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HIV Treatment and Intellectual Property Rights: The Experience of the Medicines Patent Pool

HIV Treatment and Intellectual Property Rights: The Experience of the Medicines Patent Pool Esteban Burrone Melbourne – International AIDS Conference July 2014. Innovation in HIV treatment. 29 new ARV molecules developed for the treatment of HIV since virus discovered

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HIV Treatment and Intellectual Property Rights: The Experience of the Medicines Patent Pool

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  1. HIV Treatment and Intellectual Property Rights: The Experience of the Medicines Patent Pool Esteban Burrone Melbourne – International AIDS Conference July 2014

  2. Innovation in HIV treatment • 29 new ARV molecules developed for the treatment of HIV since virus discovered • Several fixed dose combinations developed that contain 3 or 4 ARVs in one single pill • Innovation on an unprecedented scale • Need to ensure access

  3. Patents on new ARVs * Secondary patents on some of these products may extend patent protection beyond the date shown.

  4. Increased Patenting of ARVs in Developing Countries • Increased patenting of ARVs in developing countries for ARVs developed since 1995 • Analysis based on information for 75 developing countries accounting for 80% of people living with HIV Source: Medicines Patent Pool Patent Status Database on Selected ARVs (2012)

  5. Pattern particularly visible in key countries of production of generic ARVs • Patenting of ARVs in developing countries is more common for medicines developed after 1995 than for those developed before 1995 (date of entry into force of the TRIPS agreement) Source: Medicines Patent Pool Database

  6. Challenges for Fixed Dose Combinations Genericaccess  Genericaccess Patent held by A • Fixed-dose combinations improve treatment adherence for adults and children alike • But patents on single ARV can impact on the development of whole FDC • There are also patents on the combinations themselves

  7. Long Lag from Originator Market Approval to Generic Availability • Time from US FDA approval of new ARV molecules to availability as quality assured generics for developing countries has generally ranged from 5 to 10 years Timeline From Originator Approval to Generic Availability: FDA/EMA Approval Generic Approvals Years

  8. The Medicines Patent pool

  9. Medicines Patent Pool PATENT HOLDERS MANUFACTURERS PEOPLE LIVING WITH HIV Sub- Licences Licences Medicines ROYALTIES Established in 2010 with the support of

  10. Key objectives Promote development of special formulations needed for children living with HIV Promote robust competition to enable price reductions for new ARVs Facilitate the development of fixed-dose combinations Accelerate availability of new ARVs in developing countries

  11. Prioritising HIV Medicines IP Analysis: “Which drugs are patented in developing countries?” Clinical Analysis: “Which drugs are most important for HIV treatment?” + = MPP priorities

  12. List of MPP Product Priorities

  13. Key Elements of MPP licences • Negotiated from a public health perspective • Non-exclusive licensing to qualified generic manufacturers • Publication of full text of all licences • More developing countries are able to benefit • Enable development of fixed-dose combinations and paediatric formulations • Possibility of technology transfer • Enable supply to countries using TRIPS flexibilities • Seek inclusion of provisions to open up markets for key medicines Raising the bar for licensing in the HIV field

  14. MPP Agreements Concluded Agreements Under negotiation • TenofovirDisoproxil • Fumarate (TDF) • Emtricitabine • Cobicistat • Elvitegravir • Abacavir (paediatric) • Dolutegravir • Raltegravir (paediatric) • Atazanavir • Darunavir(only secondary patent) • TenofovirAlafenamideFumarate (TAF) • Valganciclovir (discounted price) • Lopinavir (paediatric) • Ritonavir (paediatric)

  15. Medicines Patent Pool Out-Licensing • MPP has licensed 7 ARVs to 10 generic partners: • TenofovirDisproxilFumarate • Emtricitabine • Elvitegravir • Cobicistat • Abacavir (paediatric) • Atazanavir • Dolutegravir • Currently managing 35 sub-licences

  16. Proportion of people living with HIV by country income category, 2000 - 2020 Key Challenge: inclusion of certain middle-income countries in licences Source: UNAIDS, IMF 2012

  17. One possible approach to address challenge in some MICs • Market Segmentation (public/private) • In many countries, national treatment programs cater for vast majority of people on treatment • Generics able to supply national treatment programs • Originators continue to cater for small private market • Introduce royalties that are differentiated according to countries’ socio-economic circumstances • Enables countries to benefit from robust generic competition which results in lower prices • Royalty could take into account different variables: GDP per capita, inequality, disease burden, others

  18. Thank you eburrone@medicinespatentpool.org

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