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Eli Lilly Loses Bid for Evista Hearing Before Canada High Court

By Joe Schneider

Oct. 22 (Bloomberg) -- Eli Lilly & Co. lost a bid for a hearing before Canada’s highest court on whether its patent for the Evista osteoporosis treatment is valid as the company tried to block Apotex Inc. from selling a generic version of the drug.

The Supreme Court of Canada today dismissed Eli Lilly’s request for the hearing.

Evista, in which the key ingredient is raloxifene, generated $1.08 billion in global sales for Indianapolis-based Eli Lilly last year, the company said Jan. 29.

Apotex, a Toronto-based maker of generic drugs, claimed the patent isn’t valid because Eli Lilly failed disclose enough information in the patent application to prove raloxifene is useful in treating and preventing osteoporosis. Closely held Apotex also said the patent was based on a prediction, rather than scientific data, which isn’t allowed.

A three-member panel of the Federal Court of Appeal upheld a trial judge’s decision favoring Apotex, saying Eli Lilly only presented studies on rats to support its patent claim that raloxifene prevents bone loss.

“Only a prediction could allow for the proposition that raloxifene had the same effect on women,” Judge Marc Noel wrote March 25 on behalf of the panel. “The claimed utility required for patentability was not demonstrated, but predicted.”

The case is Eli Lilly Canada Inc. v. Apotex Inc., 33165, Supreme Court of Canada (Ottawa)

To contact the reporter on this story: Joe Schneider in Toronto at jschneider5@bloomberg.net

Last Updated: October 22, 2009 10:10 EDT

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