Pfizer, Ranbaxy settle Lipitor dispute: UTVi

Pfizer, Ranbaxy settle Lipitor dispute : UTVi.com
Ranbaxy, Pfizer settle Lipitor patent disputes : Reuters India


Ranbaxy Laboratories has settled most of its patent disputes with Pfizer allowing it to launch a generic version of the US group's blockbuster cholesterol drug Lipitor from November 30, 2011.
Ranbaxy also said it would have 180 days market exclusivity following the US launch of the generic version of Lipitor, the world's biggest selling drug with sales of $12.7 billion in 2007.
"This comprehensively settles outstanding issues between Ranbaxy and Pfizer bringing to closure a number of on-going patent disputes," Malvinder Mohan Singh, chief executive and managing director, Ranbaxy, said in the statement.

"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," he added.Speaking to UTVi, Singh said this is the largest and the most comprehensive settlement in the history of the pharmaceutical industry. "The best news in the deal is that it opens up a $12 billion market for Ranbaxy, and we will be getting access to the $8 billion US market from November 30, 2011.... no questions, no risks...."Ranbaxy will also have the licence to sell the drug in an additional seven countries including Canada, Belgium, the Netherlands, Germany, Sweden, Italy and Australia.A Pfizer spokesperson maintained that the settlement with Ranbaxy was pro-patent and pro-intellectual property. The spokesperson also denied any intention of buying the non-promoter stake in Ranbaxy.Ranjit Kapadia, pharma analyst at Prabhudas Lilladher, while speaking to UTVi , said the market had no whiff of the deal. "Or the market would have flared up today," he added.The deal may push the Ranbaxy stock to around Rs 650 as against the open offer price of Rs 737 to be offered by Daiichi Sankyo, which has signed a deal with the promoters of Ranbaxy. "Ranbaxy is a buy at the moment," Kapadia added.

Following is the press release issued by RanbaxyRANBAXY AND PFIZER SETTLE LIPITOR LITIGATION WORLDWIDE
* Ranbaxy will Market Generic Atorvastatin in the U.S. with 180 Days Exclusivity from Nov. 30, 2011
* Agreement Also Resolves Caduet, Accupril Litigation in the US
Gurgaon, Harayana, India; Princeton, NJ, USA – June 18 , 2008 -- Ranbaxy Laboratories Limited (Ranbaxy), announced today that it has entered into an agreement with Pfizer Inc. to settle most of the patent litigation worldwide involving Atorvastatin (Lipitor), the world’s most-prescribed cholesterol-lowering medicine. This decision will allow for an earlier introduction of a generic formulation that will benefit patients and many healthcare systems throughout the world. Lipitor is the world's largest selling drug with worldwide sales in 2007 of $12.7 billion.

The agreement pertains solely to Ranbaxy and its affiliates and does not cover legal challenges to the Lipitor patents involving other generic manufacturers. However, as Ranbaxy was the first generic challenger to the listed Lipitor patents, it retains the right to the marketing exclusivity of 180 days in the United States. Under the terms of the agreement, Ranbaxy will have a license to sell generic versions of Atorvastatin and the fixed-dose combination of Atorvastatin-Amlodipine besylate in the United States effective Nov. 30, 2011.

Welcoming the development, 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. It also provides certainty and visibility to the launch of Ranbaxy’s Generic Atorvastatin, with180 day market exclusivity in the US and an early entry in other markets. This will make the worlds largest selling drug more accessible to patients who will gain from the timely availability of an affordable quality option.”

Ranbaxy will also have a license to sell Atorvastatin on varying dates in an additional 7 countries, including: Canada, Belgium, Netherlands, Germany, Sweden, Italy and Australia. Ranbaxy and Pfizer have also resolved their disputes regarding Atorvastatin in Malaysia, Brunei, Peru and Vietnam.

In addition, the lawsuits between Pfizer and Ranbaxy regarding Atorvastatin will be dismissed in select countries and the lawsuits between Pfizer and Ranbaxy regarding the fixed dose combination product containing Atorvastatin and amlodipine will be dismissed in the U.S. and Ranbaxy will no longer contest the validity of Pfizer’s patents in such countries. Such patent challenges by Ranbaxy regarding Lipitor have been underway in numerous markets since 2003.
The Atorvastatin patents involved in this agreement are the basic compound patent, which expires in the United States in 2010; the enantiomer patent, which expires in the United States in 2011; and various process and crystalline form patents, which expire in 2016 and 2017; and the combination patent for fixed-dose combination product which expires in 2018.

The agreement also covers the fixed-dose combination of Atorvastatin-Amlodipine besylate (presently marketed under the brand Caduet, which also contains crystalline Form I Atorvastatin), a fixed-dose combination product indicated for patients suffering from both high blood pressure and high levels of cholesterol. The patent for the fixed-dose combination expires in 2018. The settlement also resolves additional patent litigation between the companies involving the branded drugs Accupril (in the U.S.) and Viagra (in Ecuador) and all patent litigation with Ranbaxy relating to generic formulation of Quinapril hydrochloride in the United States and Sildenafil in Ecuador.

Litigation between Ranbaxy and Pfizer relating to Lipitor will continue in five other European countries -- Finland, Spain, Portugal, Denmark and Romania.

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