August 27, 2021

The Brazilian FDA will no longer examine pharmaceutical patent applications

Law No. 14,195, of August 26, 2021, improves the business environment in Brazil
The participation of the Brazilian agency called ANVISA – National Agency of Sanitary Supervision (equivalent to the FDA – Food & Drug Administration of the United States) in the examination of pharmaceutical patent applications has been now revoked
Such intervention by ANVISA has been a 22-year-long “soap opera”, since its approval, in 1999, through the inclusion of Section 229-C in the Brazilian Patents Act (Law 9,279/96). Section 229-C has now been revoked by Law 14,195, of August 26, 2021, which expressly aims to improve the business environment in Brazil.
The revoked Section 229-C set forth that all pharmaceutical patents were subject to the prior approval by ANVISA, in order for the Brazilian Patent Office (INPI) to be allowed to subsequently make its own examination.
From 1945 until 1996, Brazil granted no patents for pharmaceutical inventions. In 1996 the current Patents Act was approved, admitting the granting of pharmaceutical patents, but in 1999 the intervention by ANVISA was created as a reaction by the Brazilian generics industry, in an attempt to create obstacles to the issuance of pharmaceutical patents whenever the Brazilian Public Health System wished to provide a pharmaceutical drug freely to the Brazilian population.
In 1999, some sectors of the Administration had a (in our view, incorrect) opinion that the Brazilian INPI was granting patents which did not fully comply with the legal requirements. Thus, ANVISA started to examine the requisites for patentability (novelty, non-obviousness and enablement), something that generated several disputes before the Courts, due to the doubtful legal competence of ANVISA to perform such additional examination.
Thus, ANVISA and the Brazilian INPI had a long feud, from 1999 until 2017, when both agencies published a joint-regulation, and agreed that ANVISA would make an analysis limited solely to public health concerns. This compromise solution reduced the inconvenient caused to applicants by ANVISA’s intervention but continued to be a factor contributing to the long delay in the examination of pharmaceutical patents in Brazil.
Recently, the perspective for the Brazilian IP system worsened, in view of a decision by the Superior Court of Justice – SCJ, on June 22, 2021, according to which the examination of all patentability requirements, performed by ANVISA until 2017 was ruled as lawful. Fortunately, as the sole basis for such examination was Section 229-C of the Patents Act, now revoked, such precedent of the Brazilian SCJ will not produce further consequences.
Thus, with the enactment of Law 14,195/2021, this “soap opera” has a happy ending, with both domestic and international companies finally free of ANVISA’s intervention in the prosecution of pharmaceutical patents. ANVISA, or the Health Ministry, may offer subsidies to the examination before the Brazilian INPI, but now the prerogative of performing the technical exam and rendering the granting decision fall solely upon INPI, as it also is the case in the vast majority of countries worldwide.
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