Transcript The Impact of US Thai FTA A Civil Society Perspective

The impact of US-Thai FTA:
a civil society perspective
Dr. Jiraporn Limpananont
• Drug Study Group (DSG), coalition
member of FTA Watch
• Social Pharmacy Research Unit
Chulalongkorn University
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Overview Presentation
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Bilateral Negotiation US-Thailand
Recent US FTAs go beyond TRIPs (TRIPs Plus)
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Extension of Patent Term
Data Exclusivity
Linkage bet. Patent Status and Drug Registration
Limitation on CL application
Economic, Social and Development Implications
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

Affordability of Medicine
R&D of Local Drug Industry
Patent Granting Cost
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TRIPs Plus in recent US FTAs
Extension of Patent Term
 Protection Exclusivity
 Linkage bet. Patent Status and Drug
Registration
 Limitation on CL application

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1. Extension of Patent Term
Au
CA
FT
A
B
R
- Delay by Drug Registration
X X X X X X
- Delay by Pat. Grant. Process
- - - - - >4 yrs from filing
X - X X
>5 yrs from filing
- X - >2 yrs after a request for exam
X - X X
>3 yrs after a request for exam
- X - -
X
X
X
-
X
X
X
-
Extension of Patent Term
VN
JD
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G
Chi Mo
li roc
co
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Extension of patent term

Unreasonable provision in the field of drug:

to compensate for up-front administrative or
regulatory delays in granting the original patent
Filing date
0
Patent term
Expired date
20 years
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2. Data Exclusivity
Test Data Protection
-TRIPs std
-Data Exclusivity
-“reasonable period”
- 5 yrs
-Plus 3 yrs Data Exclusivity by
new clinical info.
VN
JD
S
G
Chi Mo
li roc
co
Au
CA
FT
A
B
R
X
X
X X X X X X
X X X
In this period no any flexibility in TRIPs can be applied
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PhRMA
“Special 301” Submission Priority Watch List Countries
Thailand should provide an effective period of data
exclusivity of at least five years, and we look to the
Government of Thailand to implement this in
advance of the U.S.-Thai Free Trade Agreement
(FTA) negotiations.
 In July 2002 the Royal Thai government adopted
into law a Trade Secret Act. However, Thailand does
not yet provide effective protection for intellectual
property, especially for data exclusivity as called for
by TRIPS Article 39.3.

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Thai Trade Secret Act 2002

Art. 15: As a condition in law requiring of the
marketing of pharmaceutical or of agricultural
chemical products which utilize new chemical
entities, the submission of undisclosed test or other
data, to the government agency, the origination of
which involves a considerable effort and they are
notified to be protected, the government agency
must protect such data from disclosure and against
unfair commercial use.
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TRIPS Article 39.3

As a condition of approving the
marketing of
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pharmaceutical or agri. chemical products
new chemical entities
undisclosed test or other data
protect such data against


disclosure
unfair commercial use
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Argentina-US
WTO Dispute Case on TRIPs 39.3

“…… The Governments of the United States
and Argentina have expressed their respective
points of view on the provisions of Article
39.3 of the TRIPS Agreement, and have
agreed that differences in interpretations shall
be solved under the DSU rules……..”
 Ref: WT/DS171/3, WT/DS196/4,
IP/D/18/Add.1, IP/D/22/Add.1, 20 June 2002
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unfair commercial use
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GENERIC DRUG REGISTRATION IS
USED/RELIED ON UNDISCLOSED
DATA OF ORIGINAL DRUG?
NO
POST-MARKET SURVEILLANCE
ORIGINALS
-SUBMIT UNDISCLOSED
(SAFETY & EFFICACY DATA)
GENERICS
-SUBMIT BIOEQUIVALENT
STUDY
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DATA EXCLUSIVITY in FTA
YEAR
YEAR
NO PATENT
0 APPLY for PATENT
1 DRUG REGISTRATION
2 DRUG APPROVED to be in MARKET
DATA EXCLUSIVITY
5-10 Yrs.
18 DRUG REGISTRATION
19 DRUG APPROVED to be in MARKET
20 PATENT LIFE 20 Yrs.
DATA EXCLUSIVITY
5-10 Yrs.
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3. Linkage between Patent status
and Drug Registration
Linkage bet. Patent status and
Drug Registration
-NONE
-Patent holder must be notified
when generic co. request market
approval during patent term
-Market approval of generic
drugs is prohibited
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Chi Mo
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FT
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X
X X X X X X X
X X X X X X
FDA is bound to create market monopoly and protect the
interest of drug company instead of public interest.
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4. Limitation on CL application
Limitation on CL application
VN
JD
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Chi Mo
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Au
CA
FT
A
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-TRIPs std
X X
X X
-Limit to emergency, as antitrust X X X
X
remedy and for public noncommercial use
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Economic, Social
and Development Implications
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Accessibility to Drugs
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
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High Price
No Flexibility in TRIPs can be applied
R&D of Local Drug Manufacturer
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Generic drugs can not be developed
No supply of patented active
ingredients
 Patent Granting Process Cost
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Impact on Generics Industry
R&D on NEW DRUGS
R&D on RAW MATERIALS
R&D on DRUG FORMULATION
A+B
X+Y
Other materials
ACTIVE
INGREDIENTS
FINISHED
PRODUCTS
PROCESS PATENT
PRODUCT PATENT
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Patent Granting Cost

