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Ruling maintains Lipitor Patent term.

The U.S. Patent & Trademark Office recently issued a notice allowing drugmaker Pfizer Inc. to correct a technical defect in one of the patents involving Pfizer's cholesterol medicine Lipitor, the world's top-selling drug.

The decision will result in reissuance of the drug's key patent and maintain that patent's June 2011 expiration date, crucial to Pfizer because Lipitor brings the company nearly $13 billion in annual sales.

"We have said all along that we had strong arguments for securing the reissue of the patent, and after a vigorous and thorough examination, the Patent Office agreed with this conclusion," said Raymond F. Kerins, Pfizer's vice president of worldwide communications.

The patent office decision resulted from litigation that began after India's largest drugmaker, Ranbaxy Laboratories Ltd., in 2002 sought FDA approval to sell a generic version of Lipitor, which is known chemically as atorvastatin. Ranbaxy challenged both Lipitor's basic patent and a second one.

Pfizer had sued Ranbaxy to block its challenge of both patents and initially won in federal court in Delaware, but a Court of Appeals ruling in December 2006 found the patent had a technical defect: one claim within it contained an improper cross reference to another claim in the patent. The following month, to resolve the issue, Pfizer applied with the patent office to correct the defect by removing the cross reference and have the patent reissued.

Two years later, the patent office ruled it will reissue the patent, as revised, if Pfizer pays a fee of $1,510 within three months.

Source: Associated Press
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Title Annotation:FDA UPDATE: A monthly compendium of news features, announcements, regulatory issues and approvals from the Food & Drug Administration.
Publication:Pharmaceutical Processing
Date:Jan 1, 2009
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