US embassy cable - 04ABUDHABI1824

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 
----------------------------------------- 
 
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 
------------------------------------------ 
 
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