Positive advances in Brazil

Positive-advances-in-Brazil-Photo

Ricardo Dutra Nunes and Luiz Leonardos review the legal framework for patents in Brazil and recent developments in the system.

The Brazilian patent system is one of the oldest: it was created more than 200 years ago, in 1809, by royal decree. Since then, the country experienced many changes in this area, with several developments in our legal framework having occurred in the recent past.

Our federal constitution was enacted in 1988, establishing that “the law will guarantee a temporary privilege of use to authors of industrial inventions, as well as the protection of industrial creations (…), in view of the social interest and the technological and economic development of the country”. Brazil is also a member of most of the international treaties governing patent protection. In fact, the current patent statute (Law # 9.279/96) was enacted in 1996, just after Brazil became a member of the World Trade Organization in 1995. The current statute was important to adapt the local rules to the minimum standards established by the WTO-TRIPS Agreement. For that reason, the Brazilian patent statute is reasonably similar to the ones in force in the US, Europe, and other WTO-members, although its implementation by the Brazilian executive and judiciary powers can be quite different.

In addition to the Federal Constitution, international treaties, and the patent statute, patents are also governed by regulation and guidelines enacted by the INPI (National Institute of Industrial Property), analogous to the US Patent and Trademark Office and the European Patent Office, in charge of examining patent applications.

Since Brazil joined the WTO, the INPI must issue patents in all fields of technology, including the pharmaceutical area, which was not allowed in light of the previous legal framework. The INPI must issue a patent as far as the application discloses a technical solution to a technical problem, complies with the technical requirements – such as novelty, inventive step and industrial applicability – and is not prohibited by the statute.

The patent system

The statute establishes some matters are not considered as inventions, and cannot be subject to patent protection, such as discoveries, scientific theories, mathematical methods, abstract concepts, business methods, software per se, methods of treatment, methods of diagnostic, surgical techniques, and natural living beings and biological material found in nature or isolated thereof, for example. Some other matters are considered “not patentable”, such as anything contrary to public safety, order or health, some products and processes resulting from the transformation of the atomic nucleus, and living beings, except for transgenic microorganisms that are not mere discoveries.

Brazil has a first-to-file system, with a priority scheme that assimilates the Paris Convention and a 12-month grace period for disclosures made by the inventor or third parties (including the INPI) based on information received directly or indirectly from the inventor or as a result of his acts. Where a patent is granted, it gives the patent owner the right to prevent third parties from manufacturing, using, offering for sale, selling or importing the invention without his consent, for a period of 20 years as from the filing date. The extension of the protection is conferred by the claims, which are construed based on the specification and drawings.

The statute also provides for a few exceptions to patent rights, such as the experimental use exception and the Bolar exception, the later related to acts performed for the sole purpose of producing test results and data in order to obtain marketing registration for the patented product after the patent expires, which is especially relevant in case of pharmaceutical patents. Although extremely rare, a patent might be subject to compulsory licensing in some very specific circumstances.

Patent lawsuits in Brazil

In Brazil, patent infringement lawsuits are filed by the patent owner before state trial courts. Preliminary ex parte injunctions are available, allowing the trial court judge to immediately order the defendant to stop using or selling the patented invention, to conduct searches and seizures, or to order a recall of the infringing products, for instance. Depending on the amount of evidence the plaintiff presents with the complaint, to show the plaintiff will most likely prevail on the merits and that they may suffer irreparable harm – or a harm that is hard to repair – in cases where the injunction request is not granted, it is possible to obtain a preliminary ex parte injunction order in less than 24 hours after filing the case, as we have managed to obtain in the past on behalf of our clients. Declaratory non-infringement lawsuits are also available and must be filed before state trial courts as well.

Lawsuits challenging an act performed by the INPI, such as a decision issuing or rejecting a patent application, on the other hand, are typically filed before a federal district court in the city of Rio de Janeiro, where we have our main offices. Because the city has specialized district and appellate courts to deal with intellectual property matters, each case is randomly assigned to one of its four specialized IP district courts, and each appeal is assigned to one of its two specialized appellate divisions. We have learned from our experience that most of the few district court and appellate judges in charge of those cases in Rio de Janeiro are in general reluctant to overrule a decision issued by the INPI, and are frequently considered anti-patent judges. In light of that, our law firm developed an innovative – and successful – forum-shopping strategy to be able to file those lawsuits in Brasilia, our federal capital, where one of its more than fifty non-biased federal district court judges will deal with the case.

Data package exclusivity

In recent years, our law firm has also pioneered filing lawsuits to enforce our clients data package exclusivity rights, provided for both by the TRIPS Agreement and the local provisions regarding unfair competition. Such rights are especially relevant to research-based pharmaceutical companies, who must submit a huge amount of information to the ANVISA (the Brazilian Food & Drug Agency) to demonstrate their innovative products are safe and effective. In some situations, enforcing the mentioned data package exclusivity rights is the only way to avoid the free riding performed by generic industries seeking to rely on the innovator company’s data package to obtain marketing approval to their generic versions, instead of performing their own clinical trials.

