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The future of a $4-billion-a-year Eli Lilly and Co. drug is at stake as a federal judge weighs whether the company should continue to hold its Zyprexa patent in the face of a challenge from makers of generic drugs. Lawyers for Lilly and the generic drug makers presented closing arguments Thursday that concluded a three-week bench trial before U.S. District Judge Richard L. Young, who is not expected to issue a ruling for several months. Lilly’s attorneys argued the company’s development of Zyprexa came after years of research by Lilly chemists who solved scientific problems that had stymied other chemists’ decades-long efforts to develop a schizophrenia treatment lacking the side effects of old-line anti-psychotics. Lawyers for three generic drug makers who want to make cheaper knockoff versions of Zyprexa argued Lilly was awarded its patent based on faulty research. The lawyers also contend the discovery of the drug’s molecular structure was obvious. If upheld, the generic companies’ claims could invalidate a 1993 patent that grants Lilly exclusive U.S. rights to the drug until 2011. Zyprexa, introduced in 1996, is now Lilly’s top-seller and accounts for about a third of the company’s sales. Zyprexa’s sales now exceed the level once achieved by Prozac, Lilly’s former blockbuster anti-depressant that lost patent protection in 2001 after a successful challenge by generic drug makers. With Zyprexa, Lilly hopes to avoid a repeat of the financial slide the company suffered after the Prozac patent loss. In the trial, Lilly is looking at keeping or losing its “life’s blood,” Lilly attorney Charles Lipsey said. The case began about 2 1/2 years ago when Lilly filed a patent infringement lawsuit against the first of three generic firms that have sought approval to sell non-brand versions of Zyprexa in the United States. The three are Zenith Goldline Pharmaceuticals, owned by Ivax Corp. of Miami; Indian drug maker Dr. Reddy’s Laboratories; and the U.S. arm of Israel-based Teva Pharmaceutical Industries. The companies claim Lilly knew about the Zyprexa compound for years and included it in a patent that expired in 1995. The generic companies argue that by the time Lilly was ready to market Zyprexa, time was running out on the first patent so it decided to apply for a second one, which violates patent rules. “For the past eight and a half years Lilly has benefited from a patent it does not deserve,” said Jeffrey S. Ward, an attorney for Zenith Goldline. “The patent department at Lilly went shopping for a second bite at the apple.” Ward also accused Lilly of showing a “duplicitous nature” and engaging in “evasive maneuvers” in using results from a study conducted using dogs as test subjects to gain the new patent on Zyprexa. The generic companies say Lilly misrepresented findings from a study that was flawed — contentions Lilly disputes. But Lilly attorney Lipsey said Zyprexa is “a perfectly patentable invention,” and its patent-worthiness is reflected in its “stupendous commercial success.” The generic companies making the challenge “have nothing to lose” and a new revenue source to gain if they win the case, Lipsey said. Copyright 2004 Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed.

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