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Viewing cable 07ZAGREB175, BREAKTHROUGH ON PATENT LINKAGE IN CROATIA

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Reference ID Created Released Classification Origin
07ZAGREB175 2007-02-16 12:30 2011-08-25 00:00 UNCLASSIFIED//FOR OFFICIAL USE ONLY Embassy Zagreb
VZCZCXRO0137
RR RUEHAG RUEHAST RUEHDA RUEHDBU RUEHDF RUEHFL RUEHIK RUEHKW RUEHLA
RUEHLN RUEHLZ RUEHROV RUEHSR RUEHVK RUEHYG
DE RUEHVB #0175 0471230
ZNR UUUUU ZZH
R 161230Z FEB 07
FM AMEMBASSY ZAGREB
TO RUEHC/SECSTATE WASHDC 7310
INFO RUEHZL/EUROPEAN POLITICAL COLLECTIVE
RUCPDOC/DEPT OF COMMERCE WASHDC
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