US generic group GPhA slams FTC position on patent settlements as 'misguided'

29 July 2010

Commenting on US Federal Trade Commission Chairman Jon Leibowitz' testimony before the House of Representatives Committee on the Judiciary, Subcommittee on Courts and Competition Policy (The Pharma Letter July 28), the Generic Pharmaceutical Association (GPhA) described it as misguided and failing to present the whole story regarding patent settlements.

The six months of data presented by the FTC does not override the fact that over the past 10 years patent settlements ' often described as 'pay-to-delay' deals - have enabled dozens of first-time generics to come to market many months before patents on the counterpart brand drugs expired. For instance, settlement of the patent suit involving the anti-epileptic medication Lamictal (lamotrigine) allowed the generic version to come to market three months prior to brand patent expiration, saving patients more than $190 million during the early launch period, the GPhA stated.

'Yet, FTC chairman Jon Leibowitz continues to lobby Congress to pass legislation that would prohibit brand and generic manufacturers from settling costly patent litigation. Unfortunately, the FTC's position is misguided and overlooks all the complete facts,' it said.

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