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 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