Pfizer Inc. (PFE) announced that a Spanish court has upheld the company's enantiomer patent covering the calcium salt of atorvastatin, the active ingredient in Lipitor. However, a second patent covering a stabilized formulation that includes atorvastatin was ruled invalid. The patents were challenged by India-based generic drug manufacturer Ranbaxy.
Lipitor is sold in Spain under the brand names Zarator and Cardyl. The calcium salt patent of Lipitor expires in July 2010 and the stabilized formulation patent expires in December 2013. Last year, the cholesterol-lowering drug Lipitor fetched revenues of $12.89 billion for Pfizer.
Ranbaxy is involved in a legal spat with Pfizer in more than 17 countries including the United States, over Lipitor's patents.
The Lipitor patent challenge is regarded as the 'mother of all patent challenges' in the global pharmaceutical industry. In May, Pfizer's Lipitor patents, which were challenged by Ranbaxy, were invalidated by a Norwegian Appeals Court, paving way for the generic drug company to market a generic version of Lipitor in Norway. Though the ruling, which has no bearing on Lipitor patent challenges pending in other countries, including the United States, is unlikely to impact the sales of Lipitor, some experts believe that there might be leakage of low priced generic version of the drug across the borders into other markets.
For Ranbaxy, which spent about $37 million during 2004-05, to fight the patent battle related to Pfizer's Lipitor, the launch of the atorvastatin - the generic version of Lipitor is vital in its plan if it were to generate nearly $2 billion in annual sales over the next five years. Ranbaxy has about 20 first-to-file or FTF applications, which gives the company exclusive marketing rights on the generic version of the branded drugs for six months, pending in the U.S. Of the 10 FTF applications, which are facing legal hurdles, atorvastatin or generic Lipitor remains a big bet.
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