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Lundbeck challenge to EC pay-for-delay ruling fails

Court upholds €94m fine for paying off firms to delay launch of Celexa generics

LundbeckA European court has upheld a ruling which found Lundbeck engaged in anti-competitive activity that delayed the launch of generic versions of its big-selling antidepressant Celexa.

The 2013 verdict by the European Commission resulted in a €94m ($106m) fine for the Danish drugmaker, which was held to have paid four generics firms to stay out of the market in order to keep the price of Celexa (citalopram) artificially high.

The four generics companies - Generics UK, Arrow, Alpharma and Ranbaxy - were fined around €52m, and those judgments have also been upheld by the General Court of the EU.

The Celexa case judgment was the first in a broad investigation by the EC of pay-for-delay practices by the pharma industry that kicked off in 2010.

The Commission said the court concluded it was "correct in finding that, irrespective of any patent dispute, generics competitors agreed with Lundbeck to stay out of the market in return for value transfers and other inducements," and that the behaviour amounted to a "a buying-off of competition".

Lundbeck was unable justify why the agreements were needed to protect its intellectual property rights on Celexa, according to the Commission. Lundbeck insists it did not go beyond the protection already offered by its patent rights on Celexa.

The pharma company said it "strongly disagrees" with the decision and will now decide whether to take the matter to the European Court of Justice in a bid to have the "decision annulled and/or the fine reduced". If it decides to do so it has two months and 10 days to file the appeal.

After the Lundbeck case, the Commission fined companies in two other pay-for-delay investigations - one concerning a Johnson & Johnson Duragesic (fentanyl) patch and generic drugmaker Sandoz, and the other concerning Servier's Coversyl/Aceon (perindopril) that involved four generic drugmakers.

The Duragesic decision was not appealed, but several challenges to the Servier decision are pending before the General Court. Two other investigations - involving AstraZeneca/Nycomed and Teva/Cephalon - did not result in enforcement action by the Commission.

Article by
Phil Taylor

9th September 2016

From: Sales

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