U.S. District Court Order Maintains Patent Exclusivity for Lilly's Cymbalta

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Apr 27, 2011, 04:15 ET

INDIANAPOLIS, April 27, 2011 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. District Court for the Southern District of Indiana has issued an order that prohibits the remaining defendants in the Cymbalta® (duloxetine hydrochloride) patent litigation from selling a generic duloxetine product in the United States during the term of the Cymbalta compound patent. The patent provides protection for Cymbalta until at least June of 2013.

The order came in the case of Eli Lilly and Company v. Wockhardt Limited, et al. The Court had initially entered final judgment against Wockhardt on March 21, 2011. As part of today's Court order, the defendants are further required to notify the Food and Drug Administration that they are no longer seeking approval for a generic duloxetine product during the patent term. In light of the parties' stipulation to the Court's order, the litigation has been dismissed and no appeal is possible.

"We are very pleased with the District Court's order that effectively maintains U.S. exclusivity for Cymbalta throughout its patented life," 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 patients we serve. These rights provide assurances of market exclusivity that 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 www.lilly.com. C-LLY

This release contains forward-looking statements regarding the U.S. Cymbalta patent litigation. These statements are based on management's current expectations but actual results may differ materially. Other risk factors that may affect the company's results can be found in the company's latest Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission.

Cymbalta® (duloxetine hydrochloride, Lilly)

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SOURCE Eli Lilly and Company