IP Law Daily District court erred in finding C.R. Bard’s patents for power injection access ports were invalid and not infringed by competitor
Tuesday, November 10, 2020

District court erred in finding C.R. Bard’s patents for power injection access ports were invalid and not infringed by competitor

By Cheryl Beise, J.D.

Printed matter doctrine did not automatically strip claims of subject matter eligibility, and questions of fact precluded JMOL on other issues.

The federal district court in Wilmington, Delaware, erred in ruling as a matter of law that the asserted claims of three of C.R. Bard’s patents relating to "power injection" vascular access ports with radiographic markers were invalid and not infringed by AngioDymanics, the U.S. Court of Appeals for the Federal Circuit has held. The appeals court clarified that a claim that is directed solely to non-functional printed matter may be ineligible under 35 U.S.C. § 101 if the claim contains no additional inventive concept. However, in this case, the district court erred in finding that the asserted claims were patent ineligible under Section 101 because the claims in their entireties were not solely directed to printed matter. Moreover, there remained triable issues of fact as infringement, willful infringement, and whether the asserted claims were invalid as anticipated by prior art. The district court’s judgment was reversed-in-part, vacated-in-part, and remanded for further proceedings (C.R. Bard Inc. v. AngioDynamics, Inc., November 10, 2020, Reyna, J.).

C. R. Bard Inc. and Bard Peripheral Vascular, Inc. (collectively, "Bard") and AngioDynamics, Inc., are manufacturers of vascular access ports, which are devices implanted underneath a patient’s skin to inject fluid into the patient’s veins on a regular basis. Vascular access ports were traditionally used to administer injections at a low pressure and flow rate. Certain procedures, like computed tomography (CT) imaging, required injection of fluids into patients at a high pressure and high flow rate. This type of injection is referred to as "power injection."

Bard owns three patents relating to "power" injectable ports—U.S. Patent Nos. 8,475,417, 8,545,460, and 8,805,478. The patents have substantially similar written descriptions, and each of the claims requires the presence of a radiographic marker in the form of the letters "CT" etched in titanium foil on the device to identify the claimed port as power injectable. The ’417 and ’460 patents claim "assemblies" and "systems" for identifying a vascular access port as suitable for power injection. The ’478 patent claims methods for performing a power injection procedure that include identifying a vascular access port suitable for power injections and performing the power injection.

Bard obtained FDA approval for its new product and launched it under the brand name, PowerPort, as the first vascular access port labeled for power injection. Shortly after Bard obtained FDA approval, AngioDynamics sought and obtained FDA approval to market its own vascular access port products as suitable for power injection. The company added a radiographic "CT" marker to its later products.

Bard sued AngioDynamics in the District of Delaware, asserting that its power injectable vascular access port products infringed claims 5, 6, 12, and 13 of the ’417 patent; dependent claims 2 and 4 of the ’460 patent; and claims 3, 5, 9, and 11 of the ’478 patent. AngioDynamics moved to dismiss the complaint on the ground that all claims of the patents-in-suit were ineligible under Section 101. The district court denied the motion as premature. At the close of Bard’s case-in-chief, AngioDynamics moved for judgment as a matter of law (JMOL) of non-infringement and no willfulness. In response to the motion, the court, sua sponte, asked the parties whether the issue of "patent eligibility and printed matter" was also ripe for decision. The court terminated the trial, indicating that it would grant JMOL on willfulness and ineligibility. The court issued a written opinion granting AngioDynamics’s motion for JMOL of noninfringement and no willful infringement. In its opinion, the court also stated that the asserted claims were invalid because they were directed to printed matter as ineligible subject matter and were not inventive.

Bard appealed the judgments of non-infringement, no willfulness, and invalidity, including ineligibility under Section 101.

Infringement. The district court granted JMOL of non-infringement on each of the three grounds raised by AngioDynamics: (1) that Bard’s expert, Dr. Clark, failed to apply the court’s claim construction for the terms "vascular access port" and "access port" in rendering his opinion; (2) that Bard failed to show that the accused Xcela product met the claimed flow rate requirements because Bard had relied only on AngioDynamics’s statements to the FDA regarding the product’s capabilities; and (3) that Bard’s evidence did not show that a single entity performed all claim steps of the asserted method claims of the ’478 patent.

The Federal Circuit determined that the district court erred in granting JMOL. First, while Dr. Clark testified during cross-examination that he believed there was an intent requirement "implied" in the court’s construction of the "access port" terms as "structured for power injection," this mistake did not undermine the factual basis of his infringement opinion, the court said. During his direct testimony, Dr. Clark testified that each of the accused ports were suitable for power injection based on evidence that they were structurally capable of withstanding the pressures and flow rates used during such injections. This testimony did not rest on any conclusion that the devices were intended for such use. Although this mistake might undermine his credibility, it did not make his testimony legally insufficient to support an infringement verdict, the court said.

Second, although Bard did not conduct its own tests of the Xcela port’s suitability for power injection, Bard was entitled to rely on AngioDynamics’s representations to its customers and to the FDA that the Xcela port was suitable for power injection at the flow rate and pressure required by the claims. The weight assigned to that evidence was a question for the jury.

Third, even if Bard did not present direct evidence of specific instances in which an entity performed each of the claimed steps of the ’478 patent, there was sufficient circumstantial evidence in the record to support AngioDynamics’s induced infringement of the method claims. Dr. Clark testified that, in his professional experience, (1) the steps of scanning, identifying, and injecting, as required by the asserted method claims, were generally performed by a single CT technician, and (2) the implantation of the port were typically performed by another medical provider at the same hospital, who would be acting as part of the same "entity" as the medical providers performing the other claim steps. Dr. Clark also pointed to instructional materials provided by AngioDynamics that directed medical providers to perform each step of the claimed methods.

