US embassy cable - 05ANKARA4058

UNCLAS ANKARA 004058 
 
SIPDIS 
 
DEPT FOR EB/TPP/MTA/IPE - JURBAN AND EUR/SE 
DEPT PASS USTR FOR LERRION/JCHOE-GROVES 
DEPT PASS USPTO FOR JURBAN AND EWU 
USDOC FOR ITA/MAC/DDEFALCO 
 
SENSITIVE 
 
E.O. 12958: N/A 
TAGS: ETRD, KIPR, EAGR, TU 
SUBJECT:  Zyprexa Update- MOH Issues Sales and Marketing 
Permits for the Generic Producer 
 
 
SENSITIVE BUT UNCLASSIFIED.  PLEASE HANDLE ACCORDINGLY. 
 
1.(SBU) SUMMARY: ELI LILLY TURKEY CONFIRMED THAT THE 
MINISTRY OF HEALTH (MOH) ISSUED SALES AND MARKETING PERMITS 
FOR THE GENERIC COPY OF ZYPREXA IN LATE JUNE.  FOLLOWING 
THIS DEVELOPMENT, THE ISTANBUL SPECIALIZED IPR COURT ISSUED 
A PRELIMINARY INJUNCTION, PREVENTING THE GENERIC PRODUCER 
FROM SELLING OR DISTRIBUTING ITS PRODUCTS.  ELI LILLY IS 
PLEASED WITH THE COURT RULING, PARTICULARLY WITH THE COURT'S 
RECOGNIZING THE EXISTENCE OF A POTENTIAL PATENT 
INFRINGEMENT.  TECHNICAL EXPERTS FROM LILLY AND ABDI IBRAHIM 
(THE GENERIC PRODUCER) WILL MEET TO DISCUSS POSSIBLE PATENT 
INFRINGEMENT IN THIS CASE AND SUBMIT A REPORT TO THE COURT. 
THE GENERIC PRODUCER'S PERMIT WILL BE CANCELLED IF THE COURT 
DECIDES THERE IS A PATENT INFRINGEMENT.  ELI LILLY 
REPRESENTATIVES DISCUSSED THE COURT RULING WITH THE MOH, AND 
OFFERED THEIR ASSISTANCE IN ESTABLISHING AN EFFICIENT SYSTEM 
TO PREVENT THESE PROBLEMS IN THE FUTURE.  ELI LILLY TURKEY 
WILL HAVE A MEETING NEXT WEEK TO DISCUSS THEIR FOLLOW-ON 
STRATEGY.  END SUMMARY. 
 
2. (SBU) ECON SPECIALIST CONTACTED RAZIYE GEDIKLI, ELI LILLY 
CORPORATE AFFAIRS DIRECTOR, ON JULY 12 TO RECEIVE AN UPDATE 
ON THE ZYPREXA CASE.  GEDIKLI SAID THE MOH ISSUED SALES AND 
MARKETING PERMITS FOR ZYPREXA'S GENERIC COPY IN LATE JUNE. 
FOLLOWING THIS NEWS, THE ISTANBUL SPECIALIZED IPR COURT 
ISSUED A PRELIMINARY INJUNCTION IN AN ONGOING ZYPREXA COURT 
CASE, WHICH PREVENTED THE GENERIC PRODUCER (ABDI IBRAHIM) 
FROM SELLING OR DISTRIBUTING ITS PRODUCTS UNTIL THE FINAL 
VERDICT.  LILLY IS VERY PLEASED WITH THE RULING, I.E. THAT 
THE COURT AGREES THERE IS A POTENTIAL PATENT INFRINGEMENT IN 
THIS CASE.  GEDIKLI SAID THE POSITIVE COURT RULING WAS DUE 
MAINLY TO THE COURT'S BEING A SPECIALIZED IPR COURT AND THE 
MOH'S DISCLOSING THE DOCUMENTS REQUESTED BY THE COURT.  THE 
NEXT STEP IS TO HAVE THE EXPERTS FROM LILLY AND ABDI IBRAHIM 
GET TOGETHER TO EXAMINE EXISTENCE OF A PATENT INFRINGEMENT 
IN THIS CASE, FOLLOWED BY A COURT HEARING.  THE PERMITS WILL 
BE CANCELLED IF THE COURT DECIDES THERE IS A PATENT 
INFRINGEMENT- THE COMPANY WILL START SELLING AND 
DISTRIBUTING ITS GENERIC PRODUCT IF THE COURT DECIDES 
OTHERWISE. 
 
3. (SBU) GEDIKLI SAID SHE VISITED HEALTH DEPUTY 
UNDERSECRETARY ORHAN GUMRUKCUOGLU AFTER RECEIVING THE COURT 
RULING.  GUMRUKCUOGLU REPORTEDLY SAID THAT THE MINISTRY DID 
NOT VIOLATE ANY LAWS BY ISSUING THE PERMITS, BUT CLAIMED HE 
WAS PLEASED THAT LILLY WAS ABLE TO GET A PRELIMINARY 
INJUNCTION FROM THE COURT.  GEDIKLI SAID GUMRUKCUOGLU WAS 
QUITE SURPRISED WITH THE COURT DECISION, SINCE THIS WAS THE 
FIRST RULING IN FAVOR OF LILLY FOLLOWING SEVERAL NEGATIVE 
RULINGS IN THE PAST.  SHE COMMENTED THAT THE GAPS IN THE 
LEGISLATION ENABLED THE MOH TO ISSUE THE PERMITS.  GEDIKLI 
SAID LILLY GAVE THE MESSAGE TO THE MOH THAT THERE WAS A 
CONFLICT BETWEEN THE MOH'S IMPLEMENTATION AND THE COURT 
DECISION, WHICH REVEALED THE EXISTENCE OF A PROBLEM WITH THE 
"SYSTEM."  LILLY SUGGESTED TO THE MOH THAT THEY WORK 
TOGETHER TO RESOLVE THE PROBLEM AND ESTABLISH A NEW SYSTEM. 
 
4. (SBU) GEDIKLI SAID ANOTHER POSITIVE DEVELOPMENT THEY HAD 
RECENTLY WAS RECEIVING A RESPONSE FROM THE MOH REGARDING 
THEIR REQUEST ON THE NAMES OF THE OTHER COMPANIES WHICH 
APPLIED FOR GENERIC COPIES OF ZYPREXA'S MOLECULE OLENZAPIN. 
THE MOH'S RESPONSE REVEALED THAT THERE WERE 12 COMPANIES 
WHICH APPLIED FOR THE SAME MOLECULE, WHICH WAS HIGHER THAN 
LILLY'S ESTIMATE OF 5 COMPANIES. 
 
5. (SBU) GEDIKLI SAID LILLY WAS "NEUTRAL" ABOUT THE NEWS ON 
MOH'S ISSUING SALES AND MARKETING PERMITS FOR ABDI IBRAHIM 
FOR THE MOMENT, AND THEY HAD NOT COME UP WITH A STRATEGY 
YET.  GEDIKLI TOLD US ELI LILLY TURKEY REPRESENTATIVES WERE 
PLANNING TO MEET NEXT WEEK TO DISCUSS NEXT STEPS.