The Johns Hopkins University v. Datascope Corp.

• Decision Date: 02 October 2008
• Docket Number: No. 2007-1530.,2007-1530.
• Citation: 543 F.3d 1342
• Parties: THE JOHNS HOPKINS UNIVERSITY and Arrow International, Inc., Plaintiffs-Appellees, v. DATASCOPE CORPORATION, Defendant-Appellant.
• Court: U.S. Court of Appeals — Federal Circuit

543 F.3d 1342

THE JOHNS HOPKINS UNIVERSITY and Arrow International, Inc., Plaintiffs-Appellees, v. DATASCOPE CORPORATION, Defendant-Appellant.

No. 2007-1530.

United States Court of Appeals, Federal Circuit.

October 2, 2008.

Kenneth P. George, Amster, Rothstein & Ebenstein LLP, of New York, NY, argued for plaintiffs-appellees. With him on the brief were Ira E. Silfin, Marc J. Jason, and Rebecca R. Eisenberg.

Roy H. Wepner, Lerner, David, Littenberg, Krumholz & Mentlik, LLP, argued for defendant appellant. With him on the brief was Paul H. Kochanski.

Before NEWMAN and SCHALL, Circuit Judges, and ZOBEL, District Judge.^*

Opinion for the court filed by District Judge, ZOBEL. Dissenting opinion filed by Circuit Judge, NEWMAN.

Datascope Corporation ("Datascope") appeals from a final judgment of infringement and contributory infringement of claim 1 of United States Patent No. 5,766,191 ("the '191 patent"), claims 16-17, 27 and 34 of United States Patent No. 6,824,551 ("the '551 patent") and claims 1, 3-7 and 15-18 of United States Patent No. 7,108,704 ("the '704 patent"). Johns Hopkins Univ. & Arrow Int'l, Inc. v. Datascope Corp., 513 F.Supp.2d 578 (D.Md. 2007). For the reasons set forth below, we reverse the judgment of infringement of the asserted claims of the three patents-in-suit.

BACKGROUND

Johns Hopkins University ("Hopkins") is the owner and Arrow International, Inc. ("Arrow") the exclusive licensee of the '191, '551 and '704 patents, each titled "Percutaneous Mechanical Fragmentation Catheter System." All three patents are directed to methods for mechanically fragmenting blood clots, particularly thrombus material occluding synthetic vascular grafts, and all share a common specification.

The patented methods address the problem that patients undergoing chronic hemodialysis experience blockage of their dialysis access grafts approximately three or four times per year. In each of the claimed methods, a fragmentation catheter is introduced into the vascular conduit, typically through an outer sheath. Upon deployment, a fragmentation cage or basket at the distal end of the catheter expands to conform to the inner lumen of the vascular conduit (as shown in figure 11 C reproduced below). After deployment, the fragmentation cage is rotated at a speed high enough to homogenize the thrombotic material obstructing the vascular conduit. The homogenized debris can then be safely flushed or aspirated.

NOTE: OPINION CONTAINING TABLE OR OTHER DATA THAT IS NOT VIEWABLE

Plaintiffs' complaint alleges that use of defendant's ProLumen device infringes the '191 and '551 patents. After the '704 patent issued, plaintiffs filed a second action alleging infringement of that patent as well. The two cases were consolidated and then bifurcated, with infringement and Datascope's affirmative defense of obviousness to be tried to a jury first and Datascope's affirmative defenses of inequitable conduct and unclean hands as to the '704 patent to be determined by the court after a later trial. On June 15, 2007, a jury found: (1) that Datascope indirectly infringed all asserted claims of the three patents; (2) that the asserted independent claim of each patent was not invalid and not obvious; and (3) that each plaintiff is entitled to damages, $460,583 to Arrow and $230,292 to Hopkins.

The following month, the district court held the bench trial on Datascope's defenses of inequitable conduct and unclean hands. It concluded that Datascope had not proven any misconduct by the attorney who prosecuted the '704 patent and therefore upheld the enforceability of the three patents against these defenses. Johns Hopkins Univ., 513 F.Supp.2d at 584.

On the issues of infringement and obviousness, defendant moved pursuant to Rules 50 and 59 for judgment as a matter of law ("JMOL") or, in the alternative, a new trial. The district court denied both. On obviousness, the court noted that Datascope's evidence of prior art was presented through the testimony of its expert, Dr. Thomas Aretz. Id. Because the jury was free to determine the credibility of the witness and disbelieve his testimony, its verdict was not wrong as a matter of law and the court therefore denied the motion for JMOL. Id. at 584-85. The court also denied the motion for a new trial because Datascope's arguments did not address the grounds for a new trial under Fed.R.Civ.P. 59(a), as articulated by the Fourth Circuit. On infringement, the district court held that the jury's conclusion was not against the clear weight of the evidence, and therefore denied the motion for JMOL or a new trial on that issue as well. Id. Finally, the court entered judgment in accordance with the jury's verdict and its own findings. Datascope filed a timely appeal from the judgment, and we have jurisdiction thereof under 28 U.S.C. § 1295(a)(1).

