On November 10, 2020, the United States Court of Appeals for the Federal Circuit (“CAFC”) issued an opinion reversing-in-part the invalidity judgment of the United States District Court for the District of Delaware, as it pertained to patent eligibility, and vacating its remaining infringement, willfulness, and prior art invalidity findings. C.R. Bard Inc. et al. v. Angiodynamics, Inc., __ F.3d __ (Fed. Cir. Nov. 10, 2020).

The import of this CAFC opinion is the articulation of a rule clarifying the relationship between the “printed matter” doctrine, on the one hand, and subject matter eligibility under the Supreme Court’s two-step framework set forth in Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208 (2014), on the other.

The underlying subject matter at issue has to do with vascular access ports, which are medical devices implanted underneath a patient’s skin that allow nurses (or other medical providers) to inject fluid into the patient’s veins on a regular basis without needing to start an intravenous line each time. While vascular access ports were well-known and had traditionally been used to administer injections at low pressure and flow rates, the patents-at-issue are directed to vascular access ports used for “power injections” (i.e., injections that require a high pressure and high flow rates) employed during certain medical procedures such as CT imaging. In response to certain mishaps—in which unsuitable vascular access ports ruptured when they were used for power injections—the FDA cautioned medical providers that, when performing a procedure that required a power injection, medical providers were only to use vascular access ports that were “specifically and identifiably labelled for power injections.”

Prior to the FDA’s warning, Appellants had been manufacturing vascular access ports that were suitable for power injections (but not labelled as such), and, thus, in order to comply with the FDA’s guidance, Appellants developed, and were granted patents on, identifiable features—such as a radiographic marker in the form of the letters “CT” etched in titanium foil on the device (viewable via x-ray, for example)—that would reliably convey the power-injection capability of their vascular access ports to medical providers.

Appellee subsequently sought and obtained FDA approval to market as suitable for power injection its own competing vascular access ports. Appellee’s competing products included similar identifiers such as a scalloped shape and a radiographic “CT” marker.

Appellants sued Appellee for patent infringement in district court on three patents, each of which includes claims requiring the presence of a radiographic marker identifying the claimed vascular access port as “power injectable.” The district court terminated the trial after granting Appellee’s motion for judgment as a matter of law (“JMOL”) of non-infringement and no willful infringement, and subsequently issued a written opinion to that effect. The written opinion also included an invalidity judgment, holding the asserted claims invalid on the grounds that the claims are directed to “printed matter as ineligible subject matter” and are not inventive.

With respect to the district court’s infringement and willfulness decisions, the CAFC found that the district court improperly usurped the role of the jury in assigning weight to the disputed evidence, and therefore vacated the district court’s JMOL findings. The CAFC also vacated the district court’s prior art invalidity finding, explaining that there was conflicting evidence as to whether any of the prior art access ports contained the claimed “radiographic marker” (or “radiographic feature”).

With respect to the more interesting issue in this appeal—regarding subject matter eligibility and the “printed matter” doctrine—the CAFC first explained that “printed matter encompasses any information claimed for its communicative content” and that the printed matter doctrine prohibits patenting such printed matter unless it is “‘functionally related’ to its ‘substrate,’ which encompasses the structural elements of the claimed invention.” The CAFC explained that “[i]n evaluating the existence of a functional relationship, [a court is to] consider[] 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.”

The CAFC explained that, here, the asserted claims include “printed matter,” as each claim requires one or more markers “identifying” or “confirming” that the implanted vascular access port is suitable for high pressure and/or high flow rate, and that these elements are directed to the content of the information conveyed. The CAFC rejected Appellants’ argument that this printed matter is functionally related to the power injectable port (or the method of performing a power injection, in the case of the method claims), and therefore found that the content of the information conveyed by the claimed markers is “printed matter” not entitled to patentable weight.

The CAFC explained that heretofore the “printed matter” doctrine had been applied to hold that specific limitations of a claim are not entitled to “patentable weight” for purposes of, e.g., 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. The CAFC—apparently indicating that a patent claim that contains “printed matter” indeed can be evaluated for subject matter eligibility under Alice—articulated the following rule: “[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.”

Applying that rule, the CAFC explained that the asserted claims recite an assembly, system, or method for identifying a vascular access port as power injectable using multiple means for conveying the device’s functionality, including, specifically, a radiographic marker, and that when each claim is read as a whole, the focus of the claimed advance is importantly 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—and 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 and reliably identified via x-ray, as used during CT imaging. The CAFC 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.