Brazil's Patent Reform Pedro Paranaguá Advisor to the ruling Workers Party Brazilian House of PedroParanagua 3rd Global Congress on IP & Public Interest University of Cape Town, 12 December 2013

I. why II. how III. findings IV. what V. individuals VI. future Brazil's Patent Reform

I. why Brazil's Patent Reform

– disparity – high production of knowledge – low # of patents Brazil's Patent Reform Rep. Newton Lima

II. how Brazil's Patent Reform

● 7 public hearings: House of Rep., PTO, Univ. of São Paulo, Univ. Campinas ● 30+ experts: gov., industry, academia, civil society ● extensive research: legislation (Argentina, China, India), gov. & intl. org. reports (UK, US, WHO, WIPO) Brazil's Patent Reform

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III. findings Brazil's Patent Reform

● Brazil hastily approved its patent bill in 1996 ● did not implement TRIPs flexibilities ● prejudicial consequences to innovation + extraordinary increase of prices Brazil's Patent Reform

closed 1,096 plants (Min. of Trade & Industry) no development of local production >> USD $10 billion deficit (Min. of Health) ● 70% decrease of TT (Fiocruz) revalidation patents (pipeline) >> losses of USD $529 million related to 5 ARVs (Federal Univ. Rio/Economics) Brazil's Patent Reform

IV. what Brazil's Patent Reform

● 1. Patent Reform Bill H.R. 5402/2013 ● 2. Council on IPRs ● 3. Recommendations Brazil's Patent Reform

● a) limit patent term to 20 years ● b) pre-grant opposition ● c) prohibit new forms of known substances + second uses Brazil's Patent Reform

● d) augment the level of the inventive step requirement (to promote follow-on innovation) ● e) undisclosed test data: protected by unfair competition >> rather than data exclusivity ● f) public non-commercial use Brazil's Patent Reform

● g) Anvisa's prior consent ● i) health risks >> based on previously rejected products ● ii) pharma or chemical products of interest to the National Health System (SUS) and that do not comply with the patentability requirements Brazil's Patent Reform

V. individuals Brazil's Patent Reform

you

VI. future Brazil's Patent Reform

● too many variables Brazil's Patent Reform

● new Ministers of Health + Trade & Industry 2014 national presidential election ● Patent Office ● national + intl. industry + TPP... ● civil society Brazil's Patent Reform

Dankie ! Thank you! Pedro Paranaguá Advisor to the ruling Workers Party Brazilian House of Representatives LL.M. (London), Doctorate Candidate PedroParanagua