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

Home/Policies & Legislation | Posted 07/06/2013 post-comment0 Post your comment

The European Commission (EC) is reportedly ready to fine Danish pharmaceutical company Lundbeck and eight generics makers over alleged pay-for-delay deals in Europe.

Pay for Delay V13C29

The case goes back to 2009, when an inquiry was launched into patent settlement deals between Lundbeck and several generics manufacturers. This was then followed on 25 July 2012 by the EC accusing Lundbeck and eight other pharmaceutical companies (Arrow, AL Industrier, Alpharma, Generics UK, Merck KGaA, Ranbaxy, Resolution Chemicals and Xellia Pharmaceuticals) of using pay-for-delay tactics to prevent the sale of generic versions of Lundbeck’s blockbuster antidepressant Celexa (citalopram).

In Europe, any such pay-for-delay deals infringe on Article 101 of the Treaty on the Functioning of the EU that prohibits restrictive business practices. The EC considers that the practices may have caused substantial consumer harm in delaying the entry of generic medicines for up to two years and keeping prices for citalopram high as a result.

The EU’s antitrust regulator is expected to impose a ‘significant’ fine on Lundbeck and lesser fines on the other companies involved. Lunbeck could face a fine of up to 10% of its global sales, which could amount to US$312 million.

Both the EU and the US have been coming down hard on these so-called pay-for-delay deals, accusing them of delaying generics and costing patients and payers millions of dollars or Euros. Others, such as the Generic Pharmaceutical Association argue that ‘these agreements have never delayed the availability of a generic drug past the expiration of a brand-name drug’s patent’ [1].

In January 2013, the EU also charged Johnson & Johnson and Novartis of delaying the entry of generic versions of fentanyl pain killer patches [2]. In the US, the Supreme Court is reviewing a case involving a patent settlement between Actavis and Solvay Pharmaceuticals over AndroGel (testosterone gel).

Related articles

Pay-for-delay on the increase in the US

Problematic pharma patent settlements decrease in the EU

References

1.  GaBI Online - Generics and Biosimilars Initiative. Is the end in sight for pay-for-delay? [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jun 7]. Available from: www.gabionline.net/Policies-Legislation/Is-the-end-in-sight-for-pay-for-delay

2.  GaBI Online - Generics and Biosimilars Initiative. EC accuses J&J and Novartis of delaying generic fentanyl [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jun 7]. Available from: www.gabionline.net/Pharma-News/EC-accuses-J-J-and-Novartis-of-delaying-generic-fentanyl

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