Sanofi’s Patents on Cancer Drug Taxotere Invalidated

Sanofi-Aventis SA’s patents on its cancer drug Taxotere were ruled invalid by a U.S. judge, potentially clearing the way for Hospira Inc. and Apotex Inc. to start selling generic versions of the medicine.

Two of the Sanofi patents are obvious variations of an earlier patent on docetaxel, the active ingredient in Taxotere, U.S. District Judge Gregory Sleet in Wilmington, Delaware, said in an opinion filed today. The judge also ruled that Sanofi misled the U.S. Patent and Trademark Office to obtain the patents, so it shouldn’t be allowed to enforce them.

Taxotere, used to treat prostate cancer, generated 2.18 billion euros ($2.9 billion) in global sales in 2009 for Paris- based Sanofi. Lake Forest, Illinois-based Hospira, which is seeking to sell an injectable product with the same active ingredient in Taxotere, rose the most in more than four months in New York Stock Exchange composite trading.

“This is clearly a positive step forward” for Hospira, said Frederick Wise, a New York-based analyst with Leerink Swann & Co. “There was some anticipation that we might see this sometime before the end of the year but this came faster, clearer and a little more positive than those expectations.”

Wise said every $100 million Hospira gets in sales will translate into 5 cents to 10 cents in earnings per share. Hospira has kept plans about the generic under wraps, he said.

‘Obvious’ Formula

Hospira rose $1.87, or 3.4 percent, to $57.10 at the 4 p.m. close of New York trading, the biggest percentage gain since May 10. Sanofi American depositary receipts, two of which represent one ordinary share, fell 60 cents to $33.42.

Taxotere has been on the market since 1996, according to information on the U.S. Food and Drug Administration’s website. Sanofi sought to block the generic-drug rivals until the patent terms end in 2013.

Sanofi won U.S. regulatory approval in June for a new type of chemotherapy to treat patients with advanced prostate cancer.

The Taxotere patents cover a formulation containing docetaxel, a compound that’s already covered by another patent. It would have been obvious for scientists to come up with the specific formula for Taxotere, the judge said.

A spokesman for Hospira, Dan Rosenberg, said the ruling “paves the way for launch” of their product when the compound patent expires in November. “We recognize that this is ongoing litigation” subject to appeal, he said.

Elie Betito, a spokesman for closely held Apotex, had no immediate comment on the ruling. Megan Humphrey, a Sanofi spokeswoman, didn’t return voice and e-mail messages seeking comment.

The consolidated case is Aventis Pharma SA v. Hospira Inc. and Apotex Inc., 07CV721, U.S. District Court, District of Delaware (Wilmington).

To see the patents, click: 5,714,512 and 5,750,561.

To contact the reporters on this story: Susan Decker in Washington at sdecker1@bloomberg.net; Pat Wechsler in New York at pwechsler@bloomberg.net.

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net; David E. Rovella at drovella@bloomberg.net.

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