Direitos de propriedade intelectual e saúde pública: das normas de regulação às práticas de exame de patentes na área farmacêutica no Brasil.

Abstract

This work discusses the pharmaceutical patenting in Brazil through analysis of patent examination itself, since the inception of the current Industrial Property Law (Law 9.279/1996). In order to understanding how patent examination works, it stars from the presentation of basic concepts of industrial property. It is given highlights to the importance of patents as a technological information source (bibliographic research in patent database and to recover information contained in those documents). At this point, it is presented a study on Efavirenzrelated patents, since it is an exceptional case in the discussion on industrial property and public health; once it was the first drug compulsorily licensed by Brazilian Government (within the control policy of AIDS epidemy). Next, the issue of association between industrial property rights and the access to medicaments is approached in two relevant chapters: i) issues on the patenteability of pharmaceutical polymorphs; and ii)technical procedures adopted in the examination of pharmaceutical patents under ANVISA Coordenation of Industrial Property (COOPI-ANVISA) and Industrial Property National Institute (INPI). In fact, the first intenational treaty related to industrial property the Convention of Union of Paris (CUP, of 1883), already defended the principle of independence of patentes, i.e., each country has the liberty to decide on the patenteability or not of the different invention products and processes. Then, the TRIPS Accordance (1995) does not preclude the contries the adoption of different scopes of protection, in order to achieve a balance between public and private interests in different technological fields. Finally, the Doha Declaration (2001), provides softners devices in order to precisely promote health policies and access to medicaments to the utilization of safeguards of intelectual property rights in examination of patent applications. It is concluded, in this work, that technical and legal aspects related to patenting, combined with the ability of political decision in favor of the implementation of flexibilities in the examination of medicine and drugs patent applications may be more or less favorable or detrimental to public health.