The US Court of Appeals for the Federal Circuit overturned a 2005 lower court ruling that several generic drugmakers did not violate a patent for Pfizer's Neurontin (gabapentin). The decision will enable Pfizer to "seek a judgement of infringement and, if successful, pursue full compensation for the damages it suffered due to the 2004 at-risk launch of generic versions of Neurontin," the US company stated.
In its decision, the appeals court stated that a lower court should not have granted summary judgement to the generic drugmakers, and that a full patent infringement trial over the issue should be held, Pfizer indicated. "We'll seek all remedies to which we're entitled," added company spokesman Jack Cox. The product had annual sales of over $2 billion prior to the market entry of generic versions, compared with sales of $496 million in 2006. The company believes the patent in question, which covers stabilized formulations of gabapentin, expires in 2017.
In response to the news, analyst Marc Goodman of Credit Suisse stated that the ruling is "a potential negative" for Teva, which launched its generic version of Neurontin in 2004. There is "potential onetime payment for damages that it could owe Pfizer and the potential that Teva will choose to take less risk with 'at risk' launches going forward," he explained. Other companies that manufacture generic versions of Neurontin include Novartis' Sandoz unit, Watson and Actavis.
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