The Medicines Patent Pool                          Stimulating Innovation, Improving                                      ...
Numbers of PLHIV on ART will Rise                                                                         Current         ...
The Context•   Generic competition central to treatment scale-up of past decade         Price of 1st line regimen down to...
The Medicines Patent Pool                                 Public Health Vision                 To improve access to approp...
Three Main Objectives•Enable the development of fixeddose combinations (FDCs) ofwhich the patents are held bydifferent ent...
Where we stand today•    The Medicines Patent Pool is open for business, and a     dialogue has been opened with all known...
Patent Holder EngagementPatent Holder                         Q4 2010                  Q1 2011                            ...
THANK YOUwww.medicinespatentpool.org
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The Medicines Patent Pool - Stimulating Innovation, Improving access

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Presentation with the occasion of the Technical Briefing at World Halth Assembly, Geneva, 18 May 2011

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The Medicines Patent Pool - Stimulating Innovation, Improving access

  1. 1. The Medicines Patent Pool Stimulating Innovation, Improving access Ellen ‘t Hoen Medicines Patent Pool UNITAID Technical Briefing WHA, Geneva 18 May 2011 Despite recent progress in access to HIV medicines, there is still significant need for additional treatment • > 6 million people in developing countries on 35 ART by end of 2009 30People (Millions) • But further 10 million 25 people are in urgent need 20 Will Need  of treatment as per WHO Treatment guidelines 15 In Need of  10 Treatment • An additional 18 million Treated people are HIV positive and 5 will need treatment 0 • 1.2 million new people on 2009 treatment in 2009, but 2.6 million new infectionsSource: World Health Organization. Towards universal access: Scaling up priority HIV/AIDS interventions in the health 2sector. http://www.who.int/hiv/pub/2010progressreport/summary_en.pdf
  2. 2. Numbers of PLHIV on ART will Rise Current Number on ART Tx 2.0 Community25,000,000 Optimised regimen20,000,00015,000,00010,000,000 5,000,000 0 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 Source: UNAIDS Investment Framework - preliminary data. 2011 The Context: HIV/AIDS Market • Low and middle income countries represent a small proportion of current global sales for HIV/AIDS (a fraction of 6%) and highly concentrated in a handful of countries. • For 2nd and 3rd line drugs: less than 3% • But over 90% of the disease burden
  3. 3. The Context• Generic competition central to treatment scale-up of past decade  Price of 1st line regimen down to under 1% of original price• Widespread patenting of newer drugs in developing countries  Limited generic availability and limited price reductions  Differential pricing: not same impact on pricing as robust generic competition• Promising FDCs / formulations often not developed  WHO Committee on Essential Medicines has identified opportunities• Financial crisis  budgets for purchase of HIV medicines not growing• Treatment Needs  WHO Treatment Guidelines (earlier start; drugs with less side effects)  People in developing countries developing resistance to 1st line  Special (unmet) needs of children with HIV New evidence: HIV treatment prevents transmission of HIV Context: Patents on some new ARVs Product +/- Expiry date Atazanavir (Novartis/BMS) 2017 Cobicistat (Gilead) 2027 Darunavir (J&J/Tibotec) 2023 Etravirine (J&J/Tibotec) 2019 Fosamprenavir (ViiV) 2018 GSK 572 –Dolutegravir (ViiV) 2026 Raltegravir (MSD) 2025 Rilpivirine (J&J/Tibotec) 2022 Ritonavir hs (Abbott) 2024 Tenofovir DF (Gilead) 2018 Maraviroc (Pfizer) 2019
  4. 4. The Medicines Patent Pool Public Health Vision To improve access to appropriate affordable HIV treatments in developing countries Medicines Patent Pool Mission The patent pool will bring down the prices of HIV drugs, facilitate the development and production of improved formulations (e.g., fixed dose combinations and paediatric and heat-stable formulations) by providing access to intellectual property relating to these products 7 History of the Medicines Patent Pool 2006 2008 2009 2010 May 2008  CIPIH 2006  Broad stakeholder  WHO Global Strategy  recommendation: consultation and Plan of Action  "Patent pools of  included Voluntary  Establishment of the upstream technologies  Patent Pools  Developed the  Medicines Patent may be useful in some  (upstream and  implementation plan  Pool circumstances to  downstream) for the medicines  promote innovation  patent pool relevant  Formal licensing  July 2008  negotiations begin to developing  Ongoing dialogue with  countries.” UNITAID Executive  Board  patent holders and with  NIH grants first  other ARV drug  MSF and KEI proposed  Supports the principle  licence to the Pool manufacturersto UNITAID to set up a  of establishing a medicines patent pool. patent pool and  requests the  Decision by UNITAID  secretariat to  Board to fund undertake all  necessary actions for  this establishment. UNITAID funds the operations of the Pool under a 5-year8MOU
