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.
1
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
2
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
3
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
4
Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand

5. Event on the 6th
round of Thai-US
FTA negotiation
Chiamgmai, Thailand
Jan. 2005
5
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
6
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
7
Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand

8. TPN+ Camp asking for CL on ddI patent
8
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
9
Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand

10. 10
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)
11
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”
12
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)
13
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
14
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
15
Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand

16. Reaction from Civil Society: boycott Abbott
16
Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand

17. Demonstration
17
Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand

18. Worldwide Boycott Abbott’s Products
18
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 ?

19
Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand

20. 20
Dr. Jiraporn Limpananont, Faculty of Pharmaceutical Sciences, Chulalongkorn University