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Voluntary Licensing: an analysis of current practices and key provisions in antiretroviral voluntary licenses

Voluntary Licensing: an analysis of current practices and key provisions in antiretroviral voluntary licenses C. Park, S. Moon, E. Burrone , P. Boulet , S. Juneja , E. ‘t Hoen , M. Trabanco , R. Harshaw XIX AIDS Conference, Washington 25 July 2012. Introduction and Definition.

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Voluntary Licensing: an analysis of current practices and key provisions in antiretroviral voluntary licenses

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  1. Voluntary Licensing: an analysis of current practices and key provisions in antiretroviral voluntary licenses C. Park, S. Moon, E. Burrone, P. Boulet, S. Juneja, E. ‘t Hoen, M. Trabanco, R. Harshaw XIX AIDS Conference, Washington 25 July 2012

  2. Introduction and Definition • Background • 7 of 8 ARV originator companies engage in non-exclusive voluntary licensing as part of their stated access policies. • But, very little known about various provisions that can be included in voluntary licencesand their impact on access to affordable ARVs. Definition of “Voluntary Licence (VL)” (for purposes of study): A non-exclusive licence (or IFS or NAD) granted to one or more generic producers by an originator company on an ARV as part of the originator’s stated access policy.

  3. Methodology and Research Questions • Methodology • Gatheredpublicly-available sources of information on VLs (company websites, press releases, media reports, Medicines Patent Pool website, MSF Untangling the Web report) on 8 ARV originator companies: Abbott, Boehringer-Ingelheim, BMS, Gilead, J&J, Merck, Roche and ViiVto determine nature and scope of VLs in place. Questions Posed What are the most important aspects of VLs from the perspective of public health? What is current industry practice along these aspects? What is the public health impact of various provisions? What are the “access maximising” provisions?

  4. Current state of voluntary licensing

  5. Key Terms and Conditions Covered • Geographical Scope of VLs • Number of Licensees • Provisions relating to API Manufacturing • Provisions relating to Royalties • Freedom to Co-formulate into FixedDose Combinations • Technology Transfer • Provisions Relating to Data Exclusivity • No-Challenge Clauses • Provisions Relating to Compulsory Licences Other Important Considerations

  6. Geographical Scope

  7. Number of Licensees +

  8. Number of Licensees – current practice • Bilateral negotiations between patent-holders and select generics are common • Selection criteria not known • Licensees have little negotiating power • Generics often accept limited geo scope and restrictions to get started quickly • Only some licencees have significant API manufacturing capacity

  9. Relationship Between Number of Producers and Price Source: MédecinsSans Frontières (MSF), Campaign for Access to Essential Medicines: Untangling the web of antiretroviral price reductions (online edition).[http://utw.msfaccess.org/] 14th edition, July, 2011.

  10. Provisions Related to API Manufacturing 1J. Bumpas and E. Betsch, Exploratory Study on Active Pharmaceutical Ingredient Manufacturing for Essential Medicines,Health, Nuturition and Population Discussion Paper. World Bank, Washington, D.C. 2009.

  11. Provisions on Royalties 2P. Beyer. Developing socially responsible intellectual property licensing policies – voluntary licensing initiatives in the pharmaceutical sector. Research Handbook on Intellectual Property Licensing. Edward Elgar, 2012 (forthcoming). 3J. Love. Remuneration guidelines for non-voluntary use of a patent on medical technologies. Health Economics and Drugs, TCM Series No. 18, UNDP/WHO, New York/Geneva, 2005.

  12. Freedom to Co-formulate Fixed Dose Combinations

  13. Technology Transfer

  14. Provisions Relating to Data Exclusivity

  15. No-Challenge Clauses 4 See Lear, Inc. v. Adkins, 395 U.S. 653 (1969); Commission Regulation (EC) No 772/2004 of 27 April 2004 on the application of Article 81(3) of the Treaty to categories of technology transfer agreements, 2004 O.J. (L 123) 11. 5 See MedImmunev. Genentech, 549 U.S. 118 (2007); Commission Notice, Guidelines on the application of Article 81 of the EC Treaty to technology transfer agreements, 2004 O.J. (C 101) 02, paragraph 112.

  16. Provisions Relating to Compulsory Licences

  17. Other Important Considerations • Freedom to manufacture and sell where there is no patent at origin and at country of destination • Unbundling: when more than one product is licensed, licensee should be able to pick and choose the products and terminate on a product-by-product basis • Avoid exclusive grant-back provisions • Need for transparency of licence agreements

  18. Miscellaneous provisions • Quality Assurance • National Registration Requirements • Grant-back Provisions • PharmacovigilanceRequirements • Anti-Diversion • Pricing Restrictions • Packaging • Dispute resolution • Others…

  19. Conclusions and recommendations • Industry practice on VLs varies widely in geographical scope, number of licensees, freedom to manufacture APIs, and other important terms and conditions • Full evaluation of important terms and conditions hindered as a result of an absence of transparency in VLs • Evaluation of whether VLs enhance access should include critical analyses of many terms and conditions that impact on access • Increased transparency in VL practices should be encouraged, and companies should be encouraged to adopt “access maximising” terms and conditions

  20. Selected References • P. Beyer. Developing socially responsible intellectual property licensing policies – voluntary licensing initiatives in the pharmaceutical sector. Research Handbook on Intellectual Property Licensing. Edward Elgar, 2012 (forthcoming). • J. Bumpas and E. Betsch. Exploratory study on active pharmaceutical ingredient manufacturing for essential medicines, Health, Nutrition and Population Discussion Paper. World Bank, Washington, D.C. 2009, available at: http://www.unido.org/fileadmin/user_media/Services/PSD/BEP/APIExploratoryStudy.pdf • Commission Notice, Guidelines on the application of Article 81 of the EC Treaty to technology transfer agreements, 2004 O.J. (C 101) 02, paragraph 112. • Commission Regulation (EC) No 772/2004 of 27 April 2004 on the application of Article 81(3) of the Treaty to categories of technology transfer agreements, 2004 O.J. (L 123) 11. • Lear, Inc. v. Adkins, 395 U.S. 653 (1969) • J. Love. Remuneration guidelines for non-voluntary use of a patent on medical technologies. Health Economics and Drugs, TCM Series No. 18, UNDP/WHO, New York/Geneva, 2005. • Médecins Sans Frontières (MSF), Campaign for Access to Essential Medicines: Untangling the web of antiretroviral price reductions (online edition).[http://utw.msfaccess.org/] 14th edition 2011. • MedImmune v. Genentech, 549 U.S. 118 (2007)

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