EU Court of Justice upholds Lundbeck fines over pay-for-delay

INICIO/Políticas y legislación | Posted 07/05/2021 post-comment0 Post your comment

On 25 April 2021, Danish drug company Lundbeck and four generic drugmakers lost their appeal against European Union antitrust fines of Euros 146 million (US$172 million), imposed in 2013.

Pay for Delay DrugsMoneyGeneric V13F21

Lundbeck was initially fined by the European Commission (EC), for making deals to delay sales of generic copies of its anti-depressant citalopram, following its patent expiration in 2002 [1]. It was uncovered that Lundbeck made payments to four generics manufacturers (Merck, Alpharma, Arrow and Ranbaxy), and in exchange those manufacturers agreed to refrain from entering the market. These ‘pay-for-delay’ deals were seen to be anticompetitive and in violation of the EU’s antitrust rules. This led to Lundbeck being fined US$110 million, and its potential, yet halted, rivals received collective fines of US$61.7 million.

In September 2016, the five companies challenged the fine at the European General court, but the original decision was upheld.

Now, the Court of Justice of the European Union (ECJ) dismissed all motions and again upheld the original decision that the companies had made deals aimed at blocking rivals. It was evident that the reverse payments were broadly equivalent to the generics manufacturers expected profits if they had entered the market or to the damages that they could have been awarded following successful litigation against Lundbeck. Regarding this, ECJ judges stated that the payments made by Lundbeck induced the generics manufacturers to discontinue efforts to enter the market and this practice is particularly harmful to competition.

Related articles
Servier and generics makers fined for pay-for-delay

EU problematic settlements remain at low level

US Supreme Court backs FTC in pay for delay case

EU to fine 9 drugmakers over pay-for-delay deals

EU regulators request details of drug patent settlements

LATIN AMERICAN FORUM – Coming soon!

To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.

 

LATIN AMERICAN FORUM – Próximamente!

Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.

Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa. 

Reference
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 2021 May 7]. Available from: www.gabionline.net/Policies-Legislation/Lundbeck-and-4-generics-makers-fined-for-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 © 2021 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Related content
Consulta pública para la modificación de la regulación de biosimilares
02 AA010638
INICIO/Políticas y legislación Posted 16/01/2024
COFEPRIS promueve la cooperación regulatoria en América
Latin America 1638px
INICIO/Políticas y legislación Posted 12/12/2023
Pendiente la decisión de ANVISA sobre las ‘skinny labels’ para genéricos
Labelling V14I26
INICIO/Políticas y legislación Posted 14/11/2023
Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010