EU Court Dismisses AstraZeneca Appeal - Pharmaceutical Technology

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EU Court Dismisses AstraZeneca Appeal


ePT--the Electronic Newsletter of Pharmaceutical Technology

The Court of Justice of the European Union has dismissed an appeal by AstraZeneca concerning a 2005 decision that found the company guilty of abusing its dominant position in the marketplace. The court has upheld the decision and the fine of EUR 52.50 million ($68.7 million—EUR 40.25 million and EUR 12.25 million for AstraZeneca plc (UK) and AstraZeneca AB (Sweden), respectively).

AstraZeneca companies AstraZeneca plc and AstraZeneca AB were found to have committed two abuses of a dominant position.

  • AstraZeneca made “deliberately misleading representations” to the patent offices of certain member states, with the intention of obtaining or maintaining additional, unwarranted patent protection for the ulcer medicine, Losec.
  • AstraZeneca submitted requests for deregistration of the marketing authorizations for Losec capsules in Sweden, Denmark and Norway to delay or hinder the marketing of generic ulcer medicines and to prevent parallel imports of Losec.

Case history

The fine originally imposed in 2005 by the European Commission amounted to EUR 60 million ($78.5 million). However, during an appeal in 2010, the fine was lowered by the General Court. Although the EC had proven that the deregistration in Denmark, Sweden, and Norway was made to hinder generic competition and to prevent parallel imports in Sweden, it had not proven the latter effect in Denmark and Sweden.

AstraZeneca later lodged an appeal before the Court of Justice to have the judgement of the General Court set aside.

“...in the absence of mitigating circumstances or special circumstances, the abuses must be characterized as serious infringements, and consequently the amount of the fine cannot be reduced,” explained the Court of Justice of the European Union in a statement.

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