The General Court of the European Union's judgment in Case T-321/05 AstraZeneca v European Commission
July 5, 2010
James R.M. Killick
DOWNLOAD PDF: The General Court of the European Union's judgment in Case T-321/05 AstraZeneca v European Commission
On 1 July 2010, the General Court of the European Union ('the GC') handed down its long-awaited judgment in the AstraZeneca case.
The GC rejected most of the arguments put forward by AstraZeneca ('AZ'). In doing so the GC made a number of broad pronouncements about the fact that AZ's conduct did not constitute "competition on the merits," without giving an explanation of what is covered by this concept. This potentially broad standard may have consequences going forward for the application of EU competition law to the pharmaceuticals sector and beyond.
That said, the GC described the abuses themselves in relatively narrow terms. For example, AZ would not have been guilty of an abuse had it told the relevant patent offices of its reasons and arguments for seeking an SPC. Nor would it have been found to abuse its dominant position just for having stopped selling the earlier generation product (Losec capsules) when it introduced the more advanced, later generation product (Losec MUPS).
Moreover, the specific conduct at issue is historical and could not occur today. The SPC abuse related to the transitional period following the adoption of the SPC Regulation in 1992. Equally, regarding the deregistration abuse, since 2005, a generic company can apply for a marketing authorisation under the abridged procedure foreseen by Directive 2001/83, even after the marketing authorisation of the reference medicinal product has been withdrawn and since 2002, a parallel import licence is no longer automatically revoked once the original marketing authorisation for a medicinal product is withdrawn. As a result, while the broad legal principles which the GC enunciates may become significant in the future, their present application to AZ's specific conduct is likely to be mainly of historical relevance.
Click here for our initial reaction to the Court's judgment.
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