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Zyprexa trial testimony turns to hormone levels February 10, 2004
Eli Lilly and Co. on Monday continued building its case in court for the patent-worthiness of Zyprexa, its best-selling drug. On day two of its presentation in a patent infringement trial, the drugmaker put one of its own doctors and two academic scientists on the witness stand. They testified about the validity of using dogs to study cholesterol in man, and about the link between Zyprexa and the milk-producing hormone prolactin. U.S. patent protection for Zyprexa is at stake in the federal trial, which began Jan. 26. Much of the trial has focused on a study Lilly did using beagles to show Zyprexa has fewer side effects than similar drugs, making it deserving of its separate patent, which runs from 1993 to 2011. Zyprexa also was covered by a broad patent on a family of like compounds. That patent expired a year before Zyprexa went on the market in 1996. The trial has become a replay, in far greater detail, of the issues Lilly raised to the patent examiner in the early 1990s. Lilly's attorneys have searched the country to find witnesses to testify that Zyprexa has a relatively weak tendency to cause production of prolactin in female lab dogs and doesn't cause a jump in cholesterol levels like a comparative patented compound does. Three generic drug manufacturers are behind the effort to break the patent on the blockbuster schizophrenia drug in the trial in U.S. District Court in Indianapolis. Their central allegation is that Lilly misled the patent office with some of its claims. Lilly medical adviser Dr. Bruce J. Kinon testified that Zyprexa benefits from being a "prolactin-sparing" drug. Excess prolactin can impair sexual functioning in humans, he said, and cause mammary glands to grow in males. Patrick Concannon, a retired Cornell University animal physiologist who still does research at the college in Ithaca, N.Y., said the prolactin-sparing effect with Zyprexa was even seen in two studies done by the defendants as part of their legal case. Those tests showed pronounced levels of prolactin production in most dogs given the comparable compound and much lesser levels in dogs given Zyprexa, he said. In cross-examination by defense attorney Stephen E. Arthur, Kinon acknowledged that Zyprexa carries a notice on its drug label that it can elevate prolactin levels in humans. Another Lilly witness, Dr. John E. Bauer, professor of small animal medicine at Texas A&M University, said the dog is a good predictive model for measuring cholesterol in humans. Defense witnesses testified to the opposite last week. Article courtesy of IndyStar.com FAIR USE NOTICE: This may contain copyrighted (C ) material the use of which
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