This content is from: European Union

Pharma industry fiercely criticises Lundbeck fine

The European Federation of Pharmaceutical Industries Associations (EFPIA) has criticised the European Commission’s decision to fine Lundbeck and other companies a total of €146 million

On Wednesday, Commissioner Joaquin Almunia said the Commission was fining nine companies over pay-for-delay agreements relating to Lundbeck’s anti-depressant drug citalopram (branded as Celexa or Cipramil).

Lundbeck was accused of paying generic rivals not to sell generic versions of the drug. It was fined €93.8 million. Other companies fined included Merck KGaA, Generics UK (part of Mylan) and Ranbaxy.

Lundbeck immediately said it would appeal the fine. “There is no question about the validity of Lundbeck's process patents at issue. Patent settlement agreements are efficiency enhancing and legitimate when there are bona fide grounds for dispute,” it said.

The EFPIA said it and its members were “concerned” about the decision, and added that it would prolong patent litigation and undermine confidence in the patent system.

EFPIA Director General Richard Bergström said: “The EU patent system is still a mess. It is no surprise that companies settle to save legal fees and uncertainty”. He called for a full policy debate in the Commission.

The European Generic Medicines Association did not immediately comment on the decision.

In his statement, Almunia said the “overwhelming majority” of patent settlement agreements are entirely legitimate, but ominously added: “Paying competitors to stay out of the market at the expense of European citizens has nothing to do with the legitimate protection of intellectual property: it is an illegal practice and the Commission will fight against it. We have other investigations ongoing and more decisions in this field are likely before the end of my mandate.”

The US Supreme Court last week ruled in a pay-for-delay case involving Actavis, saying that reverse-payment deals are not automatically illegal, and must be judged case-by-case.

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