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The Brazilian pharmaceutical regulatory agency ANVISA – National Sanitary Vigilance Agency recently approved new rules for the use of trademarks in pharmaceutical products, through RDC – Resolution of the Board of Directors No. 59, of Oct. 10, 2014.

Such new regulations are very important, inasmuch as all pharmaceutical products in Brazil must be registered with ANVISA for their sale to be allowed. ANVISA not only assesses the efficacy of the product and other health-related technical matters, but it also sets forth how the labeling should be done and it approves the use of trademarks in the package.

As in Brazil there is no linkage between the regulatory registration by ANVISA and the issuance of patents or trademark registrations by the Brazilian Patent & Trademark Office (BPTO), the rules approved by ANVISA are, in practice, the only rules that govern the approval for commercialization and labeling of pharmaceutical products. If there is a conflict between a decision by ANVISA and one by the BPTO (e.g. concerning the risk of confusion between two trademarks belonging to two competitors) it is usually up to the Courts to solve such conflict.

The main law regulating the health system in Brazil – Law #6,360 dated 1976 – establishes that each and every drug available in the pharmaceutical market must be approved by the Ministry of Health. Since the creation of the Brazilian FDA (called ANVISA), this autonomous autarchy subordinated to the Ministry of Health is in charge of issuing marketing authorization for drugs for human use and of establishing specific resolutions in order to regulate each of the existing categories of medicaments, such as the new drugs, generics, similars, biologicals.

According to ANVISA’s requirements, the documentation submitted by the manufacturers of both generic and similar drugs, upon applying for marketing approval, is significantly simplified compared to the reference product (the so-called “abridged process”), as only pharmaceutical equivalence and relative bioavailability/ bioequivalence assays are required to obtain approval for products pertaining to these categories.

It should be noted that, since the publication of Resolutions RDC #133 (new applications for marketing approval) and RDC #134 (similars, already approved), both dated May 29, 2003, ANVISA has begun to require proof of therapeutic equivalence also for similar drugs; therefore, it is estimated that all manufacturers of these products will have complied with such requirement by the end of 2014.

Accordingly, studies of pharmaceutical equivalence and bioavailability/bioequivalence became necessary in order to obtain marketing authorization for both generic and similar drugs, although the latter were not then yet considered to be interchangeable with the reference product.

A review od ANVISA's role in the prosecution of pharma patent applications and the latest developments reveals ongoing controversies, as Joao Luis Vianna and Maria Claudia Souza report.

INTA delegation is made aware of a pioneer study conducted by ABPI on the economic importance of intellectual property and knowledge-intensive industries in Brazil.

As we informed in our Newsletter # 2, dated January 2014, in October 2013, the Brazilian Patent Office (“INPI”) enacted Resolution No. 113 to regulate the control of the payment of annuities by patent and patent application owners. Immediately, the Resolution triggered strong reactions from patentees and patent attorneys, in view of its item 13, which contradicts Sections 86 and 87 of the country’s Industrial Property Act (Law No. 9,279/96). It is estimated that such contradiction may have jeopardized the rights of applicants and patentees over almost 10,000 issued patents and 2,300 patent applications.

According to the IP Act, failure to pay annuities shall lead to the shelving of the application or the extinction of the patent (article 86). However, Section 87 allows the restoration of the application or of the patent upon request of the corresponding owner within 3 (three) months from the moment the INPI publishes the notification of shelving or extinction.

Kasznar Leonardos is now a German Desk certified office, which means it counts on German speaker professionals who are ready to meet the needs of German companies that may be looking for IP service providers in Brazil.

Dear Colleagues, please feel free to share the presentation video of the ABPI Congress.

Dear Colleagues, please feel free to share the presentation video of the ABPI Congress.

Dear Colleagues, please feel free to share the presentation video of the ABPI Congress.

Launched on April 2012, the Brazilian Patent Office’s pilot program that establishes prioritized examination for the so-called “green patents” has now been extended for a further year, being available up to April 16, 2015.

