In a development that might result in India's leading drug maker Ranbaxy selling a generic version of Pfizer's blockbuster drug Lipitor sooner than expected in the US market, the United States patent office has made an initial rejection of Pfizer's claim on the basic patent on Lipitor. |
The cholesterol-lowering Lipitor, which has patent protection in the US till March 2010, had sales of $12.9 billion (in 2006) and is the world's top-selling drug. |
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A press release issued by Pfizer on January 14 said that the US Patent & Trademark Office has issued its first communication in the re-examination of the '893 basic patent for Lipitor, initially rejecting the patent's claims. |
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"This initial action, which is how the office raises its issues with the patentee, will now be followed by the company's response in which Pfizer will address issues raised by the examiner. An initial rejection is not unusual in re-examination proceedings," the statement said. |
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A report by Bloomberg said that the patent office agreed to take a second look at the patent at the behest of a law firm that represented Ranbaxy Laboratories. Ranbaxy declined to comment on the issue. |
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"We will respond as appropriate to the issues raised by the examiner, and believe we have compelling arguments in our favour," said Pfizer General Counsel, Allen Waxman. |
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"We continue to believe that the basic patent was properly granted and will be upheld on re-examination. This initial action, which was not unexpected, does not change that." |
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The patent remains valid and enforceable throughout the re-examination proceeding, which could take as long as a few years, the Pfizer statement said. |
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The Pfizer-Ranbaxy battle on the patent validity of Lipitor had seen Ranbaxy's opposition to the basic patent being rejected by US patent office two years ago. |
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However, Ranbaxy had succeeded in invalidating another patent on Lipitor, thereby enabling the company to prepare to launch its generic alternative by March 2010. |
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The current response from US patent office is on this basic patent, which gives Pfizer a market monopoly till March 2010. |
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