BRAZIL Law and Practice Contributed by: Ana Paula Affonso Brito and Maria Eduarda de O Borrelli Junqueira, Montaury Pimenta, Machado & Vieira de Mello
2.2 Regulatory Data and Market Exclusivity
manufacturing, using, offering for sale, selling or importing for such purposes: • a product that is the subject of a patent; and/ or • a process, or product directly obtained by a patented process. The patentee is further guaranteed the right to prevent third parties from contributing to other parties’ infringement acts. Although marketing authorisation applications or grants are usually seen as allowed pre-launch activities, applications for reimbursement, pric - ing or listing, submissions or awards of tender, and offers to supply after patent term expiry, are subject to an infringement lawsuit. Special attention is directed to marketing author - isations granted way before the patent expiry, since the regulatory framework requires the renewal of the commercialisation of the object of the authorisation within the final two thirds of the final term. The parallel importation of a product that is cov - ered by a patent, or that is obtained by means or processes patented in Brazil for commercial purposes, is also subject to an infringement law - suit, if the product has not been placed on the external market directly by the owner or with the owner’s consent. As to the skinny label, the rules in Brazil changed in December 2023 when the National Health Sur - veillance Agency ( Agência Nacional de Vigilância Sanitária , or Anvisa) issued a resolution which allows a patented indication to be carved out of a generic leaflet.
In terms of patent protection, there is no provi - sion for any market exclusivity extension related to orphan, paediatric, new indications, combina - tions, reclassifications, etc. A patent is valid for 20 years, counted from the filing date, with no possible term adjustment. However, in view of a Supreme Court decision, which declared the ten-year validity rule of pat - ents unconstitutional, some patentees are filing lawsuits requesting patent term adjustments based on the unjustified delay of the BPTO in the analysis of patent applications, on a case- by-case basis. Said court actions are new and, for now, it is not possible to predict how they are going to evolve and what their outcomes will be, since there is no case law available to support this new legal thesis. 2.3 Acceptable Pre-Launch Preparations Generics are allowed to request the marketing authorisation of a product and to perform any experimental activities with the aim of having the data required for the marketing authorisa - tion request (Bolar exemption). The patentee has the right to prevent third par - ties that do not have consent from producing, using, offering for sale, selling, importing for these purposes, or contributing to such prac - tices, a patented product, process or product obtained directly by a patented process. However, Article 43, VII of the Brazilian Industrial Property Act expressly provides exceptions to patent protection – among them, acts carried out by unauthorised third parties, related to an invention protected by a patent, which aim to obtain a marketing registration in Brazil, or in another country, for the exploitation and mar -
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