EU High Court Upholds Fine Against Drug Company Improperly Blocking Generic Competition

In AstraZeneca v. Commission, the European Court of Justice upheld a €52.5 million ($68 million) abuse of dominance fine against AstraZeneca.  The EC had fined the drug maker for manipulating the applicable regulatory systems in order to block generic versions of the defendant’s ulcer drug Losec.

The Commission found that the company provided misleading information to national patent offices in order to improperly extend its exclusive patent rights and pulled an older version of the product from the market. Both strategies, the Commission alleged, were designed to delay generic competition.

Although the court upheld the EC’s decision with respect to AstraZeneca, it indicated that false information submitted in support of a patent must be “objectively misleading” to trigger liability.  Commentators believe that this language indicates that basic IP protection strategies will not violate the antitrust laws.

“The assessment of whether representations made to public authorities for the purposes of improperly obtaining exclusive rights are misleading,” the court explained, “must be made in concreto and may vary according to the specific circumstances of each case.”   The mere rejection of a patent application, the court stressed, would not “automatically give[] rise to liability.”  The European high court appears to be struggling to draw a line between anticompetitive efforts to obtain exclusive patent rights and protecting legitimate rights as “part of the normal competitive process.”

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