The impact of US-Thai FTA: a civil society perspective

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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

• Bilateral Negotiation US-Thailand
• Recent US FTAs go beyond TRIPs (TRIPs Plus)
• Extension of Patent Term
• Data Exclusivity
• Linkage bet. Patent Status and Drug Registration
• Limitation on CL application
• Economic, Social and Development Implications
• Affordability of Medicine
• RD of Local Drug Industry
• Patent Granting Cost

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Recent US FTAs

• FTAs Signed
• Vietnam, Cambodia and LoaPDR (2001)
• Jordan (2001)
• Singapore (2003)
• Chile (2003)
• Morocco (2004)
• Australia (2004)
• DR-CAFTA (2004)
• Bahrain (2004)

• FTAs Being Negotiated
• Andean Countries (Colombia, Ecuador, Peru)
• Thailand
• Panama
• SACU

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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
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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

Expired date
Filing date
Patent term
0
20 years
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2. Data Exclusivity
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
• 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

• GENERIC DRUG REGISTRATION IS USED/RELIED ON
  UNDISCLOSED DATA OF ORIGINAL DRUG?
• NO

POST-MARKET SURVEILLANCE
GENERICS -SUBMIT BIOEQUIVALENT STUDY
ORIGINALS -SUBMIT UNDISCLOSED (SAFETY EFFICACY
DATA)
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DATA EXCLUSIVITY in FTA
YEAR
YEAR
0
NO PATENT
APPLY for PATENT
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3. Linkage between Patent status and Drug
Registration
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
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Economic, Social and Development Implications

• Accessibility to Drugs
• High Price
• No Flexibility in TRIPs can be applied
• RD of Local Drug Manufacturer
• Generic drugs can not be developed
• No supply of patented active ingredients
• Patent Granting Process Cost

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ON-PATENT or MONOPOLIZED DRUGS
OF-PATENT or COMPETITIVE DRUGS
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INDINAVIR
SAQUINAVIR
SOURCE UNAIDS, b. Samb, 2000
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2001
2002
2003
2004
BRAND
BRAND
BRAND
BRAND
BRAND
GENERIC
GENERIC
GENERIC
GENERIC
GENERIC
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DAILY COST of ARVS THERAPY
G(?) 40 57 74 138 155 192 175 85 70 220 448
REGIMEN GPO-VIR30 d4T3TCNVP AZT3TCNVP d4T3TC
EFV AZT3TCEFV AZT3TCRTVIDV d4T3TCRTVIDV d
4TddINVP AZT3TCIDV AZTddIRTVIDV AZT3TCRTV
SQV
2001 B/G 2.98 2.67 2.30 2.12 1.92 2.05 2.93 1.73
1.77 1.50
2002 B/G 10.90 7.65 5.65 3.86 3.19 2.64 2.92 4.06
2.99 1.94 1.77
2004 B(?) 438 438 443 495 498 535 530 347 252 444
791
2003 B/G 10.95 7.68 5.99 3.57 3.21 2.79 3.03 4.08
3.60 2.02 1.77
B/G 10.95 7.68 5.99 3.57 3.21 2.79 3.03 4.08 3.60
2.02 1.77
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RD sale
PROFIT sale
Rank
NET SALE Mil USD
(COMPANY)
1998 Data on the top 20 companies rank by net
sale
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Impact on Generics Industry
RD on NEW DRUGS
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Patent Granting Cost

• Online Patent Database
• 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

• Foreigners 98
• US 32.5
• German 11.9
• Japan 10.4
• Thai 1.3

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Patent Granting Period

• Filing date to Publishing date 1-1.5
  Yrs
• Publishing date to Exam date 4-5
  Yrs
• Exam date to Patent issued date 1.5-2 Yrs
• Total
  7-8 Yrs

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Claims
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

• 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
• 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 FTAs 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
  stake-holders

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Thailands Supplementary Clarificationsto the
Human Rights Committeeas part of Thailands
Presentation of its Initial Reportunder the
International Covenant on Civil and Political
Rights19-20 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 WTOs 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
• DATA EXCLUSIVITY IN TRIPS 39.3 IS NOT MARKET
  EXCLUSIVITY RIGHTS

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THANKS
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