TIFA works: UAEG Fixes IPR Problems

UNCLAS SECTION 01 OF 02 ABU DHABI 002980

SIPDIS

SENSITIVE

DEPT FOR NEA, NEA/ARP, EB/TPP/MTA/IPC
STATE PASS TO USTR - JASON BUNTIN and DOUG BELL
USDOC FOR USPTO
USDOC FOR 4250/DOC/MAC/ONE/GUGLIEMI
GENEVA PASS USTR

E.O. 12958: N/A
TAGS: ECON ETRD KIPR WTO USTR TC
SUBJECT: TIFA works: UAEG Fixes IPR Problems

Refs: Abu Dhabi 1824


1. (SBU) Summary: In a successful use of the Trade and
Investment Framework Agreement (TIFA) process, the Embassy
worked with Pfizer and the UAEG to stop violations of
Phizer's patent on Viagra. In May, we facilitated meetings
between Pfizer and the UAEG to identify Pfizer's concerns,
and the Charge subsequently wrote letters to the Ministers
of Health and Information and to the Minister of State for
Finance and Industry to help push this along. Both Minister
of Information, Sheikh Abdullah bin Zayed al-Nahyan (ABZ)
and Minister of State for Finance and Industry, Dr. Mohammed
Khalfan bin Khirbash have both personally committed
themselves to resolving outstanding IPR issues. EconChief
and Pfizer representatives met with UAEG officials on August
23 to follow up on earlier efforts to have the UAEG enforce
Pfizer's IPR on Viagra and shut down the illegal production
and sale of drugs containing the active ingredient in
Viagra. The UAEG had already taken action on one of the
drugs, Trex, and promised to take action on the remaining
two. On August 30, EconChief received copies of Ministry of
Health communiqus banning the sale of both 4M6 and Satibo.
The UAEG has asked for more information from MSD on its drug
Zocor in order to address MSD's concerns. End Summary.


2. (SBU) The Embassy used the UAE's commitment to the TIFA
process and interest in moving to a FTA to launch a
coordinated campaign with U.S. pharmaceutical
representatives to address the concerns of U.S.
pharmaceutical companies about patent infringement. The
campaign involved meetings with UAEG officials and letters
from the Charge to the Ministers of Health and Information
and to the Minster of State for Finance and Industry. In
Washington, Minster of State for Finance and Industry
Mohammed Khirbash personally committed himself to solving
the Pharmaceutical Industry's concerns. On August 23,
EconChief and Pfizer representatives met with UAEG officials
from the Ministries of Finance and Industry, and Health to
discuss steps that the UAEG had taken to address U.S.
concerns about patent infringement of U.S. pharmaceutical
products and to encourage further progress. (see reftel)
Ahmed el-Hakim, Pfizer's regional director for health
policy, raised four outstanding issues: the registration of
the Viagra composite, 4M6, which violates Pfizer's patent on
Viagra; the sale of two drugs, which also contain the active
ingredient in Viagra; and the purchase by the Dubai
Department of Health and Medical Services of a generic
version of MSD's Zocor.

4M6
---


3. (SBU) El-Hakim again noted that 4M6 violated Pfizer's
patent and asked for an update on the UAEG's efforts to stop
its production. Ministry of Finance Assistant Under
Secretary for Revenue and Budget Khalid Al-Bustani stated

SIPDIS
that the Ministry of Finance had told the Ministry of Health
that 4M6 violated the UAE's IPR law and should be
deregistered. He asked Dr. Easa Al Mansoori, the Director
of the Drug Control Department at the Ministry of Health to
respond. Al-Mansoori agreed that 4M6 violated UAE
regulations and that the UAEG needed to stop its production.
On August 30, EconChief met with Pfizer's Dubai General
Manager Zaydan Abuissa, who shared a letter from the
Ministry of Health to Julphar (the UAE company making 4M6)
stating that 4M6 violated UAE law number 17 of 2002
regarding the protection of IPR. The letter ordered Julphar
to: 1) stop manufacturing, handling, and export of 4M6; 2)
stop importing Sildenafil (the active ingredient in Viagra
and 4m6) and 3) recall all of the products from the local
market. Abuissa stated that Al-Mansoori had told him that
he expected that the Ministry of Health would issue a
ministerial decree revoking the registration of 4M6 upon the
minister's return from vacation. The letter, however, put
Julphar on notice that it was in violation of UAE law.

SATIBO
--------------


4. (SBU) During the meeting, El-Hakim representatives asked
for an update on efforts to deregister Satibo, a herbal drug
that also contained Sildenafil. The UAEG agreed that the
versions of Satibo, currently in the UAE, contained
Sildenafil and violated Pfizer's patent. They agreed to
withdraw it from pharmacies. On August 30, Abuissa and Al-
Bustani both passed EconChief a copy of a MoH circular
banning the sale and use of Satibo and ordering its
withdrawal from the market. Abuissa also passed EconChief a
copy of an article in the English language "Khaleej Times"
announcing that the MoH had banned Satibo. He added that
the story was also in many of the Arabic language papers.
(Note: It is unclear whether this circular has the legal
effect of formally withdrawing Satibo's registration,
without an additional ministerial decree. Pfizer's lawyers
will be checking.)

Trex
--------------


5. (SBU) Pfizer representatives asked for an update on the
UAEG's efforts to ban Trex, another Viagra clone. The UAEG
said that they had already issued the instructions pulling
it from pharmacies and blocking its import. Al-Bustani
passed out a circular from the Ministry of Health stating
that Trex was not registered with the Ministry and that it
was not authorized to enter the UAE and should not be sold.
He also handed out a letter from the General Secretariat of
Municipalities to all municipalities instructing them to
prohibit the sale of Trex.

Zocor
--------------


6. (SBU) Amed El-Hakim, speaking as a PhRMA representative,
also asked about the generic version of the MSD drug Zoccor,
which is being sold in the UAE. El-Hakim explained that
this was a "country of origin" and data protection issue.
Zoccor 40 mg is still protected in the U.S. although not in
Europe. Both sides agreed that PhRMA would go back to MSD
and ask it to provide the UAEG with more information and an
explanation of its position.

Comment
--------------


7. (SBU) The Embassy and U.S. Pharmaceutical companies
capitalized on the U.S. - UAE TIFA Council to orchestrate a
coordinated -- and successful -- effort to resolve some
outstanding IP concerns. Post believes that these results
demonstrate both the commitment of the UAEG at senior levels
to improving IPR protection in the UAE and the success of
the TIFA Council process. ABZ and Khirbash are both
personally seized with IPR protection. ABZ has told us that
we should let him know about any problems with IPR and
Khirbash has publicly put his prestige on the line promising
to solve the problems. UAEG interest in moving rapidly to
FTA negotiations is leading to progress on a number of
issues, including IPR. We will continue to follow-up to
ensure that the decisions are implemented.

Sison