Forest Laboratories Holdings Ltd., et al. v. Mylan Inc., et al., C.A. No. 13-1602 - SLR, July 11, 2016.
Robinson, J. Court issues opinion following trial that the asserted claims in the patents-in-suit are valid and infringed.
The disputed products are milnacipran hydrochloride tablets, generic versions of Savella® used in the treatment of fibromyalgia. A 6-day bench trial took place in this ANDA case from January 19 – 26, 2016. The 30-month stay of FDA final approval expires on July 14, 2016. The court finds that defendants induce infringement of one patent because the proposed label instructs users to perform the patented method. It is irrelevant that some users may not specifically perform that method. With respect to invalidity, the court notes that there appears to be no clear understanding of the causes of fibromyalgia and the teaching of the art has been multidirectional, with no clear course of treatment or motivation to pursue milnacipran as an effective treatment for fibromyalgia. The inventors’ development of treating this condition with milnacipran was the antithesis of anticipation and obviousness.