VZCZCXRO6145
PP RUEHAG RUEHDF RUEHIK RUEHLZ
DE RUEHAK #1898/01 0971400
ZNR UUUUU ZZH
P 071400Z APR 06
FM AMEMBASSY ANKARA
TO RUEHC/SECSTATE WASHDC PRIORITY 4657
INFO RUCPDOC/USDOC WASHDC PRIORITY
RUEHIT/AMCONSUL ISTANBUL 0264
RUEHDA/AMCONSUL ADANA 0624
RUCNMEM/EU MEMBER STATES COLLECTIVE

UNCLAS SECTION 01 OF 02 ANKARA 001898 
 
SIPDIS 
 
DEPT PASS USTR FOR JCHOE-GROVES, LERRION 
DEPT PASS USPTO FOR JURBAN AND EWU 
USDOC FOR ITA/MAC/CRUSNAK 
 
SENSITIVE 
SIPDIS 
 
E.O. 12958: N/A 
TAGS: ETRD KIPR USTR TU
SUBJECT:  TURKEY: DANISH COMPANY COULD BE FIRST TO 
SUFFER DE CASUALTY 
 
REF:  05 ANKARA 6378 
 
ANKARA 00001898  001.2 OF 002 
 
 
This message contains sensitive business information. 
Not for Internet distribution.  This message was 
coordinated with CG Istanbul. 
 
¶1. (SBU) Summary:  According to Istanbul-based U.S. 
pharmaceutical company reps, a Danish pharmaceutical 
company may be the first to have a generic application 
approved in Turkey for a product approved in the EU 
after January 1, 2001 and in Turkey after January 1, 
2005, for which they believe the period of data 
protection has not yet expired.  The facts in the case 
are not clear yet, but the EU has sent the Turkish MOH a 
"strongly worded letter" encouraging them not to approve 
such generic applications, of which the industry 
believes there are approximately 35.  We will coordinate 
a meeting with our EU counterparts to discuss this with 
the MOH and urge them to meet their obligations.  End 
summary. 
 
¶2. (SBU) According to Istanbul-based U.S. pharmaceutical 
company reps, Danish pharmaceutical company Lundbeck may 
incur the first data exclusivity casualty as it is 
rumored that generic applications to market copies of 
one of their molecules recently received marketing 
approval by the Ministry of Health.  The product in 
question was approved in the EU after January 1, 2001, 
but one dosage was given marketing approval in Turkey in 
2003 and two more dosages did not receive marketing 
approval in Turkey until the middle of 2005.  According 
to Turkish regulations, unless the generic companies 
submitted their own complete dossiers for consideration 
(which would include chemical composition and clinical 
trial information), generic applications cannot rely on 
the data of research-based companies that received 
marketing approval for a molecule after January 1, 2005. 
Therefore, under Turkey's data-exclusivity regulations, 
the Lundbeck molecule dosages that were approved in 
Turkey in 2005 should receive data protection for six 
years from the date of approval in the EU, which is 
until some point in 2007. 
 
¶3. (SBU) Pharmaceutical company reps assume, but it has 
not yet been confirmed, that the generic applications 
rely on the data supplied in Lundbeck's complete 
application to the MOH. Dossier information including 
clinical trials and chemical composition are easily 
obtained on the Internet or in medical periodicals.  The 
Lundbeck molecule in question was one of the 35 (reftel) 
for which the MOH could not guarantee data exclusivity 
because (assumedly) generic applications had been filed 
for the drug prior to January 1, 2005. 
 
¶4. (SBU) Officials at the EU mission in Ankara told us 
that the EU sent another "strongly worded" letter to 
Turkey last week encouraging them not to go through with 
their plans to approve the generic applications for the 
Lundbeck molecule.  The European pharmaceutical industry 
has suggested referring this case to the EU's DG for 
Enlargement and making data exclusivity a benchmark for 
the free movement of goods chapter during Turkey's EU 
accession process.  U.S. pharmaceutical companies 
support this proposal. 
 
¶5. (SBU) According to local PhRMA company reps, they are 
considering submitting to the USG a petition to rescind 
Turkey's GSP privileges until it implements better 
protection for confidential data.  They told us that in 
a recent conference call, PhRMA companies decided to 
wait until May so that the Lundbeck case could play out. 
They asked, however, that the Embassy consider a joint 
approach to MOH officials with local EU representatives 
in the near future to express our concern about the 
case.  As with other DE-related cases, however, they 
asked that we protect the identity of the company in 
question. 
 
¶6. (SBU) Comment:  While the facts in the Lundbeck case 
are not yet clear, we are concerned about the 
possibility that generic applications for one of the 35 
molecules in question could have been approved prior to 
the expiration of its data exclusivity period.  We 
support the idea of a combined effort with our EU 
 
ANKARA 00001898  002.2 OF 002 
 
 
counterparts in Ankara, who have also expressed their 
interest in coordinating efforts on this subject.  We 
should urge Turkey to uphold its obligations under its 
current IPR legislation.  Too many times, local PhRMA 
companies argue about Turkey's requirements under TRIPS 
and their delay in implementing IPR protection.  While 
we agree with this and continue to push the GOT to 
become fully TRIPS compliant, the pharmaceutical 
companies begrudgingly agreed to the existing regulation 
in order to implement data protection in Turkey.  The 
GOT does not respond to the argument that they provided 
too little too late and should be reminded of their 
obligations under their existing regulations.  End 
comment. 
 
WILSON