Healthy Skepticism Library item: 8070

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Publication type: news

Johnson A.
Pfizer Is Handed Setback in Canada On Lipitor Patent
Wall Street Journal 2007 Jan 27A4
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Full text:

Pfizer Inc. suffered a patent setback in Canadian court that could pave the way for a generic copycat of a cholesterol fighter years earlier than expected. A generic version of Lipitor in Canada could depress sales of Pfizer’s drug there and could make a tempting target for importation into the U.S., posing a threat in Pfizer’s lucrative home market.

A judge in Canadian Federal Court in Toronto ruled Thursday that a Pfizer patent covering a key ingredient in Lipitor couldn’t be used to block a generic version of the drug. The patent would have protected Lipitor in Canada until July 2010. Pfizer, based in New York, said it would appeal the decision. Another patent upheld by the judge only protects Lipitor through May of this year.

The dispute centers on Indian generics maker Ranbaxy Laboratories Ltd.‘s attempt to bring generic Lipitor to market in Canada. Even with this victory, Ranbaxy must surmount other legal hurdles before launching a generic there. Other patent suits between Ranbaxy and Pfizer are still pending.

The Canadian market represents more than $800 million in annual sales for Lipitor, compared with $7.85 billion of Lipitor sold in the U.S. last year. The real risk for Pfizer, though, is if generic copycats of the drug start flooding across the border, pushing prices down during its last years of patent life.

Lehman Brothers pharmaceuticals analyst Tony Butler wrote in a note to investors Friday that “Lipitor is such a staple of so many Americans’ daily therapeutic regime that its availability [as a generic] across the border could facilitate pricing pressures in the U.S. to prevent widespread trafficking from Canada, beyond direct purchasing by U.S. citizens.”

Pfizer is besieged by patent expirations on its key products. More than ever the company is relying on Lipitor, the best-selling drug in the world, with nearly $13 billion in revenue last year. The stakes for Pfizer rose after the failure last month of an experimental good-cholesterol booster called torcetrapib that the company had hoped would replace Lipitor. Generic Lipitor could appear in the U.S. as soon as 2010.