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

UNCLAS SECTION 01 OF 02 CAIRO 003755 
 
SIPDIS 
 
SENSITIVE 
 
USTR FOR SAUMS 
USDOC FOR 4520/ITA/MAC/SAMS AND JACOBS/WIEHAGEN 
 
E.O. 12958: N/A 
TAGS: ETRD KIPR EG USTR
SUBJECT: POSITIVE IPR DEVELOPMENTS IN EGYPT 
 
Sensitive But Unclassified -- Please Protect Accordingly. 
 
¶1. (SBU) Minister of Health and Population Hatem El Gabaly 
issued an order directing an Egyptian pharmaceutical company 
to cease production of a generic copy of Lilly's innovator 
drug Zyprexa.  Marketing approval for the generic drug Olapex 
had been granted to Apex Pharma in December 2005 by El 
Gabaly's predecessor and the generic has been available 
locally since January.  The order requires Apex Pharma to 
suspend sales of Olapex pending the outcome of its legal 
challenge to Lilly's exclusive marketing rights for Zyprexa. 
These exclusive marketing rights expire August 7, 2006.  If 
the court rules against Lilly prior to August 7, then the 
order stipulates that Apex Pharma will be permitted to resume 
sales of Olapex indefinitely.  If the court does not make a 
ruling, or rules in favor of Lilly before August 7, then 
Alpha Pharma will be prohibited from selling Olapex until 
Lilly's rights expire on August 7.  The only way Alpha Pharma 
will be prevented from selling Olapex after August 7 is for 
the Egyptian Patent Office (EPO) to approve Lilly's patent 
application for Zyprexa before the expiration of Lilly's 
exclusive marketing rights or an unfavorable court ruling. 
If the EPO grants a timely patent for Lilly, then Apex Pharma 
will be prohibited from resuming sales of Olapex until the 
expiration of Lilly's patent in 20 years.  If the EPO does 
not approve Lilly's patent application by August 7, then the 
restraining order on Alpha Pharma sales of Olapex will be 
lifted. 
 
¶2.  (SBU) Ayman Hassenein, Egypt Director for Eli Lilly, 
recently met with the EPO to ascertain the status of its 
pending patent application for Zyprexa.  According to 
Hassenein, the EPO is in the final stages of the approval 
process.  One of the last steps is for the EPO to send the 
Ministry of Health and Population a letter stating that a 
patent will be issued for Zyprexa at the end of 90 days 
unless the Ministry responds with a formal objection. 
According to the head of USAID's IPRA project, the Ministry 
can respond any time during the 90-day period with either an 
objection or no objection to the patent.  After that, a 
notice is published in the Patent Gazette stating the EPO's 
intention to issue a patent if there is no opposition from 
another rights holder to the product to be patented. 
According to EPO contacts, there are four pharmaceutical 
patent applications in the final stages.  Once granted, these 
pharmaceutical patents will be the first issued in Egypt 
under the WTO TRIPS mailbox procedure.  As for Zyprexa, if 
these final steps are completed before the expiration of 
Lilly's exclusive marketing rights on August 7, Lilly will 
have an inviolable patent for Zyprexa in Egypt. 
 
¶3.  (SBU) Although the window of opportunity to get patent 
protection for Zyprexa is narrow, Lilly's representative here 
is extremely pleased with the Minister's order.  He praised 
Minister El Gabaly for trying to rectify a bad decision made 
by his predecessor, who ignored Egyptian legal procedures by 
issuing a marketing approval for a Zyprexa generic while the 
legal challenge to Lilly's exclusive marketing rights was 
still pending.  Minister El Gabaly's decision, said 
Hassenein, at least revives the possibility of patent 
protection for Zyprexa in Egypt, which was dashed when the 
marketing approval for Olapex was issued last December. 
Moreover, said Hassenein, Lilly's lawyers are investigating 
the option of challenging Apex Pharma's right to sell Olapex 
after August 7 should its patent for Zyprexa not be issued by 
then. 
 
¶4.  (SBU) The GOE's interest in stronger IPR protection has 
been quite evident of late.  During a recent public 
appearance, El Gabaly promised to meet all of Egypt's IPR 
obligations under WTO, and Minister of Trade and Industry 
Rachid has been making numerous public statements about 
creating a positive IPR environment in Egypt.  Minister 
Rachid has also taken concrete steps to promote his vision, 
the latest being his hiring of a respected IPR attorney (and 
former USAID IPRA project employee) to be head of the 
Trademark Office.  Another positive step is a request made to 
the USAID IPRA project by the Minister's deputy for a list of 
specific steps the GOE could take to improve IPR protection 
in Egypt.  The stated goal was to get Egypt off the Special 
301 Priority Watch List. 
 
¶5.  (SBU) Comment:  Minister El Gabaly's decision on Zyprexa 
is welcome, as are Minister Rachid's public support and 
concrete steps for stronger IPR protection in Egypt.  We 
suspect that Minister Rachid will be more proactive in 
promoting IPR protection than Minister El Gabaly, who readily 
acknowledges the indispensable role inexpensive generic drugs 
play in Egypt's health care system.  While we may not see 
seismic changes in Egypt's IPR regime in the near term, 
Egypt's economic reformers recognize the benefits of stronger 
IPR protection are moving toward that goal.  End comment. 
RICCIARDONE