The Court observes that there is nothing in the patent or prosecution history that suggests that ingredients only present in capsule shells or tablet coatings affect the stability of the pharmaceutical formulation, so as to be considered an adjuvant within the meaning of claim 7. Therefore, the fact that Warner-Lambert did test capsule shells for lactam promotion (see 11/18/04 transcript at 108-09; Trondlin Decl.) is not helpful to claim construction.
Ingredients of dosage capsules or coatings could conceivably have an effect on the stability of a gabapentin formulation. Indeed, Warner-Lambert selected talc as a colorant for the film coating of Neurontin(R) tablets because it discovered that talc had 20 times less of an effect on lactam formation than titanium dioxide. (Warner-Lambert Opp. at 41 n. 7; Trondlin Decl., Table 1). It is argued that Warner-Lambert thus recognized that a colorant in a tablet's film coating was relevant to lactam formation, even though not intimately mixed with the active ingredient. However, Warner-Lambert also chose to use titanium dioxide in the capsule shells for its gabapentin product. ( See Warner Lambert's Opp. at 41 n. 7) ("Warner-Lambert selected titanium dioxide as a colorant for the gelatin capsule shells of Neurontin(R) capsules."); Teva's Mem. of Law in Support of Summary Judgment on Non-Infringement at 11 ("The Physician's Desk Reference ("PDR") for Neurontin(R) lists titanium dioxide as an inactive ingredient in Warner-Lambert's Neurontin(R) capsule formulation." (citing Ex. 5, PDR at 2655 (2002))). This suggests that Warner-Lambert did not consider titanium dioxide, when used as a colorant in a capsule shell, to be a significant threat to stability of a gabapentin formulation.FN9 Thus, when viewed as Warner-Lambert admissions against interest, the foregoing considerations advanced by Teva are somewhat equivocal. In any event, Warner- Lambert's apparent concession that ingredients used in tablet coatings may affect lactam formation does not determine whether the language of the '482 patent is directed at ingredients of capsule shells.
FN9. Notably, Warner-Lambert's use of titanium dioxide as a colorant in a capsule shell is consistent with its position (rejected by the Court) that it is permissible to use any adjuvant, even those that are "excluded," if such use is judicious, and is not necessarily inconsistent with a conclusion that an ingredient in a capsule or a tablet coating is not covered by the patent. Warner-Lambert's use of titanium dioxide as a colorant in its capsule shells is certainly consistent with its position (and the Court's claim construction) that titanium dioxide, as so used, is not an "adjuvant."
The Court rejects the argument briefed and jointly advanced by the generic defendants at oral argument on November 18, 2004 (Tr. at 106) that the titanium dioxide present in capsule shells or tablet coatings is used as an adjuvant for purposes of claim 7. While dependent claim 9 refers to the dry medicinal dosage form as a tablet, and dependent claim 10 refers to the dry medicinal dosage form as a capsule, titanium dioxide as a colorant/coating of those capsules/tablets is not referenced in the patent or prosecution history. There is nothing in the patent that references capsule shells or tablet coatings. The fact that capsule shells (with no defined ingredients) appear in the Trondlin declaration as being tested for their effect on lactam promotion does not answer whether the language of the '482 patent covers those ingredients. This leads the Court to conclude that claim 7 is directed at gabapentin and substances mixed intimately therewith, not the colorants used in capsule shells or tablet coatings.