United States

1. US Government Accountability Office, New Drug Development: Science, Business, Regulatory, and Intellectual Property Issues Cited as Hampering Drug Development Efforts, GAO-07-49, Nov. 2006



2. US Federal Trade Commission, Generic Drug Entry Prior to Patent Expiration: An FTC Study, July 2002



3. US Federal Trade Commission, To Promote Innovation: The Proper Balance of Competition and Patent Law and Policy, A Report by the Federal Trade Commission, Oct. 2003



4. US Congressional Research Service, Jim Hahn, Federal Drug Price Negotiation: Implications for Medicare Part D, CRS RL33782, Jan. 2007-03-13



5. Merck v. Integra Lifesciences, 545 US 193 (2005)



6. Remarks by FTC Commissioner Leibowitz, Exclusion Payments to Settle Pharmaceutical Patent Cases: They're B-a-a-a-ck!, April 2006


European Union

7. Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products



8. Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions



9. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use Official Journal L - 311, 28/11/2004, p. 67 - 128, as amended [through Directive 2004/27/EC of the European Parliament and the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use]



10. Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency



11. Regulation (EC) No ./2006 of the European Parliament and of the Council on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems, 12 Apr. 2006



12. Merck v. Primecrown, ECJ, Judgment of the Court of 5 December 1996, Joined cases C-267/95 and C-268/95



13. Bundesverband der Arzneimittel-Importeure v. Bayer, Judgment of the Court, 6 January 2004, In Joined Cases C-2/01 P and C-3/01 P


World Health Organization
14. WHO, Public Health, Innovation and Intellectual Property Rights, Report of the Commission on Intellectual Property Rights, Innovation and Public Health, April 2006

Materials from Participants

Frederick Abbott

• Frederick M. Abbott, Managing the Hydra: The Herculean Task of Ensuring Access to Essential Medicines, in INTERNATIONAL PUBLIC GOODS AND TRANSFER OF TECHNOLOGY AFTER TRIPS (K. Maskus and J. Reichman eds.)(Cambridge Univ. Press 2005)
  • The WTO Medicines Decision: The Political Economy of World Pharmaceutical Trade and the Protection of Public Health, 99 AM. J. INT’L L. 317 (2005)
  • Intellectual Property Provisions of Bilateral and Regional Trade Agreements in Light of U.S. Federal Law, UNCTAD - ICTSD Project on IPRs and Sustainable Development, Issue Paper No. 12, Feb. 2006
  • TRIPS II, Asia and the Mercantile Pharmaceutical War: Implications for Innovation and Access, Stanford Center for International Development, Working Paper No. 308 (Dec. 2006)
  • The Doha Declaration on the TRIPS Agreement and Public Health: Lighting a Dark Corner at the WTO, 5 J. INT’L ECON. L. No. 469 (2002) (Oxford)
  • WTO TRIPS Agreement and Its Implications for Access to Medicines in Developing Countries, Study Paper 2a, Commission on Intellectual Property Rights, United Kingdom, November 2001
• BATTLING HIV/AIDS: A DECISION MAKER’S GUIDE TO THE PROCUREMENT OF MEDICINES AND RELATED SUPPLIES (ed. Y. Tayler 2004), World Bank
• Frederick M. Abbott and Rudolf V. Van Puymbroeck Compulsory Licensing for Public Health: Giving Effect to the Decision on Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, A Guide and Model Documents, World Bank Working Paper No. 61 (2005)

Jorge Bermudez

• Intellectual Property in the Context of the WTO TRIPS Agreement: challenges for public health (Jorge A. Z. Bermudez and Maria Auxiliadora Oliveira eds. 2004) (Oswaldo Cruz)
  
  
• Maria Auxiliadora Oliveira, Jorge Antonio Zepeda Bermudez, Gabriela Costa Chaves and Germán Velásquez, Has the implementation of the TRIPS Agreement in Latin America and the Caribbean produced intellectual property legislation that favours public health? Bulletin of the World Health Organization, Nov. 2004, 82 (11)
  
  
• Gabriela Costa Chaves and Maria Auxiliadora Oliveira, A proposal for measuring the degree of public health–sensitivity of patent legislation in the context of the WTO TRIPS Agreement, Bulletin of the World Health Organization, Jan. 2007, 85 (1)

Carsten Fink

• Carsten Fink and Patrick Reichenmiller, Tightening TRIPS: The Intellectual Property Provisions of Recent US Free Trade Agreements, Trade Note 20, World Bank, Feb. 7, 2005

John Fraser

• John Fraser, EU-US Innovation Seminar, PowerPoint
  
  
• Goldie Blumenstyk, New Guidelines Suggested for Licensing of Academic Inventions, Chronicle of Higher Education, Mar. 16, 2007

Elisabet Helsing

• Historical Document: How to Develop, Make Claims on, and Market Nutraceuticals
  
  
• Policies on the Borderline Between Drugs and Foods

James Love

• James Love and Tim Hubbard, The Big Idea: Prizes to Stimulate R&D for New Medicines, The Ruby Hutchison Memorial Address, KEI Research Paper 2007:1 Presented November 14, 2006, Revised 26 March 2007

Malebona Precious Matsoso

• Harmonisation of Regulatory Requirements

Thomas Mays

• An Overview of Federal Trade Commission Antitrust Activities, presented by Deborah Platt Majoras, Chairman, Prepared Statement of the Federal Trade Commission before the Subcommittee on Antitrust, Competition, and Consumer Rights of the Committee on the Judiciary, United States Senate, March 7, 2007

Priti Radhakrishnan

• Priti Radhakrishnan, India and Second-Line ART, Evaluating the Way Forward, INP+ Discussion Paper, March 2007
  
  
• Tahir Amin, Vishwas Devaiah, Priti Radhakrishnan and Michael Steffen, The Impact of Article 39.3 in India: A Practical Perspective, I-MAK, July 2006
  
  
• Tahir Amin, Pre-Grant Patent Opinions in Vietnam and Their Role in Access to Medicines: A Brief Practical Guide, I-MAK, Nov. 2006
  
  
• Tahir Amin, Chapter 3, Patent Information and Searching (excerpt from forthcoming I-MAK manual on challenging patents in India)

Jerome Reichman

• Jerome H. Reichman, Procuring Essential Medicines Under the Amended TRIPS Provisions: The Prospects For Regional Pharmaceutical Supply Centers, prepared for UNCTAD, Oct. 17, 2006
  
  
• Tracy R. Lewis, Jerome H. Reichman, and Anthony D. So, The Case for Public Funding and Public Oversight of Clinical Trials, Economists’ Voice, www.bepress.com/ev, Jan. 2007

Pedro Roffe

• Pedro Roffe, Bilateral agreements and a TRIPS-plus world: the Chile-USA Free Trade Agreement, Quaker International Affairs Programme, Ottawa (2004)
  
  
• Pedro Roffe, Intellectual Property, Bilateral Agreements and Sustainable Development: The Challenges of Implementation, CIEL 2007
  
  
• Pedro Roffe and Maximiliano Santa Cruz, Los Derechos de Propiedad Intelectual en Los Acuerdos de Libre Comercio Celebrados Por Países de América Latina Con Países Desarrollados, Un-Cepal División de Comercio Internacional E Integración, Serie Comercio Internacional 70 2006

Ellen ‘t Hoen

• Ellen ‘t Hoen, Access to medicines: why it’s time to change the rules, Health Action in Crisis Situations, The Commonwealth Health Ministers Reference Book 2006

 

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