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ANVISA: Latest Developments

  • 24 April 2013
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As you are probably aware, the Brazilian Industrial Property Law (9279/96) has been modified by a new law (10196/01), which introduced a step in the prosecution of patent applications for pharmaceutical inventions.
Pursuant to the new text, the granting of pharmaceutical patents requires the previous consent of ANVISA (Brazilian Health Authority). Until now, ANVISA has been re-examining all pharmaceutical cases previously examined and accepted by the PTO, prior to giving green light (or not) to the granting of the patent.

However, the aspects involved in this “prior consent” are very controversial and, as such, have been constantly discussed.

As a result of a report from the IP Inter-ministerial Working Group that discussed the roles of ANVISA and the Brazilian PTO as far as pharma patents are concerned, the above mentioned flow has changed.

From now on, ANVISA’s review shall take place before the Brazilian PTO examines the application. If ANVISA gives its prior consent, the application will then return to the PTO for examination.

If ANVISA does not give its prior consent, the rejection notice will be published in the IP Gazette and the case will be shelved. The final report of the Working Group does not clearly specify the criteria to be used during ANVISA´s analysis, although it states that “the analysis should be made in the light of public health aspects”.
Our firm was present at the discussion of Public Consultation No. 66/2012, regarding ANVISA’s proposed new resolution RDC 21/2013, the final text of which was published in the Official Gazette of April 15.

According to the text of RDC 21/2013, not all pharma patent applications will be examined by ANVISA. In sum, ANVISA will not give prior approval to:
applications disclosing a pharmaceutical product/ process which involves a health risk, i.e. the corresponding drug has been prohibited in Brazil; and
applications disclosing a pharmaceutical product/ process of interest to the policies of the Brazilian Universal Healthcare System (SUS), and which application does not meet with the patentability requirements and other criteria established by Brazilian Law # 9.279/96.
Therefore, according to this new resolution, ANVISA will only analyze the patentability criteria of cases “of interest of”* the Brazilian Universal Healthcare System (SUS).

* the drugs and diseases considered “strategic” are listed according to Decrees 978/2008 and 1284/2010.

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ANVISA: Latest DevelopmentsANVISA: Latest Developments