Willful infringement. The district court granted judgment of no willful infringement. However, Bard introduced evidence at trial that AngioDynamics’s Director of Intellectual Property was aware of the applications that issued as the patents-in-suit prior to their issuance. Bard also introduced evidence that AngioDynamics intentionally copied Bard’s CT radiographic marker based on market demand. This evidence was sufficient to support a jury verdict of willfulness, according to the Federal Circuit. Moreover, the separate question of whether AngioDynamics reasonably believed that the asserted claims were invalid was a question of fact for the jury.

Invalidity. In its final order, the district court granted both summary judgment and JMOL that the patents were invalid and patent ineligible, without specifying the statutory grounds for invalidity. At the time the motions were granted, AngioDynamics had not yet presented its invalidity case at trial and Bard had not had the opportunity to defend the validity of its asserted claims. The Federal Circuit determined the district court’s JMOL of invalidity was procedurally improper because Rule 50 provides that JMOL against a party is only appropriate once the party "has been fully heard on an issue." Fed. R. Civ. P. 50.

Printed matter doctrine. Turning to the merits, the Federal Circuit reviewed the court’s invalidity judgment only as to eligibility and anticipation, both of which implicated the printed matter doctrine. It has long been recognized that certain "printed matter" (including any communicative information) falls outside the scope of patentable subject matter under U.S. patent law. The parties agreed that the asserted claims included printed matter, but disagreed whether the printed matter was functionally related to the power injectable port, as recited in all the asserted claims, or to the step of performing a power injection, as recited in the method claims.

Subject matter eligibilityof printed matter. Although the underlying rationale of the printed matter doctrine lies in the requirements of subject matter eligibility under Section 101, the Federal Circuit explained that its case law has typically applied the doctrine to hold that specific limitations of a claim are not entitled to patentable weight for purposes of novelty under Section 102 and non-obviousness under Section 103. In addition, since the Supreme Court articulated its two-step framework in Alice, the Federal Circuit noted that it has "not directly addressed whether a patent claim as a whole can be deemed patent ineligible on the grounds that it is directed to printed matter at step one and contains no additional inventive concept at step two." The appeals court took this opportunity to clarify that "a claim may be found patent ineligible under Section 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 next turned to the claims at issue. In concluding that the asserted claims could not be directed to the claimed means for identifying functionality, the district court accepted AngioDynamics’s assertion that all the claimed forms of identification, including radiographic marking, were routine and conventional in the art, and thus could not constitute the patentable focus of the claims. The Federal Circuit took issue with this conclusion. Even if the sole focus of the claimed advance was the printed matter, the court pointed out that AngioDynamics’s evidence was not sufficient to establish as a matter of law, at Alice step two, that the use of a radiographic marker, in the "ordered combination" of elements claimed, was not an inventive concept. "Even if the prior art asserted by AngioDynamics demonstrated that it would have been obvious to combine radiographic marking with the other claim elements, that evidence does not establish that radiographic marking was routine and conventional under Alice step two," the court said.

The district court further found the method claims were patent ineligible on the ground they contained no more than a recitation of the standards of medical care required after the FDA warned doctors about power injection through vascular access ports. This too was erroneous because while the FDA directed medical providers to verify a port’s suitability for power injection before using a port for that purpose, it did not require doing so via imaging of a radiographic marker, the Federal Circuit said. Moreover, there was no evidence in the record that such a step was routinely conducted in the prior art.

The Federal Circuit concluded that the asserted claims were not patent ineligible under Section 101 because the claims in their entireties were not solely directed to printed matter.

Anticipation. In evaluating the novelty and non-obviousness of claims, the Federal Circuit reiterated that no patentable weight is to be assigned to the nonfunctional printed matter in the claims, i.e., the information that the claimed access ports were suitable for injection at the claimed pressure and flow rate.

Bard presented largely undisputed evidence that certain prior art ports, and the use of those ports, satisfied most of the remaining elements of the asserted claims, including power injectability and the presence of external identifiers. However, there remained a factual dispute over whether any of the prior art access ports contained a "radiographic marker" or "radiographic feature" as required by the asserted claims. For example, AngioDynamics pointed to certain features of two prior art ports, the ATP and Port-a-Cath, that may be detectable via x-ray. This conflicting evidence created a genuine dispute of material fact as to the novelty of the asserted claims, the court said. Thus, the district court erred to the extent it granted summary judgment of invalidity based on anticipation under Section 102.

Conclusion. The Federal Circuit held that there was substantial evidence in the record to support a jury finding of infringement and willfulness; that the asserted claims were not directed solely to printed matter, and thus are patent eligible under 35 U.S.C. § 101; and that a genuine dispute of material fact precluded summary judgment as to anticipation. Because there remained triable issues of fact as to the infringement and validity of the asserted claims, the district court erred in not permitting Bard to fully present its case at trial.

The appeals court reversed-in-part the district court’s judgment of invalidity as it pertained to ineligibility under Section 101, vacated-in-part the court’s judgment of invalidity as to all other grounds, vacated the judgment of non-infringement and no willful infringement, and remanded the case for further proceedings consistent with its opinion.

This case is Nos. 19-1756 and 19-1934.

Attorneys: Deanne Maynard (Morrison & Foerster LLP) for C.R. Bard Inc. and Bard Peripheral Vascular, Inc. Danielle Vincenti Tully (Cadwalader, Wickersham & Taft LLP) for AngioDynamics, Inc.

Companies: C. R. Bard Inc.; Bard Peripheral Vascular, Inc.; Angiodynamics, Inc.

MainStory: TopStory Patent GCNNews FedCirNews

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