Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc. - 246 F.3d 1368 (Fed. Cir. 2001)

Rule:

Additional references may be relied on for anticipation under 35 U.S.C.S. § 102(b) solely as evidence that, more than one year prior to appellant's filing date, a method of preparing the claimed subject matter would have been known by, or would have been obvious to, one of ordinary skill in the art. Furthermore, additional references used solely to show enablement of an anticipatory reference need not antedate that reference, but must show that the claimed subject matter was in possession of the public more than one year prior to the applicant's filing date. 

Facts:

Plaintiff Bristol-Myers Squibb Co. was the assignee of the '803 and '537 patents, which related to a three-hour administration of the antitumor drug paclitaxel. The patents derived from the same parent application and share the same specification. The '537 patent was also directed to three-hour paclitaxel administration and additionally requires premedication, as shown in representative claims 1 and 5. Claims 2 and 8 of the '537 patent differ from claims 1 and 5, respectively, only in the dosage amount. Claims 6 and 9 of the '537 patent were directed to the same particular pre-medicants, claim 6 depends from claim 5 and claim 9 depends from claim 8. Defendants Ben Venue Laboratories, Inc., filed Abbreviated New Drug Applications (ANDAs) seeking approval to market paclitaxel prior to the patents' expiration, alleging that the patents were invalid over an article by Kris in which Kris treated patients with three-hour infusions of paclitaxel within the claimed dosage ranges but observed no antitumor response. Plaintiff sued for infringement based on the defendants' ANDAs under 35 U.S.C.A. § 271(e)(2) (West Supp. 2000) and the defendants moved for summary judgment that the patents were invalid for anticipation under 35 U.S.C. § 102(b) (1994) and obviousness under 35 U.S.C. § 103 (Supp. IV 1998). The district court granted defendants motion for summary judgment that claims 1-3 and 6 of 803 patent and claims 1, 2, 5, 6, 8 and 9 of 537 patent were invalid for anticipation. Plaintiffs then appealed. 

Issue:

Did the district court err in holding the claims invalid?

Answer:

Yes

Conclusion:

The appellate court affirmed the district court's decision holding claims 1-3 and 6 of the '803 patent and claims 1, 2, 5 and 8 of the '537 patent invalid, however, summary judgment was reversed concerning the district court's holding claims 6 and 9 of the '537 patent invalid. The appellate court held that the district court erred in holding claims 6 and 9 of the '537 patent invalid for anticipation. The court found that the district court relied on plaintiff's statement during prosecution concerning pretreatment as conventional medication for minimizing hypersensitivity reactions in its determination that claims 6 and 9 were anticipated. Thus, drawing all inferences in favor of the plaintiff, as non-movant on summary judgment, the court of appeals reasoned that the anticipatory reference, presumably related to the state of the art around the time of filing, was insufficient to establish enablement for purposes of anticipation under 35 U.S.C.S. § 102(b).