Online Patent Database
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

inefficient
not up-to-date
Questionable Patent of trivial inventions
were granted
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Online Patent Database related to drug
All patent application documents with the
International code of A61K from 1992 to 2002 were
collected from the Department of Intellectual
Property (2,444 application documents).
 The list of new drugs up to October 2002 was
supplied by the New Drug Section of Thai Food and
Drug Administration.
 The analysis was based on the data available in the
internet and patent database of Delphion..
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Nationality of applicants
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Foreigners 98%
 US 32.5%
 German 11.9%
Japan 10.4

Thai 1.3%
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Patent Granting Period
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Filing date to Publishing date
Publishing date to Exam date
Exam date to Patent issued date
Total
Yrs
Yrs
Yrs
Yrs
Pat issued date
Pub date
Exam date
File date
1-1.5
1-1.5
4-5
1.5-2
7-8
4 – 5 yrs
1.5-2
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Claims
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Percentage
New Process ---------------------------------- 61.10
New Chemical Entity ------------------------ 63.84
New Formulation ----------------------------- 81.37
New Use --------------------------------------- 60.55
New Delivery System ------------------------ 2.19
New Use is in the exclusion list of patentability in
Art. 9 of Thai Patent Act
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Questionable Patent of trivial
inventions were granted

Thai Civil Groups move against these
invalid patents by

sending the objection within 90 days after
publication as stated in the law
 challenged two cases to IP court: ddI
patent
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THAILAND CASE on ddI PATENT
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2 IP COURT CASES for ddI PATENT
1st CASE:
 CLAIM
in PATENT DOCUMENT BROADER THAN CLAIM
IN THE APPLICATION FILE
 RESULT: COURT ORDER TO CORRECT PATENT
DOCUMENT ACCORDING TO THE LIMIT CLAIM AS IN
THE APPLICATION DOCUMENT
PLAINTIFF IS NOT LIMITTED TO ONLY INDUSTRY,
BUT ALSO CONSUMER and NGOs
 2nd CASE:
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
REVOKE ddI PATENT
PATENT HOLDER NEGOTIATE TO END THE CASE BY
SACRIFICE THIS PATENT TO THAI PEOPLE
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Thai NGOs appeal to UN
on FTA’s effect on health
Taken into the account of human right
obligations in the FTA negotiation
 Make public the draft negotiation texts
 Conduct referendum and/or public opinion
on FTAs before further negotiations to ensure
transparency and consultation with all stakeholders

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Thailand’s Supplementary
Clarifications
to the Human Rights Committee
as part of Thailand’s Presentation of
its Initial Report
under the International Covenant on
Civil and Political Rights
19-20 July 2005
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Extension of patents and
data exclusivity
Such similar arrangement is unacceptable to the
Royal Thai Government as it would raise the price
of medicines.
 The Thai negotiators have reminded the US
partners that outcomes of FTA agreements should
not contradict with or undermine the benefits
Thailand receive from other agreements, especially
from the WTO’s TRIPS agreement.

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CONCLUSION
ACCESS to MEDICINES IS HUMAN RIGHT &
RIGHT TO HEALTH
 IPR PROTECTION ON PHARMACEUTICALS
MUST BE EXCLUDED FROM FTA
 IPR PROTECTION ON PHARMACEUTICALS

 IN THAILAND COMPLY TO TRIPS
 IN FTA IS TRIPS-PLUS
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DATA EXCLUSIVITY IN TRIPS 39.3 IS NOT
MARKET EXCLUSIVITY RIGHTS
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