While a fact specific inquiry, an adjective characterizing a claim element may be interpreted as a direct property of the claim element itself rather than an emergent property derived from the claim element’s interaction with other elements (claimed or unclaimed).
Background / Facts: The patent being asserted here in response to a generic drug ANDA submission is directed to a controlled-release oral pharmaceutical composition for treating inflammatory bowel diseases. The claims recite an “inner lipophilic matrix,” in combination with an outer hydrophilic matrix, to address the limitations of the prior art systems. The parties stipulated that “lipophilic” means “poor affinity towards aqueous fluids.”
Issue(s): Whether the matrix itself—not just an excipient within the matrix—must exhibit the stipulated-to lipophilic characteristic.
Holding(s): Yes. “A review of the intrinsic evidence as a whole reveals that the district court’s construction of ‘inner lipophilic matrix’—and thus, ‘outer hydrophilic matrix’—is overly broad. Looking first to the language of the claims, ‘lipophilic’ is an adjective that modifies matrix. … Thus, a ‘lipophilic matrix’ is more than just a matrix with at least one lipophilic excipient—the matrix itself must exhibit lipophilic characteristics. … [The] patent teaches that this occurs when ‘the main component of the matrix structure’ is lipophilic.”