DISCUSSION

I

We review the denial of JMOL without deference by applying the JMOL standard used by the district court. BBA Nonwovens Simpsonville, Inc. v. Superior Nonwovens, LLC, 303 F.3d 1332, 1336 (Fed.Cir.2002). In the Fourth Circuit, "a motion for judgment as a matter of law should be granted if a district court determines, without weighing the evidence or considering the credibility of the witnesses, that substantial evidence does not support the jury's findings." Id. The denial of a motion for a new trial is reviewed for an abuse of discretion. Id. We review "[the] jury's conclusions on obviousness, a question of law, without deference, and the underlying findings of fact, whether explicit or implicit within the verdict, for substantial evidence." LNP Eng'g Plastics, Inc. v. Miller Waste Mills, Inc., 275 F.3d 1347, 1353 (Fed.Cir.2001). The determination of inequitable conduct is committed to the discretion of the district court and we review its decision for abuse of that discretion. Scanner Techs. Corp. v. ICOS Vision Sys. Corp. N.V., 528 F.3d 1365, 1374 (Fed.Cir.2008).

II

We hold that the jury's verdict of infringement of claim 1 of the '191 patent, claims 16-17, 27 and 34 of the '551 patent and claims 1, 3-7 and 15-18 of the '704 patent was not supported by substantial evidence and that defendant's motion for JMOL should have been granted. We do not reach the other issues raised on appeal given Datascope's concession at oral argument that we need not reach a decision on invalidity if we find that its motion for JMOL was wrongly denied.

III

Each of the asserted independent claims in the patents-in-suit requires introducing, into a vascular conduit, a fragmentation catheter comprised either of a fragmentation member or an expanding distal end that automatically "expands to conform to the shape and diameter of the inner lumen" of the vascular conduit. Only claim 1 is asserted in the '191 patent. That claim provides in its entirety:

A method for fragmenting thrombotic material in a vascular conduit comprising the steps of:

introducing a fragmentation catheter in a vascular conduit to a thrombotic occlusion, wherein the fragmentation catheter comprises a fragmentation member at a distal end portion thereof that automatically expands to conform to the shape and diameter of the inner lumen of the vascular conduit upon deployment of the fragmentation member;

deploying the fragmentation member; and

rotating the fragmentation member at a speed to homogenize the thrombotic material.

'191 patent, col.8 ll.31-42 (filed Feb. 29, 1996) (emphasis added).

Asserted independent claim 16 of the '551 patent is identical to claim 1 of the '191 patent except that it does not require the "expands to conform" limitation to occur "upon deployment of the fragmentation member" and it does not include the second step requiring "deploying the fragmentation member." '551 patent, col. 9ll.44-54 (filed Dec. 3, 2002). Two of the other asserted claims of the '551 patent, 27 and 34, depend from four independent claims, 1, 9, 16 and 19, of which 16 is the broadest, but all of which include the "expands to conform" limitation. Asserted claim 17 depends solely from claim 16.

Claim 1 of the '704 patent is similar to the independent claims asserted in the other two patents except that it does not specifically require a fragmentation member. Rather, it requires only that the fragmentation catheter include an "expandable distal end." '704 patent, col.8 l.43 (filed Oct. 7, 2004). This claim also includes an additional limitation requiring "withdrawing the rotating expandable distal end through the thrombotic material in the vascular conduit." Id., col.8 ll.52-53. All of the asserted dependent claims of the '704 patent depend from independent claim 1.

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," used in the '191 and '551 patents. In its memorandum on claim construction, the district court held that the latter was a means-plus-function term and limited it to the wire cage or basket described in the specification, along with any equivalents. See 35 U.S.C. § 112, ¶ 6. As to the former, the 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." Johns Hopkins Univ. & Arrow Int'l, Inc. v. Datascope Corp., Nos. 05-CV0759 and 06-CV-2711, 2007 WL 1575077, at *3 (D.Md. May 30, 2007). Based on this interpretation, the court instructed the jury as follows:

The other term that is at issue here is the "expands to conform to the shape and diameter of the inner lumen." The claims at issue contain this phrase, which means that the fragmentation member in the '191 and '551 patents and the 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.

(Trial Tr. vol. 3, 812, Jun. 14, 2007 (...