1. IPR &
Access to Medicines in Thailand
Dr. Jiraporn Limpananont
Foundation For Consumers (FFC)
Drug Study Group (DSG)
FTA Watch
Social Pharmacy Research Unit, Faculty of
Pharmaceutical Sciences, Chulalongkorn University.
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Dr. Jiraporn Limpananont, Faculty of Pharmaceutical Sciences, Chulalongkorn University
2. Scope: IPR & Access to Medicines
IPR Protection: Patent Act
Raise up the innovation?
High price, un-affordable
Impact on the Generic Drug Manufacturing: destroy the
local generic drug manufacturer
FTA and Trade Pressure: TRIPs Plus on IPR for drugs
3 Cases of consumers’ movement for Access to
Drugs”
Revocation: ddI case
Pre-grant opposition: combid case
CL implementation
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Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
3. Impact on Generics Industry
R&D on NEW DRUGS
R&D on RAW MATERIALS
R&D on DRUG FORMULATION
A+B
X+Y
FINISHED
ACTIVE
PRODUCTS
INGREDIENTS
Other materials
PROCESS PATENT
PRODUCT PATENT
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Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
4. IPR PROTECTION IN THAILAND
Time Line
•Drug Process Patent
2522(1979)
•15 years patent life
Patent Act:
•Drug Product Patent
2528(1985)
•20 years patent life
USTR:
•Group of pharmacists
•Drug Product Patent
2535(1992) and friends
•20 years patent life
Patent Act: •Cary on research
•Drug Patent Committee
•Advocacy
2538(1995) •TRIPs •People Mobilization
WTO:
2542(1999) •Abolish Drug Patent Committee
Patent Act:
FTA Coming •DATA EXCLUSIVITY
soon?: •Limit CL implementation
•Extension of Exclusity Period
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Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
5. Event on the 6th
round of Thai-US
FTA negotiation
Chiamgmai, Thailand
Jan. 2005
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Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
6. Case 1: Revocation of ddI patent
ddI was invented by US NIH, licensed to BMS, and
not allowed to be patented in developing countries,
BMS did not patent ddI in Thailand but patented
ddI formulation
ddI formulation is not new, no inventive step, but it
was patented
The price is very high
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Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
7. Two ways of solving this problem
Issue the CL since 2000
Result: no CL was issued
Revoke the Patent
Result: BMS negotiated to end the case in the court by
voluntary withdrew this patent
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Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
8. TPN+ Camp asking for CL on ddI patent
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Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
9. Case 2: Pre-grant opposition of combid
Case:
GSK filed for the formulation of AZT 300 mg + 3TC 150 mg
AZT and 3TC were not patented in Thailand
They were already used, not new and no inventive step
The cheap generic version was sold
If it was patented then GSK can monopolize the market, the price
will be very high
Civil Society Movement to
Make opposition to this application
Result:
The process took more than 5 years
Finally GSK withdrew this patent application
Strategies:
Put pressure on the unethical practice of GSK
Mass media campaign and demonstration
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Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
11. Case 3: CL of Government Use
2 ARVs:
Efavirenz commercially known as Stocrin, of MSD (on 29
November 2006)
Lopinavir/Ritonavir commercially known as Kaletra,
made by Abbott (on 24 January 2007)
1 Heart disease drug
Clopidogrel commercially known as Plavix, made by
Sanofi-Aventis (on 25 January 2007)
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Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
12. Diagram to demonstrate that the Government Use of patent does not
affect much on the existing market size of patented products
% of population at each income level
62 million Thais
Social Welfare = 48.5 million
Social Security = 8.5 mil.
Civil Servant Medical
Benefit Scheme = 5 mil. Income
Low High
Out of
People paid by public budget with no or
pocket
limited access to patented drugs – payment –
“New market for drugs from “Existing
market for high
Government Use” price patented
“Public non-commercial use” drugs”
“Commercial
use”
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Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
13. TRIPS flexibilities
Permission
Non Public use: Prior negotiation Royalty
Terms of use
Voluntary licensing
Compulsory licensing
Public Use: No need for prior negotiation
Royalty
National emergency
Terms of use
Extreme urgency
Public non-commercial use
(TRIPS 31(b): DOHA; Thai patent act section
46-52)
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Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
14. After negotiation for 1.5 Yr After CL Announcement
MSD
MSD
- Efavirenz – 1723 to 1401 Baht
- Efavirenz – Now is 770 Baht/Bottle
(~18.7% reduction in Baht
(~ 45% price reduction)
because of the Baht appreciation:
no reduction in terms of USD)
Abbott
Abbott - Strong reaction - 9 Dossier withdrew
- Kaletra – 17548 to 6000 Baht (including Kaletra film-coated tab)
(~66% reduction in Baht or - Kaletra – no WHO pre-qualified pdts
~57% reduction in USD) available (expected to be available in film-
coated tab form in the next few months)
Roche
Roche - Saquinavir has no patent in Thailand,
- Saquinavir – 4852.66 to 4601 but GPO is in the process of production
Baht (~5% reduction in Baht or development.
~15% increase in USD) - Less used in National Health Program
BMS
BMS - Atazanavir (2nd line that can replace
- Atazanavir – No price reduction Lopinavir) – will be negotiated for price
reduction and/or CL
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Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
15. Reaction from USTR and Abbott
Under Section 301, USTR put Thailand on the PWL
Abbott withdrew all applications to register its new
drugs in Thailand
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Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
16. Reaction from Civil Society: boycott Abbott
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Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
17. Demonstration
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Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
18. Worldwide Boycott Abbott’s Products
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Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
19. Conclusion
Patent in the field of pharmaceuticals:
Market driven R&D not Public Health Need driven R&D
No drugs for the treatment of the Poor's diseases
Patented drugs are un-affordable for the Poors
What should we do for access to medicines ?
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Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
