UCB, Inc. v. Yeda Research & Dev. Co.

UCB, Inc. v. Yeda Research & Dev. Co.

Opinion

 [***1489]  [*1257]   Newman, Circuit Judge.

In this declaratory judgment action, UCB, Inc. sued Yeda Research and Development Co. in the United States District Court for the Eastern District of Virginia, requesting a declaration that UCB's Cimzia® brand antibody does not infringe Yeda's U.S. Patent No. 6,090,923 ("the '923 Patent"); UCB also sought a declaration that the '923 Patent is invalid. Yeda counterclaimed for infringement. The district court granted summary judgment of non-infringement, holding that, based on the specification and prosecution history, the monoclonal antibodies claimed in the '923 patent are not infringed by the chimeric or humanized antibodies of the Cimzia® product. [**2] ¹ We affirm the district court's judgment.

Background

The '923 Patent describes and claims a monoclonal antibody that binds a defined human cytotoxin. Claim 1 is representative:

1. A monoclonal antibody which specifically binds a human cytotoxin having a molecular weight of about 17,500 as determined by polyacrylamide gel electrophoresis, said cytotoxin being obtainable from stimulated human monocytes, said cytotoxin being further characterized by exhibiting a cytotoxic effect on cycloheximide-sensitized SV-80 cells and by being obtainable in a state of enhanced purity by adsorption of the cytotoxin from an impure preparation onto controlled pore glass beads, and subsequent desorption of the cytotoxin in a state of enhanced purity.

'923 Patent, col. 6, ll. 54-63. The question is whether the monoclonal antibody of claim 1 includes chimeric or humanized antibodies, when the patent specification describes only murine (mouse) monoclonal antibodies. Yeda argues that since chimeric monoclonal antibodies were known at the time the '923 priority application was  [*1258]  filed in 1984, the claims should be construed to cover such chimeric antibodies, as well as humanized antibodies. UCB responds that the prosecution [**3]  history prohibits coverage of chimeric and humanized antibodies, and that claim 1 cannot be construed to cover those types of antibodies.

The '923 specification states that the "CT [cytotoxin] can be isolated by the use of monoclonal antibodies against such CT which can be obtained from mice injected with partially purified or crude preparations of CT." Col. 1, l. 66-col. 2, l. 1. The specification states that "a monoclonal antibody specific for CT . . . is produced by such hybridoma cell lines and is used for isolating CT in substantially homogenous purified form." Col. 2, ll. 6-9. The specification presents examples of isolating, partially purifying, and characterizing the cytotoxin, raising and purifying the mouse monoclonal antibody, and using this mouse antibody to bind the cytotoxin.

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