“The CAFC stated that ‘[a] conclusion that mere identification of a device’s own functionality is sufficient to constitute new functionality for purposes of the printed matter doctrine would eviscerate our established case law that ‘simply adding new instructions to a known product’ does not create a functional relationship.’”
On November 10, the U.S. Court of Appeals for the Federal Circuit reversed-in-part and vacated-in-part a decision of the U.S. District Court for the District of Delaware in C R Bard Inc. v. Angiodynamics, Inc. In particular, the CAFC held that 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 were patent eligible under 35 U.S.C. § 101.
District Court Eligibility Analysis
C. R. Bard Inc. and Bard Peripheral Vascular, Inc. (collectively, Bard) filed suit against AngioDynamics, Inc. for alleged infringement of Bard’s U.S. Patent Nos. 8,475,417, 8,545,460, and 8,805,478, each of which include claims requiring the presence of a radiographic marker identifying a port as power injectable. AngioDynamics moved to dismiss the complaint on the ground that all claims of the patents-in-suit were ineligible under Section 101, but the district court denied AngioDynamic’s motion as premature. Subsequently, the parties cross-moved for summary judgment on the questions of patent eligibility, novelty, and enablement and the district court concluded that factual disputes remained on all issues and, therefore, denied the motions without prejudice.
Following a trial, the district court issued a written opinion granting AngioDynamics’s motion for judgment as a matter of law (JMOL) of non-infringement and no willful infringement. 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 to the CAFC.
Federal Circuit Review of Infringement and Invalidity
In concluding that the district court erred in granting JMOL of non-infringement in favor of AngioDynamics, the CAFC rebutted each of three reasons relied upon by the district court in granting JMOL. First, the CAFC explained that although Dr. Clark, an infringement expert, “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 CAFC also explained that the district court erroneously relied on a statement in Wiener v. NEC Electronics, Inc. that an expert’s infringement testimony did not “create a factual dispute” when the opinion “rest[ed] on an incorrect claim interpretation.” The CAFC stated that “even if Dr. Clark assumed that the claims required an additional intent element, nothing in the record suggested that this caused him to disregard the requirements of the asserted claims under the correct construction” and did not make his testimony legally insufficient to support an infringement verdict. Thus, the CAFC concluded that the district court thus erred in granting JMOL on this basis.
In rebutting a second reason relied upon by the district court, the CAFC explained that “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 CAFC noted that the district court nor AngioDynamics provided any reason for why direct testing evidence was required as a matter of law to establish infringement under these circumstances and further noted that the weight assigned to the evidence was question for the jury.
The CAFC also addressed the third reason relied upon by the CAFC in granting JMOL of non-infringement, noting that “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.” Thus, the CAFC concluded that the district court erred in granting JMOL of non-infringement as to each of the asserted claims.
The CAFC explained that the district court granted judgment of no willful infringement based on its conclusion that Bard failed to show infringement or, alternatively, because “Bard failed to meet its burden as to willfulness because AngioDynamics had obtained written opinions of counsel regarding the invalidity of the asserted claims of the patents-in-suit, and Bard had failed to show that the opinions were ‘drafted by a bad law firm’ or put forth other evidence of willfulness.” The CAFC disagreed with the district court, noting that Bard’s evidence that AngioDynamic’s Director of Intellectual Property knew of applications that resulted in the patents-in-suit and that AngioDynamics intentionally copied Bard’s CT radiographic marker was sufficient evidence to support a jury verdict of willfulness.
Printed Matter and Validity
Citing AstraZeneca LP v. Apotex, Inc., the CAFC noted courts have long recognized that certain “printed matter” falls outside the scope of patentable subject matter. The CAFC also noted that “[t]oday, 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.” The CAFC explained that the existence of a functional relationship is determined by considering 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 disagreed with Bard that the claimed printed matter, i.e. markers “identifying” or “confirming” that the implanted access port is “suitable” either “for flowing fluid at a rate of at least 1 milliliter per second through the access port” or “for accommodating a pressure within the cavity of at least 35 psi,” provided new functionality to the port because it makes the port “self-identifying.” The CAFC stated that “[a] conclusion that mere identification of a device’s own functionality is sufficient to constitute new functionality for purposes of the printed matter doctrine would eviscerate our established case law that ‘simply adding new instructions to a known product’ does not create a functional relationship.” Thus, the CAFC held that the content of the information conveyed by the claimed markers, i.e. that the claimed access ports are suitable for injection at the claimed pressure and flow rate, was printed matter that was not entitled to patentable weight.
Subject Matter Eligibility
The CAFC held 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.” Noting that the 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, the CAFC explained that the claimed advance was not solely on the content of the information conveyed, but also on the means by which that information is conveyed.
The CAFC also noted that even if the prior art asserted by AngioDynamics demonstrated that it would have been obvious to combine radiographic marking with the other claim elements, the evidence did not establish that radiographic marking was routine and conventional under Alice step two. Thus, the CAFC concluded that the claims were not patent ineligible under § 101 because the claims were “not solely directed to printed matter.”
The CAFC concluded by stating that “[b]ecause 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.” Thus, the CAFC reversed-in-part the district court’s judgment of invalidity with respect 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 the opinion.