Newsletter

Following our recent newsletter on ANVISA’s role in the examination of pharmaceutical patent applications, this is to briefly inform that the Brazilian PTO has started forwarding cases to ANVISA’s consent before substantive examination has begun, in accordance with the guidelines suggested by the Interministerial Working Group (GTI), through Ordinance No. 1,065, of 24 May 2012.

Please note, however, that neither ANVISA nor the Brazilian PTO has yet issued normative acts indicating whether the GTI’s guidelines suggested would actually be adopted and, in the affirmative, to what extent. Yet, the Brazilian PTO has claimed, in the accompanying letters sent to ANVISA with patent applic

As you may be aware, due to article 229-C of the Brazilian IP Law, as amended by Law No. 10,196/01, whenever a patent application claims a pharmaceutical product or process, consent from the National Sanitary Surveillance Agency (ANVISA) is also required prior to granting the desired patent. This provision, however, has been the source of never-ending controversy and subject to growing attacks since it entered into effect in 2001.

The lack of statutory power of ANVISA to analyse patentability requirements of pharma applications was supported by the Attorney-General’s Office in legal opinions published in 2009 and 2011. Indeed, in their opinion, ANVISA should only make health-based assessments of applications sent for prior consent; prior consent should only be denied to applications in instances that granting the patents would pose health risks. How ANVISA would assess “health risks” on the basis of the information included in patent applications was left unanswered though.

In view of the slow pace of the Brazilian Trademark and Patent Office (BPTO) and the National Health Surveillance Agency (ANVISA) on the analysis of trademark and patent applications, over the last few years there has been a significant increase in the number of judicial cases seeking the acceleration of the examination of such applications.

In fact, several court decisions have ruled that if the application is pending for a long time before the BPTO or ANVISA, it is possible to file a writ of mandamus to redress an unreasonable delay.

Following the consensus among the international community about the importance of the development of green technologies in mitigating global climate change, national governments also came to acknowledge the relevance of patent granting procedures as a mechanism to promote green innovation.

Within this context, the Brazilian Patent and Trademark Office – INPI – will launch, as of this date of April 17, 2012, a pilot program involving “green patents”, for the purpose of prioritizing examination of patent applications related to environmentally friendly technologies, by reducing the time it will take for their examination to less than two years. The pilot program is quite limited as yet and only the first 5