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The Devil Is in the Details: Bioequivalence, In Vitro Testing Not Enough to Establish Infringement

by | Dec 19, 2024 |

Addressing for the first time the issue of whether bioequivalence data and in vitro testing can show that an abbreviated new drug application (ANDA) product with different immediate and delayed release portions infringed on a patent, the US Court of Appeals for the Federal Circuit upheld the district court’s finding of noninfringement. Galderma Laboratories, L.P. v. Lupin Inc., Case No. 24-1664 (Fed. Cir. Dec. 6, 2024) (Moore, C.J.; Linn, Prost, JJ.)

Galderma owns and markets Oracea® (doxycycline USP) 40 mg capsules, which are used to treat papules and pustules associated with rosacea. Galderma’s patents cover a unique once-daily oral formulation of doxycycline, combining 30 mg of immediate release (IR) and 10 mg of delayed release (DR) pellets. Lupin filed an ANDA to market a bioequivalent 40 mg doxycycline product, featuring 22 mg IR and 18 mg DR pellets, and using the same enteric polymer for the DR portion as Oracea®. Galderma sued Lupin under the Hatch-Waxman Act, alleging patent infringement.

Despite Lupin’s different pellet composition, Galderma contended that Lupin’s product effectively contained 30 mg IR and 10 mg DR because of a “weak enteric coat” on the DR pellets, causing early release of some doxycycline. Lupin presented two key pieces of evidence:

  • A two-stage in vitro dissolution test at pH 1.1 and 4.5, showing some DR pellet release at pH 4.5.
  • Bioequivalence data comparing Oracea® and Lupin’s product.

The district court ultimately ruled in favor of Lupin. Galderma appealed. The issue on appeal was whether Galderma’s evidence of bioequivalence and in vitro testing was indeed insufficient to establish literal infringement or infringement under the doctrine of equivalents (DoE).

The Federal Circuit agreed with the district court: in vitro testing and bioequivalence were not enough to establish literal infringement. Crucially, Galderma’s two-stage in vitro dissolution test didn’t accurately mimic in vivo conditions. The Court highlighted that the pH 4.5 environment used in the test wasn’t physiologically relevant for a fasted stomach, which typically has a pH between 1 and 2. Moreover, the bioequivalence data failed to address the differing proportions of IR and DR pellets. Consequently, the Court found no clear error in the district court’s factual findings.

Nor did the DoE save Galderma. The Federal Circuit applied two different tests: the function-way-result test and the insubstantial differences test. Under the function-way-result test the court is charged with determining whether the accused product performs the same function, in the same way, to achieve the same result as the claimed invention. Under the insubstantial differences test – as its name suggests – the court is charged with determining whether the differences between the claimed invention and the accused product are insubstantial.

Again, Galderma relied on bioequivalence data and its in vitro testing to argue that either DoE test was satisfied. The Federal Circuit was not persuaded, finding no clear error in the district court’s reasoning. As for the function-way-result test, the in vitro testing did not show that Lupin’s ANDA product used the same function or method as the asserted [...]

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Neck or Nothing? “Quotation” Invalidates On-Sale Bar

by | Dec 19, 2024 | ,

The US Court of Appeals for the Federal Circuit found the patents at issue invalid based on the patent owner’s “quotation” letter to a third party, concluding it was a commercial offer for sale under pre-America Invents Act (AIA) 35 U.S.C. § 102(b) notwithstanding the patent owner’s reservation of a post-quote acceptance. Crown Packaging Technology, Inc. v. Belvac Production Machinery, Inc., Case Nos. 22-2299; -2300 (Fed. Cir. Dec. 10, 2024) (Dyk, Hughes, Cunningham, JJ.)

Crown Packaging Technology owns patents for necking machines, which reduce the top diameter of metal beverage cans. The earliest priority date for the patents was April 24, 2008, setting the critical date of April 24, 2007. On November 14, 2006, Crown sent Complete Packaging Machinery a letter quoting one of its necking machines that embodied the claims of its patents.

