IMPACTOS DOS NOVOS DISPOSITIVOS SOBRE PROPRIEDADE INTELECTUAL NA POLÍTICA INDUSTRIAL EM SAÚDE DE PAÍSES EM DESENVOLVIMENTO

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1 IMPACTOS DOS NOVOS DISPOSITIVOS SOBRE PROPRIEDADE INTELECTUAL NA POLÍTICA INDUSTRIAL EM SAÚDE DE PAÍSES EM DESENVOLVIMENTO Claudia Chamas, D.Sc. Centro de Desenvolvimento Tecnológico em Saúde (CDTS) Fundação Oswaldo Cruz (Fiocruz) Rio de Janeiro, 17 de novembro de 2015

2 Parceria Transpacífico Trans-Pacific Partnership (TPP) t pp.mfat.govt.nz /text ustr. gov/tpp

3 Evolução da Propriedade Intelectual TRIPS-plus acordos bilaterais e regionais Ausência de Acordo internacional Convenção de Paris Acordo TRIPS forum shifting

4 Fonte: USTR

5 Fonte: Congressional Research Service, 2012 Título do Slide

6 Título do Slide Fonte: Congressional Research Service, 2012

7 Fonte: USTR

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9 CHAPTER 18 INTELLECTUAL PROPERTY

10 Article 18.2 Objectives The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.

11 Article Patentable Subject Matter patents are available for inventions claimed as at least one of the following: new uses of a known product, new methods of using a known product, or new processes of using a known product

12 Article Patent Term Adjustment for Patent Office Delays 1. Each Party shall make best efforts to process patent applications in an efficient and timely manner, with a view to avoiding unreasonable or unnecessary delays. 2. A Party may provide procedures for a patent applicant to request to expedite the examination of its patent application.

13 Article Patent Term Adjustment for Patent Office Delays 3. If there are unreasonable delays in a Party s issuance of patents, that Party shall provide the means to, and at the request of the patent owner shall, adjust the term of the patent to compensate for such delays.

14 Article Patent Term Adjustment for Patent Office Delays 4. an unreasonable delay at least shall include a delay in the issuance of a patent of more than five years from the date of filing of the application in the territory of the Party, or three years after a request for examination of the application has been made, whichever is later.

15 Article Patent Term Adjustment for Unreasonable Curtailment 1. Each Party shall make best efforts to process applications for marketing approval of pharmaceutical products in an efficient and timely manner, with a view to avoiding unreasonable or unnecessary delays. 2. With respect to a pharmaceutical product45 that is subject to a patent, each Party shall make available an adjustment of the patent term to compensate the patent owner for unreasonable curtailment of the effective patent term as a result of the marketing approval process.

16 Article Protection of Undisclosed Test or Other Data 1. (a) If a Party requires, as a condition for granting marketing approval for a new pharmaceutical product, the submission of undisclosed test or other data concerning the safety and efficacy of the product, that Party shall not permit third persons, without the consent of the person that previously submitted such information, to market the same or a similar product on the basis of: (i) that information; or (ii) the marketing approval granted to the person that submitted such information, for at least five years53 from the date of marketing approval of the new pharmaceutical product in the territory of the Party.

17 Article Biologics 1. With regard to protecting new biologics, a Party shall either: (a) with respect to the first marketing approval in a Party of a new pharmaceutical product that is or contains a biologic, provide effective market protection through the implementation of Article (Protection of Undisclosed Test or Other Data) and Article , mutatis mutandis, for a period of at least eight years from the date of first marketing approval of that product in that Party

18 C o n s i d e r a ç õ e s F i n a i s

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21 "A Very Big Mistake": Joseph Stiglitz Slams Obama for Pushing the TPP "And the irony is that the president came out and said, "This is about who makes the trade rules China or the United States?" But I think the big issue is, this is about who makes the rules of trade the American people, our democratic process, or the corporations? And who they re made for, which is, for the corporations or for all of us?" Fonte: Democracy Now, November 12, 2015 "One of his big legacy is Obamacare, and that s supposed to bring access to medicine. But when you TPP will go in exactly the wrong way, because it will restrict access to medicine for many countries around the world."

22 Margareth Chan, Diretora-geral da Pacific trade deal could limit affordable drugs: world health chief Organização Mundial da Saúde "If these agreements open trade yet close the door to affordable medicines we have to ask the question: is this really progress at all" Fonte: Reuters, November 12, 2015 "I worry about interference by powerful economic operators in the new targets for alcohol, tobacco and non-communicable diseases, including many that are dietrelated. Economic power readily translates into political power."

23 Título do Slide Obrigada!