by Ivan B. Ahlert
November 01, 2001
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In our newsletter of December 1999, we have reported the issuance of Provisional Measure 2.006 of December 14, 1999. On February 14, 2001, this provisional measure was approved by the National Congress, and it was published as Law 10.196. Section 229-C of Law 10.196 conditions the grant of patents in the pharmaceutical area to the prior approval of ANVISA (the National Agency for Sanitary Surveillance, the Brazilian equivalent to the Federal Drug Administration (FDA) in the U.S.).
Notwithstanding the fact that, in our opinion, this provision represents an additional condition which conflicts with article 27.1 of TRIPS as to the fact that patents shall be available for any inventions "without discrimination as to the field of technology", we can now report that, so far, the patent applications submitted to ANVISA’s approval apparently are not suffering an insurmountable delay in their examination.
Few cases are being subject to office actions of formal nature by ANVISA, but up to this moment the re-examination by this agency does not seem to pose a major obstacle to the allowance of patents in the pharmaceutical field, since decisions to this effect are being published with certain regularity