The US District Court for the Eastern District of Michigan has granted a motion by Sun Pharmaceuticals for partial summary judgment. The court's ruling invalidates Lilly's '826 patent, or method-of-use patent, for Gemzar (gemcitabine HCl for injection) which had been set to expire in 2013. The ruling has no bearing on Gemzar's compound patent, which remains valid until November 2010.
Robert A Armitage senior vice president and general counsel for Lilly said, "We strongly disagree with the Court's ruling granting summary judgment in favour of the generic challenger. 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."
Gemzar is indicated in combination with carboplatin (another type of chemotherapy) for the patient with ovarian cancer that has returned at least 6 months after the patient had finished platinum-based therapy. It is indicated in combination with cisplatin (another type of chemotherapy) for the first-line treatment of patients with locally advanced (Stage IIIA or Stage IIIB) or metastatic (Stage IV or cancer that has spread) non-small cell lung cancer for whom surgery is not possible.
Gemzar in combination with paclitaxel is approved by the FDA for the first-line treatment of patients with metastatic breast cancer after they have received another type of chemotherapy called an anthracycline, unless their medical condition did not allow them to receive an anthracycline.
Gemzar is indicated as a single agent (given alone) as the first-line treatment for patients with locally advanced (Stage II or Stage III when surgery is not an option) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemzar is also indicated for patients previously treated with 5-FU (another type of chemotherapy). It may not be appropriate for some patients.