AstraZeneca PLC
15 June 2005
ASTRAZENECA REFUTES EC'S FINDINGS IN LOSEC DOMINANCE CASE AND APPEALS DECISION
AstraZeneca announced today that it does not accept the European Commission's
decision that it infringed Article 82 EC during the marketing of Losec
(omeprazole) in the 1990s, and will appeal the decision to fine the company 60
million Euros to the Courts.
In AstraZeneca's view, the analysis by the Commission in reaching this decision
does not take into account the substantial evidence submitted by the company
with regard to the use of Losec as just one of the treatments available for
treatment of stomach acid disorders.
AstraZeneca contends that it acted in good faith and did not make misleading
misrepresentations to Patent Offices or Courts to obtain supplementary
protection certificates (SPCs) for Losec. Indeed this matter was so unclear
that it was ultimately decided by the European Court of Justice after several
years of legal argument. The Court's judgment recognised the difficulty in
interpretation of the SPC Regulation and had no criticism of the Company.
In addition, AstraZeneca will argue in its appeal against the decision that
amongst other matters:
(S) companies are entirely within their rights to withdraw products; to
introduce new products; and to deal with product registrations as may be
necessary. In this case the new Losec (MUPS) tablet formulation in fact offers
benefits over the previous formulation. Moreover the Commission fails to
recognise that in any event generic companies could have obtained their own
registrations of omeprazole on the basis of the extensive published literature
already available at that time.
• The Commission has failed to analyse properly the crucial issue of
relevant market and the definition of dominance in the pharmaceutical industry.
The Commission's interpretation in this case could mean that any innovative
product may be considered dominant retrospectively and hence subject to the '
special responsibility' of a dominant company. This could impose unnecessary
additional burdens which will adversely affect industry competitiveness,
contrary to the express aspirations of the Commission in particular in relation
to the 'Lisbon' agenda.
This is a technically and legally complex case and AstraZeneca fundamentally
disagrees with DG Competition's findings. AstraZeneca will challenge the
Commission's decision and appeal the case because of the important negative
impact on future competitiveness that this narrow analysis of dominance will
have on innovative industry in Europe.
A background brief on the case is available at www.astrazeneca.com
Ends
June 15, 2005
Media Enquiries:
Edel McCaffrey, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033
Investor Enquiries:
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Jonathan Hunt, Tel: +44 (0) 207 304 5087
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