likelihood of success Archives

likelihood of success

Eye-Catching: Biosimilars Injunction Prevails

by Courtney Seams | Feb 6, 2025 | Patents

Addressing a preliminary injunction in patent litigation related to the Biologics Price Competition and Innovation Act (BPCIA), the US Court of Appeals for the Federal Circuit upheld the district court’s grant of a preliminary injunction, finding that there was a proper exercise of personal jurisdiction and that no substantial question of invalidity had been raised for the patents at issue that would prevent the injunction from issuing. Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., Case No. 24-1965 (Fed. Cir. Jan. 29, 2025) (Moore, C.J.; Reyna, Taranto, JJ.)

Regeneron holds a Biologics License Application for Eylea®, a therapeutic product containing aflibercept (a VEGF antagonist used in various treatments for eye diseases). Regeneron owns multiple patents related to its Eylea® product, including a patent directed to intravitreal injections using VEGF formulations. Mylan, Samsung Bioepis (SB), and other companies filed abbreviated Biologics License Applications (aBLAs) with the US Food and Drug Administration (FDA) seeking approval to market Eylea® biosimilars. Regeneron brought suit against these parties asserting infringement of its patent and filed a motion for a preliminary injunction.

The district court granted the preliminary injunction against SB, enjoining it from offering for sale or selling the subject of its aBLA without a license from Regeneron. SB appealed, arguing that:

The exercise of personal jurisdiction over it was improper.
There was a substantial question of invalidity of the patent under either obviousness-type double patenting or lack of adequate written description.
There was no causal nexus established.

The Federal Circuit upheld the exercise of personal jurisdiction on SB, finding that SB had minimum contacts with the state of West Virginia. SB is headquartered in South Korea and entered into a development and commercialization agreement with Biogen for a biosimilar to Eylea®, SB15, that gives SB continuing rights and responsibilities as the agreement is implemented. The Court found that SB did not have to distribute the product itself under the agreement for it to be subject to personal jurisdiction. Further, the Court found that SB’s aBLA and internal documentation indicated an intent to distribute SB15 US-wide, which was sufficient to establish intent to distribute the product in West Virginia.

The Federal Circuit also upheld the district court’s grant of the preliminary injunction. SB invoked another patent in the same family as the asserted patent that was directed to an intravitreal injection containing a VEGF trap as the reference patent for an obviousness-type double patenting theory. The Federal Circuit upheld the district court’s findings that the stability requirement, the “glycosylated” requirement, and the “vial” limitations in the claims of the asserted patent were all patentably distinct from the reference patent. The Court found that the stability requirement recited in the asserted patent was more specific than, and not inherent within, the reference patent. The Court further agreed that the reference patent embraced both non-glycosylated and glycosylated aflibercept, not only the glycosylated aflibercept contained in the asserted patent claims.

The Federal Circuit then addressed SB’s arguments that the specification lacked sufficient written description for the claimed [...]

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Don’t Assume Sweet Success: Forum Selection Clause Doesn’t Preclude IPR

by Thomas DaMario | Jan 11, 2024 | Patents

The US Court of Appeals for the Federal Circuit affirmed a district court’s denial of a preliminary injunction seeking to bar a petitioner from challenging certain patents at the US Patent & Trademark Office (PTO) because of a forum selection clause in a settlement agreement. The Court found that the patent owner was unlikely to succeed on the merits based on the likelihood of success factor. DexCom, Inc. v. Abbott Diabetes Care, Inc., Case No. 23-1795 (Fed. Cir. Jan. 3, 2024) (Dyk, Hughes, Stoll, JJ.)

DexCom and Abbott are competing manufacturers of continuous glucose monitoring systems. In 2014, the parties entered into a settlement agreement that included a cross-license to certain patents, covenants not to sue or challenge the patents for a “Covenant Period,” and a forum selection clause identifying the US District Court for the District of Delaware as the exclusive jurisdiction “over any dispute arising from or under or relating to [the] Agreement, to the extent permitted by law.” After expiration of the Covenant Period, DexCom sued Abbott in the Western District of Texas. Abbott moved to transfer the case to the District of Delaware and added a breach of contract counterclaim, citing the settlement agreement’s forum selection clause. The case was transferred to Delaware, after which Abbott filed eight petitions for inter partes review (IPR) at the PTO. DexCom responded to the breach of contract counterclaim by alleging that Abbott had breached the forum selection clause by filing the IPR petitions. Until this point, DexCom had consistently taken the position that the asserted claims were not subject to the cross-license, rendering the forum selection clause inapplicable.

Six months after Abbott filed the IPR petitions, DexCom moved for a preliminary injunction prohibiting the IPRs from proceeding. The district court denied the preliminary injunction. In evaluating the four injunctive relief factors (i.e., likelihood of success on the merits, irreparable harm, balance of hardships and public interest), the district court simply assumed the likelihood of success in favor of DexCom. It nevertheless denied the injunction because DexCom waited six months to file the motion (suggesting there was no irreparable harm) and because DexCom had taken inconsistent legal positions with respect to whether the challenged patents were licensed, thus weighing against DexCom in the balance of hardships factor. DexCom sought interlocutory appeal of the district court’s order.

