Who approves? RDC 21 stirs the pot
November 10, 2017

Otto Licks The Brazilian food and drug administration (ANVISA) regulation RDC 21 of 2013, effective from April 16, 2013, covering pharmaceutical patents, caught the IP and the investment community by surprise. It bluntly violates the World Trade Organization TRIPS Agreement, the Paris Convention, the Brazilian patent law and the country’s 1988 Constitution. Regulation RDC 21 of 2013 amends regulation RDC 48 of 2008, which established ANVISA’s procedures for the prior approval for the grant of pharmaceutical applications claiming pharmaceutical products or processes under the statutory authority of Article 229-C of the Brazilian patent statute. Under RDC 21, ANVISA may deny prior approval under Article 229-C for patent applications considered of interest under the Brazilian public policy of access to medicines or the public healthcare system (SUS). This covers patent applications for products and therapeutic indications listed in several regulations published by the Ministry of Health. RDC 21 is immediately applicable to all pending applications. It is not settled at this time whether applications already being examined by the Brazilian patent office (INPI) will be sent to ANVISA before the end of the examination. According to Article 2 of RDC 21, prior approval is an administrative decision that takes into account compliance regarding Article 229-C, in which ANVISA must verify if ‘the subject’ of the patent application is against public health. Article 3 states that the prior approval procedure will take place after the INPI sends the application to ANVISA, but before substantive examination of the application at the INPI. After receiving the patent application, ANVISA will perform its examination in the light of public health, through a decision produced by the Office of Coordination of IP (COOPI), the ANVISA department located in Rio de Janeiro. The patent application will be considered to be against public health when: the pharmaceutical product or process in the application presents a risk to health; or when the patent application for the pharmaceutical product or process is of interest on public policy grounds and “does not meet patentability requirements and further criteria established by Patent Statute 9,279 of 1996.” The risk to health is established when the pharmaceutical product comprises, or the pharmaceutical process results in, a substance the use of which may have been prohibited in the country. A patent application for a pharmaceutical product or process will be deemed as of interest to the public policies of access to medicines supporting the SUS when it comprises, or results in, a substance named in the ordinances published by the Ministry of Health establishing strategic products, or a substance aimed at the therapeutic purposes listed in the ordinances. The guidelines for analysing the risk to health and to the public policy interest will be established in the proper administrative act. According to Article 7, the prior approval decisions will be published by ANVISA in the Brazilian Federal Gazette. An appeal to the full board of directors of ANVISA can be filed within 60 days against application negative decision. After ANVISA’s final decision, the application will return to the INPI to conclude the administrative proceedings. It is not clear what INPI will do with patent applications in case of denial of prior approval, since the lack of prior approval is not a statutory basis for denial of patent applications, despite the fact that prior approval is required for the grant. RDC 21 goes against Article 229-C of the Brazilian patent statute, which only allows ANVISA to look into applications that have been allowed by the INPI. The reversal of the procedure does not answer what will happen when the INPI substantive examination alters the claim chart approved by ANVISA, for example. It is too soon to fully understand what will be the impact for the Brazilian patent system of the RDC 21. Nevertheless, we can presume that the research community will be disappointed with the new Brazilian landscape.

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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/who-approves-rdc-21-stirs-the-pot

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