Pfizer's Lipitor patent will not be re-issued

The US Patent and Trademark Office has rejected an application by world drug giant Pfizer to have the exclusivity for its mega-blockbuster cholesterol-lowerer Lipitor (atorvastatin) upheld until June 2011. First-quarter 2007 sales of the agent rose 8% on the comparable period the year before to $3.4 billion. In the second quarter, worldwide Lipitor sales fell 13% to $2.7 billion, as the 5% growth seen in international markets was more than offset by the 25% decline in the USA. According to a news report on CNNMoney.com, the decision could cost the New York-headquartered drug major as much as $6.0 billion.

In response to the outcome of the trial, a Pfizer press statement noted that "an initial rejection is not uncommon in re-issue application proceedings," adding that it will now review the communication from the Patent Office and respond as appropriate to address the issues raised by the examiner. "It is important to note, however, that Lipitor continues to be protected by its basic patent until March 2010, including pediatric exclusivity. Today's decision has no impact on the basic patent. The average time for obtaining a re-issue patent is about two years from the date the application is filed. Pfizer filed its re-issue application on Lipitor's calcium salt patent in January 2007," the firm noted.