The Federal Circuit focused on the first factor, likelihood of success on the merits. While the district court assumed that this factor favored DexCom, the Federal Circuit disagreed. The Court noted that the agreement required that DexCom and Abbott “shall not Challenge” each other’s patents during the Covenant Period, with the exception that “each Party reserves its rights and is permitted to Challenge any of the patents of the other Party if there is a statute, regulation, or rule that sets a deadline to make the Challenge,” assuming certain conditions were met. The Court first explained that “challenge” includes IPRs of the patents and that nothing in the forum selection clause differentiated between the [...]

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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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Not So Clean: Federal Circuit Upholds Trade Dress Preliminary Injunction, Finds Defenses Improperly Plead

by Kathleen Lynch | Nov 17, 2022 | Trademarks

The US Court of Appeals for the Federal Circuit upheld a “narrow” preliminary injunction in a trade dress case, finding that the opponent of a registered configuration mark failed to prove its lack of secondary meaning and functionality defenses. SoClean, Inc. v. Sunset Healthcare Solutions, Inc., Case No. 21-2311 (Fed. Cir. Nov. 9, 2022) (Newman, Lourie, Prost, JJ.)

SoClean manufactures Continuous Positive Airway Pressure (CPAP) machines. SoClean sued Sunset—a former distributor of SoClean products—for patent infringement and later added trademark infringement claims. At issue in this appeal was a single SoClean mark “for the configuration of replacement filters for its sanitizing devices.”

SoClean requested a preliminary injunction to stop Sunset from making or selling allegedly infringing CPAP filters. The district court granted the injunction but narrowly tailored the injunction to only enjoin Sunset from selling its filter cartridges without Sunset’s own brand name attached to the filter drawing so that customers would not falsely believe they were buying SoClean products. Sunset appealed.

While a party seeking preliminary injunction must prove all four eBay elements, this appeal focused on just one: “likelihood of success on the merits.” Sunset argued that the district court abused its discretion in finding that SoClean would likely defeat Sunset’s lack of secondary meaning defense and its functionality defense.

After noting that the parties agreed that SoClean’s trade dress was protectable only upon a showing that it had obtained secondary meaning, the Federal Circuit divided the secondary meaning issue into two subparts:

Whether the district court should have questioned the validity of SoClean’s registration in light of Sunset’s evidence
Whether the district court held Sunset to an improperly high standard of proof.

As to the first issue, the Court noted that federal registration is prima facie evidence of a mark’s validity. When, as here, the challenged mark was registered fewer than five years prior, the burden shifts from plaintiff to defendant, such that the defendant must rebut the presumption of validity. Sunset acknowledged that it had this burden, but its arguments to the district court focused only on the US Patent & Trademark Office’s decision to grant SoClean’s registration. The Court rebuffed that argument, noting that “scrutinizing the application process and deciding whether the trademark examiner was correct to issue the registration in the first place is the opposite” of the statutory presumption of validity.

Next, the Federal Circuit addressed Sunset’s standard of proof argument. The Court acknowledged that the district court misstated the law by suggesting that there was a “vigorous evidentiary requirement” on the challenging party, instead of simply a “preponderance of the evidence.” However, the Court also noted that the district court considered Sunset’s lack of secondary meaning evidence to be “equivocal, at best,” which “plainly fails to satisfy a preponderance-of-the-evidence standard.” Therefore, the Court judged the error to be harmless.

The Federal Circuit thus affirmed the finding that SoClean would likely defeat Sunset’s secondary meaning challenges.

The Federal Circuit next turned [...]

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Ordinary Observer Conducts Product-by-Product Analysis in View of Prior Art

by Tessa Kroll | Nov 3, 2022 | Patents

In one of two concurrent opinions concerning the same design patent case, the US Court of Appeals for the Federal Circuit vacated a district court’s entry of a preliminary injunction after concluding that the court had failed to properly consider the accused products separately and in view of the prior art when determining the plaintiffs’ likelihood of success. ABC Corp. I v. P’ship & Unincorporated Ass’ns Identified on Schedule “A”, Case No. 22-1071 (Fed. Cir. Oct. 28, 2022) (Dyk, Taranto, Stoll, JJ.)

Hangzhou Chic Intelligent Technology and Unicorn Global (collectively, the plaintiffs) own four patents claiming designs for handle-less, two-wheeled, motorized, stand-on vehicles commonly referred to as “hoverboards.” Urbanmax, GaodeshangUS, Gyroor-US, Fengchi-US, Jiangyou-US, Gyroshoes and HGSM (collectively, the appellants) sell Gyroor-branded hoverboards. In 2020, the plaintiffs sued the appellants for patent infringement and sought a temporary restraining order and a preliminary injunction. As explained here, the district court granted the preliminary injunction in 2020, but thereafter invited the plaintiffs to file a second motion for a preliminary injunction in light of unsuccessful motions by Fengchi-US, Urbanmax and Gyroor-US to dissolve the 2020 preliminary injunction for lack of notice under Fed. R. Civ. P. 65(a). Heeding the court’s advice, the plaintiffs filed a motion for a second preliminary injunction on August 24, 2021.

