Spectrum chemotherapy treatment patent ruled invalid by Federal Circuit

The US Court of Appeals for the Federal Circuit has upheld a lower court’s ruling that Spectrum Pharmaceuticals’s Fusilev (levoleucovorin) patent is invalid and wasn’t infringed by generics company Sandoz.

On Friday, October 2, a three-judge panel ruled unanimously that Spectrum’s patent was obvious, affirming a 2013 judgment from the US District Court for the District of Nevada.

Fusilev is used to mitigate the adverse side effects of methotrexate, a chemotherapy treatment.

Sandoz filed its Abbreviated New Drug Application in 2011 to market a generic version of the drug. Spectrum sued the generics company in January 2012 alleging both literal infringement and a breach of the doctrine of equivalents.

A party can be found liable for infringement under the doctrine of equivalents if its product does not necessarily fall within the literal scope of the patent claims, but is similar to the claimed invention.

Judge Alan Lourie, writing the opinion, said there was a “clear and convincing” evidence that Spectrum’s patent was obvious and invalid.

On Spectrum’s claim that Sandoz’s activity was in breach of the doctrine of equivalents, Lourie was unmoved.

He said: “We discern no clear error in the district court’s finding that Sandoz’s approved product would not meet the dosage claim limitation, and thus would not literally infringe.”

A spokesperson for Sandoz told LSIPR that the company welcomed the decision.