“Data Protection Exclusivity and Interface with unfair competition and patent protection”

“Data Protection Exclusivity and Interface with unfair competition and patent protection”

On the last 22nd, at 11 am, our counselor Luiz Augusto Lopes Paulino, moderated the round table “Data Protection Exclusivity and Interface with unfair competition and patent protection”. This event is part of the ABPI Congress and also had the participation of Craig Tucker (Elli Lilly); Martha Novelli from Oliveria Penna (Eurofarma), and Fabiano Andreatta (Ex-Boehringer) as speakers.

Data protection related to the health registration of products before the regulatory agency has been discussed for some years by the pharmaceutical research industry.

Almost every country in the world grants protection to the applicant’s data for registration to the health agency. Brazil, however, due to an omission in the law (Law 10.603 / 2002), does not grant applicants for health registration at ANVISA protection of data and test results, allowing these data to be used for the analysis and immediate grant of generic medicines and similar products from third parties.

The Brazilian Government has been questioned about the absence of such protection, as the laboratories carry out long (clinical trials) and costly studies to produce the information required by legislation and ANVISA, without having a counterpart, that is, a minimum period so that ANVISA does not use these data.

This table-topic discussed this issue and the relationship between data protection and “unfair competition” and patent protection. The speakers brought their experiences and impressions, including the foreign experience of one of them.