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### Viewing cable 05ANKARA839, GOT Defends New Data Exclusivity Regulation

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Reference ID | Created | Released | Classification | Origin
--- | --- | --- | --- | ---
05ANKARA839 | 2005-02-14 15:37 | 2011-08-24 01:00 | UNCLASSIFIED//FOR OFFICIAL USE ONLY | Embassy Ankara

`

    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 000839

    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:  GOT Defends New Data Exclusivity Regulation
    and Reports System for Patent Linkage

    SENSITIVE BUT UNCLASSIFIED.  PLEASE HANDLE ACCORDINGLY.

    REF: (A) State 19340 (B) Ankara 394
    (C) State 23950

    Summary
    -------

    ¶1. (SBU) Health Ministry and Foreign Trade
    Undersecretariat representatives argued that Turkey's
    new data exclusivity regulation goes as far as is
    legally possible to protect research-based companies
    within Turkey's legal framework.  The Health Ministry
    reported that it had implemented a system for ensuring
    that generic registration applications for patented
    drugs are not accepted.  End Summary.

    Data Exclusivity Demarche
    -------------------------

    ¶2. (SBU) Econoff and Econ Specialist met with Orhan
    Gumrukoglu, the Health Ministry's Director General for
    Pharmaceuticals, on February 10 to deliver ref (A)
    demarche outlining U.S. concerns with Turkey's January
    19 data exclusivity regulation (ref B).  Gumrukoglu
    responded that Turkey had gone as far as it could go in
    providing limited retroactive protection for research-
    based companies.  He maintained that generic companies
    would flood the Turkish court system with challenges if
    the GOT were to retroactively provide data exclusivity
    in cases in which generic copy applications had already
    been filed.  This would hurt the research-based
    companies by tying up implementation of the entire
    regulation, possibly for years.  Gumrukoglu asserted
    that the GOT would fully implement the protections in
    the regulation, and planned to increase the term of
    protection from six to ten years when Turkey joins the
    European Union.

    ¶3. (SBU) Gumrukcuoglu stated that he was aware of at
    least 118 molecules with license applications in Europe,
    but not in Turkey, filed before 2005; all of these drugs
    could enjoy retroactive protection.  In response to
    Econoff's question as to how many Turkish generic
    applications had been filed before 2005 for molecules
    which would otherwise be entitled to retroactive data
    exclusivity protection, Gumrukoglu stated that there
    were perhaps 30 to 50 such molecules.  However, there
    might be multiple generic applications for the same
    molecule.  Note:  Research-based industry has said that
    there are hundreds, perhaps even 1,000 or more, data
    exclusivity-infringing applications in the Health
    Ministry pipeline.  End Note.

    ¶4. (SBU) Gumrukoglu predicted that the January
    regulation would be a boon to research-based companies.
    He estimated that they would realize an extra one
    billion USD in sales over the next three or four years,
    and that this would create exceptional fiscal strain in
    connection with Turkey's IMF program since some 90
    percent of this would be publicly-funded.  Note:
    Research-based industry has claimed that the overall
    impact, especially for the GOT budget, will be far
    smaller.  End Note.

    ¶5. (SBU) In response to Econoff's caution that
    continuing gaps in data exclusivity protection would be
    a major issue in this spring's Special 301 review,
    Gumrukoglu emphasized that the GOT had done all that it
    could on this issue and expressed the hope that the USG
    would recognize Turkey's efforts in this area.

    ¶6. (SBU) Econ Counselor and Econoff also delivered ref
    (A) demarche to Tevfik Mengu, Foreign Trade's Director
    General for Agreements, on February 11.  We highlighted
    the inconsistency of the loopholes in the new
    regulations with the commitments Turkey made when it
    joined TRIPS, as well as the difficulties they created
    for expanding bilateral trade and investment.  Mengu
    noted that Turkey did not share the U.S. interpretation
    of TRIPS Article 39 and echoed the Health Ministry's
    opinion that doing more on retroactivity is legally
    impossible.  He said that GOT agencies are considering
    further amendments to the legislation that might address
    the concerns raised in our demarche.  However, he did
    not hold out any hope that "the lawyers" would be able
    to find a way around the legal problem.
    Patent Linkage
    --------------
    ¶7. (U) Recalling the Ambassador's discussion with the
    Health Minister in December 2004 on the patent linkage
    issue, Gumrukoglu reported that as of January 1, the
    Health Ministry and Turkish Patent Institute (TPI) have
    established a system to prevent generic registration of
    molecules entitled to patent protection.  Gumrukoglu
    stated that new generic applications must be accompanied
    by correspondence from TPI stating that there is no
    valid Turkish patent on the drug.  He said the Health
    Ministry would check with TPI if there were any reason
    to doubt whether an approval would infringe a Turkish
    patent.  He also told us he had asked the Research-Based
    Pharmaceuticals Association (Turkish acronym AIFD) for a
    list of patented drugs in Turkey.

    ¶8. (SBU) Gumrukoglu implied that this system has no
    impact on Eli Lilly's efforts to block registration of
    generic copies of Zyprexa, but said that the Health
    Ministry has not approved the copy registration.  He
    downplayed Eli Lilly's claim that recent layoffs in
    Turkey were in part to weaknesses in the intellectual
    property regime, claiming that most of those laid off or
    reassigned were sales and marketing personnel.

    Comment
    -------

    ¶9. (SBU) Comment.  The local EU Delegation and the
    Belgian Embassy (the local representative of the EU
    Presidency for economic issues), have told us that they
    share our views on the shortcomings of the new
    regulation.  In their presentations to the Turks, they
    highlight the inconsistency of the law with Customs
    Union obligations.  The EU will raise the issue at a
    regular bilateral Turkey-EU meeting under the Customs
    Union that will be held in Brussels at the end of
    February.  (This may account for the slightly more
    equivocal position we heard at the FTU.)  The EU
    Delegation has been attempting to assess the commercial
    impact of the loophole on retroactive application, but
    has not received useful information on pending
    applications from the Health Ministry.  The EU
    representatives have not responded to Embassy's
    suggestions that we jointly raise these issues with the
    Turks.

    ¶10. (U) Embassy also plans to deliver ref (A) demarche
    to MFA and possibly other GOT agencies involved in
    pharmaceuticals policy.  We will also provide input on
    this issue septel for the Special 301 review process.
    Edelman

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