Print PDF

District court ruling maintains patent protection of Forest’s Savella®

The District of Delaware ruled in favor of Finnegan client Forest Laboratories in a Hatch-Waxman litigation against generic pharmaceutical defendant Mylan, Inc. The suit involved Savella®, a medicine containing the active ingredient milnacipran, which is used for the treatment of fibromyalgia. The court held the asserted claims of all three patents litigated at trial valid and infringed, denying defendants claims that the patents were obvious and anticipated by prior art. In the words of the court, "[a]t best, the teaching of the art was and is multidirectional, with no clear motivation to pursue milnacipran 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 milnacipran was the antithesis of anticipation and obviousness as discussed in more detail below." The court entered final judgment and ordered the FDA not to approve Mylan’s Abbreviated New Drug Application (ANDA) for generic milnacipran until after the expiration of the last Forest patent litigated at trial.