In a short opinion dated February 24, 2014 (App. Nos. 2013-1593, -94, -95, -98), a Fed. Cir. panel made short work of the defendants’ attempt to invalidate a Glaxo claim in U.S. Pat. No. 5,565,467, to dutasteride “or a pharmaceutically acceptable solvate thereof” on the basis that the term “[dutasteride] solvate” failed to meet the written description requirement (“WDR”). The district court construed a “solvate” of this steroidal drug to mean “a complex formed by dutasteride in which dutasteride is reacted or from which it is precipitated or crystallized.”
While the parties agreed that dutasteride “is the molecule identified before ‘or a pharmaceutically acceptable solvate thereof’,” the panel noted that the defendants failed to argue that there was an inadequate description of “pharmaceutically acceptable” – this term had been construed to mean “suitable for use when administered to the recipient thereof as a pharmaceutical”- and hinted that its ruling might have been different had the defendants adopted this approach, rather than arguing simple lack of an adequate disclosure of enough species to support the genus of dutasteride solvates.
