Cablegate: Turkish Judge Lifts Zyprexa Injunction and Generic

This record is a partial extract of the original cable. The full text of the original cable is not available.

UNCLAS ANKARA 007308

SIPDIS

SENSITIVE

DEPT PASS USTR FOR LERRION/JCHOE-GROVES
DEPT PASS USPTO FOR JURBAN/EWU
USDOC FOR ITA/MAC/CRUSNAK

E.O. 12958: N/A
TAGS: ETRD KIPR TU
SUBJECT: TURKISH JUDGE LIFTS ZYPREXA INJUNCTION AND GENERIC
ENTERS THE MARKET

REF: ANKARA 4058 AND PREVIOUS

THIS INFORMATION IS SENSITIVE BUT UNCLASSIFIED. PLEASE
PROTECT ACCORDINGLY.

1. (SBU) Summary: A recent lifting of a Turkish court
injunction allowed a generic copy of the Eli Lilly product
Zyprexa to come on the market December 9. Lilly
representatives plan to continue fighting the case in court,
but asked us to refrain from discussing their specific case
with the GOT. End summary.

2. (SBU) After noticing a newspaper advertisement placed by
local generic producer Abdi Ibrahim (AI), we checked with
local Lilly representatives, who confirmed that the judge in
the Zyprexa patent infringement case recently lifted the
injunction that had prevented AI from marketing its copy of
Zyprexa. Because AI maintained an inventory that was
produced prior to the injunction, its "Rexapin" version
became available to Turkish consumers on December 9.

3. (SBU) The Lilly reps told us that while they are
disappointed by the court decision, they do not believe that
the GOT is currently "breaking its laws." They said the
judge based the decision on an independent review of Lilly's
patented Zyprexa formula that was conducted by Middle East
Technical University (METU) in Ankara. The review found
enough chemical differences to allow the judge to rule that
AI had not infringed Lilly's patent on the molecular formula.
Conceding that this type of patent is the most difficult to
protect, Lilly reps said they had hoped the judge would
continue the injunction pending a review of their process
patent. They plan to ask for such an injunction and "to
continue to fight in the courts every company that tries to
copy our products," Lilly's GM said.

4. (SBU) The Lilly reps thought the issue of patent linkage
should be included on the IPR agenda for the January 23-24
TIFA Council meeting, but asked that the discussion be kept
general to avoid possible GOT repercussions against the
company. They explained that while AI's generic Rexapin is
included in the just-released formulary for prescription
reimbursements, Zyprexa is not. (Several representatives of
research-based companies have told us that they worry that
the MOH could use non-inclusion on the reimbursement list as
a way to "punish" companies that continue to push on IPR
issues. Because of this, they have asked us to keep the
discussion of IPR-issues general and refrain from mentioning
any of the companies by name.)

5. (SBU) Comment: The low-key response of local Lilly
officials indicates that they are either content to rely on
the judicial process, are worried that direct USG
intervention could have negative repercussions, or are simply
not decided on next steps. We expect that Washington
officials may hear from Washington-based Lilly reps, and
agree that continuing to engage the GOT on the issue of
patent linkage, including at the TIFA meeting, is warranted.
WILSON

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