Prior approval by ANVISA: only to protect public health?

Abstract

The paper examines ANVISA's competence as regards the prior consent established by article 229-C of Law 9.279/96. It records the long-standing divergence of understandings, both in the federal administrative sphere and in judicial precedents, and the more recent line of decisions inclined to bar the health authority from any role in the substantive examination of the requirements of invention, novelty, inventive step, industrial applicability, descriptive sufficiency or unity of invention, confining its action to the institutional purpose set out in articles 6 and 8 of Law 9.782/99. It contrasts those decisions with the author's position, for whom prior consent is not a discretionary act but a bound duty, in the light of article 5, XXIX, of the Constitution. It covers the evolution of statutory bars to patenting since 1882, article 4quater of the Paris Convention, article 27 of TRIPS, articles 10 and 18, I, of Law 9.279/96, article 6, VII, of Law nº 11.105/2005 and the INPI examination guidelines. It holds that the agency must rule on the conditions of patentability and on the instances of non-patentability, without turning prior consent into a judgement of expediency or into pricing policy.