C R Bard Inc. v. AngioDynamics, Inc.

C R Bard Inc. v. AngioDynamics, Inc., No. 19-1756 (Fed. Cir. 2020) 

On November 10, 2020, the United States Court of Appeals for the Federal Circuit (CAFC) reversed a judgment of patent ineligibility under § 101 by the United States District Court for the District of Delaware. The lasting impact of this opinion is the articulation of a rule clarifying the relationship between the “printed matter” doctrine, and subject matter eligibility under Alice.

Background

Bard sued AngioDynamics for infringing three patents directed toward 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. Bard’s patents concerned identifiable features—such as a radiographic marker in the form of the letters “CT” etched in titanium foil on the device (visible during x-ray) that would reliably convey the power-injection capability of their vascular access ports to medical providers.

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, AngioDynamics moved for judgment as a matter of law on non-infringement and no willfulness. Ultimately, the district court terminated the trial and granted AngioDynamics’ judgment as matter of law motion for non-infringement and no willfulness. The district court further held that the claims were “invalid because they were directed to printed matter as ineligible subject matter and were not inventive.” Bard appealed to the Federal Circuit.

CAFC

The Federal Circuit began its analysis of the §101 issue by acknowledging that printed matter has long been held to fall outside the scope of patentable subject matter.  In particular, “printed matter encompasses any information claimed for its communicative content, and the doctrine prohibits patenting such printed matter unless it is functionally related to its substrate, which encompasses the structural elements of the claimed invention.  Thus, the main concern is whether “the printed matter merely informs people of the claimed information, or whether it instead interacts with the other elements of the claim to create a new functionality in a claimed device or to cause a specific action in a claimed process.” Here, Bard contended that “the information conveyed by the markers provides new functionality to the port because it makes the port self-identifying.”  The Court disagreed, stating that “mere identification of a device’s own functionality is sufficient to constitute new functionality for purposes of the printed matter doctrine” would eviscerate the doctrine.

The Federal Circuit explained that the “printed matter” doctrine had previously been applied to hold that specific limitations of a claim are not entitled to “patentable weight” for purposes of prior art invalidity, and that since the Supreme Court’s Alice decision regarding subject matter eligibility under § 101, the CAFC had not had the opportunity to directly address whether such a patent claim as a whole can be deemed patent ineligible under the two-step Alice framework. Indeed, the Federal Circuit formulated a rule indicating that a patent claim that contains printed matter can be evaluated for subject matter eligibility under Alice when the CAFC stated that a “claim may be found patent ineligible under § 101 on the grounds that it is directed solely to non-functional printed matter and the claim contains no additional inventive concept.” 

The Federal Circuit reasoned that the asserted claims recite a system or method for identifying a vascular access port as power injectable using multiple means for conveying the device’s functionality, including a radiographic marker. Furthermore, the Federal Circuit stated that when each claim is read as a whole, the focus is not solely on the content of the information conveyed, but also on the means by which that information is conveyed.  Specifically, the claimed invention is described as satisfying a specific need for easy vascular access during CT imaging. Specifically, it is the radiographic marker in the claimed invention that makes the claimed port particularly useful for that purpose because the marker allows the implanted device to be readily identified via x-ray. The Federal Circuit therefore held that the asserted claims are not patent ineligible under § 101 because the claims in their entireties are not solely directed to printed matter.

Takeaway

Through a muddling of the “printed matter” doctrine and Alice, the major takeaway is the affirmation 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.