Overcoming patent barriers to access and innovation for HIV by ert554898

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									  Overcoming patent barriers to access and
innovation for HIV medicines: the role of the
     UNITAID Medicines Patent pool:



                  Michelle Childs
            Director Policy Advocacy
   MSF Access to Essential Medicines Campaign
         Brasilia 5th-6th November 2009
Fixed Dose Combinations
      Access to Medicines:
the Effect of Generic Competition
         Access to Generics
• Until 2005 India ’s excluded pharmaceutical products
  from patenting (1970 Patents Act)

• 80% of ARVs MSF uses are purchased in India

• “Generics fuel Aids Programme”: Generics accounted
  for 57% of $131 million U.S. PEPFAR spending in
  2007 (WSJ, 31 July 08)
        But things have changed…
• 2005: WTO TRIPS agreement now fully
  implemented – globalisation of patent rules
• As a result all new drugs will be patented in
  all key generic producing countries (e.g.
  India, Brazil, Thailand)
• … while at the same need for affordable
  newer drugs increases
• Affect on the price of new ARVs are
  becoming apparent
Universal Access to What?
Need for newer drugs: a better first line regimen
                         - stavudine no longer best care -




   Source: MSF briefing document: HIV/AIDS treatment in developing countries: the battle for long term
                                            survival 2009
Need for newer drugs: switch to new
   regimens to keep people alive
                         Medical needs
• MSF project in Rwanda : 1in 6 patients need to switch from
  Stavudine (D4T)
    Improved WHO recommended 1st line treatment using TDF costs 2- 3
    times more
• MSF project in Khayelitsha: 16% of those on treatment for 5
  years need to move to 2nd.
 Can cost up to 17 times more
• 25 % of those on 2nd line for 2 years failing.
 3rd line, if available, can cost 28 times more than generic first line
• Formulations for children and new FDC’s
• 4 million people on treatment , 6 million without- need access
  and innovation NOW
   Difference paid by the Brazilian government as consequence of pipeline patent
          protection for 5 ARV, comparison with MSF UTW,, 2001-2007 (%)

            100



            80



            60

        %
            40



            20



              -
                  Sol.Oral¹




                                                                                                       Lopinavir/r



                                                                                                                     Nelfinavir
                                         Amprenavir



                                                      Amprenavir



                                                                   Efavirenz



                                                                               Efavirenz



                                                                                           Efavirenz




                                                                                                       133/33mg
                  Abacavir



                              Abacavir




                                                                                            Sol.Oral
                               300mg




                                                                                                                      250mg
                                                                    600mg



                                                                                200mg
                                          Sol.Oral²



                                                       150mg²




                                                             medicamentos
                                              %preço mínimo         % diferença MS - MSF


The amount the Brazilian MoH paid more is estimated to be USD 519 millions
(Hasenclever et all)
Patents on New ARVs - if no action taken have to wait till patent
             expires before generic competition
                      source UNITAID
    Product                     +/- Expiry date

