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>[26.Oct.09]
Patents – The Office of The Federal Attorney
General provides opinion about the role of ANVISA in
the grant of drug patents
Source: Infomail ABREU, MERKL no. 28
The Office of the Federal
Attorney General (PGF) issued, on 16.Oct.2209, a written
opinion on the competences of the Brazilian National
Institute of Industrial Property (INPI/BR) and the National
Agency of Public Health (ANVISA) regarding the role
of the latter in the process of previous approval examination
of pharmaceutical product/process patent applications.
Art.229-C of the Brazilian
Industrial Property Law (LPI
- Law no. 9279/1996) provides that “the granting
of patents to pharmaceutical products and processes
will depend upon the previous approval of the National
Agency of Public Health - ANVISA”. Thus ANVISA
understands that it can conduct, during aforesaid examination,
an analysis founded on the patentability criteria established
in the LPI, namely: novelty, inventive step and industrial
applicability. Strongly opposing such understanding,
the INPI/BR argues that this analysis is outside ANVISA's
scope, which should restrict itself to its institutional
designation to promote and protect public health.
The PGF, through the Written Opinion no. 210/PGF/AE/2009,
rendered a legal understanding for this longstanding
divergence asseverating that the institutional attributions
of the INPI/BR and ANVISA are specific and particular
of each entity, not leaving any room for confusion,
therefore, it is not ANVISA's place to decide over patentability
technical criteria of pharmaceutical products/processes,
being within INPI/BR scope to do that. Nonetheless,
it also suggested that a Decree be urgently enacted
or an Agreement signed aiming to specifically set the
scope of action and obligations of the two entities.
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