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No. 26
September 2012
International Association for the Protection of Intellectual Property
AIPPI General Secretariat |Toedistrasse 16 | P.O.Box |CH-8027 Zurich
Tel. +41 44 280 58 80 | Fax +41 44 280 58 85
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“ANVISA” examining patent applications in Brazil
Magnus Aspeby, ASPEBY & SZABAS Industrial Property, Rio de Janeiro, Brazil

While almost all countries in the world are striving towards an international harmonization of their patent laws, Brazil has adopted a conspicuous exception. It is what many in Brazil call the “jabuticaba law” after the fruit jabuticaba [Myrciaria cauliflora], which only grows in Brazil.

This amendment in the Brazilian patent law rules that any patent application for a pharmaceutical invention also must be approved by ANVISA before it can be finally granted. “ANVISA” is the Portuguese abbreviation for National Agency for Sanitary Vigilance and corresponds to the FDA (Food and Drug Administration) in the US. Many ask what ANVISA has to do with patent examination and during the years they have been double-checking the work of the INPI (the Brazilian Patent Office), they have only succeeded in proving one thing: their purpose is political, namely to avoid patents on commercial medicines for which the Brazilian Unified National Health System “SUS” has to pay for ill Brazilians.

This amendment in the Brazilian IP law was introduced by a “Provisional Measure” signed by the Brazilian President in 1999, and became a new article of the Brazilian IP law in 2001. ANVISA set up a patent examination department, which started to reexamine pharmaceutical patent applications, after INPI had accepted them. It soon turned out that ANVISA raised new substantive objections, like obviousness objections and objections of insufficient disclosure. Further, they did not accept second medical use, which the INPI did. If the applicant did not manage to overcome these objections, he never obtained final approval by ANVISA, and no grant took place.

In January 2011 patent professionals got new hope: The “AGU“ (office of the Brazilian Solicitor General) issued a communication, restricting ANVISA's role in patent examination solely to risks to public health. The IP community believed that, finally, the frustrating ANVISA examination would come to an end.

This was a false hope. The advocates of ANVISA (mainly Brazilian politicians) read this communication “like the devil reads the Bible”. With the tiny feather left (to check health risks), ANVISA construed a whole hen. ANVISA's new role was so misinterpreted, that now anything can be a health danger, e.g. insufficient disclosure, obviousness and lack of novelty. Any objection is “transubstantiated” into a risk to public health. For example, this week, the writer, received an ANVISA action denying final approval, based on insufficient disclosure, but worded in such a “Kafkaesque” way, that the alleged insufficiency became a danger to public health. In translation, ANVISA's “epoch-making” reasoning reads:

Therefore, the application becomes contrary to public health since it hinders the access to information about technological innovation, which should help third parties in developing new inventions and contribute to technological improvements, thereby restricting people's access to medicaments, especially in the area of the Unified National Health System - SUS [the general Brazilian health care].” However, in regard to clinical tests, which might prove whether or not the new medicaments could have some dangerous side effects, ANVISA did not say anything.

And this is not all: a recent agreement between ANVISA and INPI, provides that with immediate effect, ANVISA shall examine all pharmaceutical patent applications before INPI examines them. To start with, the writer supposes that ANVISA will continue their adopted line that any substantive objection amounts to a danger to public health, under the motto “the end justifies the means”. So from now on, there may not be much left for INPI to examine in pharmaceutics. Secondly, one can expect a further increase of what is already the largest backlog in the world (it takes about 9-10 years from requesting examination to receive the first official action in a pharmaceutical patent application).

In conclusion, for the time being, in the writer's opinion, the future of patenting pharmaceuticals in Brazil does not seem very bright.
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