Irreparable Harm Archives

Irreparable Harm

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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Lost Connection: Preliminary Injunction Against Unreleased Product Is a No-Go

by Tessa Kroll | Feb 15, 2024 | Patents

Addressing a preliminary injunction motion directed to a competitor’s yet-to-be-released product, the US Court of Appeals for the Federal Circuit determined that the district court did not abuse its discretion in finding that the patent holder failed to establish irreparable harm based on speculative evidence. SmartSky Networks, LLC v. Gogo Bus. Aviation, LLC, Case No. 23-1058 (Fed. Cir. Jan. 31, 2024) (Cunningham, Chen, Hughes, JJ.) (non-precedential).

SmartSky Networks and Gogo Business Aviation are competing aviation network providers that offer air-to-ground in-flight internet networks for aircrafts. SmartSky sued Gogo in early 2020, alleging that Gogo’s 5G network infringed four patents related to wireless in-flight internet connections. SmartSky also moved to preliminarily enjoin Gogo from selling its 5G network, which is not yet operational and has yet to be released. In late 2022, the district court denied SmartSky’s motion for preliminary injunction, finding that SmartSky had not shown a likelihood of success or irreparable harm. SmartSky appealed.

SmartSky first moved to supplement the record with new materials relevant to market share, sales and switching costs. The Federal Circuit first denied SmartSky’s motions to supplement the record, noting that it would not consider new evidence on appeal absent extraordinary circumstances, such as instances where the court can take judicial notice of new facts or where the facts would alter the appropriateness of injunctive relief. Because the district court found no likelihood of irreparable harm, despite acknowledging that SmartSky had shown consumer stickiness and direct competition between the parties, the Court concluded that documents related to market share, sales and switching costs would not alter the appropriateness of injunctive relief. The Court further declined to take judicial notice of the facts, which were subject to dispute.

The Federal Circuit then turned to SmartSky’s argument that the district court erred in finding no likelihood of irreparable harm from lost sales and market share, price erosion, lost reputation and goodwill, and lost research and development and investments. Regarding lost sales, SmartSky argued that the district court ignored Gogo’s sales of AVANCE L5 equipment (used for Gogo’s 4G and 5G networks) and that Gogo’s 5G network was not “yet-to-be-released” because it had been on sale since late 2021. The Court found these arguments unpersuasive. The Court noted that SmartSky did not dispute that Gogo had yet to launch its 5G network and found that the district court did not abuse its discretion in concluding that any such sales were quantifiable. As for AVANCE L5, the Court observed that the equipment was currently sold as part of Gogo’s unaccused 4G network, and that the alleged harm would only occur if Gogo launched its 5G network and customers upgraded. Thus, the Court found that any harm from the sales of AVANCE L5 was highly speculative, particularly because the parties are not the only two players in the market and customers may have other non-infringing options.

SmartSky next argued that the district court ignored testimony that customers used Gogo’s pricing to negotiate discounts from SmartSky. The Federal Circuit disregarded this [...]

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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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Preliminary Injunction, Meet Irreparable Harm

by Alexander Piala, PhD | Apr 13, 2023 | Trade Secrets

The US Court of Appeals for the Fifth Circuit, in a case where an ex-employer sought preliminary injunctive relief based on an alleged breach of non-disclosure and non-compete agreements and alleged misappropriation of confidential business information, ruled that the Texas presumption of irreparable harm for breach of non-compete clauses does not always apply and that a finding of irreparable harm requires particularized findings regarding the alleged harm. Direct Biologics L.L.C. v. McQueen, Case No. 22-50442 (5th Cir. April 3, 2023) (Davis, Dennis, JJ., Higginson, C.J.).

Adam McQueen previously was executive vice president of Direct Biologics (DB). As a member of DB’s management, McQueen had access to DB’s confidential trade secret information regarding the production and production specifications of DB’s novel medical technologies. To protect that information, McQueen signed both non-compete and non-disclosure agreements with DB, preventing him from providing “services . . . similar to that which [he] provided to [DB],” and from disclosing or using DB’s confidential information.

McQueen resigned from his position and joined Vivex, DB’s direct competitor. Almost immediately DB sued McQueen and Vivex, alleging breach of the non-compete, breach of the non-disclosure agreement and trade secret misappropriation. Shortly thereafter, DB moved for a preliminary injunction to compel McQueen to comply with the non-compete covenant and prevent him from using DB’s confidential and trade secret information. Vivex countered by arguing that McQueen’s new role as vice president of product strategy was a “non-competitive role,” and that McQueen was sequestered from all products that would compete with DB. The district court denied the preliminary injunction motion, agreeing with Vivex that DB failed to provide any evidence that DB had been harmed. DB appealed.