Crown sued Belvac Production Machinery for infringing Crown’s patents. Belvac raised an invalidity defense under § 102(b), contending that Crown’s pre-critical-date letter to Complete Packaging constituted a commercial offer for sale, which rendered the patents invalid. On summary judgment, Crown argued that its letter could not create a binding contract, was not a commercial offer for sale, and was not an offer for sale “in this country” as required by § 102(b). The district court agreed with Crown, finding that the letter was merely an invitation to make an offer, not an offer in itself. At trial, the jury found the patents valid but not infringed. Both parties appealed.

The Federal Circuit reversed the district court’s validity determination, finding that Crown’s letter was an invalidating offer for sale under § 102(b). The Court’s analysis involved five factors:

  • Whether the subject of the offer embodied the claims of the patents.
  • Whether the offer occurred “in this country.”
  • Whether the offer predated the critical date.
  • Whether the invention was the subject of a commercial offer for sale.
  • Whether the invention was ready for patenting.

Crown conceded that the necking machine embodied the asserted patent claims, was ready for patenting, and that the letter predated the critical date. Thus, the dispute focused on whether the letter was a commercial offer for sale and whether it was made “in this country.”

The Federal Circuit determined that the letter was a commercial offer for sale. While labeled as a “quotation,” the letter included definite terms typically associated with a binding offer, such as pricing, delivery schedules, payment terms, warranties, and liability conditions. These terms established the mutual obligations of the parties. The Court found that the letter required immediate performance since Complete Packaging was obligated to pay 50% of the purchase price upfront and Crown committed to begin manufacturing upon receipt of payment. Also, despite an explicit clause requiring Crown’s written acceptance, the Court found that the letter was still a commercial offer for sale under established legal precedent.

The Federal Circuit also rejected Crown’s argument that the letter was not made “in this country.” Pre-AIA § 102(b) defines an offer made to a US company at its US [...]

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For Deterrence: Inherent Power to the Rescue to Punish Meritless Lawsuit

by | Dec 19, 2024 |

The US Court of Appeals for the Federal Circuit affirmed a district court’s decision to use its inherent power to award deterrence sanctions for filing a nuisance patent infringement lawsuit. PS Products Inc. v. Panther Trading Co. Inc., Case No. 2023-1665 (Fed. Cir. Dec. 6, 2024) (Moore, Stoll, Cunningham, JJ.)

PSP filed a design patent infringement lawsuit against Panther. PSP voluntarily dismissed the case with prejudice after Panther threatened to seek Rule 11 sanctions for the filing of a frivolous lawsuit. After the case was dismissed, Panther filed a motion seeking its attorneys’ fees under 35 U.S.C. § 285 and $100,000 in deterrence sanctions under the court’s inherent power. The district court found the case exceptional under § 285 and awarded Panther its attorneys’ fees. The district court also found PSP and its counsel joint and severally liable for $25,000 in deterrence sanctions. PSP did not appeal the finding that the case was exceptional or the decision to grant attorneys’ fees, but it did appeal the award of deterrence sanctions under the court’s inherent power.

Design patent infringement requires showing that an ordinary observer would find the accused product and claimed design “substantially the same” such that the observer would be deceived into believing that the accused product was the patented design. However, in some cases the accused product and the patented design are “plainly dissimilar” such that it would be clear to an ordinary observer the two designs were not “substantially the same.”

The Federal Circuit affirmed the district court’s award of deterrence sanctions, finding that the district court did not err by inferring PSP’s bad faith conduct based on the clear lack of legal merit of the case against Panther. The Court found that Panther’s accused product was “plainly dissimilar” to the patented design (shown below), such that PSP’s case was a nuisance lawsuit.

The Federal Circuit found that bad faith was also reasonably inferred based on PSP’s history of filing 25 meritless lawsuits in the same district, even though the district court did not analyze each suit. PSP cited the general venue statute in all 25 lawsuits rather than the required patent-specific venue statute, and PSP did not have proper venue in the lawsuit against Panther.

The Federal Circuit also found no abuse of discretion when the district court imposed sanctions under its inherent power. Rule 11 sanctions were unavailable since the case was already dismissed, but the district court had no other mechanism to sanction PSP’s bad faith conduct of filing multiple meritless lawsuits except the court’s inherent power. Finally, the Court found that imposing deterrence sanctions under the district court’s inherent power was proper even when it had already awarded attorneys’ fees and costs under § 285 because the statute does not preclude separate sanctions.

