A preliminary injunction is one of the most potent weapons in a patent plaintiff's arsenal, being capable of shutting down an accused infringer's continued infringement, prohibiting the infringing product from the stream of commerce, and forcing (or at least strongly motivating) a defendant to settlement. Being so powerful, such injunctions are not easily obtained and are cabined by several requirements, the most potent being the need to show a likelihood of success on the merits at trial. In Biomedical Device Consultants and Laboratories of Colorado, LLC v. Vivitro Labs, Inc., the Federal Circuit illustrated the importance of such a showing in affirming a District Court denial based on plaintiff's failure to satisfy this prong of the eligibility test.

The case arose in litigation over U.S. Patent No. 9,237,935, directed to Biomedical Device Consultants (BDC) devices for testing heart valve durability based on accelerated fatigue rates. Claim 1 was considered representative by the Federal Circuit in its opinion (wherein only the relevant limitation was reproduced therein):*

1. A device for accelerated cyclic testing of a valved prosthetic device comprising . . .
an excess volume area capable of operating at the accelerated pulsed rate, wherein the excess volume area is in fluid communication with the fluid return chamber providing a volume for storing a volume of a test system fluid when the test system fluid is under compression.

The opinion identified three limitations in dispute: (1) that the claimed device is "capable of operating at the accelerated pulsed rate," (2) that it is "in fluid communication with the fluid return chamber," and (3) that it "provid[es] a volume for storing a volume of a test system fluid when the test system fluid is under compression," supported by specific disclosure in the specification:

The compliance chambers 135 provide excess volume area for fluid to move into when the piston 114 performs a compression stroke. As the pressure of the gas in the compliance chamber 135 increases, the volume occupied by the gas decreases to provide additional volume for displacement of the liquid working fluid within the test chamber 106.

And illustrated by a detailed figure exemplifying the return chamber 136, the compliance chamber 135, test valve sample 130, and the fluid flow path of the claimed device:

Fig. 3

The term "compliance," while being a recognized term of art was expressly defined in the specification wherein "'compliance' refers to the ability of the cavities forming the compliance chambers 135 to absorb some of the pressure placed upon the fluid in the test chamber 106 and further to control recoil toward the original volume dimensions upon removal of the compressive force"; this definition was not disputed.

The basis for the District Court's denial of a preliminary injunction to BDC for failure to establish a likelihood of success on the merits was that the Disrtrict Court considered there to be a "substantial question" regarding infringement. This determination arose due to the "preliminary construction" of the term "excess volume area" to mean that the compliance chamber of the device was "separate and needs to be fluidly connected" to the remainder of the device (emphasis in opinion) (although there was some inconsistency regarding whether this construction was based on the plain meaning of the claim or on BDC's construction in an inter partes review of a related patent). Based on this construction the District Court held that the accused infringing article did not comprise an excess volume area. Moreover, Vivitro (according to the District Court) had asserted grounds for validity not rebutted by BDC (at least not sufficient to show that those assertions "lacked substantial merit"). These included assertions of an operating manual from a competitor (Dynatek) that anticipated (for claims 1, 2, 8 and 13), or in combination with a Chinese patent to Xi rendered obvious the entirety of BDC's asserted claims; these assertions were supported by an expert declaration and the disclosures of the art illustrated in the opinion:

Dynatek prior art:

FIGURE lA

The Federal Circuit affirmed, in an opinion by Judge Lourie joined by Judges Dyk and Stark. The opinion expressly sets forth the requirements for a plaintiff to obtain a preliminary injunction (and for which the plaintiff bears the burden to establish):

"(1) it is 'likely to succeed on the merits,' (2) it is 'likely to suffer irreparable harm in the absence of preliminary relief,' (3) the 'balance of equities tips in [its] favor,' and (4) 'an injunction is in the public interest,'" citing BlephEx, LLC v. Myco Indus., Inc., 24 F.4th 1391, 1398 (Fed. Cir. 2022) (quoting Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7, 20 (2008).

Although other than the first prong, these requirements were not discussed in the opinion. Failure to rebut a substantial question of non-infringement or invalidity precludes a plaintiff from obtaining an injunction under, inter alia, Genentech, Inc. v. Novo Nordisk, A/S, 108 F.3d 1361, 1364 (Fed. Cir. 1997). The standard on appeal is a showing by a rebuffed plaintiff that the district court had abused its discretion, a standard the panel opines BDC did not satisfy here. The panel rendered its decision on the invalidity issue and did not consider the District Court's non-infringement grounds for denying BDC its injunction.

