AstraZeneca appeals EC's findings in Losec dominance case

AstraZeneca has stated 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 €60m 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 among other matters:

• 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.

Sir Tom McKillop, chief executive of AstraZeneca, said: 'AstraZeneca has not made misrepresentations or behaved inappropriately. We believe that a proper evaluation on appeal of all the facts and legal position will confirm that the Commission's analysis is fundamentally flawed.'