US drug makker Eli Lilly has announced that the US District Court for the Eastern District of Michigan has granted a motion fied by Sun Pharmaceuticals for partial summary judgment, which invalidates Lilly's '826 patent, or method-of-use patent, for Gemzar (gemcitabine HCl for injection), which had been set to expire in 2013.
In April 2007 Eli Lilly sued Sun Pharmaceuticals in the US, claiming that Sun's ANDA application filed in October 2006 infringed its patent on blockbuster cancer drug Gemzar, a commonly used cancer drug to treat non-small cell lung cancer, pancreatic, bladder and breast cancer. It is one among Eli Lilly's top selling drugs.
Lilly's basic patent on the active pharmaceutical ingredient gemcitabine hydrochloride will expire on 15 November 2010, another patent on the method to manufacture the drug, is valid until 2013.
Sun Pharma claimed that the 2013 patent was invalid. The ruling has no bearing on Gemzar's compound patent, which remains valid until November 2010.
Lilly said it plans to appeal. "We strongly disagree with the Court's ruling granting summary judgment in favor of the generic challenger," said Robert A. Armitage, senior vice president and general counsel for Lilly.
"We continue to believe that our Gemzar method-of-use patent is valid and will be upheld by the courts. We intend to pursue an appeal of this decision with the Court of Appeals for the Federal Circuit. It is also important to note that today's court decision does not allow for the immediate entry of generic gemcitabine in the US market. Gemzar's compound patent remains in force until November 2010."