TURKISH JUDGE LIFTS ZYPREXA INJUNCTION AND GENERIC

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