Appeals court ruling upholds Lilly's Evista patents

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Eli Lilly and Co. won a court ruling Wednesday that blocks plans by Teva Pharmaceutical Industries Ltd. to sell a generic version of the Evista osteoporosis treatment before March 2014.

The U.S. Court of Appeals for the Federal Circuit in Washington stood behind a lower court ruling, saying the judge made “no reversible error” in upholding the validity of four patents on the medicine. The court also said the judge was correct to invalidate two other patents that expire in 2017.

The ruling protects a drug that generated $682.2 million in U.S. sales last year for Lilly. The Indianapolis-based company is facing patent expirations on three of its top-selling drugs by 2013, accounting for more than 40 percent of revenue. Last month, it lost an appeal over cancer medicine Gemzar, and is challenging a ruling over attention-deficit treatment Strattera.

“Protection of intellectual property rights is extremely important to the biopharmaceutical industry and the patients we serve,” Lilly General Counsel Robert A. Armitage said in a statement. “We will continue to vigorously defend our rights, in order to support the development of the next generation of innovative medicines.”

He said Lilly will consider whether to appeal the invalidity ruling on the patents that expire in 2017, related to the particle size of raloxifene, the active ingredient in the drug. Outside the U.S., Evista generated $348.1 million in 2009 sales, the company said Jan. 28.

Lilly shares rose 61 cents to $34.20 in early afternoon trading. Teva’s American depositary receipts, each representing one ordinary share, climbed 71 cents to $51.33.

Lilly is trying to speed drug development with mixed results. Last month, it halted trials of a late-stage experimental Alzheimer’s treatment, one of eight drugs it had in the third stage of testing generally required by U.S. regulators. Effient, a blood-thinner Lilly introduced in the U.S. in August 2009, “got off to a slower start than we anticipated,” Chief Executive Officer John Lechleiter said in July.

Lilly’s best-selling medicine, the antipsychotic Zyprexa, loses patent protection in October 2011, while antidepressant Cymbalta and insulin Humalog face generic competition in 2013.

Teva, based in Petah Tikva, Israel, received U.S. Food and Drug Administration approval for its generic version of Evista just before the nonjury trial began in March 2009.

Teva, which claimed that Lilly’s Evista patents are obvious variations of known science, had been prepared to begin marketing the drug before the trial. Officials with the company didn’t immediately return messages seeking comment.


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