Zyprexa Update- MOH Issues Sales and Marketing

UNCLAS ANKARA 004058

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DEPT FOR EB/TPP/MTA/IPE - JURBAN AND EUR/SE
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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.