BALKANS' NEW EU MEMBER STATES THREATEN MULTINATIONAL PATENTS

Despite accession to the European Union (EU) in May 2004, a number of new member states, such as Slovenia, continue to infringe pharmaceutical patents. Croatia, which is negotiating for accession in 2004, has recently adopted new EU-compliant patent legislation, but some ongoing practices in the country remain a threat to multinationals' intellectual property.

The situation is not improved by the fact that both Slovenia and Croatia are home to two major generics firms that dominate their domestic markets, Krka and Pliva. Foreign firms have complained that Croatia's new law lacks proper provisions for data exclusivity, while the Office of the US Trade Representative (USTR) has described the country's progress on patent enforcement as "limited." The registration of copy products in Croatia reportedly continues.

Typifying a common problem across many of the new EU member states, a major problem in Slovenia is the use of the date of marketing approval in the EU as the basis for exclusivity in Slovenia. As registrations can take up to three years in Slovenia, using the usually earlier date of first approval elsewhere in the EU has significantly shortened the nominally six-year local exclusivity period on some drugs.

Nevertheless, this awkward outlook seems unlikely to last. In November, most of the new states will be obliged to implement the EU's so-called "8+2+1" legislation, which is expected to iron out some of these problems. However, it remains to be seen whether countries such as Slovenia will succeed in delaying the law's implementation, and the authorities are likely to try to retain as much influence over patenting decisions as possible.