In July 2010, the General Court of the EU ruled on an appeal by AstraZeneca against a 2005 decision of the European Commission. The Commission had fined AstraZeneca €60 million for abusing its dominant position by blocking or delaying generic versions of Losec (its proton pump inhibitor drug) and by preventing parallel imports of the same pharmaceutical. 

Dominance
 
To prove an abuse of dominance, the existence of a dominant position must first be established.  The Court found that AstraZeneca was dominant in various national markets for proton pump inhibitors due to its patent protection and “first-mover” advantage.

Abuse

While dominance per se is not illegal, dominant companies have a special responsibility not to hinder competition. The Court decided that AstraZeneca abused its dominance by misrepresenting to national authorities the date it first received marketing authorisations for the purpose of obtaining extended patent protection to which it was not entitled. The Court found that this misrepresentation delayed competition from generic manufacturers and could be particularly restrictive of competition.

The Court also supported the Commission’s finding that AstraZeneca abused its dominant position by de-registering marketing authorisations of Losec. These de-registrations were not based on legitimate commercial objectives and excluded competition from generic manufacturers and parallel traders (by making it more difficult for these parties to obtain marketing authorisations or import licences).

Comment

This decision shows that dominant firms must not misuse patent approval or marketing authorisation systems. In its 2009 report on the pharmaceutical sector, the Commission stated that it would not hesitate to take action against firms who use patent protections in an anti-competitive way. Dominant pharmaceutical companies must therefore be wary of any activity that hinders the ability of generic manufacturers and parallel traders to market competing products.