Fibromyalgia Drug Patent Not Obvious or Anticipated Given Complexity and Unknown Nature of Disease

Following a bench trial, the court found that plaintiffs' fibromyalgia drug patents were not invalid as anticipated or obvious in light of prior art patents and publications. "[T]he record demonstrates that in 2001 and continuing through today, fibromyalgia is a complex disease treated by various medications with different mechanisms of action. At this time, there appears to be no concrete understanding of the cause(s) of fibromyalgia, let alone a clear course of treatment. At best, the teaching of the art was and is multidirectional, with no clear motivation to pursue [plaintiffs' drug compound] as an effective treatment for fibromyalgia. Notably, there were no FDA-approved treatments for fibromyalgia at the time of the patents-in-suit. Consequently, the inventors' development of treating fibromyalgia with [plaintiffs' drug compound] was the antithesis of anticipation and obviousness. . . ."

Forest Laboratories Inc. et al v. Apotex Corp. et al, 1-13-cv-01602 (DED July 11, 2016, Order) (Robinson, J.)