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physical modification of the starch converting it into gelatinous form (no chemical additives or surfactants are used). ( Id.). Pregelatinization results in partial solubility, increased particle size, improved flow properties and compactability. ( Id.). Teva contends that the reference in the '482 patent to "modified maize starch," with no further discussion, is not limited to maize starch modified by acid treatment and includes even starch modified only physically, not chemically. The Court disagrees. There is support in the prosecution history for construing the language "modified maize starch" to mean maize starch modified by acid treatment, as Warner-Lambert suggests. (Pros. Hist. at 00322). The Court also cannot ignore Warner- Lambert's argument that the modification referred to in the specification cannot be pregelatinization because the specification makes clear that another pregelatinized starch (sodium starch glycolate) has "no noticeable influence" on the stability of gabapentin. ('482 patent, Col. 5, ll. 11-16).

While Teva's gabapentin capsules contain a maize starch that has been physically modified and claims 7-11 have been construed to exclude "modified maize starch," Teva has not met its burden of convincing the Court that its pregelatinized maize starch is one of the excluded substances.

Accordingly, summary judgment of noninfringement on this basis is not proper.

b. Titanium Dioxide

[6] [7] For purposes of completeness, and because it relates to other pending motions for summary judgment, the Court will also address Teva's use of titanium dioxide as a colorant in capsule shells and tablet coatings. The issue is whether claim 7, describing "[a] stable and pure pharmaceutical composition in unit dry medicinal dosage form consisting essentially of ... one or more pharmaceutically acceptable adjuvants [that meet certain stability requirements]" is directed at ingredients in capsule shells and tablet coatings.

Teva argues that claim 7 covers all inactive ingredients, regardless of whether they are intimately mixed with the gabapentin or serve as an ingredient to the capsule shell. Teva equates "adjuvant" with any inactive ingredient, invoking the expansive FDA definition of inactive ingredient as any component in the pharmaceutical dosage form other than the "active ingredient," 21 C.F.R. s. 210.3(b)(8). An FDA definition for something other than "adjuvant," specifically, while important for FDA purposes, does not advance the claim construction inquiry here.

Warner-Lambert responds that even if the Court construes claim 7 to exclude the eight lactam-promoting adjuvants listed in the '482 patent specification, which it has, Teva's use of titanium dioxide for coloration is irrelevant. The reasoning goes that an "adjuvant" is an ingredient intimately mixed with gabapentin and that while all "adjuvants" are "inactive ingredients," it does not logically follow that all inactive ingredients are adjuvants. Rather, adjuvants are that subset of inactive ingredients intimately mixed with gabapentin to form the drug mixture.

The Court agrees with Warner-Lambert that Teva's use of titanium dioxide as a colorant is irrelevant for purposes of the '482 patent.FN8 Intrinsic evidence and extrinsic evidence considered in context support this conclusion.

FN8. Warner Lambert alternatively argues that Teva's use of titanium dioxide as a colorant is insufficient to take it outside claim 7's preamble language "consisting essentially of." The Court need not reach that argument in light of its conclusion that use of titanium dioxide as a colorant is irrelevant for purposes of the

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