DB argued that the district court erred in two ways—first, by failing to apply Texas’s presumption of irreparable harm based on McQueen’s breach of a non-compete agreement, and second, by failing to correctly apply the irreparable harm analysis by looking only at past actions.

The Fifth Circuit began by reviewing Texas’s presumption of irreparable harm. Under Texas law, the breach of a non-compete agreement can result in a presumption of irreparable harm. But, as the Court explained, the presumption does not always apply. Texas courts can decline to apply the presumption when there is no independent proof of harm. Here, not only did DB fail to produce any evidence that McQueen disclosed or used DB’s confidential information, but there also was evidence showing that he had not. Based on this record, the Court held that it was not an abuse of discretion to decline to apply the presumption.

The Fifth Circuit then analyzed the district court’s irreparable harm analysis. The Court explained that the irreparable harm analysis requires that the trial court make particularized findings regarding whether the harm was likely to occur over the pendency of the litigation, and if so, whether the harm would be difficult to quantify monetarily. While the district court here made findings directed to whether McQueen had caused harm, it did not make any findings regarding what might happen during the litigation. The [...]

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Rebuttal Presumption of Irreparable Harm Still Alive When Assessing Trademark Preliminary Injunctions

by Amol Parikh | Aug 25, 2022 | Trademarks

In one of the first decisions to construe the Trademark Modernization Act of 2020 (TMA), the US Court of Appeals for the Third Circuit found that a district court properly applied the TMA’s rebuttal presumption of irreparable harm when it denied a trademark owner’s motion for a preliminary injunction. Nichino America, Inc. v. Valent U.S.A., LLC, Case No. 21-1850 (3rd Cir. Aug. 12, 2022) (Bibas, Matey, Phipps, JJ.)

Nichino and Valent sell pesticides for farming. Since 2004, Nichino has offered a trademarked product known as CENTAUR. Valent trademarked a competing product called SENSTAR in 2019, giving it a logo resembling CENTAUR’s colors, fonts and arrow artwork. Both pesticides are used in the same geographic areas against many of the same insects, and both are sold to farmers through distributors. SENSTAR is a liquid and uses a unique combination of two active chemicals. It costs $425 per gallon and ships in cases containing four one-gallon containers. CENTAUR is manufactured as a solid and sold by the pallet, with each pallet containing 622 pounds of pesticide packed into bags and cases. CENTAUR costs $24 per pound.

Nichino sued Valent for trademark infringement and sought a preliminary injunction against SENSTAR’s launch, arguing that Valent’s use of the SENSTAR mark would create confusion among consumers. The district court found that Nichino narrowly demonstrated that its infringement claim would likely succeed but explained that “there is not an abundance of evidence of likelihood of confusion” between the products. As part of its injunction analysis, the district court applied the TMA to presume Nichino would suffer irreparable harm without an injunction. However, the court noted that the presumption was rebuttable. The court credited Valent’s evidence of a sophisticated consumer class that makes careful purchases and noted the lack of any evidence of actual consumer confusion. The court also found that Nichino failed to proffer any affirmative evidence that it would suffer irreparable harm. Accordingly, the district court found that the presumption of irreparable harm was rebutted, and therefore denied the injunction request. Nichino appealed.

Nichino argued that the TMA precluded the district court from finding no irreparable harm. The Third Circuit, however, found that the district court “admirably navigated” the TMA’s rebuttable presumption by finding that Valent rebutted the presumption and Nichino did not independently show irreparable harm. The Court explained that the three-step process for applying the TMA’s rebuttable presumption requires the following:

The court must assess the plaintiff’s evidence only as it relates to a likelihood of success on the merits.
If the plaintiff’s evidence establishes likely trademark infringement, the TMA is triggered, and the burden of production shifts to the defendant to introduce evidence sufficient for a reasonable factfinder to conclude that the consumer confusion is unlikely to cause irreparable harm.
If a defendant successfully rebuts the TMA’s presumption by making this slight evidentiary showing, the presumption has no further effect.

The Third Circuit found that the district court correctly followed this three-step analysis in finding that Valent rebutted the TMA’s [...]

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Threat of ITC Exclusion Order Is Too Speculative to Constitute Irreparable Harm

by Alexander P. Ott | Jul 21, 2022 | Patents

The US Court of Appeals for the Federal Circuit affirmed a decision by a federal district court denying a defendant’s motion for a preliminary injunction seeking to enjoin a parallel International Trade Commission (ITC) investigation against it. The Federal Circuit agreed that the defendant’s alleged irreparable harm (a “cloud” over its business) was too conclusory and speculative to support relief. Koninklijke Philips N.V. v. Thales Dis Ais USA LLC, Case No. 21-2106 (Fed. Cir. July 13, 2022) (Moore, C.J., Dyk, Chen, JJ)

Koninklijke filed a complaint at the ITC requesting a Section 337 investigation based on alleged infringement by Thales of four patents designated essential to the 3G and 4G telecommunications standards. Koninklijke simultaneously filed a parallel district court action against Thales in the Delaware district court based on those four patents. At the district court, Thales moved for a preliminary injunction seeking to enjoin Koninklijke from pursuing an exclusion order at the ITC because of an alleged breach of contract. The district court denied that motion, and Thales appealed to the Federal Circuit.

