US embassy cable - 05BRATISLAVA161

UNCLAS  BRATISLAVA 000161 
 
SIPDIS 
 
 
DEPARTMENT FOR EB/IPE:WILSON 
DEPT PLEASE PASS TO USTR JCHOE-GROVES 
USDOC FOR JBOGER 
USPTO FOR JURBAN 
LOC FOR STEPP 
 
E.O. 12958: N/A 
TAGS: KIPR, ETRD, ECON, XG, LO 
SUBJECT: 2004 SPECIAL 301 REVIEW FOR SLOVAKIA 
 
REF: STATE 23950 
 
1. Slovakia has enacted nearly all of the intellectual 
property legislation required by TRIPS, and the overall IPR 
situation has improved from a historical perspective. 
Piracy of optical and other visual medias remains minimal, 
but home "burning" of CDs has likely increased.  The 
Ministry of Interior and the police have an independent 
office dedicated to computer-related crime.  Although GOS 
offices and large companies predominantly use licensed 
software, experts say entrepreneurs and small- and medium- 
size enterprises continue to use pirated software.  The sale 
of counterfeit trademarked goods is insignificant and we do 
not believe piracy is a major problem in Slovakia. 
Authorities have been generally cooperative with aggressive 
private sector efforts to combat piracy of various products 
protected by IPR legislation.  Only the pharmaceutical 
sector remains a considerable problem (see paragraphs 3-7). 
 
2.  Obligations from WIPO's Copyright Treaty (WCT) and 
WIPO's Performance and Phonograms Treaty (WPPT) were 
implemented into the Slovak Copyright Act in 2000. Slovakia 
became party to WCT and WPPT in 2002.  In addition, a new 
Copyright Law (618/2003) came into effect in 2004 and 
complies with Directive 2001/29/EC of the European 
Parliament and of the Council of 22 May 2001 on the 
harmonization of certain aspects of copyright and related 
rights in the information society. 
 
3.  Unfortunately, the pharmaceutical sector continues to be 
problematic for Slovakia.  Of greatest concern is weakness 
in the field of patent protection.  An American company 
suffered patent infringement by generic drug producers.  The 
American company was granted ten years of patent protection 
by the GOS at the time it made the decision to enter the 
product into the Slovak market. (Note: The start date for 
the ten years began on the date the product was first 
approved in an EU member country, not in Slovakia. 
Therefore, approximately six years of patent protection had 
already expired by the time the product was approved for 
sale in Slovakia).  Subsequently, the GOS changed the period 
of patent protection to six years, then back to ten (the 
product qualified as a "high tech" drug), and finally back 
to six years again.  During the first six-year protection 
period, the patent protection expired and the GOS made 
sensitive data available to generic competitors.  Then, 
during the time when the patent protection period was 
returned to ten years, a generic producer was granted 
approval to enter the Slovak market.  Reportedly, the 
Ministry of Health (MOH) felt this was acceptable because 
the patent protection period would revert to six years in 
the near future anyway. 
 
4. Numerous other pharmaceutical firms that are innovators 
of new drugs contend that, according to Slovak law, once a 
patent right has been given it cannot be changed 
retroactively.  Therefore, the aforementioned American 
company's patent protection period should be valid for ten 
years.  Because the GOS is solely responsible for approving 
pharmaceutical products for sale in Slovakia, it must take 
the lead in patent protection.  Unfortunately, it is still 
unclear which branch of the GOS accepts this responsibility 
for the pharmaceutical sector. 
 
5. As in previous years, data exclusivity protection is a 
point of contention.  The GOS has stored sensitive 
registration data on the premises of a generic drug producer 
for years.  Reportedly, it managed to move some of the data 
to a neutral storage facility, but some of it still remains 
under the care of the generic drug competitor.  Although the 
name on the title of the storage facility was changed, the 
people involved remain the same. 
 
6. American pharmaceutical companies also contend that the 
GOS violates the EU Transparency Directive by not justifying 
its decisions regarding the licensing of drugs for sale in 
Slovakia.  Finally, these same companies claim the GOS 
violates its own laws regarding the maximum allowable time 
for decision making by various approval committees. 
 
7. American pharmaceutical producers report that the 
situation in Slovakia has improved from previous years.  In 
addition, post is encouraged by new interest on the part of 
the Slovak Embassy in Washington to make needed changes to 
be removed from the 301 Watch List.  Slovakia's Ambassador 
has requested, and received, from the Department of Commerce 
a road map for correcting violations related to the Watch 
List.  However, insufficient progress has been made so far, 
and post recommends that Slovakia remain on the 301 Watch 
 
List until further improvements are made. 
THAYER 
 
 
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