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Servier fined €331m by European Commission

pharmafile | July 10, 2014 | News story | Sales and Marketing EC, European Commission, France, Krka, Lupin, Matrix, Mylan, Niche/Unichem, Servier, Teva 

The European Commission has served French pharma company Servier with a €331 million fine for delaying the entry to market of generic versions of its blood pressure drug perindopril.

Five generics firms – Niche/Unichem, Matrix (now part of Mylan), Teva, Krka and Lupin – have also been fined a total of €96.7 million for what the EC says is their part in the affair.

The crux of the EC’s case – hotly disputed by Servier – is that the companies made a series of deals aimed at protecting perindopril from price competition in the EU.

“Through a technology acquisition and a series of patent settlements with generic rivals, Servier implemented a strategy to exclude competitors and delay the entry of cheaper generic medicine to the detriment of public budgets and patients,” a statement said.

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“Servier had a strategy to systematically buy out any competitive threats to make sure that they stayed out of the market,” said EC vice president Joaquín Almunia, in charge of competition policy.

But the company’s argument is that the settlement agreements it reached with the generics manufacturers were a “legitimate means to put an end to long, costly, and uncertain disputes”.

“Patients have not been deprived of perindopril at any time,” insisted Servier spokesperson Lucy Vincent. “Moreover, generic entry has not been delayed. Servier 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.”

Servier says the EC’s decision “sets a regrettable precedent for industries that rely on intellectual property. By condemning patent settlement agreements responding to legitimate commercial concerns, the Commission makes patent disputes more risky and more costly”.

Trade body EFPIA has also weighed in to the debate, saying it is ‘concerned’ about the EC’s ruling.

“Judging patent validity is the sole prerogative of specialised patent offices and courts,” EFPIA said in a statement.

“Patent settlement agreements in the pharmaceutical sector are a symptom of the highly fragmented and inefficient IP enforcement regime in Europe. Given the economic and welfare interests at stake, competition authorities should be circumspect in assessing the lawfulness of patent settlements and promoting litigation.”

Servier remains bullish, saying it will appeal to the European Union Court of Justice because of “the novelty of the unfounded theory put forward” by the EC.

Adam Hill

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