In 1999 the Brazilian Industrial Propriety Law was amended to include Article 229-C, which requires the National Health Surveillance Agency (ANVISA) to give prior approval for the grant of invention patents involving pharmaceutical products and processes.

The lack of precision in the article allowed ANVISA to interpret the requirement as it liked. It subsequently issued resolutions stating that, in the light of new Article 229-C, its activity in the patent process would involve analysing patentability applications, the principal legal prerogative of the Brazilian Patent and Trademark Office (PTO). This prerogative stemmed from ANVISA's belief that a patent which did not meet the patentability requirements was contrary to public health interests.

ANVISA's re-examination of the patentability requirements led to debate among the legal profession, which had repercussions in the Federal Attorney General's Office, the government and the federal courts. The federal courts of Rio de Janeiro and the Federal District have issued various decisions on this matter, to a certain extent setting the judiciary against ANVISA's actions (although some magistrates are still issuing opposing judgments).

However, in the absence of a decision on the issue by the Superior Court of Justice or the Supreme Federal Court, ANVISA has maintained its opinion and continued to examine patentability applications. It now does this even before the PTO examination, at the beginning of the administrative process.

The PTO's position was previously unclear, but has now been set out in a legal case on the issue, with the PTO adopting a strong stance against ANVISA's activity in the national patent process.

A pharmaceutical company filed a case against ANVISA before the Federal Court of Rio de Janeiro, in which ANVISA's competence to analyse patentability came under scrutiny. The 13th Federal Court of Rio de Janeiro granted the PTO's request to intervene in the case. The judge, who had already issued an injunction in the case, expressed her opinion in favour of ANVISA's activity: “Should ANVISA not grant the prior approval, the patent application will be archived and a decision published in the Revista da Propriedade [Industrial Property Magazine]”. She also admitted the PTO to the case and granted it time in which to state its opinion.

In contrast to its approach adopted in other cases, the PTO presented a strong case which demonstrated a clear position not only against ANVISA carrying out patentability examinations, but also against the legal provision that made the granting of pharmaceutical patents conditional on ANVISA'a prior approval.

The PTO stated that “there is no legal provision that attributes the patentability criteria exam to ANVISA”, adding that “the short art. 229-C of the Industrial Property Law (LPI) does not grant any such prerogative to ANVISA”. It went further to state that the removal of its prerogatives would weaken the patent system, mentioning the National Public Health System in this context.

The PTO stood in defence of the Brazilian patent system, raising the country's international commitments and calling for a more transparent legal approach to replace the “creation of legal subterfuges, such as, for example, the setting up of prior approval as implemented by ANVISA”.

Finally, the PTO argued against the judge's decision in the case, claiming that there was no legal provision stating that administrative processes in the cases lacking ANVISA approval should be archived, clearly indicating that this would be the approach to be adopted. However, the PTO did not explain what it intends to do in such cases.

The PTO's approach is encouraging for the pharmaceutical industry, which has welcomed the PTO's defence of the strong patent system, while highlighting the system's importance for national universities. It remains to be seen whether this is a one-off opinion or whether the PTO will maintain a firmer stance in favour of industrial property.

Breno Akherman

This article first appeared in IAM. For further information please visit www.iam-media.com.