Federal Circuit, March 28, 2014, 2013-1409

The patent at issue in this case is owned by Shire Development, and it concerned an oral pharmaceutical composition for the treatment of inflammatory bowel disease. Shire Development, an Ireland based company with its U.S. headquarters located in New Jersey, sought to produce a generic version of the patented composition. The District Court (Southern District of Florida), construed a feature of claim 1, namely an "inner hydrophobic matrix," to mean "a matrix including at least one lipophilic excipient where the matrix is located within one or more substances." Similarly, the District Court construed the phrase "an outer hydrophilic matrix" to mean "a matrix of at least one hydrophilic excipient, where the matrix is located outside the inner lipophilic matrix."

At the Federal Circuit, Hughes J. commented that, "the District Court's constructions of the inner lipophobic matrix and outer hydrophilic matrix impermissibly broadened the ordinary meaning of the terms." The Federal Circuit held that the District Court's construction was erroneous because it focused on the lipophilic properties of an excipient in the matrix rather than the matrix itself. The District Court had also rejected a construction that described the matrices as "separate and distinct." The Federal Circuit noted that Shire had carefully characterized the prior art as not having separate matrices, but never stated that its composition had separate matrices. Hughes J. opined that a logical reading of the claims required separate matrices, and this was also admitted by counsel for Shire during oral arguments. As such, the Federal Circuit said that a matrix composed of only one lipophilic substances and several hydrophilic substances (thus the matrix would exhibit hydrophilic properties) would meet the definition of a lipophilic substance, according to the District Court's claim construction of the terms. The Federal Circuit remanded the case for further proceedings consistent with its constructions.