Universal Access What to do about patent barriers to access and innovation

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Universal AccessWhat to do about patent barriers
to access and innovation?

• Ellen t Hoen
• MSF Access to Essential Medicines Campaign
• IAS, Mexico 3-8 August 2008

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Effect of Generic Competition
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Fixed Dose Combinations
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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)

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But Times Are Changing

• 2005 WTO TRIPS Agreement fully implemented
• Medicines become patentable everywhere
• India started granting product patents following
  amendment of the Patents Act in 2005
• Affect on the price of new ARVs are becoming
  apparent

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Universal Access to What?
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Responses 1

• 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. TACs complaint at the South African
  Competition Commission and pre grant oppositions

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Responses 2

• Compulsory licensing
• Thailand gt EFV price 1400 Baht (45) to 615 Baht
  (19) a bottle.
• Brazil gt EFV 77 price drop gt increase of
  patients from 23.300 to 75.000
• DCs use government use powers to procure
  generics regardless of patent status
• LDCs exclude product patents when patented
• India strict patentability criteria
• 15 Patent-grant oppositions related to AIDS
  medicines by Indian civil society

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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

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Hand to Hand Combat

• Price increase of newer ARVs and 2nd line ARVs
  lead to rapid increase in cost of treatment
• We can no longer count on automatic generic
  competition to bring prices down
• Threat to scale up, improve care and universal
  access (to what?)
• Patent disputes break out
• ?
• Need for a more systematic approach

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Times are changing again?

• UNITAID Board decided in principle to establish
  a patent pool and set in motion a process to do
  so. (EB8 2 -3 July 08)
• Patent pools of upstream technologies may be
  useful in some circumstances to promote
  innovation relevant to developing countries. WHO
  and WIPO should consider playing a bigger role in
  promoting such arrangements, particularly to
  address diseases that disproportionately affect
  developing countries. (WHO Commission on
  Intellectual Property, Innovation and Public
  Health, April 2006)
• Examine the feasibility of voluntary patent
  pools of upstream and downstream technologies to
  promote innovation of and access to health
  products and medical devices (WHO Global
  Strategy and Plan of Action on public health,
  innovation and intellectual property. May 08)

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What is a patent pool?

• A number of patent rights held by different
  owners are brought together (pooled) and
  collectively managed
• Third parties e.g. generic manufactures of AIDS
  drugs can make use of the patents against the
  payment of a royalty
• One stop shop - no need for case by case
  negotiations

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Patent Pool and WHO recommended improved 1st
line ARV

• New WHO recommended 1st line regimen
• TDF/ 3TC or FTC/ EFV or NVP
• 4 to 11 fold increase in price compared to d4t
  containing regimen
• TDF and FTC Gilead
• 3TC GSK
• EFV Merck
• NVP BI
• TDF/FTC/EFV Gilead/BMS joint patent application

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Patent Pool and 2nd line and paediatric ARVs

• Patent pool would enable the development of FDC
  for both adult and paediatric use
• ATV/r/TDF/3TC once a day second line
• Paediatric new formulations PI adaptable for
  small children e.g. ATV/r - once a day!

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Is the Patent Pool Feasible?

• Political momentum - WHO GSPA paved the way
• UNITAID commitment
• NGO commitment
• Companies initial responses positive
• IFPMA very interesting
• GSK willing to put licensed patents in the pool
• European generics interesting
• Individual companies response at this meeting
  positive e.g. Gilead
• Hard work ahead to succeed
• Devil will be in the details of the licenses,
  remuneration

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Conclusion

• Changed environment post TRIPS era
• Newer products patented in developing countries
• Prices will not come down automatically
• IP barriers to FDC development
• Deliberate action needed to counter the
  consequences of global pharmaceutical patenting
• Momentum to do so