Background Documents: Materials of Interest*

    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

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

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

  10. 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]

  11. 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

  12. 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

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

  14. 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

  15. World Health Organization
  16. 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 Jorge Bermudez Carsten Fink John Fraser Elisabet Helsing James Love Malebona Precious Matsoso Thomas Mays Priti Radhakrishnan Jerome Reichman Pedro Roffe Ellen ‘t Hoen


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