Brazilian PTO (BRPTO)’s Normative Instruction #01/2017 on procedures for pharmaceutical patent applications under art. 229-C of the Patent Statute issued. New instruction implements Interagency Ordinance #1 of 2017.
(BRPTO’s IP gazette #2425 of June 27th, 2017)
The BRPTO published on June 27, 2017, Normative Instruction #01/2017, [NI #01/2017] which establishes the procedures to be followed by the Office for 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, 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 12.
Art. 3 of NI #1/2017 sets forth that the application shall be remitted back to the BRPTO for substantive examination after ANVISA’s prior approval analysis. Paragraph 2 of said article establishes ANVISA’s denials under art. 229-C as basis for the BRPTO’s constructive abandonment of patent applications, with no chance to revive it, as set forth by the IO #1/2017. Paragraph 3 establishes as imposing risk to public health those applications related to pharmaceutical product or pharmaceutical process resulting in a substance banned from use in Brazil.
Paragraph 4 of Art. 3 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. However, differently from the procedure defined by IO #1/2017, where the BRPTO would be obliged to issue a formal opinion on ANVISA’s technical opinion when in disagreement with it, paragraph 5 of Art. 3 of NI #1/2017 provides that the BRPTO shall follow Implementing Rule #04/2015 (available in English here and in Portuguese here). According to Implementing Rule #04/2015, the BRPTO may comment on the third-party submissions if it considers them relevant.
NI #1/2017 is even more contradictory in its Art. 3, paragraph 7, as it determines that the patent examiner may consider the amendments carried out during the prior approval proceedings, even if ANVISA’s decision was for the non-approval of the application.
In disagreement with Art. 31 of the Patent Statute, wherein third-party submissions are not accepted in the appeal stage, according to Art. 4 of Normative Instruction #01/2017 ANVISA’s technical report on patentability will also be considered by the BRPTO as third-party submissions for applications under appeal stage.
Normative Instruction #01/2017 shall be effective as of publication, on June 27, 2017.
For further details concerning Interagency Ordinance #1/2017, please click here.