Teva under scrutiny in EU pay-for-delay investigation

Home/Policies & Legislation | Posted 31/05/2021 post-comment0 Post your comment

In March 2021, the European Commission opened a formal investigation into alleged anti-competitive – ‘pay-for-delay’ – conduct, by the Israeli generics giant Teva Pharmaceutical Industries (Teva). 

Law V13C29

It is suspected that Teva took action to delay the market entry of generic drugs that competed with their multiple sclerosis drug, Copaxone.

The active ingredient of Teva’s Copaxone is glatiramer acetate. The patent for this ingredient expired in 2015 and generic drugs entered the market. In response to this competition, Teva introduced a three-times-per-week version of the drug with a different dosage. This was combined with a communication campaign over which there are concerns as it may have created a false perception of health risks associated with generic versions of the drugs. In addition, Teva engaged in practices to file, enforce and selectively withdraw divisional patents. The commission sees the combination of these actions as being purposeful in attempting to block or delay market entry of Copaxone competitors.

As such, the commission is investigating two new ‘theories of harm’. These relate to Teva’s patent filing practices –the filing and selective withdrawal of divisional patents – and communication measures impeded the market entry of generic drugs.

This case follows a host of other pay-for-delay cases investigated by the commission in recent years. An early example was against Lundbeck in 2013, for which the European Court of Justice has recently upheld the decision to fine the company, following appeals [1].

With the new theories of harm, this case does have differences to those previously investigated. However, it is hoped that the Teva investigation will shed light on relevant legal framework under EU law. It is clear that the EU continues to take antitrust enforcement seriously and will undertake investigations to prevent anti-competitive conduct.

Related articles
Teva not liable in US due to FDCA implied preemption

Servier and generics makers fined for pay for delay

US supreme Court backs FTC in pay for delay case

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


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.



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. 

1. GaBI Online - Generics and Biosimilars Initiative. EU Court of Justice upholds Lundbeck fines over pay-for-delay []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 31]. Available from:

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
Strategic plans of ANVISA and COFEPRIS to advance health regulation
11 AA010165
Home/Policies & Legislation Posted 11/03/2024
Panama enacts new bill to guarantees the supply of medicines
53 MD002445
Home/Policies & Legislation Posted 29/02/2024
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