The Federal Circuit declined to award Panther its attorneys’ fees for the appeal because while PSP’s [...]

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Change Between Provisional and Nonprovisional Application Is Lexicography

by | Dec 19, 2024 |

The US Court of Appeals for the Federal Circuit affirmed a district court judgment of noninfringement, finding that deleting a portion of a definition between a provisional application and a nonprovisional application was evidence that the patentee intended to exclude the deleted language from the claim scope. DDR Holdings, LLC v. Priceline.com LLC and Booking.com B.V., Case Nos. 23-1176; -1177 (Fed. Cir. Dec. 9, 2024) (Chen, Mayer, Cunningham, JJ.)

DDR owns a patent directed to an e-commerce system involving “‘three main parties’ aside from the end consumer: merchants, hosts, and outsource providers.” The specification describes merchants as “the producers, distributors, or resellers of the goods to be sold through the outsource provider.”

DDR sued Priceline for infringement of four patents. In response, Priceline sought inter partes review (IPR), after which three of the challenged patents were found to be unpatentable. The Patent Trial & Appeal Board found that the fourth challenged patent was patentable over the cited prior art. Although the Board’s determination did not turn on the meaning of the term “merchants,” the Board construed “merchants” as “producers, distributors, or resellers of the goods or services to be sold.” In doing so, the Board applied the then applicable  “broadest reasonable interpretation” standard.

In the district court case, Priceline proposed that, consistent with the specification, “merchants” should be construed as only including purveyors of goods, while DDR sought to also include purveyors of services. The district court agreed with Priceline and adopted a construction that excluded services. Following the district court’s claim construction, the parties stipulated to noninfringement, agreeing that the court’s construction was case-dipositive in Priceline’s favor on the issue of infringement. DDR appealed.

The Federal Circuit affirmed. The Court reviews “claim construction based on intrinsic evidence de novo and review[s] any findings of fact regarding extrinsic evidence for clear error.” With only two exceptions, the Court gives terms “their plain and ordinary meanings to one of skill in the art when read in the context of the specification or during prosecution.” The exceptions are “when a patentee sets out a definition and acts as his own lexicographer” and “when the patentee disavows the full scope of a claim term either in the specification or during prosecution.”

Here, the provisional application for the asserted patent discussed merchants as both “producers of ‘goods’ in one instance, and ‘products or services’ in another.” The asserted patent did not mention services in relation to merchants, instead limiting “merchant” to purveyor of goods. The Federal Circuit found that a skilled artisan would interpret the deletion of the reference to “products or services” between the provisional application and the asserted patent as “indicat[ing] an evolution of the applicant’s intended meaning of the claim term.” The Court found that this was reinforced by the description that limited merchants to purveyors of goods.

DDR argued that incorporating the provisional application by reference into the specification resulted in “one document” and therefore no deletion took place. However, the Federal Circuit did not find this argument persuasive, explaining [...]

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Chromatographic Clash: When Is a Lead Compound Analysis Even Necessary?

by | Dec 12, 2024 |

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s determination that 79 challenged composition claims across three related patents were unpatentable but reversed the Board’s determination that four challenged process claims were not unpatentable. Cytiva Bioprocess R&D v. JSR Corp., et al., Case Nos. 23-2074; -2075; -2191; -2192; -2193; -2194; -2239; -2252; -2253; -2255 (Fed. Cir. Dec. 4, 2024) (Prost, Taranto, Hughes, JJ.)

The patents in question pertain to chromatography matrices used in affinity chromatography for isolating antibodies. Their primary focus was on the G29A mutation in SPA IgG binding domains, which enhances stability in alkaline environments. The Board upheld the patentability of the process claims while invalidating the composition claims. Cytiva appealed, arguing that the Board erred in its lead compound analysis. JSR cross-appealed on the Board’s finding that the challenged process claim were not unpatentable.

