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>[26.Apr.11]
Patents – Limitation to previal approval
by ANVISA
Source: Infomail ABREU, MERKL no. 32
In the year of 2001,
the Industrial Property Law (LPI – Law no. 9279/1996)
was amended in order to include a provision of prior
approval by the National Agency of Public Health (ANVISA)
for the grant of patents related to pharmaceutical products
and processes (art.229-C).
The Brazilian National Institute of Industrial
Property (INPI/BR) asked then for an opinion from the
Office of the Union’s Attorney General (AGU),
through the Office of the Federal Attorney General (PGF),
on a possible interference in its legal duties. The
PGF stated that ANVISA’s responsibility shall
be restricted to the analysis of the sanitary risks
related with a patent application in the pharmaceutical
field, rendering therefore inappropriate the reexamination
of patentability requirements.
Following the first opinion, ANVISA filed
a request for reconsideration; nevertheless, the initial
position of the PGF was sustained in the Opinion 337/PGF/EA/2010
of 10.Jan.2011. On a note in its official website, ANVISA
stated that in accordance with the present board’s
understanding there is no such dispute between ANVISA
and INPI concerning the power to grant drug patents,
and that the agencies have different activities as regards
the analysis and granting of patents, which demand from
them a good synergy so that the analysis of patents
may serve the country’s needs.
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