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. -------------- 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." -------------- 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. -------------- COMMENT -------------- ¶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