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
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 • R&D of Local Drug Industry • Patent Granting Cost
TRIPs Plus in recent US FTAs • Extension of Patent Term • Protection Exclusivity • Linkage bet. Patent Status and Drug Registration • Limitation on CL application
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
2. Data Exclusivity In this period no any flexibility in TRIPs can be applied
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.
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 disclosureand against unfair commercial use.
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
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
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)
DATA EXCLUSIVITY in FTA 1 DRUG REGISTRATION 2 DRUG APPROVED to be in MARKET DATA EXCLUSIVITY 5-10 Yrs. DATA EXCLUSIVITY 5-10 Yrs. 18 DRUG REGISTRATION 19 DRUG APPROVED to be in MARKET 20 PATENT LIFE 20 Yrs. YEAR YEAR 0 NO PATENT APPLY for PATENT
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.
Economic, Social and Development Implications • Accessibility to Drugs • High Price • No Flexibility in TRIPs can be applied • R&D of Local Drug Manufacturer • Generic drugs can not be developed • No supply of patented active ingredients • Patent Granting Process Cost
Impact on Generics Industry R&D on RAW MATERIALS R&D on DRUG FORMULATION A+B FINISHED PRODUCTS ACTIVE INGREDIENTS X+Y Other materials PROCESS PATENT PRODUCT PATENT R&D on NEW DRUGS
Patent Granting Cost • Online Patent Database • inefficient • not up-to-date • Questionable Patent of trivial inventions were granted
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..
Nationality of applicants • Foreigners 98% • US 32.5% • German 11.9% • Japan 10.4 • Thai 1.3%
Patent Granting Period Pat issued date Pub date Exam date File date 4 – 5 yrs 1.5-2 1-1.5 • 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
Claims • New Process ---------------------------------- 61.10 • New Chemical Entity ------------------------ 63.84 • New Formulation ----------------------------- 81.37 • New Use --------------------------------------- 60.55 • New Delivery System ------------------------ 2.19 Percentage New Use is in the exclusion list of patentability in Art. 9 of Thai Patent Act
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
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
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 stake-holders
Thailand’s Supplementary Clarificationsto the Human Rights Committeeas part of Thailand’s Presentation of its Initial Reportunder the International Covenant on Civil and Political Rights19-20 July 2005
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.
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