02/26/14

GlaxoSmithKline v. Banner Pharmacaps: Adequate Written Description for term “solvates”

Category: 112 - Written Description
 
 
 
By: Jesus Hernandez, Blog Editor/Contributor  
 
TitleGlaxoSmithKline, LLC v. Banner Pharmacaps, Inc., No. 2013-1593, -1594, -1595, -1598 (Fed. Cir. Feb. 24, 2014).
IssueThis appeal presents 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[, in the claim recitation, “pharmaceutically acceptable solvate”]. […] The only argument actually developed in the [defendant’s] brief is that there is no adequate description of “solvates,” whether that term is limited to crystalline structures (as Defendants argue) or covers crystalline and non-crystalline structures, produced through reaction with a solvent or precipitation or crystallization from a solution (as the parties understand the district court’s construction).
GlaxoSmithKline, LLC at *7-8 (text added).
HoldingWe conclude that Defendants have not properly presented any other contention in this court, especially given the lack of elaboration on the distinct issues that would be raised by a written- description challenge to the phrase “pharmaceutically acceptable.” On the sole issue properly presented, we reject Defendants’ challenge. Under 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.
 
Procedural HistoryPlaintiff GlaxoSmithKline LLC (“GSK”) sued Banner Pharmacaps, Inc., Impax Laboratories, Inc., Roxane Laboratories, Inc., Mylan Inc., Mylan Pharmaceuticals, Inc., and Watson Laboratories, Inc.–Florida (collectively, “Defendants”). Invoking 35 U.S.C. § 271(e)(2), GSK alleged that drug products containing the molecule dutas- teride that Defendants propose to market fall within claims of U.S. Patent No. 5,565,467, which covers dutasteride and its pharmaceutically acceptable solvates. All Defendants stipulated to infringement, which is no longer an issue, but alleged that the asserted claims were invalid for anticipation, lack of utility, lack of enablement, and inadequacy of the written description. After a three-day bench trial, the district court issued an opinion concluding that Defendants did not prove the asserted claims invalid. GlaxoSmithKline LLC v. Banner Pharmacaps, Inc., No. 11-CV-046, 2013 WL 4082232 (D. Del. Aug. 9, 2013). Defendants appeal the rejection of their written-description challenge. Their appeal presents only one contention—that “solvate” is not adequately described, whether construed as Defendants urge or as the district court construed it.
GlaxoSmithKline, LLC at *3.
 
 
 
Legal Reasoning (O'Malley, Wallach, Taranto)
Background
Claim Language
This case involves claims to the chemical compound dutasteride and its pharmaceutically acceptable solvates. Claim 1 of the ’467 patent, the only independent claim, reads, “17β-N-(2,5-bis(Trifluoromethyl))phenylcarbamoyl- 4-aza-5α-androst-1-en-3-one or a pharmaceutically acceptable solvate thereof.” ’467 patent, col. 16, lines 4-6. The parties agree that dutasteride is the molecule identi- fied before “or a pharmaceutically acceptable solvate thereof.”
GlaxoSmithKline, LLC at *3.
The asserted claims cover not only dutasteride, but also any “pharmaceutically acceptable solvate thereof.” A “solvate,” by definition, is something that originates in a “solution,” which is a mixture of two substances: a “solute” dissolved in a “solvent.” Salt water is a solution, in which salt is the solute and water the solvent. A solvate is a molecule (a) consisting of a complex made up of solute molecules and solvent molecules (b) resulting from the solution.
Id. at *4.
Failure to Address “Pharmaceutically Acceptable”
Although noting that the claimed solvates must be “pharmaceutically acceptable,” Defendants’ brief does not argue that, even if the specification adequately describes “solvates,” it inadequately describes the pharmaceutically acceptable ones. There is no such contention, and there is no men- tion of the “pharmaceutically acceptable” language, in the statement of issues, in the (argument-summarizing) introduction and statement of the case, in the summary of the argument, or in any heading or subheading of the argument section of the brief.
GlaxoSmithKline, LLC at *8.
Defendant loses based on both interpretations: Solvates not a functional limitation
“Solvate” not a functional limitationNo matter which construction is adopted[, either Defendants or the district court’s interpretation], the term “solvate” involves no performance property (the claimed compound need not perform an identified function or produce an identified result) and hence raises no issue of insufficient structural, creation-process, or other descriptions to support such a property. In this situation, we affirm the district court’s finding that “solvate” is adequately described, without needing to choose between the offered constructions of “solvate.”
GlaxoSmithKline, LLC at *9.
Written Description
The Detailed Description provides a description by structure and process of creation that matches the claimed term, whichever construction is preferable. It declares:
Those skilled in the art of organic chemistry will appreciate that many organic compounds can form complexes with solvents in which they are reacted or from which they are precipitated or crystallized. These complexes are known as “solvates”. For example, a complex with water is known as a “hydrate”. Solvates of [dutasteride] are within the scope of the invention. It will also be appreciated by those skilled in organic chemistry that many organic compounds can exist in more than one crystalline form. For example, crystalline form may vary from solvate to solvate. Thus, all crystalline forms of [dutasteride] or the pharmaceutically acceptable solvates thereof are within the scope of the present invention.’467 patent, col. 3, line 58, through col. 4, line 12.
Id. at *9-10.
[In the Detailed Description defines] [t]he claimed genus [of “solvates”] by two properties. First, a solvate is a complex of dutasteride molecules and solvent molecules, with dutasteride being, as the district court found, “the key structural component.” GlaxoSmithKline LLC, 2013 WL 4082232, at *2. Second, the structure is one that is created by an identified process— specifically, by dissolving dutasteride (the solute) in a solvent.
Id. at *10.
Structural language adequate
[T]his court has repeatedly “explained that an 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.” Ariad, 598 F.3d at 1350 (emphasis added). 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,” allowing one of skill in the art to “visualize or recognize the identity of the members of the genus.”
Id. at *10.
In this case, the claim is no broader in scope than the written description: the above-quoted passage from the written description matches the claim scope (whether they are narrow or broad, as the parties dispute). […] Critically, 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. 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. And we see no basis for doing so in the present context, where “the concept of solvation . . . has been known in the art for over 100 years” and “[s]teroids in particular [such as dutaster- ide] have been known to be prone to solvate formation since 1983,” GlaxoSmithKline LLC, 2013 WL 4082232, at *2, 6, and it is now undisputed that the written descrip- tion enables a person of skill in the art to make and use the full claimed range of “solvates” of dutasteride.
Id. at *11.
Dicta: Distinguishing Precedent of Functional and Structural claim limitationsThe claims in this case, not involving functional claim language, do not present the fundamental difficulty presented by the claims in virtually all of the precedents on which Defendants rely. The claims in those cases used functional language: they “cover[ed] any compound later actually invented and determined to fall within the claim’s functional boundaries”; such language may “merely recite a description of the problem to be solved [how to produce a desired result] while claiming all solutions to it.” Ariad, 598 F.3d at 1353. […]
Id. at *12-13.
Conclusion
For the foregoing reasons, we affirm the district court’s rejection of Defendants’ written-description challenge to the validity of the asserted claims of the ’467 patent.
GlaxoSmithKline, LLC at *13.
 
 
Image Attribution Statement: Thomas Lawrence, “William Wilberforce,” available as a public domain image due to expired copyright, http://commons.wikimedia.org/wiki/ File:William_Wilberforce_by_Thomas_Lawrence_1828.jpg, (last visited Feb. 25, 2014). 
 
 
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