Ratiopharm Challenges Losec SPC

The German generics company Ratiopharm has challenged the validity of aEuropean Union Supplementary Protection Certificate granted to Astra for its antiulcerant Losec (omeprazole). The challenge has gained support in Germany's federal patent court in Munich, which says that Astra's Losec is not covered by the German SPC rules.

Astra says that it will appeal the ruling in the German Supreme Court, and will request a ruling by the European Court of Justice.

Astra argues that its SPC for Losec is valid in Germany. However, it notes that if the patent court's ruling is upheld, the substance patent for omeprazole in Germany will expire in 1999. In other major European markets, under the terms of the SPCs, protection for omeprazole expires between 2002 and 2004.