NEW YORK Teva Pharmaceutical Industries may soon get the green light to market a generic drug for brain tumors following a federal court ruling.
The U.S. District Court for the District of Delaware ruled Merck & Co.’s patent for the drug Temodar (temozolomide) was unenforceable on account of prosecution latches or inequitable conduct, though Merck has said it will appeal the ruling.
“We are very disappointed with the court's ruling, and we continue to believe the patent for Temodar in the U.S. is valid and enforceable,” Merck EVP and general counsel Bruce Kuhlik said. “Today's decision reflects a step in the lengthy patent litigation process, and we plan to appeal this decision.”
Temodar had sales of $278 million in third quarter 2009, according to financial reports by Schering-Plough Corp., the original maker of Temodar that Merck acquired last year. Teva is seeking approval for the drug in the 5, 20, 100, 140, 180 and 250 mg strengths. The drug is a chemotherapy agent used to treat newly diagnosed glioblastoma multiforme and refractory anaplastic astrocytoma, two forms of brain cancer.