UAEG ADDRESSES COMPLAINTS OF U.S. PHARMACEUTICAL

UNCLAS SECTION 01 OF 02 ABU DHABI 001824

SIPDIS

SENSITIVE

DEPT FOR NEA, NEA/ARP, EB/TPP/MTA/IPC
STATE PASS USTR - DBELL AND JBUNTIN
USDOC FOR USPTO
USDOC FOR 4250/DOC/MAC/ONE/GUGLIELMI
GENEVA PASS USTR

E.O. 12958: N/A
TAGS: ECON ETRD KIPR WTO USTR TC
SUBJECT: UAEG ADDRESSES COMPLAINTS OF U.S. PHARMACEUTICAL
COMPANIES

REF: A) 02 ABU DHABI 4287 AND PREVIOUS
B) DUBAI 2044 AND PREVIOUS


1. (SBU) SUMMARY: SEEKING TO CAPITALIZE ON THE MOMENTUM OF
THE U.S.-UAE TIFA COUNCIL MEETING IN APRIL, ECONOFF AND U.S.
PHARMACEUTICAL MANUFACTURES MET WITH KEY UAEG OFFICIALS
RECENTLY TO DISCUSS SEVERAL INCIDENCES OF PATENT
INFRINGEMENT BY UAE HEALTH AUTHORITIES AND LOCAL COMPANIES.
PRIOR TO THE TIFA COUNCIL MEETING, THE AMBASSADOR ALSO SENT
LETTERS TO THE MOF, MOH AND SENIOR SHAYKHS OUTLINING THE
PROBLEMS OF U.S. PHARMACEUTICAL COMPANIES HERE AND ADVISING
THAT IPR ISSUES WOULD PLAY PROMINENTLY IN ANY FUTURE TRADE
NEGOTIATIONS WITH THE UNITED STATES. UAE MINISTER OF STATE
FOR FINANCE DR. MOHAMMED KHALFAN BIN KHIRBASH AND HIS STAFF
UNDERTOOK TO RESOLVE THE DISPUTES IMMEDIATELY AND CONVENED A
MEETING WITH THE MOH TO ESTABLISH A WORKING GROUP ON
PHARMACEUTICAL PATENTS. THE MOF-MOH AGREED TO SETTLE THE
DISPUTES IN FAVOR OF THE U.S. PATENT HOLDERS AND IN SPITE OF
PROTESTS FROM LOCAL DRUG MANUFACTURER, JULPHAR -- A WELL-
CONNECTED COMPANY WITH TIES TO THE RAS AL KHAYMAH RULING
FAMILY. END SUMMARY.

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U.S. COMPANIES ALLEGE PATENT INFRINGEMENT
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2. (SBU) ACCOMPANIED BY ECONOFF, PFIZER'S REGIONAL
REPRESENTATIVE AND MSD'S MIDDLE EAST DIRECTOR MET SEPARATELY
WITH UAE MINISTRY OF FINANCE (MOF) ASSISTANT UNDERSECRETARY
KHALID AL-BUSTANI AND UAE MINISTRY OF HEALTH (MOH) DIRECTOR
OF DRUG CONTROL DR. EASA AL-MANSOURI ON MAY 15 AND MAY 18,
RESPECTIVELY. THE U.S. EXECS WANTED TO FOLLOW-UP ON A
NUMBER OF PATENT ISSUES DISCUSSED DURING THE U.S.-UAE TIFA
COUNCIL MEETING IN WASHINGTON IN APRIL, INCLUDING:

-- THE REGISTRATION BY THE MOH OF THE VIAGRA COMPOSITE, 4M6.
THE REGISTRATION IS A VIOLATION OF PFIZER'S VIAGRA PATENT
VALID IN THE UNITED STATES UNTIL 2006 AND A VIOLATION OF THE
2002 MOU WITH PHRMA (REF A) STATING THAT THE UAE WOULD
ACCEPT THE UNITED STATES AS THE COUNTRY OF ORIGIN FOR THIS
AND OTHER NAMED DRUGS;

-- THE REGISTRATION BY THE MOH OF A DRUG CALLED SATIBO,
WHICH ALSO CONTAINS VIAGRA AND VIOLATES PFIZER'S DATA
EXCLUSIVITY IN THE UAE AS WELL AS THE UAE ANTIFRAUD AND
ANTICHEATING LAW NO. 4 OF 1979;