The Federal Circuit disagreed with Cytiva’s argument that a lead compound analysis was necessary. A lead compound analysis is an obviousness framework that involves a two-part inquiry: whether a skilled person in the art would have selected the compound as a starting point for research, and whether the prior art would have motivated the skilled person to modify the compound into the claimed invention. The Federal Circuit noted that lead compound analyses are not always required in chemical patent cases where the prior art references expressly suggest the proposed modification, which was the case here. The Court also explained that even though a lead compound analysis was used here, in this case the claimed compounds could all be lead compounds, and the prior art expressly suggested the G29A modification of the claimed compound.

The Federal Circuit also addressed whether a claim limitation that merely recites an inherent property of an otherwise obvious combination requires additional analysis to demonstrate that a person of ordinary skill in the art would have a reasonable expectation of success. The Court found that additional analysis was unnecessary because “the sole disputed limitation was an inherent property of the claimed composition already determined to be obvious.” The Court found that the Fab binding property of the chromatography matrices was inherent and thus did not require a separate reasonable expectation of success analysis.

As for the process claims that the Board found not unpatentable, the Federal Circuit determined that the composition and process claims were “nearly identical and contain[ed] no substantive distinction relevant to th[e] appeal.” Therefore, the Court held that the Board erred in separating the composition and process claims and found “no basis for treating the claims differently.” The Federal Circuit reversed the Board’s “not unpatentable” determination on those claims and held all challenged patent claims obvious and therefore unpatentable.



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Plausible Alternative Understanding of Prior Art? So What?

by | Dec 12, 2024 |

Affirming the Patent Trial & Appeal Board’s final determination that three claims were invalid for obviousness, the US Court of Appeals for the Federal Circuit ruled that a “plausible alternative understanding” of the prior art did not compel a reversal under the substantial evidence review standard. Koninklijke KPN N.V. v. Vidal, Case No. 19-2447 (Fed. Cir. Dec. 2, 2024) (Prost, Reyna, Chen, JJ.)

Three computer networking companies filed a petition for inter partes review (IPR) to challenge the patentability of claims of a patent for regulating access to a telecommunications network owned by Koninklijke. The challenged claims included limitations concerning devices, identified by a controller with a unique identifier, that requested access to a network. The controller allowed each device network access based on a “grant access time interval.” The petitioners argued that the challenged claims were unpatentable as obvious in view of three prior art references: Obhan, Shatzkamer, and Budka.

After considering the parties’ argument over what was disclosed by the references, the Board found that Obhan disclosed an admission control system for a wireless network that included assigning devices a “good till time.” The Board found that Shatzkamer disclosed managing a wireless network using a system to identify specific devices, add those devices to a “blacklist,” and deny network access to the blacklisted devices. The Board determined that the combination of Obhan, Shatzkamer, and Budka taught the limitations of the challenged claims. Koninklijke appealed.

Koninklijke argued that the Board erred in its determination that the prior art references taught certain claim limitations and provided motivation to combine the references.

Koninklijke first argued that substantial evidence did not support the Board’s finding that Obhan disclosed the access request limitations of the challenged claims. Koninklijke also argued that Obhan did not teach consulting a “good till time” to determine whether to allow a device to access the network. The Federal Circuit disagreed, finding that Koninklijke’s argument merely presented “a plausible alternative understanding of Obhan.” The Court explained that under the substantial evidence standard of review, this was not enough to conclude that the Board’s decision was unsupported by substantial evidence. The Court declined to reweigh the evidence or make factual findings of its own.

Second, Koninklijke argued that the Board’s determination was not supported by substantial evidence because the Board misread and misstated one of the challenged claims. An exemplary claim of the challenged patents recited “an access operation to deny access for the terminal if the access request is received within the time period,” whereas another recited “denying the terminal access to the telecommunications network responsive to the access request being received within the time period defined by the accessed identification of at least one associated deny access time interval.” In its decision, the Board stated that second claim “requires only that the access request be denied if it is received within the time period during which access is denied.” Koninklijke faulted the Board for using the term “if” instead of “responsive to.”

The Federal Circuit did not find [...]

