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Updated: Nov 22, 2025

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
Inventive step assessment of top selling monoclonal antibodies in Brazil
Louise Azulay Palavecino1,2, Carlos Rangel Rodrigues3, Murilo Lamim Bello3
1Departamento de Biologia Geral (GBG), Universidade Federal Fluminense (UFF), Instituto de Biologia, Laboratório de Antibióticos, Bioquímica, Educação e Modelagem Molecular (Labiemol), Niterói, RJ, Brazil.
Abstract:
Introduction: The patent system is fundamental for the pharmaceutical industry development, providing a return on the large investment of time and financial resources. Among the patentability requirements, understanding how to comply with the inventive step is especially important for patent applicants. Regarding mAbs, due to the high affinity and specificity for their molecular therapeutic target, minimal structural changes can lead to unexpected properties, being a common issue among Patent Offices.Areas covered: The present research investigated the Brazilian patents covering top-selling mAbs.Expert Opinion: The more complete and detailed the mAb when the patent application is filed, the greater the chance of the patent being granted. It is necessary to disclose, at least, the six CDRs, the complete variable region, and/or the hybridoma. The Applicant shall specify faced obstacles during mAb generation, mainly if it is a common issue and resulted in improved properties. If it is possible, the Applicants shall compare the claimed mAbs to previous ones, focusing on the achieved unexpected or improved properties. After an objection by BRPTO, the Applicant shall submit data with quantitatively data about qualitative information disclosed at the Specification when filed. If applicable, show different epitope-binding and highlight clinical advantages of successful mAbs.
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