Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., Appeal Nos. 2025-1228, -1252 (Fed. Cir. July 8, 2025)

Our Case of the Week focuses on obviousness.  More particularly, the decision included a lengthy discussion on a so-called “presumption” of obviousness that has been invoked in cases involving overlapping ranges.  Nearly 10 pages of the Court’s decision addressed this “presumption,” providing a must-read dissertation for those who face this issue.  The Court otherwise considered whether there was sufficient motivation to combine various features.

The patent at issue concerns dosing regimens of long-acting injectable antipsychotic medications.  Teva filed an ANDA, which triggered an infringement lawsuit brought by Janssen.  Teva stipulated to infringement, but challenged the patent as invalid on multiple grounds.

Teva’s challenge was based on three prior art references, all Janssen documents.  The first is a publication that details a Janssen Phase III clinical trial for testing the hypothesis that a regimen of three equal-amount doses of paliperidone palmitate would be more effective than a placebo.  The document is a mere testing protocol— for administering at least three equal doses of 50, 100, or 150 mg-eq. of paliperidone palmitate at specified time intervals, it “does not contain clinical results or safety data.”  The second prior art reference is Janssen-owned U.S. Patent No. 6,555,544 (’544 patent), which discloses a “pharmaceutical composition suitable as a depot formulation for administration by intramuscular or subcutaneous injection, comprising,” among other materials, a “therapeutically effective amount” of paliperidone palmitate.  The third prior art reference is a Janssen-owned patent application (WO ’384), which describes “a process for preparing aseptic crystalline’’ paliperidone palmitate.  The WO ’384 reference states that the formulation was “filled aseptically into sterile syringes’’ in dose volumes “between 0.25 ml and 1.50 ml depending on the dose needed,” “which corresponds to 25 to 150 mg-eq. of paliperidone.”

Following a bench trial, the district court found the patent not invalid, including for indefiniteness and obviousness.  Teva appealed.  While the Federal Circuit affirmed on the indefiniteness finding, it remanded for further considerations on the question of obviousness.  We highlighted that case as our Case of the Week in April 2024.  Our write-up can be found here.

On remand, the district court again found the patent not invalid as obvious.  The district court again determined that the patent’s claims had not been proven invalid for obviousness.  The district court found against Teva on the factual issues of motivation to combine references and reasonable expectation of success to arrive at the regimen recited in claim 2 of the patent. The court then rejected Teva’s argument that it was entitled to a presumption of obviousness, citing three Teva-acknowledged differences between the claim limitations and prior art, while adding that such a presumption would in any event be overcome based on “unexpected results and other pertinent secondary considerations.

The Federal Circuit affirmed.  With respect to the asserted presumption of obviousness, Teva cited a series of cases involving overlapping ranges.  Those cases were relevant here because the patent requires equal loading doses of 150 mg-eq. or of 100 mg-eq.  But a prior art reference discloses a range that includes both of those values.  Teva argued that it was entitled to a presumption of obviousness.

In addressing the issue, the Court provided a lengthy discussion of those cases, and the presumption that it has previously referenced in relation to cases involving overlapping ranges.  It noted three observations about its prior precedent:

First: We have ruled that the presumption applies, even where there is no strict overlap with a teaching of a single piece of prior art, if the ranges are “close enough that one skilled in the art would have expected them to have the same properties.” . . . Second: We have suggested that the presumption might apply to, and we have made clear that it at least supports analogous treatment of, some cases in which a plurality of prior-art references together (rather than a single reference alone) may be understood as teaching a range. . . . Third: We have indicated that the overlapping-range presumption can apply even when a claimed compound is structurally similar (rather than identical) to prior-art compounds, stressing that whether the presumption applies in such a situation is a factual question dependent on what properties the relevant artisans would “expect” to follow from the structural similarity.

But the Court made clear that it has never “declare[d] a blanket rule that the presumption only applies” “when the only difference from the prior art is a difference in the range or value of a particular variable.”  The Court explained that “the premises on which the presumption rests properly guide whether it should be held to apply in a given setting. The presumption is justified by interrelated premises: ‘where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation,’ . . .; ‘[t]he normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages,’ . . .; ‘discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art,’ . . .; and numerical amounts can be ‘close enough such that one skilled in the art would have expected them to have the same proper.’”

Ultimately, the Court found that, while the district court erred to some extent in evaluating that, the Court’s factual findings confirmed that “there is an insufficient basis in the record evidence for us to apply the invoked presumption in the face of the district court’s clear findings against Teva on the issues of relevant artisans’ motivation and expectations.”

The Court also analyzed Teva’s arguments that the district court erred in its motivation-to-combine analysis, providing a detailed factual analysis of the testimony before the district court before ultimately concluding that the district court did not err.

The full opinion can be found here.

By Nika Aldrich

ALSO THIS WEEK

Egenera, Inc. v. Cisco Systems, Inc., Appeal No. 2023-1428 (Fed. Cir. July 7, 2025)

In an appeal from a jury trial finding non-infringement of Egenera’s virtual networking patent by Cisco’s Unified Computing System or “UCS” products, the Federal Circuit affirmed.  Egenera presented a laundry list of reasons the district court had purportedly erred—including in granting summary judgment of non-infringement of certain patent claims, denying judgment as a matter of law on others, and denying Egenera’s motion for a new trial—all of which were rejected by the reviewing panel.  The Court most prominently discussed the grant of summary judgment, which the parties had presented in the lower court and on appeal as implicating only a factual question concerning the sufficiency of Egenera’s proof.  On review, the panel opined that the real dispute had actually been over proper construction of the phrase “emulate Ethernet functionality” in the asserted claims.  However, because neither party presented that claim construction dispute to the district court or raised it on appeal—indeed, Egenera expressly denied that its arguments depended on construction of the “emulate” term—the Federal Circuit declined to review any unresolved issue of claim construction that may have underpinned the district court’s order, and affirmed the grant of summary judgment.

Among other things, the Court also found that substantial evidence supported the jury’s finding of non-infringement as to the remaining asserted claims; that Egenera had not shown any purported deficiencies in the lower court’s jury instructions to be prejudicial; that under First Circuit law, Egenera had not sufficiently preserved objections concerning opinion testimony purportedly offered by two lay witnesses; and that while close to the line, comments by Cisco’s counsel during trial had not violated the literal terms of pre-trial orders concerning references to Egenera’s litigation financing or status as a non-practicing entity.

The full opinion can be found here.

By Jason A. Wrubleski

This article summarizes aspects of the law and does not constitute legal advice. For legal advice with regard to your situation, you should contact an attorney.