U.S. District Court Rules on Validity of Lilly's Gemzar Patent

Thursday, April 1, 2010 General News J E 4

INDIANAPOLIS, Ind., April 1 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. District Court for the Southern District of Indiana has upheld the validity of the company's compound patent on Gemzar® (gemcitabine HCl for injection). This decision maintains Lilly's U.S. exclusivity for Gemzar through November 15, 2010.

A second patent for Gemzar, related to its FDA-approved uses, has a 2013 expiration date and was ruled invalid by the U.S. District Court for the Eastern District of Michigan in a separate case. Pending the outcome of the appeal on the invalidity ruling in Michigan for this method-of-use patent, the U.S. District Court for the Southern District of Indiana determined that Lilly was prevented from enforcing the 2013 patent in the Indiana action based upon the legal doctrine of collateral estoppel. Lilly's appeal of the Michigan ruling to the Court of Appeals for the Federal Circuit will be heard on May 7, 2010 and, if successful, will remove the collateral estoppel issue that is preventing the enforcement of the 2013 patent.  

"We are pleased with the court's ruling upholding the validity of Gemzar's compound patent and remain optimistic that a successful appeal of the Michigan decision on the Gemzar method-of-use patent will retain U.S. exclusivity for Gemzar into 2013," said Robert A. Armitage, senior vice president and general counsel for Lilly. "Protection of intellectual property rights is extremely important to the biopharmaceutical industry and the physicians and patients we serve, as these rights help support the development of the next generation of innovative medicines to treat unmet medical needs."

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs.  Additional information about Lilly is available at  C-LLY

This release contains forward-looking statements regarding the U.S. Gemzar patent litigation. These statements are based on management's current expectations but actual results may differ materially.  There can be no assurance that the company will prevail in any appeal. Other risk factors that may affect the company results can be found in company's latest Form 10-K dated February 2010.

Gemzar® (gemcitabine HCl for injection, Lilly)

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SOURCE Eli Lilly and Company



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