After years of impasse, the Brazilian Health Surveillance Agency (ANVISA) and the Brazilian National Institute of Industrial Property (INPI) have recently reached an agreement regarding the legal provision of "prior consent," which establishes that ANVISA needs to approve the grant on the grant of patent applications in the pharmaceutical field.
The agreement, which was approved on March 14, 2017 by the ANVISA's Board of Directors, defines the duties of each organization during the patent examination proceedings.
According to ANVISA's President Jarbas Barbosa, there will be more transparency in the patent examination proceedings of pharmaceutical applications. The Health Surveillance Agency will continue to assess the applications first, and will send its technical report to the INPI, which may or may not accept ANVISA's opinion. In case INPI does not agree with ANVISA's opinion, the PTO's opinion will prevail. However, INPI will have to justify the decision. Additionally, according to the agreement, ANVISA's analysis of patent applications in the pharmaceutical field will be limited to the examination of public health issues, whereas INPI will evaluate the patentability requirements.
A joint ordinance will be published soon, containing the details and implementation schedule of the agreement. Also, an inter-institutional working group, including representatives of INPI and ANVISA, will be set up with the goal of promoting the exchange of technical information and the harmonization of the processes.
Law No. 10,196 of February 14, 2001, introduced Article 229-C in the Brazilian IP Law, which establishes that, whenever a patent application claims a pharmaceutical product or process, consent from ANVISA is required prior to granting the desired patent.In view of this change in the law, pharmaceutical patent applications that had been considered allowable by the INPI were subsequently submitted to ANVISA's prior consent. Moreover, instead of issuing opinions only based on public health issues, ANVISA also assessed their patentability requirements, which is a competence of the INPI.
In 2013, an Administrative Ordinance issued by an inter-ministerial group comprising representatives of the INPI, ANVISA, the Ministry of Health, the Ministry of Development, Industry and Foreign Commerce, and the Attorney General's Office established that pharmaceutical patent applications should first be submitted to ANVISA for its preliminary analysis and only upon ANVISA's prior consent the patentability of the application could be examined by the INPI.
The intervention of ANVISA in the examination of pharmaceutical patent applications has been reviewed on several occasions by the Attorney General's Office, which in legal opinions published in 2009 and 2011 confirmed that ANVISA´s duty to assess pharmaceutical patent applications should be limited to the examination of public health issues.
Additionally, several judicial decisions have been issued by federal courts in Brazil recognizing that ANVISA does not have the authority to examine patentability requirements under Article 229-C of the IP Law.
The lack of understanding between the two organizations has contributed to an enormous backlog in the examination of patent applications in Brazil. It is estimated that, because of this conflict, at least 21,000 pharmaceutical patent applications are shelved in the INPI and ANVISA.
According to Barbosa, this agreement will provide more legal clarity and help reduce the examination time for pharmaceutical patent applications in Brazil.
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