Challenging Generic Drug Deals | August 6, 2012 Issue - Vol. 90 Issue 32 | Chemical & Engineering News
Volume 90 Issue 32 | p. 11 | News of The Week
Issue Date: August 6, 2012

Challenging Generic Drug Deals

Pharma companies in Europe, U.S. face scrutiny over so-called pay-to-delay tactics.
Department: Business
Keywords: patent settlement, generic pharmaceuticals

The European Commission last week claimed that patent settlements between the French drug company Servier and several of its generics competitors may be delaying entry of a generic version of the heart drug perindopril in Europe. The accusation is the latest by officials on both sides of the Atlantic involving the so-called pay-for-delay tactic of drug firms to thwart generic drug competition.

The EC lists generic drug manufacturers Teva Pharmaceutical Industries, Niche/Unichem, Matrix (now Mylan Laboratories), Krka, Lupin, and others in its charge that Servier induced competitors to enter settlements in which they agreed to hold off introducing generic versions of perindopril.

If the EC finds sufficient evidence of collusion, it can impose a fine of up to 10% of annual revenues on the companies involved.

Earlier this month, European authorities filed similar charges against drugmaker Lundbeck as well as Merck KGaA, Ranbaxy Laboratories, and other generic drug firms. Meanwhile, the U.S. Supreme Court may take up a pay-for-delay case after a federal appeals court’s finding last month that a settlement between Bayer and Barr Laboratories, now part of Teva, is anticompetitive.

The Generic Pharmaceutical Association, a U.S. trade group, issued a statement on the Philadelphia court ruling contending that patent settlements are a legitimate means of doing business that does not delay introduction of generic drugs.

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