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The Court of the Administrative Council for Economic Defense decided, this Wednesday (4/10), to archive an administrative process that investigated the pharmaceutical company Lundbeck Brasil Ltda. and its controlling company H. Lundbeck A/S for allegations of abuse of the right to petition and damage to free competition.
The process began in 2011, after receiving a representation from Pró-Genéricos, an association of generic medicine manufacturers. According to the entity, Lundbeck initiated actions and took extrajudicial measures without legal basis to exclude generics of Lexapro, an antidepressant medication based on escitalopram oxalate, from the market.
For the author, the accused company caused damage B2B Lead to free competition by questioning marketing authorizations for manufacturers of generic escitalopram granted by ANVISA, based on results of clinical and pre-clinical studies carried out by the company itself.
Represented by lawyers José Del Chiaro and Ademir Pereira Junior , from Advocacia José Del Chiaro, Lundbeck argued that, by granting marketing authorizations for generic escitalopram drugs based on its dossier, ANVISA violated the protection against unauthorized use of drug dossiers. clinical and pre-clinical studies conferred by the Industrial Property Law and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
For Cade, which accepted the defense's thesis, after an investigation lasting more than six years, it was possible to conclude that Lundbeck did not abuse its right to petition. According to the court's unanimous decision, taken under the report of counselor Polyanna Ferreira Silva Vilanova, the company's actions did not completely lack legal basis. The council also verified that the pharmaceutical company did not hide data or present false information to the courts.
The Council highlighted that the merit analysis of whether or not the dossier of Lundbeck study results should be protected against use for the granting of authorizations for generics by Anvisa is the responsibility of the Judiciary, where a Lundbeck action is still pending.
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發表於 11:32:40