Global drugs behemoth Pfizer says that the US Patent and Trademark Office has issued a "Notice of Allowance" accepting the company's application to correct the technical defect in the '995 enantiomer patent for atorvastatin calcium, the salt form of atorvastatin sold as Lipitor, the firm's blockbuster cholesterol-lowering drug, which has generated peak annual sales of nearly $13.0 billion. The company noted that certain formalities must be completed before the re-issue patent will be granted. The new patent will have the same force and effect as the original, as well as the same June 2011 expiration date (including the six-month pediatric exclusivity period).
"This is a very positive development, not just for Pfizer but for all those who believe that defending intellectual property is vital to supporting the enormous investments required to develop life-saving new medicines," said Raymond Kerins, vice president, worldwide communications at Pfizer.
The USPTO decision strengthens Pfizer's efforts to prevent generics groups such as Apotex and Teva from launching copy versions of Lipitor before November 2011, when India-headquartered Ranbaxy is set to come to market with its product, which has 180-days exclusivity, following a settlement with Pfizer.
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