AstraZeneca PLC
21 March 2000
ASTRAZENECA TO APPEAL DECISION BY GERMAN PATENT COURT
AstraZeneca today announced that the company will appeal a ruling handed down
by the German Federal Patent Court. The Patent Court nullified the
formulation patent for omeprazole in Germany. The patent covering the
formulation, expiring in 2007, has been subject to nullity actions by the
generic manufacturing companies Azupharma GmbH & Co and ratiopharm GmbH.
Omeprazole is the active ingredient in 'Losec'.
'We will continue to strongly assert all patent rights pertaining to
omeprazole. Patent legislation varies from country to country. The research
and development work behind the product is very extensive and concerns - in
addition to the formulation - substance, manufacturing methods and
intermediates. As a result of this advanced work, Losec is protected by a
number of different patents,' said Dr. Martin Nicklasson, Executive Vice
President GI Franchise.
In 1999, Losec had sales of USD150 million in Germany, representing 2.5 per
cent of total sales of the product. In Germany, omeprazole is marketed under
the brand name 'Antra MUPS' (MUPS - Multiple Unit Pellet System).
AstraZeneca has filed requests in Germany for preliminary injunctions against
ten companies, has filed ten main actions and is currently defending its
patent rights in eight other patent cases related to omeprazole. In August
1999, AstraZeneca was granted an interlocutory injunction to prevent
ratiopharm GmbH and Merckle GmbH selling a generic version of omeprazole,
which is still in force.
In February 2000, the German Supreme Court referred a number of questions
about AstraZeneca's SPC for omeprazole in Germany to the European Court of
Justice. Earlier this month the German Federal Patent Court dismissed a
nullity action by Merck dura GmbH against the substance patent of omeprazole
21 March 2000
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