Patent Eligibility of Claims Directed to Printed Matter: Clarification or Confusion?
In C R Bard Inc. v. AngioDynamics, Inc., the U.S. Court of Appeals for the Federal Circuit (“CAFC”) held for the first time 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,” combining the traditional “printed matter” doctrine of patent ineligibility with the modern Alice analytical framework, potentially sowing even more confusion in the area of patent-eligible subject matter under 35 U.S.C. section 101.
The U.S. Food & Drug Administration 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. C.R. Bard proceeded to develop such specifically and identifiably labeled vascular access ports, and obtained patents on the ports. In 2015, Bard sued AngioDynamics for infringement of its patents claiming vascular access ports suited for use with a power injector employed to inject contrast media at high pressure into a peripherally inserted intravenous (IV) line for proper imaging of a vascular system via computed tomography. Bard’s access ports include, among other indicia, a radiographic marker in the form of the letters “CT” etched in titanium foil on the device, so that it may be observed by conventional radiographic imaging techniques. Soon after Bard introduced its access ports, AngioDynamics started to sell competing ports also provided with a radiographic “CT” marker, in response to market demand, with knowledge of Bard’s patents.
During the trial before a jury in the U.S. District Court for the District of Delaware, and after Bard presented its opening case-in-chief, the court terminated the trial and granted judgment as a matter of law (JMOL) and summary judgment for the defendant on several grounds. This article concerns the court’s entry of judgment that Bard’s asserted patent claims were invalid as being directed to patent-ineligible subject matter, namely, printed matter.
Printed matter has long been held to fall outside the scope of patentable subject matter; this is not a controversial proposition of law. “Printed matter” encompasses any information claimed for its communicative content, and the “printed matter doctrine” has prohibited patenting such printed matter since before enactment of the modern Patent Act in 1952, unless it is functionally related to its substrate, which encompasses the structural elements of the claimed invention. Thus, the main concern is, and has for over 80 years, been 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."
There is no indication or suggestion that the U.S. Supreme Court meant to abrogate, modify, or replace the traditional printed matter doctrine with any other rubric when it addressed the legal analysis for deciding patent eligible subject matter in Alice Corp. v. CLS Bank (“Alice”).[1] It is thus not surprising that the CAFC had not previously discussed the relationship between the printed matter doctrine and Alice and its progeny. As the Court of Appeals recognized, “since the Supreme Court articulated its two-step framework in Alice, this court 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.”
However, it is far from clear that any such relationship is required or necessary. Nonetheless, the CAFC has decided that the two doctrines are indeed related. The tenuous premise offered is that the court had previously held, in applying Alice, that “the mere conveyance of information that does not improve the functioning of the claimed technology is not patent-eligible subject matter under § 101.”
Turning to the C.R. Bard decision, first the CAFC held that the content of the information conveyed by the claimed radiographic markers constitutes printed matter and is therefore not entitled to “patentable weight.” This finding allows a court to disregard the printed matter, as such, when determining patentability under the sections of the statute relating to novelty (Section 102) and non-obviousness (Section 103).
Next, the CAFC purported to apply the Alice two-step framework to rule on “printed matter” ineligibility. While the court seems to have hinted that printed matter is a category or subset of the “abstract idea” category of judicial exceptions to patentable subject matter, this is never explicitly stated in the decision. Consequently, the CAFC did not explain how or why the radiographic “CT” marker formed by etching a titanium film is an abstract idea at Alice step one; this conclusion appears to be assumed. Thus, it is not entirely clear why resort to Alice step 2 is necessary.
More importantly, the CAFC does not explain why the traditional printed matter doctrine is insufficient for resolution of the case, one way or the other. There is no discussion whatsoever of any perceived inconsistency between the printed matter doctrine and Alice, or whether in or by Alice the Supreme Court somehow implicitly overruled scores of years of judicial precedent relating to the printed matter doctrine. In fact, the CAFC found that "the focus of the claimed advance is not solely on the content of the information conveyed, but also on the means by which that information is conveyed." Bard’s patent claims were acknowledged as addressing "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.” Why this is not easily sufficient to dispose of AngioDynamics’s printed matter invalidity challenge is a mystery.
Nevertheless, the CAFC decided that AngioDynamics’s evidence did not establish that radiographic marking of vascular access ports is “routine and conventional” under Alice step 2, and thus the “claims are not directed solely to printed matter, and thus are patent eligible under § 101.” This holding is at least somewhat surprising (especially to AngioDynamics) in light of the procedural circumstance that the Delaware trial court had terminated the trial before AngioDynamics had presented its defenses, including its defense of patent ineligible subject matter, to the jury.
Whether the CAFC has clarified any aspect of the law regarding Section 101 patent eligibility, or has merely sown even more confusion, will be seen in future decisions by trial courts and the CAFC, as well.
