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“There Is Simply ‘No There There’”

March 23, 2001

Decision icon Decision

Last Month at the Federal Circuit - April 2001

Judges: Lourie (author), Rader, and Gajarsa

In Research Corp. Technologies, Inc. v. Gensia Laboratories, Inc., No. 00-1166 (Fed. Cir. Mar. 23, 2001) (nonprecedential decision), the Federal Circuit affirmed a district court’s holding that the claims-in-suit were invalid for obviousness-type double patenting.

Research Corporation Technologies, Inc. (“Research”) charged Gensia Laboratories, Inc. (“Gensia”) with infringement of U.S. Patent No. 5,562,925 (“the ‘925 patent”) by Gensia’s filing of an Abbreviated New Drug Application with the Food and Drug Administration. The ‘925 patent claims platinum complexes used for treating cancer. Independent claim 1 claims a platinum-complex composition that must be protected from light and that is suitable for therapeutic administration by injection. Dependent claim 2 claims the composition of claim 1 dissolved in a stabilizing amount of saline.

The district court had held that the asserted claims of the ‘925 patent were invalid for obviousness- type double patenting in view of U.S. Patent Nos. 4,177,263 and 4,339,437 (collectively “the method patents”) in combination with other references. Those patents claim methods of treating cancer in animals using platinum complexes. The district court had held that the only material difference between the claims of the ‘925 patent and the claims of the method patents was that the asserted claims of the ‘925 patent recite that the platinum complexes must be protected from light. Based on prior art references teaching that platinum complexes were degraded in light, the district court had concluded that the asserted claims were invalid for obviousness-type double patenting.

On appeal, the Federal Circuit affirmed the district court’s construction of the claim phrase “protected from light,” ruling that the phrase was merely a direction for care and did not add an additional limitation to the structure of the composition. “There is simply ‘no there there,’” the Court stated. Research Corp., slip op. at 10 (citation omitted).

Since the phrase “protected from light” was nonlimiting, the Federal Circuit held that it could not be a basis for distinguishing the composition claims over the prior method patents.

The Federal Circuit also concluded that the phrase “suitable for therapeutic administration by injection in solution” was not a patentable distinction over the method patents. Instead, the Court held that the method claims were also directed towards administration of therapeutic compositions. Similarly, the Federal Circuit rejected Research’s arguments that the phrase “dissolved in a stabilizing effective amount of saline or buffer solution” was a patentable distinction of the ‘925 patent claims over the method patents. According to the Federal Circuit, both the ‘925 patent and the method patents, which each share the same specification, employ saline to stabilize the solution of the platinum complexes and, thus, that recitation in the ‘925 patent could not be an unobvious distinction between the patents.