The European Court of Justice has dismissed an appeal brought by AstraZeneca against a 60 million euro fine from over seven years ago imposed for abuse of its dominant position relating to the antiulcerant blockbuster Losec.
In June 2005, the European Commission said the Anglo-Swedish drugmaker had committed two abuses, the first of which consisted mainly of "a pattern of allegedly misleading representations made before the patent offices in Germany, Belgium, Denmark, Norway, the Netherlands and the UK". The second related to the submission of requests for deregistration of the marketing authorisations for Losec (omeprazole) capsules in Denmark, Norway and Sweden.
That move was combined with the withdrawal from the market of Losec and the launch of a new version of that product (Losec MUPS tablets) in the latter three countries. AstraZeneca was therefore accused of two infringements involved misuses of public procedures and regulations in a number of European states aimed at excluding generic firms and parallel traders from competing against the big-selling antiulcerant.
In July 2010, Europe's General Court, which is second only to the Court of Justice, "very largely dismissed the appeal by AstraZeneca, upholding the Commission's decision" of 2005. However, the fine was slightly lowered to 57.5 million euros.
The EC welcomed the latest decision, saying the court judgment is "significant as it clarifies a number of issues of principle in relation to market definition, dominance and the concept of an abuse". It also "confirms the Commission's method to define the relevant product market and existence of a dominant position in the pharmaceutical sector".
The Losec case led to an industry-wide investigation in Europe in 2008 concerning policies to delay generic competition. It also resulted in raids on drugmakers followed by a damning report.
AstraZeneca said it is disappointed with the decision to dismiss its appeal, and insisted that it "takes compliance with all laws seriously and has a fundamental commitment to doing business in an ethical and proper manner".