BREAKTHROUGH ON PATENT LINKAGE IN CROATIA

UNCLAS ZAGREB 000175 SIPDIS SIPDIS SENSITIVE STATE FOR EUR/SCE, EB/TPP/IPE E.O. 12958: N/A TAGS: ECON KIPR HR INTELLECTUAL PROPERTY SUBJECT: BREAKTHROUGH ON PATENT LINKAGE IN CROATIA ¶1. (SBU) Summary: The Croatian State Intellectual Property Office signed a memorandum of understanding on cooperation with the State Drug Agency on February 15, initiating cooperation on intellectual property protection for the first time. This agreement, which came about after extensive Embassy intervention with the two agencies and the Foreign Ministry, will establish a joint working group between the State Intellectual Property Office and the Drug Agency to exchange information on proprietary pharmaceutical and medical product patents. This new mechanism, together with data exclusivity, should prevent new instances of patented drugs being given marketing approval by the Drug Agency before the expiration of the patent. End Summary. ¶2. (SBU) The signing of a memorandum of understanding between the Croatian State Intellectual Property Office and the State Drug Agency on February 15, 2007 creates the first mechanism for "patent linkage" for medical and pharmaceutical products in Croatia. Under the MOU, the two agencies have agreed to set up a joint working group to exchange information on medical and pharmaceutical products. ¶3. (SBU) The absence of patent linkage in Croatia created significant problems for U.S.-based pharmaceutical companies in the past and was an on-going risk in their operations in the country. Past cases of generic copies of proprietary drugs receiving marketing authorization before the expiration of their Croatian patents inflicted losses on the companies and helped Croatia claim its place on the Special 301 Watch List for the last several years ¶4. (SBU) The signing of this MOU between two agencies that have had no communication whatsoever in the past came about after extensive and sustained Embassy intervention on this issue. Although the State Intellectual Property Office has long favored this type of cooperation, the State Drug Agency was resistant, not believing that enforcement of patents was within its legal mandate. In a January 2007 meeting that Econ Off scheduled with a view to the 301 Review Cycle, however, the Agency's director accepted that an MOU with the State Intellectual Property Office to open a regular channel of communication to ensure that existing patents are reviewed prior to the issuance of marketing authorization for pharmaceuticals was not beyond the scope of the Agency's mandate. ¶5. (SBU) Comment: Although an MOU between the State Intellectual Property Office and the State Drug Agency does not have the force of law, we believe that both agencies recognize the importance of this issue and are serious about making sure that past patent infringements are not repeated. The GOC seems to be cognizant of the fact that issues like this and Croatia's inclusion on the 301 Watch List convey larger messages about intellectual property rights and the rule of law in the country. We are confident that this new mechanism, combined with existing (though slightly less-than-ideal) data exclusivity provisions, will prevent a repetition of past pharmaceutical patent infringements in Croatia. BRADTKE