Los Angeles – The Aliso Viejo, Calif.-based drug manufacturer Avanir Pharmaceuticals Inc. filed a new patent infringement lawsuit against Impax Laboratories Inc. in Delaware federal court Monday over Impax’s proposed generic version of Avanir’s neurological disorder treatment Nuedexta.
Avanir’s U.S. Patent Number 8,277,484, titled “Pharmaceutical compositions comprising dextromethorphan and quinidine for the treatment of neurological disorders,” issued in July.
Hayward, Calif.-based Impax recently filed an abbreviated new drug application with the U.S. Food and Drug administration seeking to make and sell its own dextromethorphan and quinidine combination treatment. In connection with the ANDA filing, Impax claimed that the claims of the ’484 patent are either invalid or will not be infringed by the generic version.
Upon FDA approval of the ANDA, Impax will induce infringement of the patent and directly and contributorily infringe the patent itself, according to Avanir.
“Impax has had and continues to have knowledge that Impax’s proposed product is especially adapted for a use that infringes the ’484 patent and that there is no substantial non-infringing use for Impax’s proposed product,” the complaint says.
Avanir is asking the court to find that Impax’s ANDA and accompanying plans to make, sell and market its generic Nuedexta infringe the ’484 patent, and for an order keeping the FDA from approving the ANDA until the patent’s expiration. It is also seeking an injunction against the sale of the generic Impax product or any other infringement on the generics maker’s part, plus damages if Impax does sell the drug and the costs of the action.
Nuedexta is used to treat “emotional lability” arising from brain damage in patients suffering from strokes, head injuries and the like.
The terms emotional lability and pseudobulbar affect are used by psychiatrists and neurologists to refer to a set of symptoms that are often observed in patients who have suffered brain damage from a head injury, stroke, brain tumor, or encephalitis. The term is also used in association with those who are suffering from a progressive neurodegenerative disease such as Lou Gehrig’s disease, Parkinson’s disease, Alzheimer’s disease or multiple sclerosis.
Emotional lability is characterized by intermittent spasmodic outbursts of emotion, usually manifested as intense or even explosive crying or laughing, at inappropriate times or in the absence of any particular provocation.