preliminary injunction/PI Archives

Preliminary Injunction Upheld in Cancer Relapse Detection Case

by Tim Dunker | Jul 25, 2024 | Patents

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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E for Effort? PI Analysis in Trade Secret Suit Riddled With Errors

by Tessa Kroll | Jun 27, 2024 | Trade Secrets

The US Court of Appeals for the Federal Circuit reversed the granting of a sweeping preliminary injunction (PI) in a trade secret suit against a competitor, finding that the district court’s analysis failed to consider potentially dispositive issues and the requirements of the Defend Trade Secrets Act (DTSA). Insulet Corp. v. EOFlow, Co., Case No. 24-1137 (Fed. Cir. June 17, 2024) (Lourie, Prost, Stark, JJ.) Among other things, the district court:

Failed to consider whether the plaintiff’s claims were time-barred.
Used an incorrect definition of “trade secret.”
Based its irreparable harm analysis on an unsubstantiated fear of a competitor’s potential acquisition of the defendant.
Failed to meaningfully assess the balance of harm and the public interest factors.

Insulet and EOFlow are medical device manufacturers that make insulin pump patches. Insulet began developing its OmniPod product in the early 2000s and launched next-generation models in 2007 and 2013. EOFlow began developing its own insulin pump product, the EOPatch, in 2011 and began work on its second-generation product in 2017. Around the time that EOFlow began developing its second-generation device, four Insulet employees joined EOFlow.

In early 2023, Medtronic allegedly started a diligence process to acquire EOFlow. Shortly thereafter, Insulet sued EOFlow for trade secret misappropriation, seeking an injunction to bar all technical communications between EOFlow and Medtronic. The district court granted Insulet’s request, finding that Insulet was likely to succeed on its trade secret claim because EOFlow had hired former Insulet employees who retained Insulet’s confidential documents, and Medtronic’s intended acquisition of EOFlow would cause irreparable harm to Insulet. The injunction broadly prevented EOFlow from “manufacturing, marketing, or selling any product that was designed, developed, or manufactured, in whole or in part, using or relying on the Trade Secrets of Insulet.”

EOFlow appealed the injunction. EOFlow argued that the district court failed to address whether Insulet’s claim was time-barred under 18 U.S.C. § 1836(d) of the DTSA and to consider factors relevant to Insulet’s likelihood of success or meaningfully assess the balance of harm and public interest factors.

The Federal Circuit first observed that the district court had expressed no opinion regarding EOFlow’s § 1836(d) statute of limitations (SoL) argument, even though Insulet’s compliance with the SoL was a material factor that would significantly impact Insulet’s likelihood of success. This alone constituted an abuse of discretion meriting reversal.

The Federal Circuit found that even if the district court had addressed the SoL, the injunction was not adequately supported. The Federal Circuit explained that the district court had improperly and broadly defined “trade secret” as “any and all Confidential Information of Insulet,” where “Confidential Information” was defined by the district court to mean any materials marked “confidential” as well as any CAD files, drawings or specifications. The Federal Circuit explained that the district court should have required Insulet to define the allegedly misappropriated trade secrets with particularity. Instead, the district court allowed Insulet to “advance a hazy grouping of information” and stated that “it would be unfair to require at [...]

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Whisk-y Business: Notice Alone Is Sufficient for Preliminary Injunction

by Alexander Piala, PhD | Sep 7, 2023 | Trademarks

The US Court of Appeals for the Fifth Circuit concluded that only notice of a preliminary injunction (PI) motion, and not perfected formal service, is needed to assert jurisdiction to issue an injunction. Whirlpool Corp. v. Shenzhen Sanlida Elec. Tech. Co., Ltd., Case No. 22-40376 (5th Cir. Aug. 25, 2023) (Barksdale, Southwick, Higginson, JJ.)

Shenzhen Sanlida sells stand mixers within the United States, primarily through online sales. Whirlpool filed a complaint for trademark infringement and dilution against Sanlida, arguing that Sanlida’s mixers were too close in appearance to Whirlpool’s iconic KitchenAid stand mixer. Shortly after filing its complaint, Whirlpool requested a PI hearing. In its request, Whirlpool provided evidence that Sanlida had actual notice of the pending hearing. The district court granted the request and scheduled a hearing.

Counsel for Whirlpool and Sanlida attended the hearing. At the hearing, Sanlida argued it had never been properly served under the Hague Convention and that without service, the district court could not assert personal jurisdiction over it. The district court disagreed and granted the PI. Sanlida filed an emergency motion to stay the order, but the district court rejected Sanlida’s request. Sanlida appealed.

Sanlida argued that the district court did not have the power to issue a PI and that it abused its discretion in awarding the injunction. The Fifth Circuit found no error or abuse and affirmed.

The Fifth Circuit explained that service is not a prerequisite to issuing a PI. Citing Fed. R. Civ. P. 65, the Court explained that the only requirement for issuing a PI is notice to the adverse party. Since it was undisputed that Sanlida had notice of the PI hearing, the Court found that the district court had the power to issue the PI. In doing so, the Court distinguished this case—where there was no dispute that the district court would have personal jurisdiction over Sanlida after the process was perfected—from cases where personal jurisdiction was a live question at the PI hearing.

Turning to the merits of the PI, the Fifth Circuit addressed the four factors the district court had to consider before issuing the injunction: likelihood of success on the merits, threat of irreparable injury, balance of harms and public interest.

On the first factor—likelihood of success—the Fifth Circuit found that the district court made no clear error. The two components of the likelihood of success analysis are validity and likelihood of confusion. On both points, the Fifth Circuit upheld the district court’s finding. While Sanlida argued that Whirlpool’s trademark was invalid because it covered “functional” elements, the Court found insufficient factual support for that argument. Nothing in the record showed that Whirlpool’s mixer head shape had any effect on the “cost or quality” of the mixer. Nor did Sanlida point to any evidence showing that the housing shape would put competitors at a “significant non-reputation-related disadvantage.” Without a showing on either element, Sanlida failed to rebut the presumption of validity. Sanlida also failed to show [...]

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