German Supreme Court to consider patent case
12/22/1998 3:13 AM EST
Södertälje, Sweden, December 22, 1998
GERMAN SUPREME COURT TO CONSIDER IMPORTANT PATENT CASE FOR ASTRA
The German Supreme Court will consider Astra's appeal concerning the
invalidation of a previously granted Supplementary Protection Certificate
(SPC) for the period 1999-2003 for the substance in the antipeptic ulcer
medication Losec (omeprazole). The SPC was granted in accordance with the EU's
regulation governing Supplementary Protection Certificates, which is intended
to compensate pharmaceutical companies for the long time spent on development
and gaining regulatory approvals.
A German generics company challenged the validity in Germany of the SPC for
the substance omeprazole on formal grounds. In June 1997 the SPC was declared
invalid by the German patent court. Astra immediately appealed the ruling to
the Supreme Court.
In addition to the substance patent, Losec is also protected by a number of
other patents directed to formulation, use, intermediates and processes. In
Germany and most other countries these patents expire between 2005 and 2016.
"The Supreme Court's ruling is highly significant for Astra as well as the
entire research-intensive pharmaceutical industry," says Martin Nicklasson,
head of Therapy Area Gastrointestinal at Astra. "The court can now rule on the
interpretation of the rules that the EU adopted in 1993 to grant extended
patent protection to the pharmaceutical companies."
Astra's sales of Losec in the German market amounted to approximately
SEK 1 bn. for the period January-September 1998. Losec MUPS, the new tablet
formulation that offers patients additional benefits, was recently launched in
Germany.
Contact persons:
Staffan Ternby, Vice President, PR & Information, Astra AB, +46 8 553 261 07
Mikael Widell, Press Officer, PR & Information, Astra AB, +46 8 553 264 28
Michael Olsson, Manager, Investor Relations, Astra AB, +46 8 553 259 52
Jörgen Winroth, Investor Relations U.S., Astra AB, +1 609 896 4148