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Moving to Recuse? Too Little, Too Late

by | Nov 14, 2024 |

The US Court of Appeals for the Federal Circuit ruled that waiting until well after an adverse summary judgment motion to move for a district court judge’s recusal is untimely and moot, especially where an appeal from the adverse decision is already filed and where the recusal motion is based on public information. Cellspin Soft, Inc. v. Fitbit LLC, et al., Case No. 22-1526 (Fed Cir. Nov. 1, 2024) (Taranto, Prost, Reyna, JJ.) (nonprecedential).

Cellspin filed a complaint for patent infringement against Fitbit and others in October 2017. In February 2021, Fitbit amended its corporate disclosure statement to reflect the completion of its acquisition by Google (an indirect subsidiary of Alphabet). Almost a year later, in January 2022, Fitbit and the other defendants moved for summary judgment of noninfringement in their respective cases, and in June 2022, the district court granted summary judgment.

Months later, in January 2023, after the grant of summary judgment and the filing of notices of appeal from that grant, Cellspin filed a motion to recuse the district court judge based on the judge’s mutual fund investments that were likely to invest in Google. The consulting firm for which the judge’s husband worked also sold Google services, but the judge’s spouse did not do work for Google. The district court denied the motion on the merits as untimely and because the district court lacked authority to vacate the summary judgment that was already on appeal.

Applying Ninth Circuit law and reviewing for abuse of discretion, the Federal Circuit found that Cellspin’s behavior in waiting until well after it had lost on summary judgment, and almost two years after Google’s acquisition of Fitbit became final, “raises obvious concerns of lack of equity and strategic misuse of recusal.” The sources Fitbit cited for the judge’s spouse and the activities of the spouse’s employer were also public well before the summary judgment motion was granted, as were the judge’s financial disclosures.

While there is no specific time limit for seeking recusal, the Federal Circuit (citing its 1989 decision in Polaroid v. Eastman Kodak) noted that “timeliness is a well-established consideration in application of the [recusal] statute. In deciding motions to vacate orders issued by an allegedly disqualified judge, the courts have used ‘untimely’ as a synonym for ‘unfair’ when the circumstances, like those present here, are such that a grant of the motion would produce a result inequitable, unjust, and unfair.”

The Federal Circuit also noted that the risk of injustice to the parties from denying vacatur would also be essentially nonexistent here because the Federal Circuit’s concurrent holding on the summary judgment appeal against other defendants had preclusive effect, resolving Cellspin’s infringement assertions against Fitbit as well.

Practice Note: Any motion for recusal should be promptly filed when grounds for the motion become apparent.



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Equivalence Requires Element-by-Element Proof With Linking Argument

by | Nov 7, 2024 |

The US Court of Appeals for the Federal Circuit affirmed a district court determination that a patent owner had not provided the “particularized testimony and linking argument” required to demonstrate equivalence under the doctrine of equivalents. NexStep, Inc. v. Comcast Cable Commc’ns, LLC, Case No. 2022-1815 (Fed. Cir. Oct. 24, 2024) (Chen, Taranto, JJ.) (Reyna, J., concurring in part and dissenting in part). In his dissent, Judge Reyna criticized the majority for ignoring the totality of the evidence presented by the patent owner and imposing a new rule requiring patentees to always present expert testimony to prove infringement under the doctrine of equivalents.

NexStep owns a patent directed to a “concierge device” for assisting users with obtaining customer support for smart devices. The claims are directed to a concierge device that initiates a technical support session in response to “a single action” (i.e., a single button press) by a user. After the claimed “single action,” the concierge device conveys consumer device identification information for the product at issue, identifies an appropriate technical support team for the product, and causes the home gateway to initiate a support session for the device and forward the consumer device information during the session.

NexStep sued Comcast for patent infringement, asserting that three tools in Comcast’s mobile smartphone application infringed the concierge device patent: Xfinity Assistant, Troubleshooting Card, and Diagnostic Check. Each of these tools assists users with troubleshooting a given device in response to the user pressing a series of buttons on a smartphone’s display. At trial, NexStep argued that pressing a series of buttons literally met the single action limitation because a single action could comprise a series of steps. By way of illustration, NexStep’s expert explained that throwing a baseball – a single action – required multiple steps: “[W]hen you throw a baseball, you pick it up, you orient it, you get it in your palm, you throw it.”

