ruling also makes clear that, when dealing with non-use cancellation actions involving pharmaceutical trademarks, the trier of fact cannot limit the analysis to the provisions of the IP Act. To the contrary, it is fundamental to also examine the case from a regulatory standpoint, since the existing rules expressly provide that a medication cannot be sold or advertised in Brazil without being first registered at ANVISA. 

As a result, there is no doubt that regulatory measures taken within the 5-year investigation period constitute valid evidence that the trademark owner has taken the necessary steps to start the use of the mark in the country.  

Thus, even if the regulatory process before ANVISA starts close to the 5th anniversary of the registration grant, the legitimate reason exemption can be applied if the trademark owner is able to prove that it has taken bona fide measures to introduce the medication in the market. 

Once the product registration is granted, however, it is imperative to start to use the mark within a reasonable time. Otherwise, the non-use would become unjustified, thereby eliminating the legitimate reason envisaged in section 143 §1° of the IP Act.

Pharmaceutical companies, therefore, are strongly encouraged to pay attention to this important court precedent, in order to preserve their registrations and avoid the loss of trademark rights in Brazil.

1 Wyeth vs. Farmoquímica, Special Appeal n° 1.377.159 – RJ (2013/0092320-4), Reporting Judge: Hon. João Otávio de Noronha, Date of the judgment session: May 5, 2016.
2  Section 12 – None of the pharmaceutical products regulated by this statute, including the imported ones, can be manufactured, offered for sale or be delivered for consumption without firs being registered at the Ministry of Health. 
Section 18 – The registration of drugs, medications and pharmaceutical ingredients of foreign origin will depend on the evidence that it is already registered in its country of origin, aside from all conditions and proceedings envisaged in this statute.

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