-- THE PURCHASE BY THE DUBAI DEPARTMENT OF HEALTH AND
MEDICAL SERVICES (DOHMS) OF A GENERIC VERSION OF MSD'S
ZOCOR. ONLY THE U.S. PATENTED VERSION OF ZOCOR IS
REGISTERED IN THE UAE; THE VARIOUS HEALTH AUTHORITIES HERE
MUST PURCHASE DRUGS REGISTERED BY THE MOH;

-- THE NEED FOR FEDERAL LEGISLATION IN THE UAE CODIFYING THE
TERMS OF THE 2002 MOU AND MINISTRY OF HEALTH DECREE 404
PROTECTING PHARMACEUTICAL PATENTS AND DATA EXCLUSIVITY IN
THE UAE.


3. (SBU) IT BECAME CLEAR DURING THE MEETINGS THAT THE CAUSE
OF CONFUSION WAS TWO-FOLD: (1) LOCAL COMPANY JULPHAR HAD
INAPPROPRIATELY USED A U.S. PATENT IMPROVEMENT TO OBTAIN
MARKETING APPROVAL IN THE UAE FOR THE VIAGRA COMPOSITE 4M6;
THE MOH WAS UNAWARE THAT A U.S. PATENT DOES NOT/NOT GRANT A
COMPANY MARKETING RIGHTS IN THE UNITED STATES (OR IN A THIRD
COUNTRY),AND (2) MOH WORKING-LEVEL OFFICIALS AND THE
VARIOUS HEALTH AUTHORITIES WERE NOT FAMILIAR WITH THE TERMS
(SPECIFICALLY, THE COUNTRY OF ORIGIN COMMITMENTS) OF THE
2002 MOU. (NOTE: ALMOST EVERY EMIRATE IN THE UAE MAINTAINS
ITS OWN HEALTH AUTHORITY, WHICH COORDINATES THE PURCHASE AND
DISTRIBUTION OF DRUGS AMONG THE NETWORK OF GOVERNMENT-RUN
CLINICS AND HOSPITALS WITHIN ITS JURISDICTION. END NOTE.)


4. (SBU) DR. EASA'S ADVISER INITIALLY ARGUED THAT THE 2002
MOU WAS UNFAIR TO EUROPEAN AND FOREIGN DRUG MANUFACTURERS
AND WAS NO LONGER NECESSARY GIVEN THE UAE'S NEW PATENT
LEGISLATION. ECONOFF REMINDED THE UAEG OFFICIALS THAT THE
2002 MOU SOUGHT TO ADDRESS SPECIFIC CONCERNS RAISED BY THE
USG AND PHARMACEUTICAL MANUFACTURES FOR PROTECTION OF U.S.
INTELLECTUAL PROPERTY. FURTHERMORE, THE 2002 MOU WOULD
REMAIN IN EFFECT UNTIL THE UAEG AND PHRMA SOUGHT TO ANNUL
THE AGREEMENT, AND UNTIL SUCH TIME, THE VARIOUS HEALTH
AUTHORITIES IN THE UAE WOULD BE REQUIRED TO ABIDE BY THOSE
COMMITMENTS. DR. EASA ACQUIESCED, BUT SAID THAT HE WOULD BE
UNABLE TO DEREGISTER ANY OF LOCAL MANUFACTURER JULPHAR'S
PRODUCTS "FOR POLITICAL REASONS."

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MOF TAKES THE LEAD TO RESOLVE THE DISPUTES
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5. (SBU) AL-BUSTANI SUBSEQUENTLY CONVENED A SERIES OF
MEETINGS MAY 25-27 WITH MOF PATENT DIRECTOR JAMAL NASSER
LOOTAH AND DR. EASA TO DISCUSS THE ISSUES OF U.S.
PHARMACEUTICAL COMPANIES IN DETAIL. WE UNDERSTAND THAT AL-
BUSTANI REMINDED HIS COLLEAGUES THAT DR. KHIRBASH HAD
PLEDGED HIS PERSONAL ATTENTION AT THE TIFA COUNCIL MEETING
TO RESOLVE THE PHARMACEUTICAL PATENT ISSUES WITH U.S.
COMPANIES IMMEDIATELY. (COMMENT: AL-BUSTANI PROBABLY ALSO
INFORMED HIS COLLEAGUES THAT IPR ISSUES WOULD HINDER THE
UAE'S EFFORTS TO CONCLUDE LONGER-TERM AN FTA WITH THE UNITED
STATES. END COMMENT.)