  5. 5. Three Main Objectives•Enable the development of fixeddose combinations (FDCs) ofwhich the patents are held bydifferent entities•Enable the development ofadapted formulations for childrenor for specific developing countryneeds (e.g., heat stable)•Accelerate the availability ofgeneric versions of new ARVs indeveloping countries • 9 How the Pool Works Royalties Sub- Licensee Licensor Pate nts Sub- Licensee Licensor Patents Sub- Licensee Pool Sub- Patents Licensor Licensee Sub- Licensee Patents Licensor Sub- Licensee Patents Licensor Sub- Licensee Royalties
  6. 6. Where we stand today• The Medicines Patent Pool is open for business, and a dialogue has been opened with all known patent holders• Medicines Patent Pool is fully staffed and equipped to deal with its responsibilities• The NIH became the first to licence patents to the Pool• Negotiations on terms and conditions are on-going with 5 potential licensors• Consultations have also been held with generic manufacturers• External legal / licensing experts in collaboration with WIPO• Prioritisation based on latest scientific evidence in collaboration with the WHO and UNITAID• Information about and produced by the Pool made available on the website• Exploring potential opportunities and financing mechanisms for developing formulations and FDCs with UNITAID, WHO and Chatham House – 11 July London meeting on innovation in HIV treatment 11 Support for the Medicines Patent Pool"One promising “We urge all public “We think that the Medicines "A successfulinitiative that can institutions and Patent Pool is an important patent pool willhelp decrease the pharmaceutical companies initiative towards achieving help in acceleratingcost of patents for to follow the measures universal access to the newer the scaling up ofthe Index taken by the NIH, and to HIV medicines….At WHO we access to care andCountries is the share without delay their will be pleased to give priority treatment and willpatent pool patents on this and other to any of the newly developed reduce the risk ofinitiative of antiretrovirals with the FDCs for assessment by our stock out ofUNITAID" Medicines Patent Pool, in WHO/ UN Prequalification medicines in the order to facilitate access Programme in order to developing world"ATM Index 2010 to these treatments at the facilitate its rapid uptake by(Engagement with Michel Sidibe, lowest possible price for the funding agencies andPP included as UNAIDS Executive countries in need national governments.”one of the issues Director (Julymeasured in the Prof. Kazatchkine, Dr. Hans Hogerzeil, Director 2010)Index) Executive Director Global Essential Medicines and Fund Pharmaceutical policies (October 2010) “This licence underlines the U.S. Government’s commitment to the Medicines Patent Pool and its goal to increase the availability of HIV medicines in developing countries. We are now discussing licensing to the Medicines Patent Pool other patents that could have a positive impact on the treatment of HIV/AIDS.” NIH Director Francis S. Collins, M.D., Ph.D. 12
  7. 7. Patent Holder EngagementPatent Holder Q4 2010 Q1 2011 Sent letter on Not currently in negotiations.Abbott Laboratories 1 December Reply received 26 January Sent letter on Not currently in negotiations.Boehringer-Ingelheim* 1 December Reply received 19 January Sent letter on Not currently in negotiations.Bristol-Myers Squibb* 1 December Reply received 26 January Sent letter onF. Hoffman-La Roche In negotiations 1 December Sent letter onGilead Sciences In negotiations 1 December Sent letter on Not currently in negotiations.Merck & Co.* 1 December Reply received 28 JanuarySequoia Pharmaceuticals In negotiations Sent letter on Not currently in negotiations.Tibotec/Johnson & Johnson* 1 December Reply received 31 January Licence grantedUS National Institutes of Health In negotiations September Sent letter onViiV Healthcare In negotiations 1 December Patent Status Database
  8. 8. THANK YOUwww.medicinespatentpool.org

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