Another recent major change that affects pharmaceutical companies in Brazil is the new patent prosecution procedure for the analysis of pharmaceutical patent applications. Since the last decade, pharmaceutical patents cannot be issued without the ANVISA’s prior consent. Until now, the INPI would examine a pharmaceutical application and forward it to the ANVISA only in cases where the examination performed by the INPI determined that the patentability requirements were met. There is no legal provision, however, expressly regulating the basis for the ANVISA to grant or reject its prior consent with regard to a patent application. Until recently, the ANVISA was insisting on reexamining the patentability requirements already examined by the INPI, denying prior approval in cases where it disagrees with the technical opinions issued by the INPI.

Two years ago, after our law firm filed many lawsuits on behalf of our clients to challenge such illegal understanding, the Attorney General’s Office issued an opinion clarifying that the patentability analysis should only be performed by the INPI, and that the ANVISA should grant or deny prior approval exclusively based on issues related to public health. To avoid further controversy, the government decided to change the procedure with regard to pharmaceutical applications. Now, the application is filed with the INPI, which immediately forwards it to the ANVISA if the application is related to a pharmaceutical product or process. Subsequently, the ANVISA will examine the application in light of public health issues, granting or rejecting its prior approval. The application will then be returned to the INPI, which will shelve the application if the prior approval is denied by the ANVISA, or perform the examination of the patentability requirements if the prior approval is granted by the ANVISA, eventually issuing or denying the patent.

INPI activities

In recent years, the INPI has also taken a few important measures that affect the patent system. First of all, the INPI is doing a decent job at dealing with the huge backlog, even though its more than 400 patent examiners still take an average of 5.4 years to examine a patent application after an examination request is filed. The INPI’s objective is to hire more patent examiners to decrease the average examination time to four years. This is crucial, especially because in some fields of technology, such as chemical, biotech and electric, an applicant might still have to wait more than ten years to have their patent application duly examined. Part of the success in dealing with the backlog was due to a modernization of the INPI’s workflow and IT structure. Now a portion of its office actions are available online, and the INPI has just launched a system that will soon make it possible to file a patent application online.

In an attempt to contribute to the development of innovative green technologies, the INPI developed in April a fast-track procedure to examine some patent applications related to alternative energies and energy conservation, transportation, waste management and agriculture. This expedite procedure is already available and can dramatically reduce the time taken by the INPI to examine the application. Also, the INPI created a new optional procedure for applications originally filed in Brazil, allowing the applicant to request the INPI to perform a preliminary analysis and issue a preliminary opinion with regard to the patentability requirements. This preliminary opinion might be relevant to give the applicant more information about their chances of ultimately obtaining a patent.

In addition to that, the INPI drafted new general guidelines for the examination of patent applications, and society is currently reviewing this first draft to suggest insertions and adjustments. The INPI also drafted new guidelines for the examination of polymorphs, providing applicants with more legal certainty in this sophisticated field that was deemed to be a grey area before the specific guidelines were published, since some specialists were trying to sustain that polymorphic inventions were not patentable.

In spite of the many challenges faced by national and foreign companies with regard to the ever evolving Brazilian patent system, the country has witnessed some positive advances in recent years, as the executive, legislative and judiciary powers understand the importance of having a vigorous and practical structure that stimulates the technological and economic development of the country.

Résumé

Luiz Leonardos, Senior Partner, LUIZ LEONARDOS & CIA 

Luiz helped shape Brazil’s current Intellectual Property scenario and gives his name to LUIZ LEONARDOS & CIA., which was created as a direct result of the split of the traditional I.P. firm Momsen Leonardos & Cia. on April 30, 2012.

He has been President and member of the Board of Directors of the Brazilian Industrial Property Association (ABPI), of which he is Honorary President. He has been Executive President of the International Association for the Protection of Intellectual Property (AIPPI) and is currently Honorary Member. He is also Honorary Member of the International Federation of Intellectual Property Attorneys (FICPI).

His notable career in Intellectual Property Law is widely recognized in Brazil and abroad. Legal excellence makes him one of the most respected IP practitioners of his generation.

Ricardo Dutra Nunes, Partner, Luiz Leonardos Advogados

Ricardo is a partner at Luiz Leonardos Advogados IP litigation group, focusing on the pharmaceutical industry, and has a Master of Laws degree in IP Law, summa cum laude, from The George Washington University Law School (USA). Ricardo is admitted to practice law in Brazil and passed the NY State Bar examination (awaiting admission). Ricardo represented international pharmaceutical companies in an advertisement case regarding prescription drugs, in an unfair competition lawsuit filed against a company providing false information to consumers, in a declaratory patent non-infringement lawsuit regarding an erectile dysfunction drug, amongst many others, and represented several Fortune 500 companies.