E-Book, Englisch, Band 25, 275 Seiten, Format (B × H): 153 mm x 227 mm
Mitsuuchi Kunisawa The TRIPS Agreement Implementation in Brazil
1. Auflage 2015
ISBN: 978-3-8452-5962-8
Verlag: Nomos
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)
Patents in the Pharmaceutical Area
E-Book, Englisch, Band 25, 275 Seiten, Format (B × H): 153 mm x 227 mm
Reihe: Munich Intellectual Property Law Center - MIPLC
ISBN: 978-3-8452-5962-8
Verlag: Nomos
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)
Brazil?s insertion into the World Trade Organization (WTO) has stimulated economic growth, as the country has been benefiting from lower trade barriers. The country has accepted the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) ? Annex 1C of the WTO agreement ? which sets out minimum standards of protection for Intellectual Property (IP) rights. Law No. 9,279, of May 14, 1996 was enacted to comply with TRIPS, suppressed restrictions to patentable subject matter, allowing patents in the pharmaceutical field. The granting of compulsory licenses as one of the flexibilities to patent rights provided in TRIPS and in the Brazilian law plays an important role in the governmental program of free distribution of drugs for the treatment of AIDS, evidencing the complex relationship between private and public interests.
This study has been conducted with use of bibliographical method, providing for an analysis of the Brazilian patent law within the framework provided by TRIPS. The provisions on patents in the pharmaceutical area and compulsory license have been chosen to serve as the main driver for such analysis.
Viviane Yumy Mitsuuchi Kunisawa is a Brazilian attorney specialized in IP Law.
Autoren/Hrsg.
Fachgebiete
Weitere Infos & Material
1;Cover;1
2;I. CHAPTER. INTRODUCTION;18
3;II. CHAPTER. THE FRAMEWORK OF TRIPS;24
3.1;A. Brazilian context prior to TRIPS;24
3.2;B. TRIPS Agreement;27
3.2.1;1. General Principles;27
3.2.2;2. TRIPS Provisions on Patent Law;35
3.2.2.1;2.1. Patentable Subject Matter and Conditions on Patent Applicants;35
3.2.2.2;2.2. Rights Conferred and Term of Protection;44
3.2.2.3;2.3. Flexibilities within TRIPS concerning Patents;48
3.2.2.3.1;2.3.1. Rules on Implementation and Protection of Existing Subject Matter;49
3.2.2.3.2;2.3.2. Exclusions from Patentable Subject Matter;56
3.2.2.3.3;2.3.3. Exhaustion and Parallel Importation;57
3.2.2.3.4;2.3.4. General Exception Rules;62
3.2.2.3.5;2.3.5. Compulsory Licenses;65
3.2.2.4;2.4. Other Provisions;72
3.2.3;3. The Pharmaceutical Industry Context;74
3.2.3.1;3.1. The Doha Declaration on the TRIPS Agreement and Public Health;77
3.2.3.2;3.2. The Decision Implementing Paragraph 6 of the Doha Declaration;80
3.3;C. Remarks on the Applicability of TRIPS in Brazil;83
4;III. CHAPTER. THE BRAZILIAN PATENT SYSTEM;88
4.1;A. Overview;88
4.1.1;1. The Constitutional Clause;88
4.1.2;2. General Provisions on Patentability;90
4.1.3;3. Term of Protection and Rights Conferred by Patents;94
4.2;B. Patents on Pharmaceuticals;105
4.2.1;1. The Prior Consent Requirement;105
4.2.1.1;1.1 ) Introduction of Article 229-C in the Patent Statute and Competence of the ANVISA;105
4.2.2;2. Second Medical Use Inventions;117
4.2.2.1;2.1 ) INPI Examination Guidelines, ANVISA Policies and Debates on New Examination Guidelines;117
4.2.2.2;2.2 ) Discussions in Congress and Court Decisions;122
4.2.2.3;2.3 ) Further Remarks;128
4.3;C. Provisions on Compulsory License;129
4.3.1;1. Previous Law;130
4.3.2;2. Provisions of Law 9279/1996;131
4.3.2.1;2.1 ) Abuse of Economic Power and Lack of Local Exploitation;132
4.3.2.1.1;2.1.1 ) Abusive Exercise of Rights or Abuse of Economic Power;132
4.3.2.1.2;2.1.2 ) Insufficient or Non-Exploitation in Brazilian Territory;136
4.3.2.1.2.1;2.1.2.1 ) Analysis under TRIPS;137
4.3.2.1.2.2;2.1.2.2 ) The Panel filed by the USA before the WTO;141
4.3.2.1.3;2.1.3 ) Economic Capacity of the Licensee and the Importation Exception;143
4.3.2.2;2.2 ) Dependent Patents;144
4.3.2.3;2.3 ) Procedural Aspects;145
4.3.2.4;2.4 ) Cases of National Emergency or Public Interest;146
5;IV. CHAPTER. ANALYZING THE BRAZIL CASE;152
5.1;A. General Overview: Brazilian statistics and the public healthcare system;152
5.2;B. AIDS in Brazil;156
5.2.1;1) Statistics;156
5.2.2;2) The Anti-AIDS Program;158
5.3;C. The Cases of Kaletra and Efavirenz;160
5.4;D. Impacts of the WTO Free Trading System on Brazil;168
5.4.1;1. The Panel Against the US for Cotton Subsidies;169
5.4.1.1;1.1. Cross-retaliation on IP rights;170
5.4.1.2;1.2. Ongoing Discussions;173
5.4.2;2. Remarks on the Overall Pharmaceutical Scenario;176
6;V. CHAPTER. CONCLUDING REMARKS;180
7; ANNEX: Law 9279, of May 14, 1996;184
8; Bibliography;236
8.1;I. Books, Articles, Manuscripts and Other Documents;236
8.2;II. International Treaties / National Legislation;259
8.3;III. Cases;267
