EGYPTIAN GOVERNMENT APPROVES GENERIC COPY OF U.S.

UNCLAS CAIRO 000090

SIPDIS

COMMERCE FOR 4520/ITA/ANESA/MTALAAT/JBOGER
USTR FOR SAUMS

SENSITIVE

E.O. 12958: N/A
TAGS: KIPR ECON ETRD EG USTR
SUBJECT: EGYPTIAN GOVERNMENT APPROVES GENERIC COPY OF U.S.
INNOVATOR DRUG

Sensitive But Unclassified. Please protect accordingly.


1. (SBU) Representatives of Eli Lilly met with trade
officer January 4 to provide information on a recently
approved and marketed Egyptian generic copy of one of its
innovator drugs. According to Lilly, sometime in December
2005, the Ministry of Health and Population (MOHP) gave
approval to Apex Pharma to market Olapex, a copy of Eli
Lilly's drug Zyprexa, which is used to treat schizophrenia
and other psychoses. Eli Lilly learned of the approval only
last week, when Olapex became available in Egypt's retail
market, and the Olapex packages showed MOHP registration
numbers 23758 and 23759, issued in December 2005.


2. (SBU) Olapex is the first marketing approval for a
generic copy of a protected U.S. company product in more
than a year. This move comes despite warnings from USG
officials that any further marketing approvals for copies of
U.S. innovator drugs -- especially Zyprexa -- would call
into question the GOE's commitment to protect intellectual
property rights.


3. (SBU) Eli Lilly took every available step to enforce its
intellectual property rights. The company filed a patent
application for Zyprexa with Egyptian officials in August

1995. Because Egypt was not obligated to begin reviewing
patent applications until 2005 under WTO rules, Eli Lilly
took steps to obtain interim protection for its product.
Unlike many western innovator companies in a similar
situation, Eli Lilly did not rely exclusively on WTO
provisions that obligate Egypt to refrain from granting
marketing approval for generic drugs based on the innovator
company's confidential test data. Rather Eli Lilly also
sought a five-year exclusive marketing right certificate for
Zyprexa, which the GOE granted in August, 2001. However,
Apex challenged the Eli Lilly's exclusive marketing rights
on a technicality. The court ruled in Apex's favor, and Eli
Lilly promptly filed an appeal, which was expected to be
heard on January 17, 2006. Eli Lilly was surprised by the
approval for Olapex because, according to its lawyers,
Egyptian legal procedure requires that a challenged judgment
is to remain unexecuted until a final ruling has been made.


4. (SBU) Eli Lilly is seeking meetings with GOE officials
to request a reversal of the marketing approval or expedited
review of Eli Lilly's patent application for Zyprexa. They
are also asking the GOE to prevent further commercialization
of the generic Olapex, and to refrain from approving any
marketing requests from other Egyptian companies to make
their copies of Zyprexa (Egyptian law allows up to four
generics in the market for the same product). The embassy
will raise this issue with all relevant GOE contacts in
hopes of getting marketing approval for Olapex revoked and
dissuading the MOHP from granting any more generic marketing
approvals for Zyprexa or other U.S. innovator drugs.

RICCIARDONE