The primary issue before the district court concerning the 2021 preliminary injunction was whether the plaintiffs had demonstrated a likelihood of success on the merits that the accused products infringed the plaintiffs’ patents in light of certain prior art hoverboards. The prior art included a hoverboard with an hourglass-shaped body, which was a significant feature of the patented designs and the majority of the accused products. Despite the similarities between the prior art board and the claimed designs, the plaintiffs generally disregarded the prior art in their analysis. After comparing the four accused products as a group to the claimed designs, the plaintiffs’ expert opined that the accused products infringed the asserted patents based in large part on their similar hourglass bodies, in addition to other features.

The appellants’ expert countered that “the attention of the hypothetical ordinary observer will be drawn to those aspects of the claimed design that differ from the prior art,” rather than the hourglass shape, and that the additional ornamental features of the accused products were not substantially similar to the claimed designs. While the district court acknowledged that “resolving this expert dispute will likely require a trial,” it nonetheless concluded that the plaintiffs had demonstrated likelihood of success and entered the preliminary injunction order. The appellants filed a notice of appeal.

On appeal, the Federal Circuit concluded that the lower court had erred in four material respects:

Applying the wrong legal standard
Failing to conduct the ordinary observer analysis in view of the prior art
Failing to apply the ordinary observer analysis on a product-by-product basis
Crafting an overbroad injunction.

First, the Federal Circuit took issue with the district court’s entry of a preliminary injunction despite its [...]

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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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Counterfeit Dealer Gets Smoked in Trademark Preliminary Injunction Proceeding

by Tessa Kroll | Jun 2, 2022 | Copyrights, Trademarks

The US Court of Appeals for the Ninth Circuit affirmed a preliminary injunction barring the defendant from selling counterfeit e-cigarette and vaping products bearing the plaintiff’s logo because the plaintiff’s psychoactive products were legal and could support a valid trademark. AK Futures LLC v. Boyd St. Distro, LLC, Case No. 21-56133 (9th Cir. May 19, 2022) (Kleinfeld, Fisher, Bennett, JJ.)

AK Futures manufactures e-cigarettes and vaping products, including delta-8 THC goods marketed under its “Cake” brand. Delta-8 THC is a psychoactive compound found in the Cannabis sativa plant, which encompasses both hemp and marijuana. The compound is similar in effect to delta-9 THC, the primary psychoactive agent in marijuana, but delta-8 THC is typically manufactured from hemp-derived cannabidiol (CBD). The cultivation and possession of hemp was legalized by the Farm Act in 2018.

AK Futures sued Boyd Street Distro, a Los Angeles purveyor of smoke products, for trademark and copyright infringement. Boyd Street sold virtually identical counterfeit Cake-branded e-cigarettes and vaping products containing delta-8 THC. At the time of suit, AK Futures had a registered copyright protecting its Cake logo—a stylized “C” overlaying a two-tier cake—and pending trademark applications for six marks incorporating the word “Cake” or the Cake logo for use in connection with e-cigarette products. The district court granted AK Futures’ motion for preliminary injunction. Boyd Street appealed.

On appeal, Boyd Street conceded the copyright claim, but argued that AK Futures could not own a valid trademark in connection with its e-cigarettes and vaping products because the sale of delta-8 THC was prohibited under federal law. In response, AK Futures argued that the 2018 Farm Act legalized delta-8 THC and products containing the compound.

The Ninth Circuit agreed that AK Futures’ use of the marks in commerce was lawful and could give rise to trademark priority. The Court found that the “plain and unambiguous” text of the Farm Act indicated that delta-8 THC products were lawful. The Farm Act removed “hemp” and “tetrahydrocannabinols in hemp” from Schedule I in the Controlled Substances Act, where “hemp” is defined as “the plant Cannabis sativa L. and any part of that plant, including . . . all derivatives, extracts, [and] cannabinoids . . . with a delta-9 concentration of not more than .3 percent.” The Court noted that the delta-9 THC concentration level was the only statutory metric for distinguishing marijuana from hemp, and that the terms “derivative, extract, or cannabinoid” were substantially broad. The Court thus concluded that “hemp” encompasses delta-8 THC products that contain no more than 0.3% delta-9 THC.

Boyd Street argued that the US Drug Enforcement Agency had interpreted the Farm Act as not applicable to delta-8 THC because it is “synthetically derived” and argued that US Congress never intended the Farm Act to legalize psychoactive substances. The Ninth Circuit perfunctorily dismissed these arguments based on the clear and unambiguous statutory language. Since the Cake-branded products allegedly contained less than 0.3% delta-9 THC, the Court held that AK Futures was likely to succeed in demonstrating that its [...]

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