GlaxoSmithKline LLC v. Banner Pharmacaps, Inc.

The U.S. Court of Appeals for the Federal Circuit affirmed a district court rejection of a written description challenge to patentability, concluding that under either parties’ construction of a disputed claim term the written description would convey to a skilled artesian that “the inventor[s] actually invented the invention claimed.” GlaxoSmithKline LLC v. Banner Pharmacaps, Inc., Case Nos. 13-1593, -1594, -1595, -1598 (Fed. Cir., Feb. 24, 2014) (Taranto, J.).

GlaxoSmithKline (GSK) sued multiple defendants alleging drug products (each containing the molecule dutasteride) listed in defendants’ Abbreviated New Drug Applications (ANDA), and which defendants intended to market, fall within the scope of claims of GSK’s patent (the GSK Patent) claiming a specific molecule identified as dutasteride “and its pharmaceutically acceptable solvates.” Dutasteride had been approved by the U.S. Food and Drug Administration (FDA) as effective in the treatment of benign prostatic hyperplasia. The only issue before the Federal Circuit was whether the written description of the GSK Patent supported the claimed recitation to “solvates” of dutasteride.

The parties agreed on the following: dutasteride is the specific molecule identified in the claim; a solvate, by definition, is “something that originates in a ‘solution,’ which is a mixture of two substances: a ‘solute dissolved in a solvent’”; a solvate is a molecule consisting of a complex of solute molecules and solvent molecules resulting from the solution; and a solvate complex is frequently “crystalline,” a structure referring to a regular, periodic arrangement of the constituent molecules or atoms. The defendants argued that the patent failed to describe the crystalline form of solvate or, more generally, a wide enough range of the solvates, which need not be crystalline and could be produced through reaction, precipitation or crystallization. After the district court rejected the defendants arguments, this appeal followed.

The Federal Circuit concluded that the patent specification defined the claimed genus by two properties: “a solvate is a complex of dutasteride molecules and solvent molecules, with dutasteride being… ‘the key structural component’” and “the structure is one that is created by an identified process-specifically, by dissolving dutasteride (the solute) in a solvent.” Regardless of the construction of the disputed term “solvate” and reading of the specification, the Court explained that the written description matches the claim language, and regardless of which party’s construction is correct, the description remains entirely based on structure of the compound and its process of creation. Describing a complex of dutasteride and solvent molecules is an identification of “structural features commonly possessed by members of the genus that distinguish them from others.” The Court saw no reason to require more than the written description matching the claim scope, stating that the concept of solvation has been known for over 100 years and steroids [such as dutasteride] have been known to be prone to solvate formation since 1983.

Of importance to the Court was the finding that under either parties’ preferred claim constructions, “solvates” of dutasteride are not distinguished either by functional language or by a particular performance property. In holding the claim language to be structural, and matching the language of the specification, the Federal Circuit held that the written description was adequate to support the claim language.