The Hindu Business Line : Ranbaxy settles worldwide patent litigations with Pfizer

New Delhi, June 18 Ranbaxy Laboratories Ltd and Pfizer Inc have agreed to settle most of their patent litigations worldwide involving the blockbuster cholesterol-lowering drug, Atorvastatin (Lipitor).

Lipitor is the world’s largest selling drug with global sales in 2007 of $12.7 billion.

Under the agreement, Ranbaxy will be allowed to sell generic versions of the drug in the US from November 30, 2011. Ranbaxy, in which Japanese pharma major Daiichi Sankyo is picking up 51 per cent stake for over $4 billion, was earlier pushing for a launch in 2010, when the drug is supposed to go off patent. The delay will give Pfizer more revenues and time to prepare before cheaper generic forms of the best-selling drug flood US drugstores.

For Ranbaxy, this will give a certainty that it will be able to get exclusive rights to sell copies of Lipitor for six months and avoid further litigation costs. The Indian company is also expected to earn revenues of over $1.5 billion starting 2011 as a result of this agreement with Pfizer.

Patent challenges by Ranbaxy regarding Lipitor have been under way in numerous countries since 2003. Analysts said that the high cost of fighting the litigations and the recent acquisition by the Japanese company may have led Ranbaxy to resolve the issue with Pfizer. “The agreement with Pfizer is a direct fallout of the acquisition by Daiichi Sankyo which may have wanted to resolve all major disputes before it acquired Ranbaxy. The Japanese company is an innovator and, therefore, Ranbaxy is not dependant only on generic drugs anymore. This deal gives a certainty on Lipitor,” said Mr Sujay Shetty, Head of Life Sciences, PricewaterhouseCoopers.

Ranbaxy will have a licence to sell the drug on varying dates in an additional seven countries - Canada, Belgium, the Netherlands, Germany, Sweden, Italy and Australia. Ranbaxy and Pfizer have also resolved their disputes in Malaysia, Brunei, Peru and Vietnam. However, litigation between Ranbaxy and Pfizer relating to Lipitor will continue in five other European countries – Finland, Spain, Portugal, Denmark and Romania.

Welcoming the development, Mr Malvinder Mohan Singh, CEO and MD, Ranbaxy Laboratories Ltd, said, “This comprehensively settles outstanding issues between Ranbaxy and Pfizer bringing to closure a number of ongoing patent disputes. This will make the world’s largest selling drug more accessible to patients who will gain from the timely availability of an affordable quality option.”

The agreement also allows Ranbaxy to market generic version of Caduet, a drug for patients suffering from both high blood pressure and high levels of cholesterol. The settlement also resolves additional patent litigation between the companies involving the branded drugs Accupril (in the US) and Viagra (in Ecuador) and all patent litigation relating to generic formulation of Quinapril hydrochloride in the US and Sildenafil in Ecuador.

Ranbaxy’s shares closed 2.7 per cent up on the NSE today at Rs 597.50.

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More Stories on : Pharmaceuticals | IPR | Courts/Legal Issues | Ranbaxy Laboratories Ltd

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