C R Bard Inc. v. AngioDynamics, Inc.
| Decision Date | 10 November 2020 |
| Docket Number | 2019-1756, 2019-1934 |
| Citation | 979 F.3d 1372 |
| Parties | C R BARD INC., Bard Peripheral Vascular, Inc., Plaintiffs-Appellants v. ANGIODYNAMICS, INC., Defendant-Appellee |
| Court | U.S. Court of Appeals — Federal Circuit |
Deanne Maynard, Morrison & Foerster LLP, Washington, DC, argued for plaintiffs-appellants. Also represented by Seth W. Lloyd, Brian Robert Matsui ; Vincent Joseph Belusko, Dylan James Raife, Los Angeles, CA.
Danielle Vincenti Tully, Cadwalader, Wickersham & Taft LLP, New York, NY, argued for defendant-appellee. Also represented by Jaclyn Hall, Christopher A. Hughes, John Moehringer, Michael Brian Powell.
Before Reyna, Schall, and Stoll, Circuit Judges.
The appellants, manufacturers of implantable medical devices for intravascular injections, sued their competitor for patent infringement. Partway through the jury trial, the district court granted judgment that the asserted claims were not infringed, were not willfully infringed, and were invalid as directed to printed matter. We hold that there was substantial evidence in the record to support a jury finding of infringement and willfulness. We also hold that the asserted claims are 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 precludes summary judgment as to anticipation. Thus, we reverse-in-part and vacate-in-part the district court's judgments and remand for further proceedings.
The appellants, C. R. Bard Inc. and Bard Peripheral Vascular, Inc. (collectively, "Bard"), and the appellee, AngioDynamics, Inc., are manufacturers of vascular access ports, which are devices implanted underneath a patient's skin that allow medical providers to inject fluid into the patient's veins on a regular basis without needing to start an intravenous line each time. Vascular access ports were traditionally used to administer injections at a low pressure and flow rate. However, 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." As of 2005, vascular access ports were not specifically approved by the FDA for use with power injection. Nonetheless, certain medical providers were using existing ports for power injection, and in some cases, the pressure of the injection ruptured the port, seriously injuring the patient. In light of these reported cases, the FDA cautioned medical providers in 2004 and 2005 that they should not use vascular access ports for power injection unless the ports were specifically and identifiably labeled for such use. J.A. 31850–51, 32089.
At the time, Bard's commercially marketed vascular port product was already structurally suitable for power injection, although it had not been approved for such use. Around the time of the FDA warnings, Bard confirmed the power injection capability of its product and proceeded to develop identifiable features that would reliably convey that capability to medical providers after the port was implanted. The primary identifying feature Bard developed was a radiographic marker in the form of the letters "CT" etched in titanium foil on the device. This marker could be detected during an x-ray scan such as the "scout scan" typically performed at the start of a CT procedure. Other identifiers incorporated into the device included a triangular shape and small bumps that were palpable through the skin. Bard also included identifiers with its product that were separate from the device itself, such as labeling on the device packaging and small items to be carried by the patient or kept in the patient's medical records (i.e. a keychain, wristband, or sticker). 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.
Bard also filed patent applications claiming its strategies for identifying a power injectable port. These applications eventually issued as the patents-in-suit in this case, 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 require the presence of a radiographic marker identifying 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. Bard asserted claims 5, 6, 12, and 13 of the ’417 patent, which each depend from either claim 1 or claim 8; and dependent claims 2 and 4 of the ’460 patent, which depend from claim 1. Claim 1 of the ’417 patent is illustrative of these claims:
’417 patent col. 30 l. 51–col. 31 l. 6. The asserted dependent claims of the ’417 and ’460 patents further require that the radiographic marker be in the form of radiographic letters or other symbols, patterns, or characters, and that the extrinsic identifier include one or more of a key chain, a bracelet, a wrist band, a sticker provided on a patient's chart, a patient ID card, or a label provided on the product packaging.
