UNCLAS ABU DHABI 004594

SIPDIS

SENSITIVE

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

E.O. 12958: DECL: 10/14/03
TAGS: PREL KIPR ETRD TC
SUBJECT: UAE HEALTH MINISTRY STRENGTHENS IPR PROTECTION FOR
PHARMACEUTICALS

REFS: 02 ABU DHABI 5438 AND PREVIOUS


1. (U) Classified by Charge D'Affaires Richard A. Albright
for reasons 1.5 (b) and (d).


2. (U) Summary and comment: The UAE Ministry of Health
(MoH) issued a circular this week stating the mechanism of
granting exclusive marketing rights in the UAE for all
innovative pharmaceutical products registered in other
countries. The circular also implied that the MoH would
coordinate with the UAE Ministry of Finance (MoF) to approve
exclusive marketing rights, and offer protection for data
secrecy.


3. (SBU) Summary and comment continued: This is good news
for U.S. pharmaceutical manufactures that have sought to
codify the prevailing practice under the terms of the patent
protection agreement reached with U.S. pharmaceutical
industry group, PhRMA in March 2002 (see refs). The
circular also extends the benefits of the March 2002
agreement to all patent-protected drugs (not only U.S.
origin pharmaceuticals) and strengthens the UAE's Patent Law
released last year -- which failed to provide a mechanism
for granting exclusive marketing rights absence MoH-MoF
cooperation or afford any protection of data secrecy. End
summary and comment.


4. (U) The MoH circular issued this week explained that
pharmaceutical manufacturers seeking patent protection in
the UAE should register their innovative product with the
MoF Patent Directorate, produce a Certificate of
Pharmaceutical Product from the regulatory authority in the
country of origin, and submit details of the original patent
of the innovative product to the Patent Directorate.


5. (U) Once the MoF process is complete, the MoH will then
grant exclusive marketing rights to the manufacturer for the
innovative product. The circular also suggests that there
will be some protection of data exclusivity, and that this
data secrecy period will run coterminous with the period of
patent protection in the country where the original patent
was granted. The circular adds that patent protection in
the UAE will be provided "as long as the patent is not
rejected by the Patent Directorate or the courts in the
country of origin." An application to market generic drugs
in the UAE would be accepted 12 months before the expiration
date of the UAE protection of the innovative product.


6. (SBU) PhRMA's legal representative in the UAE told
Econoff that the circular was welcome news to U.S.
pharmaceutical companies. He noted that this was the first
step to strengthening the UAE's IPR legislation vis-a-vis
pharmaceuticals, and is an obvious show of good faith by the
UAEG to honor the terms of the March 2002 agreement. He was
skeptical however, that the circular would be applied evenly
to U.S. and non-U.S. innovative products. An expat adviser
to the MoH admitted to him that the Ministry, in practice,
grants exclusive marketing rights in the UAE only to
patented products from the United States and Europe.

Albright