Originally published as Covington E-Alert on May 17, 2012

On 15 May 2012, the Advocate General of the EU Court of Justice issued his opinion on the appeal of the General Court’s judgment in AstraZeneca v. Commission.1 The Advocate General largely agreed with the reasoning and holdings of the General Court, and recommended that the Court of Justice reject all appeals, including AstraZeneca’s appeal challenging the General Court’s analysis of the definition of the relevant markets and the findings that AstraZeneca’s regulatory activities related to its product Losec constituted an abuse of a dominant position in violation of Article 102 TFEU.

This opinion will come as a disappointment to many life science companies, which are struggling to come to terms with the new concept of an abuse of regulatory procedures. As demonstrated by the January 2012 decision against Pfizer in Italy, no clear legal standard for the finding of such an abuse exists, resulting in significant uncertainty for parties operating in this highly-regulated sector.

In this note, we first provide an overview of the facts in this case, and then analyze the key substantive issues addressed by the Advocate General.

Read the complete article here

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Photo of Peter Bogaert Peter Bogaert

Peter Bogaert has a broad European life sciences practice. He has detailed regulatory expertise under EC and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the European Courts in Luxembourg and in…

Peter Bogaert has a broad European life sciences practice. He has detailed regulatory expertise under EC and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the European Courts in Luxembourg and in local litigation in Belgium. Mr. Bogaert’s practice covers pharmaceuticals, biotechnology, medical devices, special foods and feed, cosmetics and other consumer products and he presents numerous innovative life sciences companies, including start-ups, as well as several industry associations.