The grant of the '482 Patent came after a series of continuation United States patent applications and multiple reviews by the patent examiner. Warner-Lambert filed its initial patent application on August 21, 1990. Claim 5 of the application stated: "A pharmaceutical composition which comprises a therapeutically effective amount of a compound according to claim 1 in combination with a pharmaceutically acceptable carrier [ i.e., adjuvant]." (Rakoczy Decl., Ex. B at 00033).FN3 An April 1991 Office Action rejected all the claims (1-6) as being anticipated under 35 U.S.C. s. 102(b) and, alternatively, as obvious under 35 U.S.C. s. 103 in light of U.S. Patent No. 4,024,175 ("the Satzinger patent"), the products of which "appear [ed] to be substantially free from the corresponding lactam." ( Id. at 00058-59).
FN3. For ease of reference, the Court cites to the bates-numbered version of the '482 Patent Prosecution History (00001-00342) attached as Exhibit B to the Declaration of William A. Rakoczy, which was submitted in support of the Motion of Apotex Corp., Apotex, Inc., and TorPharm, Inc. for summary judgment of noninfringement based on use of certain adjuvants (Civ.A. No. 01-611(JCL)).
Warner-Lambert responded by adding a new claim 7 that identified particular adjuvants found to "have no noticeable influence on the stability" of gabapentin. ( Id. at 00071). The examiner again rejected the claims, stating:
Applicants' assertions as to certain additives affecting the stability of [gabapentin] is [sic] of no moment. First, claims 1, 2, 5 and 6 have no requirement of to [sic] specific additives. Second, the reference suggest [sic] the use of some of the specific additives listed in claim 7. Third, the allegations as to unexpected results are unsubstantiated and as such cannot be given any weight. Forth [sic], none of the claims, including claim 7, excludes that present [sic] of additives alleged to adversely affect the stability of [gabapentin], note the use of the open language 'comprising' in parent claim 5.
( Id. at 00078).
In response to subsequent claim rejections on the basis of the Satzinger patent, Warner-Lambert amended claim 5 by (1) replacing the term "comprises" with "consists of" and (2) requiring a pharmaceutically acceptable carrier "wherein the carrier does not promote the formulation of a lactam." ( Id. at 00122). Warner-Lambert explained the amendments as "exclud[ing] the presence of additives which would adversely affect the stability of a compound of [gabapentin]." ( Id. at 00129).
A May 1994 Office Action allowed claim 5. Warner-Lambert subsequently petitioned to withdraw its application and requested entry of, inter alia, an amendment canceling the allowed claim 5 and replacing it with a new claim 21 in independent form. ( Id. at 00175-77).
On January 25, 1995, Warner-Lambert filed the '618 application,FN4 which ultimately issued as the '482 patent in suit. Claim 21 was directed to a
FN4. The '618 application was a continuation of application No. 08/020,270, February 18, 1993, abandoned, which was a continuation of application No. 07/865,723, April 8, 1992, abandoned, which is a continuation of application No. 07/570,500, Aug. 21, 1990, abandoned.
pharmaceutical composition which consists of a compounds of Formula VII wherein n is an integer of 5