6. (SBU) LOOTAH CONTACTED ECONOFF ON MAY 29 AND -- SPEAKING
ON BEHALF OF DR. KHIRBASH -- CONFIRMED THAT MOF AND MOH ARE
"TOTALLY" COMMITTED TO THE 2002 MOU. LOOTAH FURTHER STATED
THAT THE MOF HAD GIVEN THE MOH A GRACE PERIOD OF ONE WEEK
(UPON REQUEST OF THE MOH) TO SETTLE THE MATTERS WITH PHRMA,
OTHERWISE THE MOF UNILATERALLY WOULD CANCEL ALL MARKETING
APPROVALS THAT U.S. COMPANIES CLAIM INFRINGE UPON THEIR
PHARMACEUTICAL PATENTS.


7. (SBU) LOOTAH ALSO EXPLAINED THAT THE MOH WOULD MEET WITH
THE GENERAL DIRECTOR OF EVERY HEALTH AUTHORITY IN THE UAE TO
PUT AN END TO THE PURCHASE OF UNREGISTERED DRUGS BY HEALTH
AUTHORITIES THROUGH AN UNAUTHORIZED SUPPLIER OR GENERIC
MANUFACTURER. IN A SEPARATE CONVERSATION, AL-BUSTANI TOLD
ECONCHIEF THAT HE EXPECTED THE MOH ALSO TO INSTRUCT THE
VARIOUS HEALTH AUTHORITIES ABOUT THE DETAILS OF THE UAEG'S
COMMITMENTS UNDER THE 2002 MOU.


8. (SBU) MOF AND MOH ALSO MET WITH JULPHAR'S
REPRESENTATIVES MAY 31 TO EXPLAIN THE RIGHTS AND LIMITATIONS
OF ITS U.S. PATENT FOR 4M6. BACKED BY INFORMATION FROM
USPTO, MOH SAID IT WOULD DEREGISTER 4M6 IN THE UAE BECAUSE
THE U.S. PATENT DID NOT ALLOW THE COMPANY TO MARKET THE DRUG
IN THE UNITED STATES. MOH, THEREFORE, WOULD NOT ALLOW
JULPHAR TO MARKET THE SAME DRUG IN THE UAE. MOH ALSO
UNDERTOOK TO ISSUE A LETTER TO ITS COUNTERPART AGENCIES IN
THE GCC INFORMING OF THE DEREGISTRATION OF 4M6.

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COMMENT
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9. (SBU) WE ARE OPTIMISTIC THAT THE MOH WILL PULL 4M6 AND
SATIBO FROM THE SHELVES OF UAE PHARMACIES IMMINENTLY, AND
WILL MAKE GOOD ON ITS PROMISES TO BETTER INFORM THE VARIOUS
HEALTH AUTHORITIES OF THE UAE'S COMMITMENTS TO U.S.
PHARMACEUTICAL PATENT HOLDERS UNDER THE 2002 MOU. NO DOUBT
THE RECENT TIFA COUNCIL MEETING AND THE PROSPECT OF FTA
NEGOTIATIONS WITH THE UNITED STATES PROVIDED MOMENTUM WITHIN
THE UAEG TO RESOLVE THESE LONG-STANDING PHARMACEUTICAL
PATENT ISSUES AS QUICKLY AS POSSIBLE. THIS INCIDENT
HIGHLIGHTS THE NEED, HOWEVER, FOR FEDERAL LEGISLATION
CODIFYING THE TERMS OF THE 2002 MOU (ISSUES OF COUNTRY OF
ORIGIN, DATA EXCLUSIVITY AND MARKETING RIGHTS) TO AVOID SUCH
MISUNDERSTANDINGS IN THE FUTURE.


10. (U) THIS CABLE WAS COORDINATED WITH DUBAI.

WAHBA