Jiraporn Limpananont - Ip Event

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

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

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

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

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

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

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

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

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

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

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

Jiraporn Limpananont - Ip Event

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