The Federal Circuit Reinforces the Breadth of the Printed Matter Doctrine

Over the past decade, the “printed matter doctrine” has rarely been invoked in life sciences cases, but recently on Nov. 10, the Federal Circuit issued a decision in C R Bard Inc. et al. v. Angiodynamics, Inc., No. 2019-1756, 2019-1934, 2020 WL 6573331 (Fed. Cir. Nov. 10, 2020), where it reviewed the applicability of the printed matter doctrine in the context of patent eligibility under 35 U.S.C. §101 and anticipation under 35 U.S.C. §102. In CR Bard, the Federal Circuit found the asserted patent claims eligible as they were not solely directed to printed matter, and remanded other issues to the district court. Id. at *9.

Historically, the printed matter doctrine was invoked to preclude patenting of the mere arrangement of printed lines or characters, and has its origins in the context of patenting of business forms. See Praxair Distribution, Inc. v. Mallinckrodt Hospital Products IP Ltd., 890 F.3d 1024, 1038 (Fed. Cir. 2018) (“The mere arrangement of printed matter on a sheet or sheets of paper, in book form or otherwise, does not constitute any new and useful art, machine, manufacture, or composition of matter or any new and useful improvements thereof”) (citing In re Russell, 48 F.2d 668, 669 (CCPA 1931)). Ten years ago, the Federal Circuit held that the printed matter doctrine could be applied to preclude patenting of certain instructions to a patient, even if such instructions were not “printed.” King Pharm., Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1279 (Fed. Cir. 2010); see also AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1063-64 (Fed. Cir. 2010) (finding claimed printed label of instructions to be invalid when instructions were not entitled to patentable weight under the printed matter doctrine).

Recently, the Federal Circuit reinforced that the printed matter doctrine is broad in scope and precludes the patenting of the mere conveyance of information “using any medium.” C R Bard Inc., 2020 WL 6573331 at *6 (citing Praxair, 890 F.3d at 1032). In C R Bard, the Federal Circuit held: “Today, 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.” Id. (citations omitted). The test is “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.” Id. at *7.

In C R Bard, the asserted patents covered systems that utilized radiographic markers to identify vascular access ports suitable for injecting fluid into a patient’s veins on a regular basis without needing to start an intravenous line each time. Id. at *1. In applying the “functional relationship” test, the Federal Circuit found that the use of radiographic markers to “identify” or “confirm” a flow rate or pressure in the port was “printed matter” that had no functionality tied to the invention. Id. at *2, 7. Nevertheless, it found that the patent claims were eligible under Alice because when “read as a whole,” they were not solely directed to “the content of the information conveyed, but also on the means by which that information is conveyed,” i.e., identification of a suitable vascular access port by means of the markers. Id. at *8 (emphasis added). In evaluating the second part of the Alice test, it held that the claimed radiographic markers were part of an inventive step in identifying vascular access ports, and they were not routine or conventional for that purpose. Id. at *9. In evaluating anticipation under Section 102, the Federal Circuit gave no weight to the nonfunctional printed matter of the claims, and overturned summary judgment of anticipation based on factual disputes about the prior art. Id.

Two years ago, in Praxair, Judge Newman’s concurring opinion expressed her concern that the printed matter doctrine was applied beyond its original intent of precluding the patenting of solely printed matter. 890 F.3d. at 1038-41. The majority in Praxair held there was no meaningful distinction between claim limitations directed to written information, verbal information or mentally processed information. Id. at 1033-1034. Judge Newman disagreed with the majority’s reasoning, finding that it “adds neither clarity nor precision to the law” and that the doctrine had been broadened beyond its original intent. Id. at 1040.

Based on these recent cases, it appears that the printed matter doctrine will continue to be interpreted broadly. Practitioners may see increasing Section 101 challenges under the printed matter doctrine, particularly in cases involving methods of treatment and medical devices, as well as claims involving instructions, labels or other means of communication where the challenger makes an argument that claims are directed to only conveying information, even where such information is not printed.