Ranbaxy, Pfizer bury Lipitor dispute

In a significant move that will have ramifications in the global healthcare sector, US drug giant Pfizer Inc and Ranbaxy Laboratories...

In a significant move that will have ramifications in the global healthcare sector, US drug giant Pfizer Inc and Ranbaxy Laboratories have settled their patent dispute over cholesterol drug Lipitor, delaying the release of generic versions in the US until November 30, 2011. Pfizer8217;s Lipitor is the world8217;s best-selling drug, generating nearly 12.7 billion in 2007 sales.

The settlement has come at a time when speculation is still rife about a takeover bid by Pfizer on Ranbaxy which is being acquired by Daiichi Sankyo of Japan.

The settlement provides Ranbaxy with licences to all the patents it needs to make the generic version and enables Ranbaxy to make and launch a generic before Lipitor8217;s crystalline and amorphous patents expire in 2016 and 2017 8212; but after November 30, 2011.

Under terms of the deal, Ranbaxy will also be able to sell generic versions of Lipitor in Canada, Belgium, the Netherlands, Germany, Sweden, Italy and Australia. Pfizer and Ranbaxy have also resolved their disputes regarding Lipitor in Malaysia, Brunei, Peru and Vietnam, and regarding hypertension drug Accupril in the US and Viagra in Ecuador.

As the first generic challenger to Lipitor patents, Ranbaxy wins rights to 180 days of marketing exclusivity in the US. Patent infringement litigation between Pfizer and Ranbaxy over Lipitor will continue in Finland, Spain, Portugal, Denmark and Romania. 8220;This comprehensively settles outstanding issues between Ranbaxy and Pfizer bringing to closure a number of ongoing patent disputes,8221; said Malvinder Mohan Singh, chief executive of Ranbaxy. Buoyed by the settlement news, Ranbaxy shares rose 2.88 per cent to Rs 598.20 on the BSE on Wednesday.

A cure-all?

8226;It enables Ranbaxy to launch a generic before Lipitor8217;s crystalline and amorphous patents expire in 2016 and 2017 but after November 30, 2011

8226;As the first generic challenger to Lipitor patents, Ranbaxy wins rights to 180 days of marketing exclusivity in the US

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8226;The Indian firm can sell generic versions of Lipitor in Canada, Belgium, the Netherlands, Germany, Sweden, Italy and Australia