    Atazanavir (Novartis)       2017

    Darunavir (Tibotec)         2023

    Etravirine (Tibotec)        2019

    Fosamprenavir (GSK)         2018

    Raltegravir (MSD)           2025

    Ritonavir hs (Abbott)       2024

    Tenofovir DF (Gilead)       2018

    Maraviroc (Pfizer)          2019
Responses 1 - to access and innovation in a world of
                     patents
• Differential pricing
   – Discounts not steep enough and not as effective
     as generic competition
   – No solution to patent barriers to the development
     of FDCs and new formulations e.g. for children
• ‘Voluntary’ licenses
   – Restrictions that hamper full effect of generic
     competitions e.g on trade in API, export markets
   – Rare and response to threats e.g CL or legal
     action, e.g. TAC’s complaint at the South African
     Competition Commission and pre grant
     oppositions
                      Responses 2
• Compulsory licensing
     • Thailand => EFV price 1400 Baht (45$) to 615 Baht (19$) a
       bottle.
     • Brazil ==> EFV 77% price drop benefited from price
       reduction for Lpv/r after Thailand issued CL
     • DC’s use “government use” powers to procure generics
       regardless of patent status
• LDC’s exclude product patents when patented
• India – strict patentability criteria
  – over 15 Patent-grant oppositions related to AIDS
    medicines by Indian civil society
   Prioritising Health over Patent Protection
• Harsh criticism on countries with AIDS programmes
  aiming at universal access that use CL to increase
  access
• Retaliation e.g. Abbott refusal to make new drugs
  avaiable in Thailand (withdrawal of new drug
  applications at the NDRA incl heatstable lopi/r)
• Legal action Novartis against section 3d of the Indian
  Patents Act
• Limiting the scope and effectiveness of TRIPS
  flexibilities through TRIPS+ measures in bilateral
  trade agreements
• Have to fight country by country patent by patent
Response 3 UNITAID medicines
         Patent Pool
  an additional systematic approach to
patent barriers to access and innovation
                  What is a patent pool?
• A number of patent rights ,held by different owners are
  bought together (pooled) and collectively managed
• Pool is created to promote & facilitate more affordable access to
  medical technologies and innovation
   – Def: A portfolio of assets consisting of the entire set of patents
     & related information held by various actors (companies,
     universities, government institutions) related to a particular
     technology that are made available on a non-exclusive basis to
     manufacturers and distributors of medicines
• The patent holders receive royalties that are paid by those who use
    the patents & information. The pool manages the licenses, the
   negotiations with patent holders and the receipt and payment of
                               royalties.
• “One stop shop”- no need for case by case negotiations.
UNITAID Medicines Patent pool- how would it work?

•   Licenses are offered on non-discriminatory
    basis to any person to make, sell, import or
    export
•   A person who used the patents would pay a
    single royalty to the patent pool. The
    amount of that royalty would be determined
    by the Pool
•   The Pool would divide the royalty payments
    amongst the patent owners based on pre
    determined formula that takes into account
    the actual use of each patent in the
    manufacture of products.
           Pool planning is moving fast
• 2006- MSF+KEI made a proposal for a Medicines Patent
  Pool to UNITAID
• 2007- UNITAID carried out a feasibility study

• July 2008- UNITAID board decided in principle to
  established a medicines patent pool for ARV’s ( Brazil on the
  board)
• May 2009- Budget for implementation plan approved

• Aug- Dec 2009- UNITAID finalising implementation plan for
  consideration at Board meeting 14-15th December 2009
• Important UNITAID hears from all stakeholders-
  opportunities for Brazil generics?
• 2010- Establishment of the pool
      13 Guiding Principles of the Medicines Patent Pool
                                                     source UNITAID


1.    Public health driven: The Patent Pool will be driven by public health needs
2.    ARV focus: The Patent Pool will initially focus on antiretroviral (ARVs) medicines
3.    Voluntary: The Patent Pool will operate on a voluntary basis
4.    Additional: The Patent Pool will be additional to other mechanisms and measures to promote access to medicines
5.    Intellectual Property: The Patent pool will operate within the current IP framework; Patent owners will be compensated
      through royalties as appropriate
6.    Developing country focus: The Patent Pool will focus on developing countries Low Income Countries (LIC) & Middle
      Income Countries (MIC)
7.    Price reductions: The Patent Pool will focus on achieving price reductions primarily through increased generic
      competition
8.    Quality assurance : The Patent Pool will leverage existing mechanisms (e.g. WHO pre-qualification, FDA. EMEA) to
      ensure quality medicines are produced
9.    Enable product development: The Patent Pool will enable "access to patents" to facilitate development of appropriate and
      adapted formulations
10.   Standardized licenses: Key license terms and conditions will be standardized across all licensees / licensors to ensure
      transparency
11.   Flexibility The Patent Pool will be sufficiently flexible to adapt to evolving health needs and opportunities
12.   Non discriminatory Licenses: Licenses will be available on a non-exclusive and non-discriminatory basis
13.   Independent entity: The Entity administering the Patent Pool must be independent




