Plaintiffs Pfizer, Inc., Warner-Lambert Co., and Godecke Aktiengesellschaft (collectively, "Warner- Lambert") brought suit against Defendants Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd. (collectively, "Teva"), alleging infringement of U.S. Patent No. 6,054,482, entitled "Lactam- Free Amino Acids" (" '482 patent"). FN1 Before the Court is the Motion of Teva for summary judgment of noninfringement of claims 7-11 of the '482 patent based on use of certain adjuvants. For the reasons set forth herein, Teva's Motion will be denied.
FN1. Warner-Lambert filed separate patent infringement actions against multiple generic drug manufacturers. The Judicial Panel on Multidistrict Litigation directed that all such actions be consolidated before this Court for coordinated pretrial proceedings. This Motion pertains to a "first-wave" defendant. There are also "second-wave" and "third-wave" defendants, sued by Warner-Lambert after close of discovery for first-wave defendants.
Neurontin(R) is sold by Warner-Lambert as an aid in the treatment of epileptic seizures and other cerebral disorders. The active ingredient in Neurontin(R) is a chemical compound called gabapentin, discovered by Warner-Lambert in the mid 1970s. Early research demonstrated that gabapentin had a propensity to undergo a chemical reaction resulting in an impurity known as gabapentin lactam, which was more than twenty-five times as toxic as gabapentin. Lactam caused rather than prevented seizures. FN2 Subsequent research revealed that both the purity of the starting gabapentin and the "catalytic effects" of certain ingredients, or adjuvants, mixed therewith contributed to the production of lactam. The development of a stable gabapentin formulation became the focus of first a German, and then a United States patent application that ultimately issued to Warner-Lambert on April 25, 2000 as the '482 patent. The '482 patent expires on April 25, 2017.
FN2. Given the severe risk posed by lactam, the Food and Drug Administration capped the allowable lactam impurity in gabapentin.
A. The '482 Patent
The '482 patent includes eleven claims. Claims 1 through 6 of the '482 patent are process claims. (Col. 6, l. 55 to Col. 8, l. 28). Claim 7 of the '482 patent, the only independent product claim, states:
7. A stable and pure pharmaceutical composition in unit dry medicinal dosage form consisting essentially of:
(i) an active ingredient which is gabapentin in the free amino acid, crystalline anhydrous form containing less than 0.5% by weight of its corresponding lactam and less than 20 ppm of an anion of a mineral acid and
(ii) one or more pharmaceutically acceptable adjuvants that do not promote conversion of more than 0.2% by weight of the gabapentin to its corresponding lactam form when stored at 25 (deg.)C and an atmospheric humidity of 50% for one year.
(Col. 8, ll. 29-40 (emphasis added)). Claims 8-11 depend from claim 7 and, therefore, incorporate all the limitations of claim 7. Claim 8 limits the selection of "pharmaceutically acceptable" adjuvants. (Col. 8, ll.41-49). Claims 9 and 10 limit the dry medicinal dosage forms to a tablet and capsule, respectively. (Col.