SPECIAL 301: HEALTH MINISTRY PLANS TO IMPROVE

UNCLAS ANKARA 002717

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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
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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
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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
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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