Lundbeck fights back against EU pay-for-delay fine

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Lundbeck fights back against EU pay-for-delay fine

Home/Policies & Legislation | Posted 06/09/2013 0 Post your comment

Lundbeck announced on 2 September 2013 that it had filed an appeal against the European Commission’s decision to fine the Danish pharmaceutical company, along with four generics makers for pay-for-delay deals.

Lundbeck aims to have the decision annulled and/or the fine of Euros 93.8 million reduced. The fine was imposed on Lundbeck for its part in what the Commission terms ‘anticompetitive agreements’ [1]. The Commission found that agreements that Lundbeck entered into in 2002 with generics manufacturers delayed the entry of generics for its blockbuster antidepressant Celexa (citalopram) [2].

Lundbeck strongly disagrees with the Commission’s decision, and considers that it contains several serious legal and factual errors, as well as several violations of Lundbeck’s right of defence.

The company believes that the Commission’s decision misinterprets the main criterion to determine whether an agreement restricts potential competition as established in case law and ignores key facts of the case. Lundbeck states that the decision also contains manifest errors regarding its assessment of value transfers in the context of patent settlement agreements.

Lundbeck also argues that it did not have any opportunity of being heard on changes that were made before the Commission’s decision was taken – infringing the company’s right of defence.

Lundbeck expects a decision on the appeal within two to three years; however, the company will still be obliged to pay the fine and will do so during the third quarter of 2013.

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References

1. GaBI Online - Generics and Biosimilars Initiative. Lundbeck and 4 generics makers fined for pay-for-delay deals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Sep 6]. Available from: www.gabionline.net/Policies-Legislation/Lundbeck-and-4-generics-makers-fined-for-pay-for-delay-deals

2. GaBI Online - Generics and Biosimilars Initiative. EU to fine 9 drugmakers over pay-for-delay deals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Sep 6]. Available from: www.gabionline.net/Policies-Legislation/EU-to-fine-9-drugmakers-over-pay-for-delay-deals

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Source: Lundbeck