Newsletter

The Brazilian FDA (ANVISA) has offered, for public consultation, a proposal of a new resolution relative to the prior consent proceedings applied to applications encompassing pharmaceutical products and processes, as set forth in Section 229-C of the Brazilian IP Law.

This Public Consultation #66 was published in the Official Federal Gazette on October 16, 2012, opening a 60-day term for submission of any comments/suggestions on the changes in the examination procedures that will proposedly be applied by ANVISA in the future. Such term of 60 days started on October 24, 2012, when the proposal actually became available to the public, so that anyone is able to make comments and criticize the proposal up to December 22, 2012.,/pgt;

This comes in consequence to previous opinions raised by the Brazilian Federal Attorneyship (AGU) which stated that, upon complying with the dispositions of Section 229-C, ANVISA should limit their analysis to public health factors and should not examine the app

New Resolution No. 291 published by the BPTO on September 4, 2012 establishes new proceedings for nationalizing, in Brazil, applications filed under the PCT ? Patent Cooperation Treaty ? following Rule 49.6 of such treaty.

Rule 49.6 sets forth that the applicant may reinstate the rights after failure to timely enter the national phase, provided that this failure was unintentional or occurred in spite of due care required by the circumstances having been taken.

The major change introduced by this Resolution is the establishment of the procedures applied concerning PCT Rule 49.6, thus including the possibility of reinstating the rights of the applicant with respect to the national phase entry, if the delay in meeting the 30

It is with great pleasure that we announce the opening of a new office and the admission of a new partner on September 1st.

Our new office is located in Porto Alegre, the capital of the state of Rio Grande do Sul, in the South of Brazil. In the last decades, this region has attracted investments in all areas, which have fostered the growth of new technologies and the development of new businesses.

We are honored to admit to our partnership, as head of the Porto Alegre Office, the renowned lawyer Fabiano de Bem da Rocha, born and raised in the South. Fabiano is a good friend of ours and a bright professional, who is widely admired in Brazil.

After a long period of darkness on this subject, the BPTO has just released an official communication on how the Coexistence Agreements shall be treated. The former BPTO’s Guidelines for the Analysis of Trademarks (issued in May/1997) formally admitted that Coexistence Agreements excluded the application of the norm contained in Section 124, item XIX, of the Brazilian IP Law, which prohibits the registration of marks that are identical or similar to another previously registered for the same or related goods or services, being susceptible of causing confusion or association with the senior mark.

Notwithstanding the fact that this guideline has lasted for over 13 years, it has always been refuted by the BPTO Attorneys’ Office, under the allegation that the Agreement by itself could never override that statutory prohibition. During the discussions for the revision of the BPTO’s Guidelines for the Analysis of Trademarks, which final version was released in December 2010, the BPTO Attorneys’ Office

After a long period of darkness on this subject, the BPTO has just released an official communication on how the Coexistence Agreements shall be treated. The former BPTO’s Guidelines for the Analysis of Trademarks (issued in May/1997) formally admitted that Coexistence Agreements excluded the application of the norm contained in Section 124, item XIX, of the Brazilian IP Law, which prohibits the registration of marks that are identical or similar to another previously registered for the same or related goods or services, being susceptible of causing confusion or association with the senior mark.

Notwithstanding the fact that this guideline has lasted for over 13 years, it has always been refuted by the BPTO Attorneys’ Office, under the allegation that the Agreement by itself could never override that statutory prohibition. During the discussions for the revision of the BPTO’s Guidelines for the Analysis of Trademarks, which final version was released in December 2010, the BPTO Attorneys’ Office

On 20 July 2012, Law No. 12,689, of 19 July 2012, was published in the Federal Official Gazette. This law seeks to create generic veterinary medicinal products in the country and to establish rules concerning the marketing authorisation of such products to be applied by the Ministry of Agriculture, Animal Husbandry and Supply (MAPA).

In brief, two new categories of veterinary medicinal products have been created in addition to the existing reference veterinary drugs: similar (“branded generic”) and generic medicinal products for veterinary use.

According to Law No. 12,689/12, a similar veterinary medicinal product shall mean a medicinal product which has the same active substance, the same concentration and pharmaceutical form as the reference medicinal product for veterinary use, but which excipients may or not be identical, always being identified by its trade mark. Law No. 12,689/12 has apparently not considered a similar veterinary medicinal product to be interchangeable with the re

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