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

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

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

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

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

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

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

TPN+ Camp asking for CL on ddI patent
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Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand

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

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Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand

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

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

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

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

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

Reaction from Civil Society: boycott Abbott
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Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand

Demonstration
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Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand

Worldwide Boycott Abbott’s Products
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Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand

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

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Dr. Jiraporn Limpananont, Faculty of Pharmaceutical Sciences, Chulalongkorn University