This program’s purpose is to prioritize the examination procedures of patent applications involving “green technologies”, reducing the current average time for concluding the examination of patent applications – which currently takes more than 10 years – to a promised lag time of about 2 years.

Until now, only Paris Convention filed applications, or Brazilian originated national applications, were eligible to enter into this special program.

The big novelty in extending the “green patents” program is that, in this new phase, also Brazilian national phases of PCT applications can benefit from this prioritized route. These can be either new patent applications, still to be filed, or pending patent applications, already filed at the Brazilian Patent Office. For

Partner João Luis Vianna represented Kasznar Leonardos at the BIO International Convention 2014, which took place in San Diego, California, from June 23rd to the 26th. Kasznar Leonardos was a member of the Brazil Pavilion, where João appears below, between Estevão Mano (left) and Norberto Prestes (right), both from the BIO-RIO Foundation. The BIO Convention 2014 had a welcoming reception inside an american aircraft carrier and, yesterday, there was a lunch with lecture by the former US Secretary of State, Hillary Clinton.

The past couple of years have seen some major developments in how Brazilian courts interpret and enforce trademark law at all levels. This article reviews some of the latest changes related to protection for non-traditional trademarks, the special rule for determining jurisdiction in trademark infringement cases and the administrative seizure of counterfeits by Customs.

The 1996 Brazilian Industrial Property Act (9,279/96) establishes a mixed trademark protection system by which an attributive arrangement grants first-to-file protection rights along with some declaratory system exceptions, such as *bona fide* six-month prior use of an unregistered trademark. Despite general satisfaction with this system, it is a fact that the law admits only the registration of visual-perceptive signs as trademarks (Section 122).

However, this limitation does not mean that non-visual signs which function as trademarks are bereft of protection. The Industrial Property Act sets out a so-called ‘gen

The growth of the Brazilian market and economy is paralleled by the increase in counterfeiting activities. The enforcement of IP rights involves planning, technology, intelligence, training and coordination, with support from a number of laws and treaties, as well as the relevant rules of the Federal Constitution, the Civil Code, the Criminal Code, the Civil Procedure Code, the Criminal Procedure Code and administrative statutory instruments.

The legal framework for anti-counterfeiting includes:

• the Industrial Property Law (9,279/96);

• the Copyright Law (9,610/98); and

• the Software Law (9,609/98).

In addition, Brazil is a signatory to the main international IP instruments, such as:

• the Paris Convention for the Protection of Industrial Property (as reviewed in Stockholm in 1967);

• the Agreement on Trade-Related Aspects of IP Rights (TRIPs);

• the Berne Convention for the Protection of Literary and Artisti

Despite being usually seen as comparable parts of the BRICs , the emerging economies of China and Brazil have more differences than similarities, not to mention the countries’ historic and cultural backgrounds. Ever since the creation of the World Trade Organization (WTO), China has impressed the world with very good indicators: substantial and steady increase in its GDP, relevant internal market, increasing participation in global trade, impressive rates of innovation and an environment that is globally much welcoming to foreign investment. Brazil, on its side, has managed to surpass economic chaos caused by hyperinflation in the beginning of the 1990s and to create a market that is both friendly to foreign investments and strongly responsive to its internal demands, after years of economic stagnancy. Both countries are heralded as strong healthy economies, with a good share of natural resources and good perspectives for the future. On the verge of organizing two major sports events in the window of two

Despite being usually seen as comparable parts of the BRICs , the emerging economies of China and Brazil have more differences than similarities, not to mention the countries’ historic and cultural backgrounds. Ever since the creation of the World Trade Organization (WTO), China has impressed the world with very good indicators: substantial and steady increase in its GDP, relevant internal market, increasing participation in global trade, impressive rates of innovation and an environment that is globally much welcoming to foreign investment. Brazil, on its side, has managed to surpass economic chaos caused by hyperinflation in the beginning of the 1990s and to create a market that is both friendly to foreign investments and strongly responsive to its internal demands, after years of economic stagnancy. Both countries are heralded as strong healthy economies, with a good share of natural resources and good perspectives for the future. On the verge of organizing two major sports events in the window of two