likelihood of success on the merits Archives

Pre-Markman Claim Construction Is OK, Within Limits

In an appeal stemming from the denial of a preliminary injunction and dismissal of the complaint, the US Court of Appeals for the Federal Circuit clarified its precedent and explained that a district court may construe claims at the motion to dismiss Rule 12(b)(6) stage, but only to the extent necessary to decide the motion. UTTO Inc. v. Metrotech Corp., Case No. 23-1435 (Fed. Cir. Oct. 18, 2024) (Prost, Taranto, Hughes, JJ.)

UTTO sued Metrotech in the US District Court for the Northern District of California for patent infringement and tortious interference with prospective economic advantage under California law. UTTO also moved for a preliminary injunction. The asserted patent describes and claims methods for detecting and identifying “buried assets,” which refers to underground utility lines. The district court denied the preliminary injunction because of UTTO’s failure to show a likelihood of success on the merits for infringement based on the district court’s construction. The district court adopted a construction of the term “group” as requiring at least two data points per buried asset. The district court then dismissed the original complaint for failure to state a claim on which relief could be granted but allowed UTTO to amend, explaining that infringement of the claims as construed at the preliminary injunction stage was not pled.

UTTO then filed an amended complaint, which the district court also dismissed, noting that UTTO failed to plead facts supporting infringement of other limitations under the claim construction issued at the preliminary injunction stage. The district court again granted UTTO leave to amend, which UTTO did. But the district court dismissed that third complaint as well, this time with prejudice, citing the claim construction in its order at the preliminary injunction stage.

On appeal, UTTO (citing 2018 Federal Circuit precedent Nalco v. Chem-Mod) challenged the district court’s claim construction and its reliance on a claim construction in an order denying summary judgment to dismiss a complaint. The Federal Circuit explained that claim construction by a district court “to resolve . . . particular claim construction issues in [a] case” may be necessary and is not categorically barred at the Rule 12(b)(6) stage. The Court explained that there is a “logical relationship of claim construction” between “infringement and the normal function of courts deciding whether to grant a Rule 12(b)(6) motion.” An infringement analysis first requires an analysis of the scope and meaning of the claims asserted and then the “properly construed claims” are compared to the accused device or method. Often, claims are construed based on intrinsic evidence alone, which the Federal Circuit concluded “is not different in kind from the interpretation of other legal standards, which is proper and routine in ruling on a motion under Rule 12(b)(6).” As an example, the Court cited its routine dismissals under Rule 12(b)(6) in connection with motions under 35 U.S.C. § 101.

The Federal Circuit cautioned that not all claim construction issues need to be construed at the Rule 12(b)(6) stage, but only those issues necessary to decide a [...]

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Preliminary Injunction Upheld in Cancer Relapse Detection Case

The US Court of Appeals for the Federal Circuit affirmed the grant of a preliminary injunction (PI) in the biopharmaceutical space, concluding that the plaintiff satisfied the requirements for injunctive relief, including likelihood of success on the merits. The injunction included “carve outs” for patients requiring access to the affected cancer detection kits. Natera, Inc. v. NeoGenomics Laboratories, Inc. Case No. 24-1324 (Fed. Cir. July 12, 2024) (Moore, CJ; Taranto, Chen, JJ.)

Natera and NeoGenomics are both research-focused healthcare companies manufacturing products used for early detection of cancer relapse. Natera and NeoGenomics both offer products designed to identify circulating tumor DNA (ctDNA) within the bloodstream to assess the efficacy of cancer treatment and the risk of recurrence. NeoGenomics’s product is named RaDaR.

Natera owns two patents, one claiming methods for amplifying targeted genetic material, such as cfDNA, while reducing amplification of non-targeted genetic material, and the other claiming methods for detecting variations in genetic material indicative of disease or disease recurrence, such as ctDNA. Natera sued NeoGenomics, alleging that RaDaR infringed both of Natera’s patents, and moved for a PI. The district court granted the PI, finding that Natera satisfied the requirements for injunctive relief, including likelihood of success on the merits as set forth in Purdue Pharma v. Boehringer Ingelheim (Fed. Cir. 2001). The injunction barred NeoGenomics from making, using, selling, offering for sale, marketing, distributing or supplying RaDaR, with certain carve outs for patients already using RaDaR and for finalized or in-process research projects, studies and clinical trials.

To show a likelihood of success on the merits, Natera had to show that it would likely prove infringement and that its infringement claim would likely withstand challenges to the validity and enforceability of the patents. On appeal, NeoGenomics argued that the district court did not properly evaluate the likelihood of success on the merits factor because it failed to resolve a claim construction dispute and instead applied an erroneous construction.

The Federal Circuit noted that NeoGenomics first raised the erroneous claim construction issue in its motion to stay the PI pending appeal, and that neither party raised a claim construction dispute during the PI briefing. The Court therefore concluded that the district court did not abuse its discretion by not engaging in explicit claim construction before evaluating likelihood of infringement. The Federal Circuit also found that the district court did not err by implicitly construing the claims because Natera presented evidence suggesting that RaDaR’s multi-cycle polymerase chain reaction (PCR) process likely practiced the tagging and amplifying steps of the relevant claims.

NeoGenomics also argued that the district court applied an incorrect legal standard in evaluating NeoGenomics’s obviousness challenge, asserting that “mere ‘vulnerability’” of the patent to an invalidity challenge sufficed to defeat a PI. The Federal Circuit explained that the correct analysis addresses whether the patentee has shown that it is more likely than not to prevail over an invalidity challenge. The Court explained that it was not sufficient to merely allege that the individual elements of the claimed [...]

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Pre-Markman Claim Construction Is OK, Within Limits

Preliminary Injunction Upheld in Cancer Relapse Detection Case

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