                                                                21
  Possible PATENT POOL
       SCENARIOS
How could the UNITAID patent pool
             work?
                                 Scenario I
Without the Patent Pool – Access options for Medicine X

                                                    patent granted for X

                                                  Africa
              patent granted for X



                                                      Africa’s access options:

                    Brazil                            -Originator company of X
                                                      -Local production or importation under CL
     Brazil’s access options:
     - Originator company of X
     - Local production or importation under CL
                                      Scenario II
       With the Patent Pool – Access options for Medicine X


                                           Originator company for X
          PATENT
                                                                       patent granted for X
            POOL
                                                            Africa

                            patent granted for X

 License to Brazilian
Generic Manufactures
                                                                              Africa’s access options:

                        Brazil                                         -Local production (through the pool)

                                                                     - Import from Brazil etc. through the pool
               Brazil’s access options:
                                                                     - Local production or importation under CL
               - Originator company of X
               - Local production or importation through
               the pool.
               - Local production or importation under CL
                    The right pool
• Not a pool at any costs. Details of the licenses, remuneration
  and governance structure crucial.
• Based on medical need- beyond current 1st and 2nd line-
  not dumping ground for old patents
• Needs to apply to all developing countries not defined as
  high income by the World Bank- this is a key issue.
 For production - based on economic realities of generic
  production
 For use- meeting access needs
• For innovation- for new formulations and combinations
• Address market entry & regulatory barriers
https://www.actionformsfaccess.org/pt_BR/action
Company                   Patents Requested     Headquarters
Abbott                    Lopinavir (LPV)       US (Abbott Park, Chicago,
                          Ritonavir (r)         Illinois)
Bristol-Myers Squibb      Didanosine (ddI)      US (New York, NY)
                          Atazanavir
Gilead Sciences           Tenofovir (TDF)       US (Foster City, San
                          Emtricitabine (FTC)   Francisco, CA)
                          GS-9350
                          Elvitegravir
Merck                     Efavirenz (EFV)       US (Whitehouse Station,
                          Raltegravir           NJ)
Pfizer                    Maraviroc (MVC)       US (New York, NY)
Sequoia Pharmaceuticals   SPI-452               US (Gaithersburg, MD)
Johnson & Johnson /       Darunavir             US (Langhorne, PA)
Tibotec                   Etravirine
                          Rilpivirine
Boehringer Ingelheim      Nevirapine (NVP)      Germany
                          Tipranavir
GlaxoSmithKline (GSK)     Lamivudine (3TC)      England
                          Abacavir
                          Fosamprenavir
                       Why these drugs?
• FDCs
   – First-line regimens: need for TDF-based triple combinations
   – Second-line regimens: LPV/r or ATZ/r, Darunavir/r
• Pediatric ARVs
   – Of 22 approved ARVs: 6 have no pediatric indication, 7 have no
     pediatric formulations available- remove patent barriers but will
     need added incentives for development and supply
• Newer drugs
   – Would otherwise be blocked for 20 year patent term
           – Integrase inhibitors: raltegravir, elvitegravir; entry
              inhibitors: maraviroc (MVC); new booster to avoid
              Abbott monopoly on ritonovir: GS 9350, SPI 452; new
              NNRTIs: rilpivirine, etravirine
                 Conclusion
• We have a unique opportunity
• Voluntary approach can avoid confrontation
  and litigation
• Doing nothing is not an option
• Not for any patent pool but a good one,
  based on medical needs and serving the
  needs of people living with HIV in the whole
  of the developing world
• See the vision ( MSF animation)
      Thank you!


For more information please visit:

      www.msfaccess.org

								
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