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 asserted claims 3, 5, 9, and 11 of the ’478 patent, which each depend from either claim 1 or claim 8. Claim 8 is illustrative of the method claims:
’478 patent col. 31 ll. 41–56. The asserted dependent claims of the ’478 patent contain additional limitations concerning the radiographic feature and external features that are analogous to those in the asserted dependent claims of the ’417 and ’460 patents.
Not long after Bard obtained FDA approval for its PowerPort product, AngioDynamics sought and obtained FDA approval to market its own vascular access port products as suitable for power injection. While its initial power injection product did not include any features intrinsic to the device that identified its functionality, the company added identifiers such as a scalloped shape and a radiographic "CT" marker to its later products for easier identification. These new products were sold under the brand names Smart Port CP, Smart Port LP, Smart Port mini, Xcela, Xcela Plus, and BioFlo.
Bard sued AngioDynamics in the District of Delaware, asserting that AngioDynamics's power injectable vascular access port products infringed the ’417, ’460, and ’478 patent claims. AngioDynamics moved to dismiss the complaint on the ground that all claims of the patents-in-suit were ineligible under § 101. The district court denied the motion as premature. C. R. Bard, Inc. v. Angiodynamics, Inc. , 156 F. Supp. 3d 540, 554 (D. Del. 2016). The parties later cross-moved for summary judgment on the questions of patent eligibility, novelty, and enablement. Judge Bataillon concluded that factual disputes remained on all issues and denied the motions without prejudice. C R Bard, Inc. v. AngioDynamics Inc. , No. 1:15CV218, 2018 WL 3130622, at *12–13 (D. Del. June 26, 2018)
In advance of trial, the court requested a report and recommendation from Magistrate Judge Fallon on certain remaining claim construction issues, including whether the "radiographic letters" and "visually perceptible information" limitations were entitled to patentable weight under the printed matter doctrine.1 Judge Fallon determined that these limitations were not entitled to patentable weight because they were directed to the content of information that was not "functionally or structurally related" to the claimed ports. Bard Peripheral Vascular, Inc. v. AngioDynamics, Inc. , No. CV 15-218-JFB-SRF, 2019 WL 1996022, at *3–6 (D. Del. Feb. 11, 2019). The district court adopted the recommendation.
The parties proceeded to trial. Bard presented its case on infringement, willfulness, and damages through live testimony from a named inventor, infringement expert Timothy Clark, M.D., and a...
To continue reading
Request your trial
-
Longhorn Vaccines & Diagnostics, LLC v. Spectrum Solutions LLC
...contrary were all decided before Bayer and, thus, are unpersuasive in light of its holding.138 See, e.g. , C R Bard Inc. v. AngioDynamics, Inc. , 979 F.3d 1372, 1380 (Fed. Cir. 2020) ; Polara Eng'g Inc. v. Campbell Co. , 894 F.3d 1339, 1354 (Fed. Cir. 2018) ; Arctic Cat Inc. v. Bombardier R......
-
PureWick Corp. v. Sage Prods.
...AngioDynamics, Inc., 979 F.3d 1372, 1379 (Fed. Cir. 2020). This is true “even when there is no direct evidence of a specific person doing so.” Id. Here, evidence at showed that Defendant has sold thousands of PrimaFit products to hospitals since the '989 patent issued. (DTX-199). Defendant ......
-
Ex parte Lyren
...to create a new functionality in a claimed device or to cause a specific action in a claimed process. CR Bard Inc. v. AngioDynamics, 979 F.3d 1372, 1381 (Fed. Cir. 2020) (citing Praxair, 890 F.3d at 1032; Distefano, 808 F.3d at 849). The court has said that once it is determined that the li......
-
Ex parte Klemm
..."simply adding new instructions to a known product" does not create a functional relationship. C R Bard Inc. v. Angio Dynamics, Inc., 979 F.3d 1372, 1382 (Fed. Cir. 2020) (citation omitted). However, we cannot make this determination because it is unclear what is being claimed by "a prompt ......