Otto Licks Brazil's judiciary is fixing a Trade-Related Aspects of TRIPS Agreement violation that mandates prior approval for all patents claiming pharmaceutical inventions for human use. Ten years after amendments to the Brazilian Patent Law, the nation’s judiciary is fixing a Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement violation created by article 229-C, which mandates prior approval for all patents claiming pharmaceutical inventions for human use. Article 229-C established a fourth patentability requirement and a burdensome procedure creating uncertainty for applicants when the law granted to the country’s Food and Drug Agency (ANVISA) the statutory authority to decide the fate of patent applications according to political convenience. [blockquote]"THE DECISION ESTABLISHED THAT ANVISA HAS NO STATUTORY AUTHORITY TO EXAMINE PATENTABILITY REQUIREMENTS, STATING THAT THE ONLY LEGITIMATE GOVERNMENT AGENCY IN CHARGE OF REVIEWING THE PATENTABILITY REQUIREMENTS IS THE BRAZILIAN PATENT OFFICE."[/blockquote] Brazilian Federal Courts have been coping with the task of finding ways to ensure the predictability of the country’s patent system under the rule of law. Two recent decisions show a remarkable ability to harmonise ANVISA’s statutory authority under article 229-C with the work expected from a patent office and a sound patent system. A writ of mandamus was decided on January 24, 2012, by Judge Solange Salgado of the First Federal Court in Brasilia, ruling that ANVISA must restrict itself to public health issues when faced with a request for prior approval. Judge Salgado’s decision established that ANVISA has no statutory authority to examine patentability requirements, stating that the only legitimate government agency in charge of reviewing the patentability requirements is the Brazilian Patent Office (BPTO). The decision goes further, analysing the different types of patents available in Brazil, such as normal utility patents and pipeline patents. In a similar, and equally game-shifting, ruling of January 25, 2012, Chief Appellate Judge Jirair Aram Meguerian of the Court of Appeals for the First Circuit, rejected ANVISA’s motion regarding how a prior approval examination should be carried by the agency, in light of article 18, item I, of the Brazilian Patent Law (Article 18. The following are not patentable: I. Anything contrary to morals, good customs and public security, order and health;). Chief Appellate Judge Meguerian ruled that the greater objective of article 229-C is to grant the possibility for ANVISA to guard against patents for pharmaceutical products and processes when facing them against article 18, item I, of the patent law. The distinction of functions between the BPTO and ANVISA were once more reinforced in this decision because, in prior approvals, ANVISA denied patent registrations based on patentability requirements (novelty, inventive step, written description, etc) that should only be reviewed by the BPTO. [blockquote]“ANVISA’S RELUCTANCE TO GRANT PRIOR APPROVAL MADE NO SENSE, SINCE IT HAD ALREADY GRANTED CERTIFICATE OF REGISTRATION TO THE PRODUCT COVERED BY THE PATENT APPLICATION.”[/blockquote] Furthermore, in the case at hand, ANVISA’s reluctance to grant prior approval made no sense, since it had already granted certificate of registration to the product covered by the patent application. Therefore, by granting the registration, ANVISA already recognised that the product did not go against good moral principles and conduct, security or public health. The Brazilian judiciary’s decision to confine ANVISA’s statutory authority under article 229-C to examination of the specific exclusion of patentable subject matter under article 18, item I, seeks to reduce the impact of such prior approval. The decisions give new hope to applications denied since the enactment of the offending law. All applications denied for lack of patentability requirements can seek to have ANVISA’s decisions denying prior approval nullified in Brazilian courts. The possibility is even more attractive because the Brazilian patent law established the possibility of a patent term of at least 10 years from grant, in addition to the 20 years from the filing date.

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This article was originally published in “WIPR”, World Intellectual Property Review. For further information, please access the following website: http://www.worldipreview.com/article/brazilian-courts-fight-to-fix-trips-violations