FDAnews Drug Daily Bulletin

An appeals court has overturned a lower court ruling that several generic manufacturers, including Teva Pharmaceutical, did not infringe Pfizer’s patent for the anticonvulsant Neurontin, the company announced recently.

The U.S. Court of Appeals for the Federal Circuit ruled the U.S. District Court for the District of New Jersey should not have granted summary judgment in 2005 to the generic manufacturers and a full trial should be held on Pfizer’s allegations of patent infringement.

The district court had granted summary judgment on the issue of noninfringement with regard to the ’482 patent, which does not expire until 2017, Teva said. The appeals court affirmed the claim construction but found there were facts in dispute preventing summary judgment and requiring a trial.

Pfizer said the ruling will allow the company to seek a judgment of infringement. If successful, the company can pursue full compensation for the damages it suffered due to the 2004 at-risk launch of generic versions of Neurontin (gabapentin). Before the launch, annual sales of Neurontin were more than $2 billion, the company said.