C.R. Bard Inc. v. AngioDynamics, Inc., Appeal No. 2019-1756, -1934 (Fed. Cir. Nov. 10, 2020)

Our Case of the Week is one of two cases decided this week in which the Federal Circuit finds that a district court jumped the gun on granting judgment where there were genuine disputes of material fact to be tried. In the Ferring case, discussed below, the court granted summary judgment concerning equitable estoppel. In the C.R. Bard case, the case got halfway through trial before the judge issued judgment as a matter of law of noninfringement. A Federal Circuit panel remanded the case for retrial, issuing a precedential decision on the "printed matter" doctrine, and finding there was sufficient evidence of infringement and willfulness to present the questions to a jury.

The patents at issue concern vascular access ports—ports implanted in a patient to allow a medical provider to inject fluids into the patient's veins. Certain procedures required the use of high pressure, high flow rate injections (called "power injections"), and vascular access ports on the market sometimes ruptured during such procedures. The FDA cautioned against the use of power injections to vascular access ports unless the port was specifically and identifiably labeled for such use.

C.R. Bard had been selling a vascular access port that was structurally suitable for power injections. It invented a way of identifying that fact for medical providers—it etched the letters "CT" on the device in titanium foil, so it would be picked up in an x-ray scan. It also developed a triangular shape and small bumps that could be felt through the skin—and it identified the product capabilities on package labeling. It was first to obtain FDA approval for its new product. It also filed patent applications, claiming the presence of a radiographic marker identifying the port as power injectable.

AngioDynamics launched a competing access port, which included the radiographic marker "CT." Bard sued, and the case proceeded to trial. Following the presentation of Bard's case in chief, AngioDynamics moved for judgment as a matter of law, arguing that the evidence was insufficient to support a finding of infringement. AngioDynamics also argued that it could not be liable for willfulness because it had received invalidity opinions from counsel. During argument, the Court sua sponte asked whether the issue of patent eligibility and the printed matter doctrine was ripe for determination, and then issued judgment that the claims were invalid because they were directed to printed matter and where thus addressed to ineligible subject matter.

The Federal Circuit reversed. First, on each of the three bases of alleged insufficient evidence, the Federal Circuit held that the evidence was sufficient to support a finding of infringement. For example, AngioDynamics argued that Bard failed to prove that the accused products met certain flow rate and pressure requirements. But the Federal Circuit held that AngioDynamics' own representations to its customers constituted sufficient evidence. The Court also held that direct evidence that someone had practiced the method claims was unnecessary—the circumstantial evidence of AngioDynamics' instructions to users was sufficient evidence of infringement.

Regarding willful infringement, the Court held that the mere presence of invalidity opinions was not dispositive of willfulness, particularly when AngioDynamics was aware of the patents and copied the technology.

The Court then addressed the printed matter issue, noting, at first, that the district court erred by granting JMOL of invalidity at trial before the defendant had introduced any evidence. The Court thus reverted back to the summary judgment briefing on invalidity, and relied on the evidence of record at that stage in the case on appeal.

The first question the Court addressed was whether the radiographic markers claimed in the patent were entitled patentable weight. The Court revisited the "printed matter" doctrine, summarizing that it encompasses "any information claimed for its communicative content" and that it "prohibits patenting such printed matter unless it is 'functionally related' to its 'substrate,' which encompasses the structural elements of the claimed invention." After surveying the case law, the Court held that the radiographic markers in this case were not functionally related to the substrate, and were therefore entitled to no patentable weight.

The Court then broke new ground in deciding that claims directed to printed matter can be determined under the two-step framework set forth in Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208 (2014). In the past, the printed matter doctrine often has been invoked in a Section 102 or 103 analysis—i.e., if the claim has printed matter that is entitled to no patentable weight, the claim is then assessed for invalidity based on what remains of the claim under Sections 102 or 103. In this case, the Court held that when a claim is directed to printed matter, and it is determined that the printed matter is entitled to no patentable weight, the court may then proceed under a Section 101 assessment of whether the claims are eligible for patenting. Thus, the court may consider whether the entire claim is directed to the printed matter, or whether what remains of the claim includes an "inventive concept."

With that framework, the Court held that the claims in this patent were not ineligible for patenting. The Court held that even with the printed matter excised from the patent, there was an inventive concept.

Finally, the Court held that the claims were not anticipated over the prior art, based on the art of record at the summary judgment stage.

The Court remanded the case for trial on the issues of infringement, invalidity, and willfulness.

The opinion can be found here.

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