PIUG 2022 - Tuesday

T U E S D A Y A F T E R N O O N

Eculizumab and the Administrative Nullity Processes of patent in Brazil: a case study Larissa Dutra &Wanise Barroso (Oswaldo Cruz) 1:45 - 2:15 pm

ABSTRACT Eculizumab is a monoclonal antibody drug and has already been described as the most expensive in the world, with an estimated cost of $500,000 per patient per year. For this reason, the Brazilian Minis try of Health (MH) has requested the Oswaldo Cruz Foundation (Fiocruz) for the possibility of establish ing the nullity of two patents granted in Brazil for the use of this drug to treat paroxysmal nocturnal hemoglobinuria (PNH), registered by Alexion Phar maceuticals in the country. Although the patent for Eculizumab (Soliris®) expired on 05 January 2015, which fell within the public domain in Brazil, these two patents prevent the man ufacture, commercialization and use of Eculizumab by interested third parties in the national territory. Against this background, the Administrative Nullity Processes (ANP) were filed at the Brazilian Patent Office (BPO), as the requirements for patentability established in IP Law 9.279/96 (BR) were not met, i.e., inventive activity and novelty of the drug Eculizum ab in its use for PNH. Subsequently, the ANP docu ments were analyzed by the examiners of the BPO and it was decided that the anteriorities and expla nations were valid and it was suggested the Nullity in November 2021.

BIOGRAPHY LARISSA DUTRA holds a pharmacy degree, BA. Currently is a master’s student at Professional Post graduate Program in Management, Research and Development in the Pharmaceutical Industry by Farmanguinhos/Fiocruz. Also holds a postgraduate degree in Scientific and Technology Information in health by ICICT/Fiocruz, as well as an advanced knowledge certification in industrial property by the National Institute of Intellectual Property in Brazil in corporations with Pontifical Catholic University of Rio de Janeiro. WANISE BARROSO is PhD in Information and Com munication Sciences by Université de Toulon et du Var (France). Head Researcher in Health at Fundação Oswaldo Cruz (Fiocruz). She has been working for more than 40 years in Competitive Intelligence, Industrial Property and Management of Technologi cal Innovation, mainly in the areas: patent, database, public domain, technological surveillance and patent oppositions. Substitute coordinator of the Techno logical Innovation Center of Farmanguinhos. Coor dinator of the Professional Postgraduate Program in Management, Research and Development in the Pharmaceutical Industry of Farmanguinhos/Fiocruz.

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