Addressing the issue of substantial evidence to support an allegation of infringement, the U.S. Court of Appeals for the Federal Circuit overturned a jury verdict of infringement of three patents, holding that the jury's verdict was not supported by substantial evidence. The Johns Hopkins University v. Datascope Corp., Case No. 07-1530 (Fed. Cir., Oct. 2, 2008) (Zobel, J.; Newman, J. dissenting).

Johns Hopkins University (Hopkins) is the owner of three patents for methods of mechanically fragmenting blood clots. Arrow International, Inc. is its exclusive licensee. The patented methods used catheters with expandable wire basket ends to fragment blood clots that often form in vascular access grafts in patients undergoing chronic hemodialysis. Hopkins alleged that the use of Datascope's ProLumen device infringed the three Hopkins patents. Hopkins presented evidence in the form of expert testimony, and the jury found that Datascope indirectly infringed all asserted claims of the three patents. Datascope then moved for judgment as a matter of law (JMOL), or in the alternative, a new trial. The district court denied both motions, holding that the jury's conclusion was not against the clear weight of the evidence. Datascope subsequently appealed.

Each of the asserted independent claims in the suit required introducing into a vascular conduit a fragmentation catheter comprised of either a fragmentation member or an expanding distal end that automatically expand to conform to the shape and diameter of the inner lumen of the vascular conduit. Hopkins' only evidence supporting the contention that Datascope's ProLumen device literally met the "expands to conform" limitation was presented by expert Dr. Valji, who testified that the S-shaped wire on the distal end of the ProLumen device met the claim limitations when it was rotated in the vascular lumen in a corkscrew manner. However, on cross-examination, Dr. Valji testified that the ProLumen device only contacts the lumen at two points, even while rotating.

The Federal Circuit determined that the "expands to conform" limitation must be met whether or not the distal end of the fragmentation member is rotating. Accordingly, despite Hopkins' evidence that the ProLumen device contacts the lumen and fragments blood clots, the Court cited Valji's contradictory testimony that the device only contacts the vessel in two places in holding that the jury's finding of infringement was not supported by substantial evidence. The Court reversed and remanded the district court's denial of Datascope's motion for JMOL for entry of a final judgment in favor of Datascope, determining that no reasonable jury could have found that the ProLumen device literally met the claim limitation that the device expands to conform to the shape and diameter of the inner lumen.

In dissent, Judge Newman reminded the panel majority that it is not in the Federal Circuit's province to reweigh the evidence when there was substantial evidence by which a reasonable jury could have reached its verdict. While she did not disagree with the panel majority that there was evidence and argument on Datascope's side, Judge Newman deemed determinative that a reasonable jury could have reached the verdict of infringement.

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