Regarding invalidity, the opinion notes that the burden on the defendant is not to establish these grounds by clear and convincing evidence (and further noting that to prevail at trial the defendant would need to satisfy that standard). Rather to avoid a preliminary injunction a defendant must merely raise a question of "vulnerability" having a lower standard (albeit not expressly defined in the opinion). A district court's refusal to grant a preliminary injunction on this basis is reviewed by the Federal Circuit deferentially for clear error Rule 52(a) of the Federal Rules Civil Procedure.

On the merits of BDC's arguments on appeal, the Federal Circuit rejected the argument that the Dynatek reference did not anticipate claims 1, 2, 8 and 13 because "(1) its capacitance tank is in fluid communication with the distribution chamber, not the return chamber, (2) its capacitance tank cannot store test fluid when 'the test system fluid is under compression' because the test system as a whole is not under compression, and (3) its capacitance tank is not physically capable of 'operating at the accelerated pulsed rate.'" The panel distinguished BDC's arguments based on Vivitro's expert testimony to the contrary and the panel's appreciation of deficiencies in those arguments, such as questions regarding positioning of the test valve between the capacitance tank and the return chamber and BDC's failure to show how the District Court's assessment was erroneous (this interpretation being supported by the '935 specification itself). The Court also rejected BDC's arguments regarding Dynatek's failure to disclose that its test system was under pressure, on the grounds that BDC's claims required that the test system fluid, not the test system itself be under such pressure. Similarly, the panel rejected BDC's distinction that the Dynatek system could not "operate at the accelerated pulsed rate" wherein "the capacitance tank is designed to address only small variations in volume over longer periods of time and that the tube connecting the capacitance tank to the test system is, 'as a matter of ordinary physics,' too narrow to allow fluid to transfer back and forth at an accelerated rate" because these properties are not required by the plain language of the asserted claims.

Turning to the obviousness grounds for the District Court's decision, the Federal Circuit rejected BDC's assertions that the error was that "further briefing" was requested to support an obviousness determination based on the combination of the Dynatek and Xi references with a third reference BDC argued should have been included, because in the panel's opinion the evidence from the combination of Dynatek and Xi was sufficient. The Court further rejected BDC's arguments that it was an abuse of discretion for the District Court to find a sufficient question of obviousness had been raised by the combination of Dynatek and Xi alone, based on the same logic applied to BDC's arguments distinguishing its device from those disclosed in Dynatek and Xi. The Court also rejected BDC's arguments that the District Court had not established a motivation to combine the Dynatek and Xi teachings, stating that "simple substitution [of certain components] would result in a tester with fewer parts that would be easier for an end user to assemble, setup, and transport." Nor were BDCs "teaching away" arguments persuasive because those allegations did not "'criticize, discredit, or otherwise discourage' investigation into the invention claimed," citing for this standard DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009). Finally, regarding the "secondary considerations" of non-obviousness the opinion states that this argument was first raised in BDC's Reply brief, leaving Vivitro to argue at the oral hearing for the first time against these grounds of non-obviousness.

The opinion recognizes that neither claim construction nor validity (nor infringement) has been definitively decided yet and that the Court's decision here is expressly limited to BDC not being entitled to a preliminary injunction. Those remaining questions await trial.

* Claim 1 in its entirety reads:

1. A device for accelerated cyclic testing of a valved prosthetic device comprising
a pressure source configured to drive a test system fluid cyclically within the device above a normal physiological rate, at an accelerated pulsed rate of greater than 200 beats per minute within the device; and
a pressurizable test chamber for containing the test system fluid and further comprising
a fluid distribution chamber positioned on a first side of the valved prosthetic device and in fluid communication with the pressure source;
a fluid return chamber positioned on a second side of the valved prosthetic device;
a fluid return conduit both structurally and fluidly connecting the fluid distribution chamber to the fluid return chamber; and
an excess volume area capable of operating at the accelerated pulsed rate, wherein the excess volume area is in fluid communication with the fluid return chamber providing a volume for storing a volume of a test system fluid when the test system fluid is under compression.

Biomedical Device Consultants and Laboratories of Colorado, LLC v. Vivitro Labs, Inc. (Fed. Cir. 2024)
Nonprecedential disposition
Panel: Circuit Judges Lourie, Dyk, and Stark
Opinion by Circuit Judge Lourie

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