The TRIPS Agreement Implementation in Brazil

1 - Cover [Seite 1]
2 - I. CHAPTER. INTRODUCTION [Seite 18]
3 - II. CHAPTER. THE FRAMEWORK OF TRIPS [Seite 24]
3.1 - A. Brazilian context prior to TRIPS [Seite 24]
3.2 - B. TRIPS Agreement [Seite 27]
3.2.1 - 1. General Principles [Seite 27]
3.2.2 - 2. TRIPS Provisions on Patent Law [Seite 35]
3.2.2.1 - 2.1. Patentable Subject Matter and Conditions on Patent Applicants [Seite 35]
3.2.2.2 - 2.2. Rights Conferred and Term of Protection [Seite 44]
3.2.2.3 - 2.3. Flexibilities within TRIPS concerning Patents [Seite 48]
3.2.2.3.1 - 2.3.1. Rules on Implementation and Protection of Existing Subject Matter [Seite 49]
3.2.2.3.2 - 2.3.2. Exclusions from Patentable Subject Matter [Seite 56]
3.2.2.3.3 - 2.3.3. Exhaustion and Parallel Importation [Seite 57]
3.2.2.3.4 - 2.3.4. General Exception Rules [Seite 62]
3.2.2.3.5 - 2.3.5. Compulsory Licenses [Seite 65]
3.2.2.4 - 2.4. Other Provisions [Seite 72]
3.2.3 - 3. The Pharmaceutical Industry Context [Seite 74]
3.2.3.1 - 3.1. The Doha Declaration on the TRIPS Agreement and Public Health [Seite 77]
3.2.3.2 - 3.2. The Decision Implementing Paragraph 6 of the Doha Declaration [Seite 80]
3.3 - C. Remarks on the Applicability of TRIPS in Brazil [Seite 83]
4 - III. CHAPTER. THE BRAZILIAN PATENT SYSTEM [Seite 88]
4.1 - A. Overview [Seite 88]
4.1.1 - 1. The Constitutional Clause [Seite 88]
4.1.2 - 2. General Provisions on Patentability [Seite 90]
4.1.3 - 3. Term of Protection and Rights Conferred by Patents [Seite 94]
4.2 - B. Patents on Pharmaceuticals [Seite 105]
4.2.1 - 1. The Prior Consent Requirement [Seite 105]
4.2.1.1 - 1.1 ) Introduction of Article 229-C in the Patent Statute and Competence of the ANVISA [Seite 105]
4.2.2 - 2. Second Medical Use Inventions [Seite 117]
4.2.2.1 - 2.1 ) INPI Examination Guidelines, ANVISA Policies and Debates on New Examination Guidelines [Seite 117]
4.2.2.2 - 2.2 ) Discussions in Congress and Court Decisions [Seite 122]
4.2.2.3 - 2.3 ) Further Remarks [Seite 128]
4.3 - C. Provisions on Compulsory License [Seite 129]
4.3.1 - 1. Previous Law [Seite 130]
4.3.2 - 2. Provisions of Law 9279/1996 [Seite 131]
4.3.2.1 - 2.1 ) Abuse of Economic Power and Lack of Local Exploitation [Seite 132]
4.3.2.1.1 - 2.1.1 ) Abusive Exercise of Rights or Abuse of Economic Power [Seite 132]
4.3.2.1.2 - 2.1.2 ) Insufficient or Non-Exploitation in Brazilian Territory [Seite 136]
4.3.2.1.2.1 - 2.1.2.1 ) Analysis under TRIPS [Seite 137]
4.3.2.1.2.2 - 2.1.2.2 ) The Panel filed by the USA before the WTO [Seite 141]
4.3.2.1.3 - 2.1.3 ) Economic Capacity of the Licensee and the Importation Exception [Seite 143]
4.3.2.2 - 2.2 ) Dependent Patents [Seite 144]
4.3.2.3 - 2.3 ) Procedural Aspects [Seite 145]
4.3.2.4 - 2.4 ) Cases of National Emergency or Public Interest [Seite 146]
5 - IV. CHAPTER. ANALYZING THE BRAZIL CASE [Seite 152]
5.1 - A. General Overview: Brazilian statistics and the public healthcare system [Seite 152]
5.2 - B. AIDS in Brazil [Seite 156]
5.2.1 - 1) Statistics [Seite 156]
5.2.2 - 2) The Anti-AIDS Program [Seite 158]
5.3 - C. The Cases of Kaletra and Efavirenz [Seite 160]
5.4 - D. Impacts of the WTO Free Trading System on Brazil [Seite 168]
5.4.1 - 1. The Panel Against the US for Cotton Subsidies [Seite 169]
5.4.1.1 - 1.1. Cross-retaliation on IP rights [Seite 170]
5.4.1.2 - 1.2. Ongoing Discussions [Seite 173]
5.4.2 - 2. Remarks on the Overall Pharmaceutical Scenario [Seite 176]
6 - V. CHAPTER. CONCLUDING REMARKS [Seite 180]
7 - ANNEX: Law 9279, of May 14, 1996 [Seite 184]
8 - Bibliography [Seite 236]
8.1 - I. Books, Articles, Manuscripts and Other Documents [Seite 236]
8.2 - II. International Treaties / National Legislation [Seite 259]
8.3 - III. Cases [Seite 267]