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New Result from Known Use of Known Process Is Not Novel

April 20, 2001

Decision icon Decision

Last Month at the Federal Circuit - May 2001

Judges: Lourie (author), Gajarsa, and Dyk

In Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., No. 00-1304 (Fed. Cir. Apr. 20, 2001), the Federal Circuit affirmed-in-part, vacatedin- part, and remanded a district court’s decision granting SJ that the effective claims of two issued U.S. patents were invalid for anticipation.

U.S. Patent Nos. 5,641,803 (“the ’803 patent”) and 5,670,537 (“the ’537 patent”), assigned to Bristol-Myers Squibb Company (“Bristol”), relate to a three-hour administration of the antitumor drug paclitaxel.

A number of companies, including Ben Venue Laboratories, Inc., filed Abbreviated New Drug Applications (“ANDAs”), seeking approval to market paclitaxel prior to the expiration of the two patents. Bristol sued those companies (collectively “the Defendants”) in the U.S. District Court for the District of New Jersey for infringement based on these ANDAs. In response, the Defendants moved for SJ that the two patents were invalid for anticipation and obviousness. Following a Markman hearing, the district court granted the motion for SJ based on anticipation but denied the motion based on obviousness. Subsequently, Bristol disclaimed a total of six claims of the two patents.

On appeal, the Federal Circuit first affirmed the district court’s claim construction. Specifically, the Court found preamble language in the claims nonlimiting, determined that the doctrine of claim differentiation did not prevent the Court from concluding that two independent claims in one patent shared an identical scope, and found expressions of efficacy in the claims nonlimiting because these expressions did not distinguish over the prior art. Importantly, the Court restated that newly discovered results from a known use of a known process are not patentable.

The Federal Circuit also found all but two of the remaining claims of the two patents invalid for anticipation. Those two claims, both from the ’537 patent, recite specific classes of premedicants. Because the prior art disclosed only the general use of premedicants, the Court concluded, the prior art could not anticipate those two claims. Thus, the Court vacated the SJ with regard to those two claims and remanded this issue.