In Forest Laboratories, LLC v, Sigmapharm Laboratories LLC, [2017-2369, 2017-2370, 2017-2372, 2017-2373, 2017-2374, 2017-2375, 2017-2376, 2017-2389, 2017-2412, 2017-2436, 2017-2438, 2017-2440, 2017-2441]( March 14, 2019) the Federal Circuit vacated and remanded the district court’s validity determination, and we vacated and remanded the question of infringement under a corrected claim construction.
The district court construed claim 1 to be limited to buccal and sublingual formulations. Although claim 1 does not expressly refer to buccal or sublingual administration, the Federal Circuit noted that claims “must be read in view of the specification, of which they are a part.” The Federal Circuit held the district court properly construed claim 1 to be limited to buccal and sublingual formulations.
As to obviousness, the district court found Appellants had not established that there was a motivation to combine asenapine maleate into a sublingual or buccal form, and even if there were a motivation to combine, a skilled artisan would not have had a reasonable expectation that it would work. The Federal Circuit noted that an invention is not obvious simply because all of the claimed limitations were known in the prior art at the time of the invention. Instead, the question is whether there is a reason, suggestion, or motivation in the prior art that would lead one of ordinary skill in the art to combine the references, and that would also suggest a reasonable likelihood of success. The motivation can be found explicitly or implicitly in the prior art references themselves, in market forces, in design incentives, or in any need or problem known in the field of endeavor at the time of invention and addressed by the patent.
The Federal Circuit noted that the district court failed to make an express finding as to whether compliance concerns for patients with trouble swallowing would provide a motivation to combine, and remanded for the district court to address this question.
As to secondary considerations, the Federal Circuit found that the district court did not err in finding long felt need weighs in favor or non-obviousness. However, the Federal Circuit found that the district court did err in finding unexpected results, finding that the results were not surprising and unexpected, since one of ordinary skill in the art would not have expected differently.
On the issue of written description, the Federal Circuit held that the district court’s finding that the specification contains sufficient written description support for the claims was not clearly erroneous.
On the issue of infringement, the district court construed claim 4 to not cover the treatment of bipolar disorders. Because the district court erred in treating “excitation” as being limited to “excitation disorders,” we vacate its finding of non-infringement. We construe “excitation” to refer to a symptom and remand for the district court to assess infringement in light of this construction.