This record is a partial extract of the original cable. The full text of the original cable is not available.

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