US District Court favors Teva over Merck & Co in Temodar patent dispute

The US District Court for the District of Delaware ruled against drug giant Merck & Co in a patent infringement suit against Teva Pharmaceuticals USA, a subsidiary of the Israel-based global leader in generics. In her decision, Judge Sue Robinson ruled that Merck's patent on Temodar (temozolomide) was unenforceable due to prosecution latches and/or inequitable conduct.
However, the US company said it will appeal the decision.

"We are very disappointed with the court's ruling, and we continue to believe the patent for Temodar (in the USA is valid and enforceable," said Bruce Kuhlik, executive vice president and general counsel at Merck. "Today's decision reflects a step in the lengthy patent litigation process, and we plan to appeal this decision," he added.

Teva is seeking Food and Drug Administration approval to sell in the USA a generic version of the 5, 20, 100, 140, 180 and 250 mg capsules of Temodar, a chemotherapeutic agent approved for the treatment of adult patients with newly diagnosed glioblastoma multiforme and for refractory anaplastic astrocytoma, two forms of brain cancer. Temodar, which Merck acquired along with its $68 billion purchase of Schering-Plough last year, generated annual global sales of about $1 billion, including about $380 million in the USA.

As the first company to file for a generic copy of the drug, Teva is eligible to receive 180-day- Hatch-Waxman statutory exclusivity to market this product.