United States: The Structural Definition Of Species Properties May Provide Adequate Written Description Of A Genus

In GlaxoSmithKline LLC v. Banner Pharmacaps, Inc., Nos. 13-1593, -1594, -1595, -1598 (Fed. Cir. Feb. 24, 2014), the Federal Circuit affirmed the district court's rejection of the written-description challenge to U.S. Patent No. 5,565,467 ("the '467 patent").

GlaxoSmithKline LLC ("GSK") is the holder of the '467 patent, which includes claims directed to the chemical compound dutasteride or a "pharmaceutically acceptable solvate thereof."  Slip op. at 3 (citation omitted).  GSK markets Avodart® and Jalyn", which contain dutasteride.  Banner Pharmacaps, Inc., Impax Laboratories, Inc., Roxane Laboratories, Inc., Mylan Inc., Mylan Pharmaceuticals, Inc., and Watson Laboratories, Inc.–Florida (collectively "Defendants"), each filed at least one ANDA to market generic versions of Avodart® and Jalyn".  GSK, in turn, sued for infringement.  

At trial, Defendants stipulated to infringement but challenged the validity of the '467 patent on the grounds of anticipation, lack of utility, lack of enablement, and inadequacy of written description.  Defendants' arguments centered on the claim term "pharmaceutically acceptable solvate," more specifically, "solvate."  The parties, during trial, agreed that solvates are molecules that either consist of solute molecules and solvent molecules or result from a solution of the solute and solvent molecules.  The parties further agreed that solvate complexes may be crystalline.  The parties, however, disagreed as to whether, in the context of the '467 patent, solvates must be crystalline.  Defendants urged a narrow construction, but the district court construed the claims more broadly to include both crystalline and noncrystalline structures.  Defendants asserted that the written description of the '467 patent failed under either construction of the term "solvate."  The district court disagreed, finding that "[t]here is no reason why a person skilled in the art would not credit a patentee with possession of a solvate merely because the patentee did not disclose solvates formed by each solvation process."  Slip op. at 7 (alteration in original) (quoting GlaxoSmithKline LLC v. Banner Pharmacaps, Inc., No. 11-CV-046, 2013 WL 4082232, at *5 (D. Del. Aug. 9, 2013)).  After a bench trial, the district court upheld the validity of the '467 patent.

"The claim term and its corresponding description, however broad, identify certain structures produced by certain processes.  We have not required more for an adequate written description that matches claim scope."  Slip op. at 11.

On appeal, Defendants presented a single issue:  "whether, under what is now 35 U.S.C. § 112(a), the written description of the '467 patent adequately supports the claims to 'solvates' of dutasteride."  Id. at 7-8.  The Federal Circuit rejected Defendants' challenge because, "[u]nder either the district court's claim construction or Defendants' claim construction, the claim term 'solvate' refers to a molecular complex defined by structure and by the process of creating it, not by what the molecule does."  Id. at 8.  The Court explained that, under Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., "adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials."  Id.  at 10 (quoting Ariad, 598 F.3d 1336, 1350 (Fed. Cir. 2010) (en banc)).  Here, the written description described the same class by identifying a particular structure obtained by particular processes.  Accordingly, the Court affirmed the district court's finding because, regardless of which construction was adopted, the term "solvate" involved no performance property and thus raised no issue of insufficient description to support such a property.

The Court differentiated this case from those cited by Defendants by emphasizing the structural nature of the claim term "solvate."  The Court stated that "[c]ritically, moreover, the claim term at issue, 'solvate,' is not functional:  to be a 'solvate,' a compound need not produce a desired result or otherwise perform a certain function."  Id. at 11.  In the precedential cases cited by Defendants in support of their position, the Court explained, the disputed claim terms were of a functional nature, claiming a particular performance property.  Such claims have the "fundamental difficulty" of potentially claiming future inventions and may therefore exceed the scope of the written description.  Id. at 12.  In contrast, the claims of the '467 patent, being structural in nature, the Court reasoned, cannot exceed the scope of the written description, as the structure is set forth in the specification.

Accordingly, the Federal Circuit affirmed the district court's rejection of Defendants' written-description challenge to the validity of the '467 patent.

Judges:  O'Malley, Wallach, Taranto (author)

[Appealed from D. Del., Judge Andrews]

This article previously appeared in Last Month at the Federal Circuit, March, 2014

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