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August 14, 2017
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The National Agency for Sanitary Surveillance (ANVISA) of the Brazilian Ministry of Health published in Official Gazette no. 153 of today, August 10, 2017, their Resolution no. 168/2017 (RDC 168/2017), which establishes administrative procedures for patent applications relating to pharmaceutical products and processes according to Article 229-C1 of Brazilian Industrial Property Law no. 9,279/1996.
On April 12, 2017, the Brazilian Patent and Trademark Office (INPI) and ANVISA formally signed Joint Ordinance no. 01 on examination of pharmaceutical patent applications, which regulates the procedures for applying said Article 229-C of the Brazilian IP Law, aiming at finally solving the conflict and polemic on double examination that has been carried out so far by them. For further details, please see our Newsletter of April 12, 2017.
INPI published their ruling on this matter on June 27, 2017, namely Normative Instruction no. 01, providing guidelines on administrative procedures at the PTO’s sphere, as reported in our Circular no. 07 of June 2017.
ANVISA’s RDC 168/2017 contains directives on administrative procedures in the Agency’s sphere, which were formerly foreseen in its Resolution no. 45 of June 23, 2008 (RDC 45/2008) and Resolution no. 21 of April 10, 2013 (RDC 21/2013). This new Resolution basically brings no alteration and merely ratifies the above-mentioned Joint Ordinance no. 01 and Normative Instruction no. 01.
We now have to await further developments with a view to have confirmation as to how the above new rules will be implemented in practice by ANVISA and INPI.
The above RDC 168/2017 is in force as of today, August 10, 2017, and revokes former RDC 45/2008 and RDC 21/2013.
The original version of RDC 168/2017 can be downloaded here. If you need an English version thereof or any additional information about any specific case, please let us know.
“Article 229-C – The grant of patents for pharmaceutical products and processes will depend on prior consent from the National Agency for Sanitary Surveillance [ANVISA].”