Bracco Diagnostics Inc. v. Maia Pharm., Inc.

This appeal concerns a patent infringement action brought by Bracco against Maia under the Hatch-Waxman Act. Bracco's patent has claims directed towards sincalide, a synthetic peptide hormone typically administered to stimulate gallbladder contraction and pancreatic secretion. All 36 claims at issue in the litigation require sincalide, a buffer, and, depending on the claim, either a surfactant/solubilizer or a surfactant. Maia's proposed product contains amino acid excipients, which it asserts do not act as buffers, surfactants/solubilizers, or surfactants, and thus do not infringe. The district court's claim construction defined the terms (buffer, surfactant/solubilizer, and surfactant) functionally. However, the court's construction of each term specified that the term encompassed "amino acids.'' Maia stipulated to infringement, based on its assumption that, under the court's claim construction, even an amino acid that does not function as a buffer would constitute a "buffer'' for purposes of infringement (the same would apply to the "surfactant/solubilizer'' and "surfactant'' limitations). On appeal, the Federal Circuit found that although the district court had erred in specifically listing "amino acids'' in its claim constructions, the error was harmless because the district court had specifically limited buffers to excipients able to perform a buffering function (same for "surfactants/solubilizers'' and "surfactants.'' Maia was forced to live with its stipulation of infringement, regardless of whether its amino acid excipients actually functioned as buffers, surfactants/solubilizers, or surfactants. The Federal Circuit also rejected Maia's argument that the district court had erroneously construed the backslash between surfactant/solubilizer to mean "and'' or "or,'' and erroneously included "may'' in its definition of surfactant. The court found that Bracco used a backslash ["/''] throughout the specification to indicate "and/or,'' and that while the word "may,'' standing alone, presents some ambiguity, the plain and ordinary meaning of "may'' within the context of this specification is properly understood as indicating "an inherent measure of likelihood or possibility.''