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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
                    30
People (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 infections


Source: World Health Organization. Towards universal access: Scaling up priority HIV/AIDS interventions in the health   2
sector. http://www.who.int/hiv/pub/2010progressreport/summary_en.pdf
Numbers of PLHIV on ART will Rise

                                                                         Current
                                    Number on ART                        Tx 2.0
                                                                         Community
25,000,000                                                               Optimised regimen



20,000,000



15,000,000



10,000,000



 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
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
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
                                                             manufacturers
to 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
Three Main Objectives



•Enable the development of fixed
dose combinations (FDCs) of
which the patents are held by
different entities

•Enable the development of
adapted formulations for children
or for specific developing country
needs (e.g., heat stable)

•Accelerate the availability of
generic versions of new ARVs in
developing 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
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 successful
initiative that can   institutions and             Patent Pool is an important        patent pool will
help decrease the     pharmaceutical companies     initiative towards achieving       help in accelerating
cost of patents for   to follow the measures       universal access to the newer      the scaling up of
the Index             taken by the NIH, and to     HIV medicines….At WHO we           access to care and
Countries is the      share without delay their    will be pleased to give priority   treatment and will
patent pool           patents on this and other    to any of the newly developed      reduce the risk of
initiative of         antiretrovirals with the     FDCs for assessment by our         stock out of
UNITAID"              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 and
PP included as                                                                        UNAIDS Executive
                      countries in need            national governments.”
one of the issues                                                                     Director (July
measured 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
Patent Holder Engagement
Patent 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 on
F. Hoffman-La Roche                                         In negotiations
                                    1 December
                                   Sent letter on
Gilead Sciences                                             In negotiations
                                    1 December
                                   Sent letter on    Not currently in negotiations.
Merck & Co.*
                                    1 December        Reply received 28 January

Sequoia Pharmaceuticals                                     In negotiations

                                   Sent letter on    Not currently in negotiations.
Tibotec/Johnson & Johnson*
                                    1 December        Reply received 31 January
                                   Licence granted
US National Institutes of Health                            In negotiations
                                      September
                                   Sent letter on
ViiV Healthcare                                             In negotiations
                                    1 December




                              Patent Status Database
THANK YOU




www.medicinespatentpool.org

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The Medicines Patent Pool - Stimulating Innovation, Improving access

  • 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 30 People (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 infections Source: World Health Organization. Towards universal access: Scaling up priority HIV/AIDS interventions in the health 2 sector. http://www.who.int/hiv/pub/2010progressreport/summary_en.pdf
  • 2. Numbers of PLHIV on ART will Rise Current Number on ART Tx 2.0 Community 25,000,000 Optimised regimen 20,000,000 15,000,000 10,000,000 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. 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. 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 manufacturers to 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. Three Main Objectives •Enable the development of fixed dose combinations (FDCs) of which the patents are held by different entities •Enable the development of adapted formulations for children or for specific developing country needs (e.g., heat stable) •Accelerate the availability of generic versions of new ARVs in developing 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. 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 successful initiative that can institutions and Patent Pool is an important patent pool will help decrease the pharmaceutical companies initiative towards achieving help in accelerating cost of patents for to follow the measures universal access to the newer the scaling up of the Index taken by the NIH, and to HIV medicines….At WHO we access to care and Countries is the share without delay their will be pleased to give priority treatment and will patent pool patents on this and other to any of the newly developed reduce the risk of initiative of antiretrovirals with the FDCs for assessment by our stock out of UNITAID" 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 and PP included as UNAIDS Executive countries in need national governments.” one of the issues Director (July measured 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. Patent Holder Engagement Patent 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 on F. Hoffman-La Roche In negotiations 1 December Sent letter on Gilead Sciences In negotiations 1 December Sent letter on Not currently in negotiations. Merck & Co.* 1 December Reply received 28 January Sequoia Pharmaceuticals In negotiations Sent letter on Not currently in negotiations. Tibotec/Johnson & Johnson* 1 December Reply received 31 January Licence granted US National Institutes of Health In negotiations September Sent letter on ViiV Healthcare In negotiations 1 December Patent Status Database