Meanwhile, the ITC investigation continued, and the administrative law judge (ALJ) issued an initial determination finding no violation of Section 337 with respect to any of the four patents. Subsequently, the Federal Circuit held oral arguments on the district court appeal, during which the judges questioned whether there could be irreparable harm if the ITC were to adopt the ALJ’s determination and consequently not issue an exclusion order. Thales argued that the threat of an exclusion order had left a “cloud” over its business and cited customer concerns that Thales might not be able to deliver products in the future. The ITC subsequently affirmed the ALJ’s finding of no violation and terminated the investigation without issuing any exclusion order.

A week later, the Federal Circuit issued a decision affirming the district court’s denial of the preliminary injunction motion. The Court held that Thales had failed to meet its burden to establish irreparable harm because it had not presented any evidence that it had actually lost any customers, that any customers had delayed purchases or that it had struggled to gain new customers because of the threat from the ITC investigation. The Court also found that the cloud over Thales’ business and the potential loss of business were too speculative to justify a preliminary injunction.

Practice Note: While the ITC investigation was ongoing, Thales filed a civil action in France against Koninklijke—a fellow European company—alleging that Koninklijke’s attempt to obtain injunctive relief in the United States for standard essential patents constituted an anti-competitive act that violated French civil law. Thales sought EUR 13.5 million in damages for the legal fees that it had incurred in defending the ITC investigation.

Unlikely to Succeed: Preliminary Injunction Denied Despite Stipulation to Irreparable Harm

by Paul Devinsky | Aug 13, 2020 | Patents

In a dispute over the terms of a settlement agreement, the US Court of Appeals for the Federal Circuit found that a patent owner was not entitled to a preliminary injunction despite a stipulation that it would be irreparably harmed if the accused infringer breached certain provisions of the agreement. Takeda Pharmaceuticals U.S.A., Inc. v. Mylan Pharmaceuticals, Inc., Case Nos. 20-1407, -1417 (Fed. Cir. July 31, 2020).

Takeda originally sued Mylan to prevent Mylan’s launch of a generic version of Takeda’s branded drug Colcrys. The parties ultimately settled under terms set forth in a settlement/license agreement, including a provision in Section 1.2(d) stating that Mylan would be entitled to launch a generic product after a Final Court Decision holding that all unexpired claims of the licensed patents that were asserted and adjudicated against a third party were either (i) not infringed or (ii) any combination of not infringed and invalid or unenforceable. The licensed patents included 17 Orange-Book-listed patents that Takeda had asserted against Mylan. The parties further agreed that a breach of this provision “would cause Takeda irreparable harm.”

While Takeda and Mylan were negotiating the settlement, another patent litigation that involved some of the licensed patents was ongoing (the West-Ward litigation). The West-Ward litigation involved a different party and a different drug product. Takeda did not assert all 17 patents in the West-Ward litigation. It only asserted eight and ultimately dismissed five with prejudice. On summary judgment, the district court in the West-Ward litigation found that the asserted claims of the remaining three patents were not infringed.

Mylan informed Takeda that it would launch its generic product, arguing that summary judgment in the West-Ward litigation triggered Section 1.2(d), allowing it to launch its generic product because all of the asserted claims remaining in the suit had been found not infringed. In response, Takeda filed a complaint alleging breach of contract and patent infringement, and sought a preliminary injunction to enjoin Mylan from its launch. The preliminary injunction motion was denied. Takeda appealed.

A plaintiff seeking a preliminary injunction must show (i) that it is likely to succeed on the merits, (ii) that it will suffer irreparable harm in the absence of preliminary relief, (iii) that the balance of equities tips in its favor, and (iv) that an injunction is in the public interest. The Federal Circuit’s decision focused on the first two factors: likelihood of success and irreparable harm.

The Federal Circuit’s analysis of the likelihood of success prong turned on the meaning of Section 1.2(d). Takeda argued that Section 1.2(d) had not been triggered because not all unexpired claims that were asserted in the West-Ward litigation had been found not infringed, specifically the asserted claims of the five withdrawn patents. Mylan argued that triggering Section 1.2(d) only required that all unexpired claims that had been asserted and adjudicated to be found not infringed or invalid, and because the asserted claims of the five dismissed patents were not adjudicated, it was not necessary that the dismissed claims be [...]

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