Wednesday 19 June 2013

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E.U. Fines Drug Companies for Delaying Generics

BRUSSELS — European antitrust officials on Wednesday fined a group of drug companies, including Denmark’s Lundbeck, a total of 146 million euros, or $195 million, for colluding to delay market entry of a less-expensive generic version of a blockbuster antidepressant, citalopram.

The case mirrors a decision Monday by the United States Supreme Court, which is likely to increase the number of generic drugs in the marketplace to benefit consumers. The timing of the European decision appeared to signal a trans-Atlantic crackdown on so-called “pay for delay” tactics by major pharmaceutical companies that keep prices artificially high.

“It is unacceptable that a company pays off its competitors to stay out of its market and delay the entry of cheaper medicines,” Joaquín Almunia, the European competition commissioner, said in a statement on Wednesday. “Agreements of this type directly harm patients and national health systems, which are already under tight budgetary constraints.”

In a news conference, Mr. Almunia said he welcomed the Supreme Court ruling, which empowered the Federal Trade Commission to sue pharmaceutical companies over pay-for-delay deals. Mr. Almunia said that Europe’s highest court, the European Court of Justice, should take a similar stance.

Lundbeck, which received the largest of the fines assessed Wednesday, 93.8 million euros, said that it would appeal. “The company acted transparently and in good faith in trying to protect our patents,” Lundbeck said in a statement posted to its Web site. “Upon entering the agreements they were all reviewed by external antitrust experts,” it said.

Mr. Almunia also fined generic makers including Ranbaxy Laboratories, the German drug maker Merck, Arrow Group and Zoetis Products a total of 52.2 million euros.

Instead of competing with Lundbeck when its basic patent on the drug Citalpram expired, the generic makers agreed with Lundbeck in 2002 not to enter the market in return for “substantial payments and other inducements from Lundbeck amounting to tens of millions of euros,” according to the European Commission, which is the highest antitrust authority in the 27-nation European Union.

As part of their investigation, officials from the commission said in a statement that they had found documents referring to a " ‘club’ being formed and ‘a pile of $$$’ to be shared among the participants.” Lundbeck also purchased supplies of generic versions of the medicine “for the sole purpose of destroying it,” the officials said.

Agreements to delay the introduction of generic drugs have come under heightened scrutiny in both Europe and the United States in recent years, with regulators on both sides of the Atlantic concluding that such deals are anticompetitive.

In January, the European Commission accused the drug giants Johnson & Johnson and Novartis of colluding to delay the availability of a less expensive generic version of a powerful pain-relief medication, fentanyl. At issue were transdermal patches, which deliver the drug through the skin.

That case focuses on monthly payments that a Netherlands-based subsidiary of Johnson & Johnson made to Sandoz, a unit of the Swiss company Novartis. While those companies have said the payments were legitimate, Mr. Almunia has said money probably changed hands to keep lower-cost versions of fentanyl off the market in the Netherlands.


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