Federal Circuit Affirms Denial of Preliminary Injunction

The case is Biomedical Device Consultants & Laboratories of Colorado, LLC v. ViVitro Labs, Inc., nonprecedential opinion published last Thursday and authored by Judge Lourie, joined by Judges Dyk and Stark.  Plaintiff BDC, which manufactures and sells heart valve durability testing devices, sued its competitor ViVitro for infringement of U.S. Patent 9,237,935, which is “directed toward accelerated rate fatigue testing devices for prosthetic valves” (p.2). The district court denied BDC’s motion for a preliminary injunction, “finding that it failed to establish a likelihood of success on the merits for two independent reasons,” namely substantial questions as to both infringement and validity.  On appeal, the Federal Circuit affirms on the basis that there is a “substantial question of validity,” and does not address the infringement issue (though toward the end of the opinion it "caution[s] that claim terms are generally not limited to the preferred embodiments"(p.14), which might be interpreted as expressing some possible discomfort with the district court's claim construction and hence infringement analysis).  Without rehashing the evidence before the court, I would note only that the opinion does not appear to break any new ground on the legal questions.  It cites Titan Tire Corp. v. Case New Holland, Inc., 566 F.3d 1372 (Fed. Cir. 2009), which is probably the leading opinion addressing the parties’ burdens when a defendant responding to a motion for preliminary injunction challenges validity, only in passing, but the analysis seems consistent with that case.  In particular, the court states that

At the preliminary injunction stage, a defendant may raise a substantial question of validity “on evidence that would not suffice to support a judgment of invalidity at trial.” Amazon.com, 239 F.3d at 1358. The question here is one of “vulnerability,” which “requires less proof than the clear and convincing showing necessary to establish invalidity itself.” Id. Furthermore, the district court’s assessment of prior art references is an issue of fact reviewed for clear error. . . (p.8).

Proceeding from these premises, the court concludes that “the district court did not make a clear error in its assessment of the prior art,” and “therefore did not abuse its discretion in finding that BDC failed to demonstrate that ViVitro’s anticipation defense lacked substantial merit.  See Titan Tire Corp. v. Case New Holland, Inc., 566 F.3d 1372, 1377 (Fed. Cir. 2009) (“[I]t is the patentee, the movant, who must persuade the court that, despite the challenge presented to validity, the patentee nevertheless is likely to succeed at trial on the validity issue.”)” (pp. 10-11).  The court also rejects BDC’s arguments that the district court did not address four of the eight claims in suit, finding that the district court did indeed conclude that there was a substantial question of obviousness as to those claims, and did not abuse its discretion in so concluding.