Patent Pools
Increasing access to
Medicines and Innovation
Ellen „t Hoen
MSF Access to Essential Medicines Campaign
Barcelona 9 Dec. 2008
Effect of Generic Competition
Fixed Dose Combinations
Access to Generics
• Until 2005 India ‟s excluded pharmaceutical products from
patenting (1970 Patents Act)
• Overall, 60% of ARVs taken by 3 million people on
treatment are from India
• 1st line ARV only, 75-80% are from India
• 80% of ARVs MSF uses are purchased in India
• “Generics fuel Aids Programme”: Generics accounted for
57% of $131 million U.S. PEPFAR spending in 2007
(WSJ, 31 July 08)
But …Times Are Changing
• 2005 WTO TRIPS Agreement fully implemented
• Medicines become patentable everywhere
• India started granting product patents following
amendment of the Patents Act in 2005
• China started product patents in 1993
• Affect on the price of new medicines are
becoming apparent
Access to treatment for CMV
retinitis
CMV retinitis is an infection of the eye that
most commonly occurs in people at an
advanced stage of AIDS who have severely
weakened immune systems (CD4 white
blood cell count of less than 50). Early
detection is crucial because vision loss is
irreversible once it has begun.
Valganciclovir
• Valganciclovir price: US$ 10,000 per
treatment
• Patented in India
• MSF asked a better price to Roche
Results of 2 years of talks with Roche
• Sets the price: 500 CHF per pack
(60 tabs of 450 mg ) US$ 1,900 per treatment
• Determines where it can be used: initially for Sub-Saharan
African Countries, least-developed countries, after complaints
middle income countries
• Determines the indication: for use in AIDS patients only
• Determines who can use it: by NGOs only
• Where to buy it: purchasing directly from Basel, Switzerland
(special labeling) min. USD10,000 order
• How: Through import only (not from local suppliers) not
available where we need it e.g. China
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. 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 ==> increase of
patients from 23.300 to 75.000
• DC‟s use “government use” powers to procure
generics regardless of patent status
• LDC‟s exclude product patents when patented
• India – strict patentability criteria
– 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
available in Thailand (withdrawal of new drug
applications incl heat-stable 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
Hand to Hand Combat
• Price increase of newer medicines 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
• Patent disputes break out – including over
treatments for non-infectious diseases
Need for a more systematic approach
to deal with monopolies
Doha Declaration
“We affirm that the (TRIPS) Agreement can and
should be interpreted and implemented in a
manner supportive of WTO Members' right to
protect public health and, in particular, to
promote access to medicines for all.”
WTO Ministerial Declaration on the TRIPS
Agreement and Public Health
November 14, 2001
WHO Commission on IP,
Innovation and Public Health
(CIPIH)
• “For diseases affecting millions of poor
people in developing countries, patents
are not a relevant factor or effective in
stimulating R&D and bringing new
products to the market”
WHO commission on intellectual property, innovation and public health,
April 2006
World Health Assembly
- to encourage the development of proposals for health-
needs driven research and development for discussion at
the Intergovernmental Working Group that includes a
range of incentive mechanisms including also addressing
the linkage between the cost of research and
development and the price of medicines, vaccines,
diagnostic kits and other health-care products and a
method for tailoring the optimal mix of incentives to a
particular condition or product, with the objective of
addressing diseases that disproportionately affect
developing countries; (WHA 60.30)
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)
What is a patent pool?
• A number of patent rights held by different owners
(companies, universities, government institutions)
are brought together (pooled) and made available
on a non-exclusive basis to manufacturers and
distributors of medicines against the payment of
royalties.
• Third parties e.g. generic manufactures of drugs
can make use of the patents against the payment of
a royalty
• “One stop shop” - no need for case by case
negotiations
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
• Potentially 5 patent holders:
– TDF and FTC– Gilead
– 3TC – GSK
– EFV – Merck
– NVP – BI
– TDF/FTC/EFV – Gilead/BMS joint patent application
Is the Patent Pool Feasible?
• Political momentum
– WHO IP/PH negotiations paved the way
– UNITAID commitment
– NGO commitment
• Companies‟ initial responses positive:
– IFPMA “very interesting”
– European Generics Association: “interesting”
– Indian Generics Association endorsed UNITAID‟s board decision
– Individual companies response positive
• Hard work ahead to succeed
– Devil will be in the details of the licenses
– If any of you can help let us know!
Conclusion
• Changed environment post TRIPS era
• Newer products patented in developing countries
– Prices will not come down automatically
– IP barriers to the development of specific
formulations e.g. FDC
• Deliberate action needed to counter the consequences
of global pharmaceutical patenting
– Use of the flexibilities in patent law by governments e.g.
compulsory licensing
– New licensing mechanisms: UNITAID Patent Pool
– Alternative mechanisms for R&D financing
Thank You!
http://www.accessmed-msf.org/
Ellen.t.hoen@paris.msf.org