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The Brazilian FDA (ANVISA) issues Rule #168/2017 on procedures for pharmaceutical patent applications under Art. 229-C of the Patent Statute. New rule implements Interagency Ordinance #1 of 2017.

August 11, 2017

(Federal Register of August 10 th , 2017)

The ANVISA published at the Federal Register #153 today, August 10 th , 2017, Rule #168/2017 which establishes the procedures to be followed by the Agency during the prior approval analysis of patent applications claiming pharmaceutical products and processes under the authority of art. 229-C of the 1996 Patent Statute, as amended.

As informed in our client alert of April 25 th , 2017, new proceedings for the interaction between the BRPTO and the ANVISA were provided in Interagency Ordinance #01/2017, [IO #1/2017] signed by the two agencies on April 12th.

Rule #168/2017 establishes shorter deadlines for replying to the preliminary opinion and for
appealing the denial decision, both issued by the ANVISA. According to Art. 5, the applicant has a 60-day deadline to reply to the Agency’s preliminary opinion rather than the 90 days previously established by the now revoked Rule RDC #45/2008. Paragraph 1 of Art. 6 provides a 30-day deadline to file the appeal against the Agency’s denial decision rather than the 60 days previously established by Rule RDC #45/2008.

Art. 4 of Rule #168/2017 sets forth that any interested party might file third-party submissions to aid ANVISA’s prior approval analysis until the end of such analysis. Art. 7 confirms the new proceedings regulated by IO #1/2017, which establishes that the patentability examination carried out by ANVISA shall be considered as third-party submissions by the BRPTO.

Art. 9 further establishes that (1) those applications for which ANVISA’s prior approval analysis has been initiated before the publication of IO #1/2017, and that do not impose risk to public health, will be prior approved by ANVISA and remitted to the BRPTO; (2) appeals already lodged, but not yet analyzed by ANVISA, will be remitted to the unit responsible for the initial analysis inside the Agency for retraction judgment, based on the provisions of this Rule; and (3) ANVISA’s opinions grounded on patentability requirements and issued before the publication of IO #1/2017 will correspond to third-party submissions, as already established for those applications analyzed after IO #1/2017 came into force.

Rule #168/2017 revokes ANVISA’s Rules RDC #45/2008 and RDC #21/2013, and shall be effective as of publication, i.e., August 10 th , 2017.

The Portuguese version of this rule is available here and the English translation can be downloaded here. For more information, please contact info@lickslegal.com.

For further details concerning Interagency Ordinance #1/2017, please click here, and concerning the BRPTO’s normative instruction #02/2017, please click here.