GlaxoSmithKline LLC v. Banner Pharmacaps, Inc. et al.

Docket No. 2013-1593, -1594, -1595, -1598

February 24, 2014

Brief Summary: Term “solvate” found not to require any “performance property…and hence raises no issue of insufficient structural, creation-process, or other descriptions to support such a property” (e.g., no functional limitation). DC holding of no invalidity for lack of written description was therefore affirmed.

Summary: Banner appealed DC finding that GSK’s US 5565467 directed to dutasteride (for treating androgen responsive diseases such as benign prostate hyperplasia, male pattern baldness, prostate cancer, acne; marked as Avodart® and JalynTM for BPH) and “pharmaceutically acceptable solvate[s]” thereof was not invalid for lack of written description (arguing that “solvate” is not adequately described). The parties agreed that “[a] solvate, by definition, is something that originates in a ‘solution,’ which is a mixture of two substances: a ‘solute’ dissolved in a ‘solvent’” (e.g. salt water) and that “a solvate complex is ‘crystalline’, a purely structural description of the regular, periodic arrangement of the constituent molecules or atoms.” The DC construed “pharmaceutically acceptable” to mean “[s]uitable for use when administered to the recipient thereof as a pharmaceutical.” A solvate of dutasteride was construed as “[a] complex formed by dutasteride with a solvent in which dutasteride is reacted or from which it is precipitated or crystallized.” The parties agreed that this construction refers to three processes for making solvates: reaction of dutasteride with a solvent; precipitation of a dutasteride-solvent complex; or by crystallization of a complex from a solution of dutasteride and a solvent (and the resulting complex does not need to be crystalline). Banner argued that the specification did not describe “a wide enough range of solvates included in the [DC’s] construction” (e.g., the crystalline form of solvate). The FC opinion explained that Banner had not appealed the WD issue with respect to “pharmaceutically acceptable” solvates, but only whether there is an adequate description of ‘solvates’” and whether it is limited to crystalline structures (as argued by Banner) produced through reaction with a solvent or precipitation or crystallization from a solution. The FC agreed with the DC conclusion that the term includes “any complex of dutasteride and solvent” because “the term ‘solvate’ involves no performance property…and hence raises no issue of insufficient structural, creation-process, or other descriptions to support such a property” (e.g., the specification provides “an identification of ‘structural features commonly possessed by members of the genus that distinguish them from others’” (e.g., citing Regents of the Univ. of Calif., FC 1997 and Boston Scientific, FC 2011; and, and “the concept of solvation…has been known in the art for over 100 years”) and differs from the pre- and post-formulation size issues raised in Eli Lilly (FC 2010). The issue of conception was also raised, to which the FC explained that “it can be enough to identify a compound ‘by its method of preparation’” (citing Amgen, FC 1991 and Fiers, FC 1993).

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