Moving From Everyday Dosing To Less Frequent Dosing Is Obvious

In a consolidated Hatch-Waxman patent infringement action, a district court judge in Delaware recently found claims directed to a treatment for multiple sclerosis invalid as obvious.

Plaintiffs were the holders of a New Drug Application for the administration of 40 mg/ml glatiramer acetate (GA) three times per week to treat patients with relapsing forms of multiple sclerosis. They marketed their product under the brand name COPAXONE®. Plaintiffs filed suit alleging patent infringement after several defendants submitted Abbreviated New Drug Applications seeking approval to market generic versions of COPAXONE®. After conducting a seven-day bench trial, the court held that all of the asserted patent claims were invalid as obvious.