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."
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