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Infringement Judgment Reversed Where Expert’s Testimony Did Not Address Claim Limitation

07-1530
October 02, 2008

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Last Month at the Federal Circuit - November 2008

Judges: Newman (dissenting), Schall, Zobel (author and District Judge sitting by designation)

[Appealed from: N.D. Md., Judge Quarles]

In Johns Hopkins University v. Datascope Corp., No. 07-1530 (Fed. Cir. Oct. 2, 2008), the Federal Circuit concluded in a split decision that the jury’s verdict of infringement was not supported by substantial evidence and that the defendant’s motion for JMOL should have been granted. Accordingly, the Court reversed the denial of the JMOL motion and remanded for entry of final judgment in favor of Datascope Corporation (“Datascope”).

Johns Hopkins University is the owner and Arrow International, Inc. (collectively “Hopkins”) is the exclusive licensee of U.S. Patent Nos. 5,766,191 (“the ’191 patent”), 6,824,551 (“the ’551 patent”), and 7,108,704 (“the ’704 patent”). The patents are directed to methods for mechanically fragmenting blood clots and share a common specification. In each of the asserted methods, a fragmentation catheter is introduced into the vascular conduit. Upon deployment, a fragmentation cage or basket at the distal end of the catheter expands to conform to the shape and diameter of the inner lumen of the vascular conduit. After deployment, the fragmentation cage is rotated at a speed high enough to homogenize the thrombotic material obstructing the vascular conduit.

Hopkins sued Datascope, alleging that the use of Datascope’s ProLumen device infringes the patents. The infringement claims and Datascope’s defense of obviousness were tried to a jury, which found the patents infringed and valid. The district court held a bench trial on Datascope’s defenses of inequitable conduct and unclean hands, upholding the enforceability of the three patents. On the issues of infringement and obviousness, Datascope moved for JMOL or, in the alternative, for a new trial, which the district court denied.

On appeal, the Federal Circuit concluded that the jury’s verdict of infringement was not supported by substantial evidence and that Datascope’s JMOL motion should have been granted. In the district court, the parties disagreed on the meaning of the phrase “expands to conform to the shape and diameter of the inner lumen” and the term “fragmentation member.” The district court construed “fragmentation member” as a means-plus-function term and limited it to the wire cage or basket described in the specification, along with equivalents. As to the disputed “expands to conform” phrase, the district court concluded that “diameter” referred to a “horizontal cross-section” of the vein “regardless of whether it forms a circle,” while “shape” referred to the capability of the fragmentation member to “adjust to remain in contact with the sides of the inner lumen along its length.” Based on this interpretation, the district court instructed the jury that “expands to conform to the shape and diameter of the inner lumen” means that the “fragmentation member” (in the ’191 and ’551 patents) or “expandable distal end” (in the ’704 patent) “expands and adjusts to remain in contact with the inner lumen in three dimensions along its length and width.” Slip op. at 6.

The Federal Circuit found that, in the place of a cage or basket, the ProLumen device uses a single “S” shaped wire (“S-wire”) that is rotated to break up thrombotic material. The only evidence at trial supporting the contention that the use of the ProLumen device literally meets the “expands to conform” limitation was testimony by Hopkins’s expert that the ProLumen fills the lumen in all three dimensions as it rotates. Because all of the asserted claims require that the distal end contact the inner lumen in three dimensions prior to the rotation step, the Court found that the expert’s testimony was insufficient. Further, the Court found no evidence that the S-wire makes contact with the inner lumen in three dimensions at any particular instant in time, as the “expands to conform” limitation requires. Rather, Hopkins’s expert testified that the ProLumen only contacts the inner lumen at two points. For these reasons, the Court concluded that “no reasonable jury could have found that the ProLumen device literally met” the “expands to conform” limitation and reversed the denial of Datascope’s JMOL on the issue of infringement. Id. at 11. The Court declined to reach the other issues raised on appeal.

In a dissenting opinion, Judge Newman characterized the Court’s opinion as an “independent appellate trial of the factual issues that were decided by the jury and sustained by the district court” and stressed that all reasonable inferences must be made in favor of the verdict. Newman Dissent at 1. In Judge Newman’s view, because no fragmentation occurs until the structure is rotated in either the claimed device or the accused device, a reasonable jury could have found that the S-wire is a “fragmentation member.” Moreover, Judge Newman agreed with the district court that the jury’s finding was not against the clear weight of the evidence. Judge Newman concluded that there was substantial evidence that the “expands to conform” limitation was met, regardless of whether there was also evidence to support Datascope’s position. Accordingly, Judge Newman concluded that a reasonable jury could have reached the verdict of infringement.