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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.

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.

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

Very recently, by means of Resolution 113/2013, the Brazilian Patent and Trademark Office, henceforth the INPI, declared a change in its interpretation of the restoration clause that was inserted by the legislators in Law 9279/96 — the Brazilian Industrial Property Law[1].

This restoration clause gives to those that did not pay an annuity during the regular and extended terms, the opportunity to revive their case after a notice communicating its forfeiture is published.

Until the advent of this new interpretation, a single notice could be published in connection with a set of unpaid annuities. Actually, as the INPI had very little control over the annuity fees that were paid, it was quite common that many years would pass before a notice was published. Therefore, whenever it came to be published, the notice would inform that the forfe

As of February 1st, when Federal Law No. 12,846 will come into force, Brazilian and foreign companies in the country will face a new and different scenario in their relations with public entities. This is because this law, which has been popularly known as the “anti-corruption law”, comes to combat and severely punish any and every act committed by companies, their representatives, suppliers and business partners who violate or cause damage and injury to the domestic or foreign public assets, against principles of public administration or against the international commitments assumed by Brazil.

On August 19, 2013 the Brazilian PTO published the Resolution number 17/2013, which sets the new rules for recognizing the highly reputed trademark status. This resolution will be enforced on the date of the publication of the new official fees for this procedure, but, until now, the BPTO has not estimated yet when it will be published.

The main innovation brought by this Resolution is the adoption of a standalone procedure, which allows the titleholder to require, at any time, the recognition of high reputation for its trademark before the Brazilian PTO. This request can be made when registering the mark, without the need of third parties' procedures.

Since July 15, 2013, the Brazilian Patent and Trademark Office (INPI) started offering a voluntary mediation service for administrative disputes arisen from trademark proceedings. Such alternative may help decreasing the number of current disputes as well the time for their solution and backlog. Moreover, it may facilitate internation parties seeking to settle related disputes in multiple jurisdictions.

Brazilian PTO’s new Resolution No. 80 of March 19, 2013 sets forth rules for granting priority examination for patent applications related to pharmaceutical products and processes, and equipments and materials related to public health

The Brazilian PTO published Resolution No. 80, on March 19, 2013 in the Official Gazette, which establishes the proceedings for requesting priority examination of patent applications related to pharmaceutical products and processes, and equipments and materials related to public health. We are pleased to hereby enclose a complete English language version of the resolution for your review.

According to the new resolution, now in full force, priority for the examination of patent applications related to public health may be requested by:
(i) The Ministry of Health when the object of the patent is considered strategic to the policies within the National Public Health System (the SUS) — the possibility of having a

The Brazilian Patent amp; Trademark Office (PTO) has recently opened a new Public Consultation, this time on the draft guidelines for the examination of patent applications in the biotechnology field. The Public Consultation was published in the Federal Official Gazette on December 5, 2012 and any interested party may make their submissions within a 60-day-term counted as from that publication date.

The new draft provides more definitions and illustrations on biotech subject matter not expressly mentioned in Law # 9,279/96 (ESTs, primers, SNPs, cDNAs, ORFs, fusion proteins, etc.), indicating whether they would patentable or not in view of the main statutory prohibitions found in articles 10, (IX) and 18, (I) and (III) of that Law.

Operational Rule No. 005/2012 was issued by the Brazilian Patent Office on October 30, 2012, ruling on the interference of the Biosafety Law (No No. 11,105 of 24 March 2005) on the granting of Biotechnology patent applications.

This operational rule came as a consequence of previous Brazilian Patent Office's Notification No. 0182-2012-AGU-PGF/INPI/COOPI-ALB-2.2, published on August 21, 2012 in Official Gazette No. 2,172, which considered not to be patentable subject-matter involving genetic use restriction technologies (GURTs) for plants, as set forth by the Biosafety Law (BL).

This BL establishes, in its Section 6º VII, that it is forbidden to: “use, sell register, patent and license genetic use restriction technologies”, these technologies being defined in the sole paragraph of said section as “any process by which human intervention generates or multiplies genetically modified plants to produce sterile reproductive structures, as well as any manner of genetic manipulation that aims a

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