Europe Fines Servier in Pay-for-Delay Crackdown

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Europe Fines Servier in Pay-for-Delay Crackdown

BRUSSELS — Fines totaling 427.7 million euros ($581.8 million) were imposed Wednesday on several European drug makers, including the French company Servier, for keeping more affordable forms of a popular heart treatment off the market.

The case is part of a broader crackdown in Europe against drug makers that pay to delay the introduction of generic versions of their medications after some of their patent protections expire. Regulators in the United States are also clamping down.

Servier, which was fined €331 million ($450 million), condemned aspects of the decision by Europe’s top antitrust enforcer as “absurd,” and said it would be “detrimental to patients” because it would limit its research efforts. The company, based in Suresnes, near Paris, said it would appeal the decision to the General Court, the second-highest tribunal in the European Union.

The case against Servier focused on how it protected its blood pressure medicine, perindopril.

“Servier had a strategy to systematically buy out any competitive threats to make sure that they stayed out of the market,” Joaquín Almunia, the European Union’s commissioner for competition policy, said at a news conference in Brussels. Such “behavior is clearly anticompetitive and abusive” and such “practices directly harm patients, national health systems and taxpayers,” Mr. Almunia said.

Servier’s tactics included buying the rights to an alternative process for manufacturing a version of perindopril, preventing makers of generics from bringing a competing product to market, according to European Union officials. The makers of generics then challenged some of Servier’s secondary patents in court, but Servier effectively bought them off with settlements, including significant cash payments, the officials said.

One generics company, which was not named, acknowledged that it was “bought out of perindopril.” Another producer said it agreed to market generic perindopril in just seven national markets in Europe, according to the evidence.

In a case in Britain, where the patent on the perindopril molecule expired in 2003, Servier blocked the introduction of a generic version for four years. Prices dropped by an average of 90 percent once the generic version was allowed onto the British market in 2007, the officials said.

The commission did not name the companies in the evidence it presented. But fines totaling €96.7 million were levied against five producers of generics: Unichem Laboratories, based in India, and a subsidiary, Niche Generics; Matrix, now part of Mylan of Pennsylvania; Teva Pharmaceutical, based in Israel; Krka, based in Slovenia; and Lupin, also based in India.

In a statement, Teva said, “We stand by our belief that Teva did not engage into any anticompetitive behavior.” It said it had not yet decided whether to appeal against its fine of €15.6 million.

The push to rid the industry of such pay-for-delay deals could give patients better access to less costly medicines at a time when patents worth tens of billions of euros have been expiring.