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U.S. Court of Appeals Rules on Validity of Lilly's Gemzar Method-of-Use Patent

Thursday, July 29, 2010 General News J E 4
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INDIANAPOLIS, July 28 Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Court of Appeals for the Federal Circuit has upheld a prior ruling by the U.S. District Court for the Eastern District of Michigan that Gemzar's method-of-use patent is invalid.

"We strongly disagree with the ruling by the U.S. Court of Appeals regarding Gemzar's method-of-use patent. We continue to believe that our Gemzar method-of-use patent should be found valid and should remain in effect until mid-2013," said Robert A. Armitage, senior vice president and general counsel for Lilly. "We will consider all possible legal options, including a request for a further review of this panel decision by the full Court."

Today's court decision does not allow for the immediate entry of generic gemcitabine in the U.S. market. Supported by the compound patent, the company expects to maintain market exclusivity for Gemzar until November 15, 2010. As a result, today's court decision will not cause the company to modify its current 2010 financial guidance.

"Protection of intellectual property rights is extremely important to the biopharmaceutical industry and the patients we serve, as these rights help support the development of the next generation of innovative medicines to treat unmet medical needs," said John Lechleiter, Ph.D., chairman and chief executive officer.

"Despite today's ruling, our business remains strong, supported by the growth of key marketed products and a promising pipeline of potential new medicines that currently boasts nearly 70 molecules in clinical development. We remain confident in our ability to deliver on our innovation-based strategy."

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 www.lilly.com. 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's results can be found in the company's latest Form 10-K, filed February 2010, and Form 10-Q, filed April 2010.

GemzarŪ (gemcitabine HCl for injection, Lilly)

(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )

(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO )

SOURCE Eli Lilly and Company
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