Pfizer Wins Lipitor Reversal
This article was originally published in The Pink Sheet Daily
Executive Summary
Patent office's decision blocks generic atorvastatin until 2010.
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The U.S. Patent and Trademark Office upheld a key Lipitor patent, allowing Pfizer exclusivity for its blockbuster cholesterol lowering drug until 2010. Pfizer said April 30 that the patent office "issued a communication notifying the company that it will confirm the patentability of the claims of Pfizer's [No. 4,681,893] patent for Lipitor." At first, the agency rejected six claims on the basic patent over prior art, while finding one claim was patentable (1 (Also see "Pfizer Lipitor Patent Fails PTO Reexamination" - Pink Sheet, 14 Jan, 2008.)). New York-based Pfizer reported in January that the patent office had issued a first office action in its reexamination of the patent. The reexamination was requested by Ranbaxy in July 2007. If the initial conclusion had been upheld by the patent office, it would have contradicted an appeals court decision in Pfizer's favor. In 2006, a Federal Court of Appeals affirmed a Delaware federal court ruling that Ranbaxy infringed the '893 patent, which expired March 24, 2010 (2 (Also see "Lipitor Generics Could Come 15 Months Earlier Than Anticipated After Patent Deemed Invalid" - Pink Sheet, 2 Aug, 2006.)). The appellate court, however, overturned part of the lower court decision, ruling that another patent, No. 5,273,995, which covers the calcium salt of atorvastatin, was invalid because a patent claim was not drafted properly. According to FDA's "Orange Book," '995 will expire June 28, 2011. Pfizer, facing the loss of its biggest-selling drug, has been under tremendous pressure to come up with new products to fill the Lipitor sales gap. During its March 5 analyst day, the company unveiled a productivity push expected to translate into 15 to 20 regulatory submissions from 2010 to 2012 (3 (Also see "Pfizer Plots Major Phase III Push" - Pink Sheet, 5 Mar, 2008.)). Sales of Lipitor sank 7 percent in the first quarter to $3.1 billion, but the drug still accounted for one-quarter of Pfizer's global sales in the period (4 (Also see "Pfizer Earnings Fall 18% On Loss Of Zyrtec, Norvasc" - Pink Sheet, 17 Apr, 2008.)). Pfizer stands to lose $2 billion in revenues this year due to the generic launches of Zyrtec (cetirizine) and Camptosar (irinotecan). -Brooke McManus ([email protected]) |