EU Court Cuts Big Pharma Fine Over Heart Drugs

(CN) – While the French maker of medication to treat high blood pressure made illegal agreements with other pharmaceutical companies to keep a generic version of the drug off the market, the European General Court found abuse of dominant position hadn’t been proven and cut the fine by $117 million Wednesday.

Servier developed the ACE inhibitor perindopril in 1981 for the treatment of hypertension and heart failure. While drug’s patent expired in EU member states throughout the 2000s, Servier took out a new patent covering the active ingredient erbumine and its manufacturing processes in 2004.

Generic drugmakers challenged the validity of that patent, leading Servier to enter agreements with six companies who promised to stay out of the perindopril market. A Servier subsidiary agreed to license and supply the drug to one of the generic drugmakers, Niche.

In 2014, the European Commission found the agreements violated EU antitrust laws by restricting competition. All the companies received fines, with Servier hit the hardest: $376 million, $150 million of that for its licensing agreement with Niche.

While the Luxembourg-based European General Court agreed Wednesday that Servier’s deals with the generic drugmakers restricted competition – even though they were presented as mutually agreed “settlements” – the court found the fine against Servier excessive. The court also found no competition restriction as to Servier’s agreement with one of the generic drugmakers and cut the fine against that drugmaker entirely.

As to whether Servier abused its dominant market position with the agreements, the EU court found the commission made several errors. Regulators incorrectly decided perindopril was somehow different than other ACE inhibitors, underestimated the propensity for people taking perindopril to change medications, and put too much weight on price factors in its analysis of competition constraints, the court said.

Accordingly, because perindopril faced competition from other ACE inhibitors Servier was not the dominant market force the commission found it to be, the court ruled – cutting the fine for that entirely.

All parties have two months to appeal the court’s decision to the European Court of Justice.

The ruling on Servier was only made available in French at press time.

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