Pfizer and Ranbaxy settle majority of Lipitor dispute

Pfizer settled with generics manufacturer Ranbaxy Laboratories Ltd. of India on the majority of its patent litigation worldwide involving Lipitor, the world's most-prescribed cholesterol-lowering medicine.

Under the terms of the agreement, Ranbaxy will have a license to sell generic versions of Lipitor and Caduet in the US effective November 30, 2011. Caduet is a medicine that combines the active ingredients of Lipitor and Norvasc and treats both high blood pressure and high cholesterol.

The settlement means November 30, 2011 will be the date for entry of a generic version of Lipitor in the US. In addition, the agreement provides a license for Ranbaxy to sell generic versions of Lipitor on varying dates in seven additional countries: Canada, Belgium, Netherlands, Germany, Sweden, Italy and Australia. Pfizer and Ranbaxy have also resolved their disputes regarding Lipitor in Malaysia, Brunei, Peru and Vietnam.

The settlement also resolves all patent litigation with Ranbaxy relating to Accupril in the United States and Viagra in Ecuador.

The patent infringement litigation between Pfizer and Ranbaxy relating to Lipitor will continue in five other European countries -- Finland, Spain, Portugal, Denmark and Romania. Court cases involving the enantiomer patents are pending in Spain and Portugal, while an infringement action on the commercial process patent is pending in Finland. Patent cases involving the enantiomer patent are pending in Denmark and Romania.

'This agreement is a win-win-win because it is pro-patient, pro-competition and pro-intellectual property,' said Ian Read, president of Worldwide Pharmaceutical Operations for Pfizer. 'The agreement provides patients with access to a generic product much earlier than if Ranbaxy were unsuccessful in obtaining approval for its product and overcoming the relevant patents. It provides substantial certainty regarding the timing of the entry of a generic version of Lipitor. Finally, the agreement clearly reaffirms the value and importance of intellectual property and this country's well-balanced system of creating incentives to develop innovative medicines while at the same time establishing a strong generic drug business.'

Pfizer has been defending Lipitor patent challenges by Ranbaxy throughout the world since 2003. The agreement pertains solely to Ranbaxy and its affiliates and does not cover legal challenges to the Lipitor patents involving other generic manufacturers. However, Ranbaxy was the first generic challenger to the listed Lipitor patents and, as such, holds the rights to 180 days of marketing exclusivity in the US.