EC fines Servier, Teva, four others 427.7 million euros for delaying Coversyl generics

By: Matthew Dennis

The European Commission announced Wednesday that Servier and five other companies, including Teva, have been fined a total of 427.7 million euros ($582.2 million) for entering deals that delayed the launch of generic versions of the hypertension drug Coversyl (perindopril) in the EU. European Competition Commissioner Joaquin Almunia said “Servier had a strategy to systematically buy out any competitive threats to make sure that they stayed out of the market,” adding “such behaviour is clearly anti-competitive and abusive.”

The Commission said that through a technology acquisition and a series of patent settlements with generic rivals, including Teva, Krka, Mylan’s Matrix Laboratories unit, Unichem Laboratories’ Niche Generics division and Lupin, Servier “implemented a strategy to exclude competitors and delay the entry of cheaper generic medicine.” Almunia remarked “competitors cannot agree to share markets or market rents instead of competing, even when these agreements are in the form of patent settlements. Such practices directly harm patients, national health systems and taxpayers.”

Specifically, the regulator fined Servier 331 million euros ($450.4 million), Lupin 40 million euros ($54.4 million), Mylan 17.2 million euros ($23.4 million) and Teva 15.6 million euros ($21.2 million). In addition, Unichem has been penalised just under 14 million euros ($19.1 million), with Krka facing a fine of 10 million euros ($13.6 million). Sources suggested last month that Servier, Teva and a number of other companies were likely to be issued fines in relation to delays in the entry of generic versions of Coversyl.

In response to the news, Servier spokeswoman Lucy Vincent said “generic entry hasn’t been delayed,” adding that the company “has acted in a transparent and legitimate way to defend its patents, which are essential if we are to continue the development of innovative medicines for the benefit of patients.” Meanwhile, Teva spokesman Raz Meirman commented “we stand by our belief that Teva did not engage into any anti-competitive behaviour,” noting that the drugmaker “will consider whether to appeal the decision before the General Court of the European Union.”

The Commission started a broad inquiry of the pharmaceutical sector in 2008, opening antitrust probes into a number of companies. Last year, the regulator finednine drugmakers 146 million euros ($198.6 million) regarding alleged pay-for-delay agreements related to Lundbeck’s antidepressant Celexa (citalopram). In addition, the Commission fined Johnson & Johnson and Novartis a total of 16.3 million euros ($22.2 million) for delaying the market entry of generic fentanyl in the Netherlands later that year.

Meanwhile, a recent report suggested that the US Federal Trade Commission has opened several new probes into agreements between pharmaceutical companies that may delay the entry of generic drugs following a decision from the Supreme Court last year ruling that antitrust law may bar pay-for-delay deals surrounding generic medicines, paving the way for drugmakers to be sued (for related analysis,