In a tour de force of issues related to the printed matter doctrine, the US Court of Appeals for the Federal Circuit reversed various rulings that the patents-in-suit were not infringed, not willfully infringed and invalid as directed to printed matter. Instead, the Court held that there was substantial evidence in the record to support a jury finding of infringement and willfulness, and that the asserted claims were not directed solely to printed matter and thus were patent eligible under 35 USC § 101 (thereby raising a genuine dispute of material fact that precludes summary judgment as to anticipation). C R Bard Inc. v. AngioDynamics, Inc., Case Nos. 19-1756, -1934 (Fed. Cir. Nov. 10, 2020) (Reyna, J.)

This dispute began when Bard sued AngioDynamics for infringing three patents directed to identifying a vascular access port that is suitable for power injection, which is a medical procedure requiring injecting fluids into a patient at a high pressure and flow rate. Generally, the identification was accomplished by certain markings on the vascular access port that can be detected during an x-ray scan.

Prior to trial, AngioDynamics moved for summary judgment on patent eligibility, novelty and enablement. This summary judgment motion was initially denied, but the district court sought a report and recommendation prior to trial regarding whether certain limitations relating to radiographic marker images were entitled to patentable weight under the printed matter doctrine. The magistrate judge concluded that the limitations were not entitled to patentable weight, and the district court adopted the recommendation. At trial and at the end of Bard’s case-in-chief, AngioDynamics moved for judgment as a matter of law (JMOL) on non-infringement and no willfulness. Ultimately, the district court terminated the trial and granted AngioDynamics’ JMOL motion for non-infringement and no willfulness. The district court further held that the claims were invalid because they were directed to printed matter and were not inventive. Bard appealed, challenging each of the district court’s findings.

In reversing the summary judgment of no infringement, the Federal Circuit explained that Bard’s expert’s reliance on an incorrect understanding of the district court’s claim construction was alone insufficient to grant judgment as a matter of law. Instead, the expert’s misunderstanding went to credibility, and the Court found the record reflected that the expert properly testified that the various claim elements were met under the proper claim constructions. The Court further explained that Bard did not have an affirmative duty to test AngioDynamics products, but rather was entitled to rely on AngioDynamics’ representations to the US Food and Drug Administration and to its customers. With regard to induced infringement, the Court explained that if an alleged infringer instructs its users to use the product in an infringing way, there is sufficient evidence for a jury to find infringement. Because the district count found no inducement based on its erroneous summary judgment of no infringement, that ruling was similarly reversed.

The Federal Circuit also reversed the district court on its summary judgment of no willfulness, concluding that Bard had presented sufficient evidence to support a willfulness verdict. For example, Bard introduced evidence that AngioDynamics had knowledge of the patent applications prior to issuance and that AngioDynamics intentionally copied Bard’s marker based on market demand. The Court explained that while the existence of an invalidity opinion of counsel (as was presented by AngioDynamics) is a relevant factor in a willfulness analysis, it is not determinative. Thus, the issue of whether there is sufficient evidence to establish willfulness is a question for the jury.

Finally, the Federal Circuit reversed the district court’s opinion that the asserted claims were invalid under § 101 as containing printed matter. Printed matter is any information claimed for its communicative context, and such printed matter is unpatentable unless it creates a new functionality in a claimed device or causes a specific action in a claimed process. Although printed matter has long been unpatentable, a claim (even one reciting elements that are printed matter) remains patent eligible if it is not “directed solely to non-functional printed matter” and has an inventive concept. Applying these principles, the Court found that although aspects of the claimed invention were not patentable, the claims as a whole were valid. The Court explained that because the focus of the claimed invention includes the means by which information is conveyed, the claims remain eligible:

We conclude that although the asserted claims contain printed matter that is not functionally related to the remaining elements of the claims, each claim as a whole is patent eligible because none are solely directed to the printed matter. We also conclude that when we assign no patentable weight to the claimed printed matter, material disputes of fact remain as to whether other elements of the claim are novel over the prior art.

As a result, the Court reversed the district court’s judgment and remanded to the district court.

Practice Note: This opinion further highlights that claims including recitations going to printed matter remain patentable under § 101 if the printed matter aspect of the claim is functional and does not merely display or manipulate information.