Wednesday, 2 July 2008

ANVISA to review Brazilian pharma patents -- but is this lawful?


On 23 June 2008 the Brazilian National Health Surveillance Agency (ANVISA) issued Resolution RDC 45 on the approval process for patent applications for pharmaceutical products and processes. This resolution is made under Article 229-C of the Law 9.279/96 (Industrial Property Law), according to which all patent applications for pharmaceutical products and processes must have the approval of ANVISA.

Under Resolution RDC 45, applies to all pending patent application filed from 15 December 1999 onwards, the Brazilian Patent Office will send the patent application files to ANVISA in order to obtain official approval, which will state reasons for giving or denying its approval. ANVISA may ask the applicant to submit documents, objections, searches as well as the results of examination in other countries. additionally, interested third parties will be able to submit documents so as to support ANVISA’s examination during the proceeding.

If ANVISA’s preliminary report concludes that the patent cannot be allowed, or if the agency raises an office action, the patent applicant has 90 days receipt of its decision in which to respond. Failing such a response, the decision is final. There is also a 60- day term, following the date of publication of the decision in the Brazilian Official Gazette, in which the patent applicant may file an appeal against the decision

According to the authors of this information, this resolution in their opinion exceeds ANVISA’s competence, since the patentability examination falls within the competence of the Brazilian Patent Office. Accordingly the legality of this resolution may be subject to court proceedings
[source: Di Blasi Parente, Vaz e Dias & Associados circular, 1 July 2008].

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