Lundbeck fights back against EU pay-for-delay fine

Home/Policies & Legislation | Posted 06/09/2013 post-comment0 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.

Pay for Delay V13C29

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.

Related articles

Brand-name drug and generics makers fight to save pay-for-delay

Pay-for-delay on the increase in the US

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2013 Pro Pharma Communications International. All Rights Reserved.

Source: Lundbeck

comment icon Comments (0)
Post your comment
Related content
Public consultation for the modification of the biosimilars regulation
02 AA010638
Home/Policies & Legislation Posted 16/01/2024
COFEPRIS promotes regulatory cooperation in the Americas
Latin America 1638px
Home/Policies & Legislation Posted 12/12/2023
ANVISA's decision on 'Skinny labels' for generics pending
Labelling V14I26
Home/Policies & Legislation Posted 14/11/2023
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010