Servier and generics makers fined for pay-for-delay

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Servier and generics makers fined for pay-for-delay

INICIO/Políticas y legislación | Posted 08/08/2014 0 Post your comment

French drugmaker Les Laboratoires Servier (Servier) and five generics companies have been fined a total of Euros 427 million by the European Commission due to practices delaying the entry of generic perindopril, a medicine to treat high blood pressure.

The Commission opened proceedings against Servier and the five generics companies: Niche-Unichem and Matrix (now part of Mylan), Teva, Krka, and Lupin, on 8 July 2009.

According to the Commission’s decision Servier acquired new technologies to produce perindopril and used patent settlements with generics makers to make generics market entry more difficult or delayed, violating European antitrust law.

According to the Commission, the patent settlements and technology acquisition meant that Servier retained the monopoly on its blockbuster blood pressure control medicine Coversyl (perindopril) for a further four years. During which time patients and national health systems were deprived of the benefits of competition, meaning earlier access to a cheaper version of the medicine.

The Commission investigation concluded that Servier committed an abuse by pursuing an anticompetitive strategy to delay the entry of cheaper generic versions of its drug perindopril. The Commission’s decision of 9 July 2014 therefore imposes a fine of Euros 331 million on Servier and a total amount of Euros 96.7 million on the generics manufacturers.

Mr Joaquin Almunia, Vice President of the EC responsible for Competition Policy, said of the decision that ‘these so-called “pay-for-delay” agreements are not acceptable’ and that this case ‘is a serious breach of EU antitrust rules, and the companies have been sanctioned accordingly’.

This is not the first time the Commission has imposed fines on companies for what it terms ‘anticompetitive agreements’. Denmark’s Lundbeck and four generics companies were fined Euros 146 million in June 2013 for similar pay-for-delay deals, related to Lundbeck’s antidepressant Celexa (citalopram) [1].

Six months later, Johnson & Johnson and Novartis were fined Euros 16.3 million for anticompetitive agreements, which the European Commission believes delayed the market entry of a generic version of the painkiller Duragesic (fentanyl) in The Netherlands [2].

References
1. GaBI Online - Generics and Biosimilars Initiative. Lundbeck and 4 generics makers fined for pay-to-delay deals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 8]. 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 problematic patent settlements remain at low level [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 8]. Available from: www.gabionline.net/Reports/EU-problematic-patent-settlements-remain-at-low-level

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Source: Europa