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."