Documents on Compulsory Licensing of Patents on Medical Technologies

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Examples of recent health-related compulsory licenses and disputes.

Examples of national legislation to allow TRIPS-compliant exports of health products produced under compulsory license.

CPTech Page on WTO Negotiations over Paragraph 6 of the Doha Declaration on TRIPS and Public Health.

December 12, 2006. James Love. Letter asking USTR to not interfere with the Thai government decision to issue a government-use license on patents covering the AIDS drug efavirenz.

October 26, 2006. James Love. "Use of competition rules to address abuses of intellectual property rights." In Trinidad at the CARRIBEAN REGIONAL WORKSHOP ON INTELLECTUAL PROPERTY AND ACCESS TO MEDICINES.

2005. James Love. "Remuneration Guidelines for Non-Voluntary Use of a Patent on Medical Technologies." Paper published by the World Health Organization. Health Economics and Drugs, TCM Series No. 18.

November 29, 2005. James Love. Not True that Public Health Emergencies Necessary for Compulsory Licensing of Patents.

February 3, 2003. South Africa - Competition Commission Complaint Against GlaxoSmithKline and Boehringer Ingelheim.
  • Affidavit of James Love.
  • Statement of Information by Consumer Project on Technology Concerning an Alleged Prohibited Practice in Terms of Section 49B(2)(a) of the Competition Act 89 of 1998.
  • Additional documents relating to this case can be found at the Treatment Access Campaign's Webpage on this Case.

  • September 29, 2001, James Love and Michael Palmedo. Examples of Compulsory Licensing of Intellectual Property in the United States.

    September 26, 2001, James Love, Checklist for Fast Track Compulsory Licensing.

    August 21, 2001, James Love Implementing TRIPS safeguards with particular attention to administrative models for compulsory licensing of patents, presented at WHO meeting in Harare, Zimbabwe.

    January 21, 2001. Access To Medicine And Compliance with the WTO TRIPS Accord: Models For State Practice In Developing Countries, report for UNDP Human Development Report.

    January 20, 1999, James Love Frequently asked questions about compulsory licenses

    CPTech page on the Cipro patent dispute.

    CPTech page on the Tamiflu Dispute over shortage of Tamiflu to treat Avian Influenza.

    Background Documents on Legal Framework for Compulsory Licensing                 Index

    October 19, 2005. FAQ published by the World Trade Organization. Compulsory licensing of pharmaceuticals and TRIPS. This is a short, easy-to-read document explaining the current WTO rules for issuing compulsory licenses.

    Treaty Framework on compulsory licensing.

    Compulsory licensing in various countries
  • North America
  • Europe and Russia
  • Asia, Australia and Pacific
  • Sub Saharan Africa
  • North Africa and Middle East
  • Latin America and Caribbean

  • March 1, 2004. Alicia Ely Yamin. Not Just a Tragedy: Access to Medications As A Right Under International Law.

    February, 2005. Covington & Burling. Legal Issues Raised by Rx Council's Compulsory Licensing Proposal.

    Excerpt on compulsory licenses from the 2001 UN Development Report. 2001 UN Development Report. (pdf, see pages 107-108):
    "Turning compulsory license provisions into feasible policy options means creating a legal structure suited to developing countries. Five recommended features:
    1. Administrative approach. Any system that is overly legalistic, expensive to administer or easily manipulated is of little use; the best option is an administrative approach hat can be streamlined and procedural.
    2. Strong government use provisions. The TRIPS agreement gives governments broad powers to authorize the use of patents for public non-commercial use, and this authorization can be fast-tracked, without the usual negotiations. No developing country should have public use provisions weaker than German, Irish, UK or US laws on such practices.
    3. Allow production for export. Legislation should permit production for export when the lack of competition in a class of drugs has given the producer global market power h at impedes access for alternative drugs, or when the legitimate interests of the patent owner are protected in the export market - as when that market provides reasonable compensation.
    4. Reliable rules on compensation. Compensation needs to be predictable and easy to administer; royalty guidelines reduce uncertainty and speed decisions. Germany as used rates from 2-10%, while in Canada the government used to pay royalties of 4%. Developing countries could award an extra 1-2% for products of particular therapeutic value and 1-2% less when research and development as been partly covered by public funds.
    5. Dispute demand disclosure. The onus should fall on the patent holder to back up claims that the royalty rate is inadequate. This will help promote transparency and discourage intimidating but unjustified claims."
    Summer, 2003. Colleen Chien for the Berkeley Technology Law Journal. Cheap Drugs at What Price to Innovation: Does the Compulsory Licensing of Pharmaceuticals Hurt Innovation?

    March, 2003. Richard Epstein. Univeristy of Chicago Law & Economics, Olin Working Paper No. 152. Steady the Course: Property Rights in Genetic

    March 27, 2003. Sherrod Brown. Statement to House Committee on Energy and Commerce.

    September, 2002. Jerome H. Reichman and Catherine Hasenzahl. Published by the UNCTAD/ICTSD Capacity Building Project on Intellectual Property Rights and Sustainable Development. Non-voluntary Licensing of Patented Inventions: Historical Perspective, Legal Framework under TRIPS, and an Overview of the Practice in Canada and the United States of America.

    July, 2002 Udo Schuklenk and Richard Ashcroft. (abstract) Affordable Access to Essential Medication in Developing Countries: Conflicts Between Ethical and Economic Imperatives.

    December 2001. Joseph A. Yosick. Compulsory Patent Licensing for Efficient Use.

    August 9, 2001. Brook Baker. The Importance of Combo Drugs: Another Argument for Compulsory and Voluntary Licenses.

    July 10, 2001. Collection of papers from the International Policy Network. TRIPS and Healthcare: Rethinking the Debate.

    May 25, 2001, Brook K. Baker. TRIPS Reform - Voluntary Licenses, Compulsory Licenses, and Parallel Importation.

    October 2000, Carlos Correa. Integrating Public Health Concerns Into Patent Legislation in Developing Countries.

    October 1999, Carlos Correa. Intellectual Property Rights and the Use of Compulsory Licences: Options for Developing Countries.

    July 1999. Marget Duckett, Compulsory Licensing and Parallel Importing: What do they mean? Will they improve access to essential drugs for people living with HIV/AIDS?

    May 1998. Backgrounder on Compulsory Licensing distributed at 51th World Health Assembly.

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