US embassy cable - 04ANKARA7016

UNCLAS SECTION 01 OF 02 ANKARA 007016 
 
SIPDIS 
 
DEPT FOR E, EB/TPP/MTA/IPC, EUR/ERA, EUR/SE 
USTR FOR LERRION/BPECK 
USEU FOR CHRIS WILSON 
USPTO FOR ELAINE WU 
USDOC FOR ITA/MAC/DDEFALCO 
 
SENSITIVE 
 
E.O. 12958: N/A 
TAGS: ETRD, KIPR, TU 
SUBJECT:  Ambassador Discusses IPR Protection with 
Health Minister 
 
REF: (A) STATE 263410 (B) ANKARA 6966 
 
SENSITIVE BUT UNCLASSIFIED.  PLEASE HANDLE ACCORDINGLY. 
 
1. (SBU) Summary:  In his meeting with the Health 
Minister, the Ambassador raised the USG's concerns 
regarding lack of data protection and patent linkage in 
Turkey, and urged the GOT to take immediate action to 
resolve these problems.  The Ambassador pointed out the 
specific problem Eli Lilly was facing with its patented 
product Zyprexa, and asked the GOT not to issue 
marketing approval for generic copies of patented U.S. 
products. The Health Minister noted the GOT's recent 
decision to start implementing data exclusivity in 2005, 
which he claimed would resolve that issue.  The Minister 
mentioned the court ruling on the Zyprexa case, which 
allowed the Ministry to move forward with the licensing 
process.  The Minister stated that the court ruling was 
binding and the Ministry would proceed accordingly 
unless a new ruling supported Eli Lilly's appeal.  The 
Ambassador advised the Minister to take the initiative 
to bring the research-based and generic producers 
together for a long-term solution to this problem.  He 
also pointed out possible consequences, such as loss of 
GSP privileges, if Turkey failed to uphold its TRIPS 
obligations.  End Summary. 
 
2. (SBU) In his December 15 meeting with Health Minister 
Recep Akdag, the Ambassador raised intellectual property 
problems research-based pharmaceuticals manufacturers 
face in Turkey, particularly lack of data protection and 
patent linkage.   The Ambassador pointed out that these 
issues, also brought up by Senator Lugar and Under 
Secretary Larson in their correspondence with the 
 
SIPDIS 
Minister, were important both for improving U.S.-Turkey 
bilateral relations and to make good use of the creative 
potential of Turkish people.  The Ambassador said Eli 
Lilly's recent decision to downsize in Turkey was a 
matter of concern.  The Ambassador pointed out the other 
consequences the GOT may face if it failed to realize 
its obligations under WTO TRIPS, such as loss of 
privileges under the Generalized System of Preferences 
(GSP).  The Ambassador made special reference to an IP 
problem Eli Lilly was facing in Turkey with its patented 
product Zyprexa.  The Ambassador stated that due to a 
lack of coordination between the Health Ministry and the 
Patent Institute, a generic copy of Zyprexa was at the 
stage of receiving approval from the Health Ministry, 
and the Zyprexa patent would be infringed.  The 
Ambassador left a paper explaining patent linkage with 
the Minister. 
 
3. (SBU) Minister Akdag said the GOT had recently 
decided to move the implementation date for data 
exclusivity from late 2007 to early 2005.  Akdag stated 
that the EU too, closely followed this issue and 
expected Turkey to realize its obligations regarding 
data exclusivity.  Akdag noted that the implementation 
would not cover licenses issued and applications made 
before 2005.  Regarding Zyprexa, Akdag said this issue 
was in litigation and the Ministry was not authorized to 
intervene in the judicial process.  Akdag said the court 
made a ruling on this case, which Eli Lilly may appeal. 
The court ruled out Eli Lilly's demand to stop the 
Ministry's licensing process, based on the Patent Law, 
which states that patent infringement does not take 
place until a new license for a generic product is 
issued.  Akdag added that the Court received an expert 
opinion on this case, which pointed out that the two 
products (the original and generic) were using different 
versions of the same molecule, but only the molecule 
Zyprexa was patented in Turkey.  Akdag said using 
slightly different version of the same molecule and 
marketing it as a different one is a problem the 
pharmaceuticals industry faced worldwide. 
 
4. (SBU) The Ambassador reiterated the long-term 
importance of implementing a patent linkage system to 
avoid patent infringement and offered USG assistance in 
establishing such a system.  He suggested that the GOT 
take the initiative to bring together the research-based 
companies and generic producers.  The Ambassador pointed 
out that the two groups needed each other to exist, and 
as long as this conflict remained unresolved, Turkish 
doctors' and patients' access to innovative drugs would 
be limited.  Minister Akdag asked for the Ambassador's 
assistance in bringing the two groups together, and 
noted that Turkey, like many other EU candidate 
countries, needed to go through a transition period to 
fully implement data exclusivity. 
 
5. (SBU) Comment:  The GOT has not "solved" the data 
exclusivity problem by bringing forward planned 
implementation to January 2005, since this allows 
approval of copies of drugs which should, under both 
TRIPS and the EU customs union, have long since been 
entitled to data exclusivity protection, with huge 
losses to research-based industry.  Embassy understands 
that this issue is still in negotiation with the 
European Commission in the context of the Trade Barrier 
Report. Edelman