Lipitor Patent To Be Reexamined At PUBPAT's Request: Patent Office Agrees There is a "Substantial Question" Regarding Blockbuster Cholesterol-Lowering Drug Patent's Validity

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The United States Patent and Trademark Office has issued an Order granting the Public Patent Foundation's Request for Reexamination of Pfizer's patent on Lipitor, touted by the pharmaceutical giant as being "the best-selling treatment for lowering cholesterol and the best-selling pharmaceutical product of any kind in the world." In its Order, the Patent Office found that PUBPAT's request raised "a substantial new question of patentability" regarding all 44 claims of the patent.

The United States Patent and Trademark Office has issued an Order granting the Public Patent Foundation's Request for Reexamination of Pfizer's patent on Lipitor, touted by the pharmaceutical giant as being "the best-selling treatment for lowering cholesterol and the best-selling pharmaceutical product of any kind in the world." In its Order, the Patent Office found that PUBPAT's request raised "a substantial new question of patentability" regarding all 44 claims of the patent.

During the past year, Pfizer filed numerous infringement lawsuits asserting the patent against websites offering generic or lower priced versions of Lipitor. Meanwhile, a one-month supply of Lipitor in New York costs from $105 to $132 and filings with the Securities and Exchange Commission show that Pfizer made $2.4B from the sale of Lipitor in just the second quarter of 2004 alone.

When it requested the reexamination in September, PUBPAT argued that "millions of Americans are not getting the cholesterol lowering treatment they need and deserve [because] the price for Lipitor is too high." PUBPAT's request pointed out that the challenged patent is relevant to the price of Lipitor in that "Pfizer is able to charge such a high price for Lipitor because the '156 patent stands as an impediment to the marketing of a generic atorvastatin pharmaceutical product (atorvastatin is the generic name of the compound marketed by Pfizer under the Lipitor brand name)."

Pfizer has the opportunity to make an opening statement to the Patent Office, to which PUBPAT has the right to make a response. After opening statements, if any, the Patent Office will proceed to determine whether the patent is indeed invalid in light of the new questions raised by PUBPAT's request. Third party requests for reexamination, like the one filed by PUBPAT, are successful in having the subject patent either narrowed or completely revoked roughly 70% of the time.

"We are obviously very pleased with the Patent Office's decision to grant our request to reexamine Pfizer's Lipitor patent that they are attempting to use to prevent Americans from getting generic atorvastatin," said Dan Ravicher, PUBPAT's Executive Director and Founder. "This is the first step towards ending the significant financial and public health harms being caused to the public by this patent that should have never been issued."

More information about PUBPAT's Request for Reexamination, including a copy of the Patent Office's Order Granting the Request, can be found at http://www.pubpat.org/Protecting.htm.

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Karen Duffin, Bite Communications
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