US embassy cable - 05ANKARA2717

UNCLAS ANKARA 002717 
 
SIPDIS 
 
DEPT FOR EB/TPP/MTA/IPE - SWILSON/JURBAN AND EUR/SE DEPT 
PASS USTR FOR JCHOE-GROVES 
DEPT PASS LIBRARY OF CONGRESS FOR STEPP 
DEPT PASS USPTO FOR JURBAN 
USDOC FOR ITA/MAC/DDEFALCO AND JBOGER 
 
SENSITIVE 
 
E.O. 12958: N/A 
TAGS: ETRD, KIPR, TU, USTR 
SUBJECT: SPECIAL 301: HEALTH MINISTRY PLANS TO IMPROVE 
DATA EXCLUSIVITY REGULATION; COURT DECISIONS ON ZYPREXA 
 
REF: (A) State 79058 (B) State 66948 
 
(C) Ankara 2522 and previous 
 
Summary 
------- 
 
1. (SBU) The Deputy Undersecretary of the Turkish Health 
Ministry told us that the GOT had committed to the EC to 
extend data exclusivity protection to nonpatented drugs, 
which would address a major shortcoming in Turkey's 
regulatory regime.  Separately, Lilly's Managing 
Director in Turkey informed us of positive court 
decisions related to the Zyprexa case, and suggested 
that it might be counterproductive to push the GOT on 
this issue at present.  End Summary. 
 
Data Exclusivity 
---------------- 
 
2. (SBU) Meeting with Econoff and Econ Specialist on May 
10, Orhan Gumrukcuoglu, the Deputy Undersecretary of 
Health, expressed disappointment with Turkey's Priority 
Watch List designation in the 2005 Special 301 review. 
He argued that the GOT had taken far-reaching measures 
to improve the environment for research-based companies, 
and that it plans to do more. 
 
3. (SBU) Gumrukcuoglu informed us that the GOT had 
committed in writing to the European Commission at their 
joint council meeting April 26 to extend the six-year 
period of data exclusivity protection to non-patented 
molecules registered in European countries.  The term of 
protection will begin on the date of first licensing in 
an EU member state.  The Deputy U/S said that the EC 
welcomed this move, and that U.S. companies would have 
the most to gain from it.  Gumrukcuoglu advised that GOT 
interagency discussions on new legislation to effect 
this change are ongoing and should be completed in June. 
Gumrukcuoglu added that the GOT would extend protection 
to ten years upon accession to the EU. 
 
4. (SBU) While noting that the USG continues to have 
other intellectual property concerns in this sector, 
Econoff applauded the plan to offer data exclusivity to 
nonpatented drugs.  Gumrukcuoglu responded that the GOT 
puts a high priority on encouraging advances in 
medicine, technology and IP, and that it hopes to 
attract investment in these areas. 
 
Zyprexa 
------- 
 
5. (SBU) In a separate meeting on May 9, Lilly Turkey's 
Managing Director briefed us on recent court decisions 
which should help the company in the Zyprexa case on 
potential patent infringement.  One decision provided 
for the right of patent holders to be informed of 
potentially infringing copy applications.  Another opens 
the way to making the copy manufacturer's dossier 
available to help establish whether an application would 
infringe a patent.  Lilly told us that Gumrukcuoglu had 
asked for an in-house legal opinion on compliance with 
these court decisions with respect to Zyprexa. 
 
6. (SBU) The Managing Director commented that 
Gumrukcuoglu, with whom he met just before our 
discussion, has been very transparent in his dealings 
with Lilly.  The company is guardedly optimistic that 
these developments will either forestall final Health 
Ministry approval for the Abdi Ibrahim copy, or if the 
copy is actually approved, that Lilly would have a good 
chance of obtaining an injunction to stop marketing. 
The Managing Director thanked us for extensive USG 
advocacy, which he said was instrumental in raising the 
profile of the case at senior levels of the GOT and in 
preventing final approval of the copy.  However, given 
the strong message conveyed in our Special 301 review 
and other demarches and the prospect of favorable action 
by the Health Ministry in response to court decisions, 
he suggested it might be counterproductive to push the 
Health Ministry further on Zyprexa at this time. 
Edelman