The jury returned a verdict of no literal infringement but found infringement under the doctrine of equivalents. Comcast moved for judgment as a matter of law, which the district court granted after finding that NexStep had failed to offer the “particularized testimony and linking argument” required to demonstrate equivalence. NexStep appealed.

The Federal Circuit emphasized that the doctrine of equivalents provides a “limited exception” to the principle that the claim defines the scope of the patentee’s exclusivity rights, and that a finding under the doctrine of equivalents is “exceptional.” To guard against overbroad applications of this exception, the Court’s precedent imposes specific evidentiary requirements necessary to prove infringement under the doctrine. The patent owner must provide proof on an element-by-element basis and from the perspective of someone skilled in the art, “for example through testimony of experts or others versed in the technology; by documents . . . and . . . by the disclosures of the prior art.” Finally, the patent owner must provide “particularized testimony and linking argument as to the insubstantiality of the differences between the claimed invention and the [...]

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Can’t Stop the FRAND: Navigating SEP Licensing Disputes

by | Nov 7, 2024 |

The US Court of Appeals for the Federal Circuit vacated a district court’s decision to deny an antisuit injunction prohibiting a patent owner from enforcing injunctions that it obtained in Columbia and Brazil on standard essential patents (SEPs). Telefonaktiebolaget LM Ericsson, et al. v. Lenovo (United States), Inc., Case No. 24-1515 (Fed. Cir. Oct. 24, 2024) (Prost, Lourie, Reyna, JJ.)

Lenovo and Ericsson entered into negotiations to cross-license their SEPs to each other. SEPs are patents declared essential to complying with a technical standard. Because SEPs by definition must be practiced to comply with a given standard, SEP holders wield significant power over standard implementers during licensing negotiations. Standard setting organizations therefore typically have an intellectual property policy under which SEP holders agree to license their SEPs on fair, reasonable, and nondiscriminatory (FRAND) terms. Here, the parties agreed that the FRAND commitment was a contract, governed by French law, that each party could enforce against the other, and that the FRAND commitment included an obligation to negotiate in good faith over licenses to SEPs.

After the parties were unsuccessful in reaching agreement, Ericsson sued Lenovo in US district court alleging that Lenovo infringed four of Ericsson’s US SEPs related to the 5G wireless communication standard. Ericsson also alleged that Lenovo breached its FRAND commitment by failing to negotiate in good faith and asked the district court to determine a FRAND rate for a global cross-license between the parties. Lenovo counterclaimed, alleging that Ericsson infringed four of Lenovo’s 5G US SEPs and asking for a similar outcome. Lenovo also asked the district court to enter an antisuit injunction prohibiting Ericsson from enforcing the preliminary injunctions Ericsson obtained in Colombia and Brazil that prohibited Lenovo from infringing Ericsson’s Columbian and Brazilian 5G SEPs. The district court denied Lenovo’s motion, following the antisuit injunction framework in the Ninth Circuit’s 2012 decision in Microsoft v. Motorola. The district court concluded that the instant suit was not dispositive of the foreign action, which was a threshold requirement to enter such an injunction. Lenovo appealed.

The Federal Circuit disagreed with the district court’s determination, finding that a party with a FRAND commitment must negotiate in good faith over a license to its SEPs before it pursues injunctive relief based on those SEPs. Interpreting the “dispositive” requirement, the Court concluded that the “requirement can be met even though a foreign antisuit injunction would resolve only a foreign injunction (and not the entire foreign proceeding), and even though the relevant resolution depends on the potential that one party’s view of the facts or law prevails in the domestic suit.” Here, the Court found that the requirement was met because the “FRAND commitment precludes Ericsson from pursuing SEP-based injunctive relief unless it has first complied with the commitment’s obligation to negotiate in good faith over a license to those SEPs.” If the district court were to determine that Ericsson had not complied with that obligation, that determination would dictate the impropriety of Ericsson pursuing SEP-based injunctive relief. Accordingly, the [...]

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Pre-Markman Claim Construction Is OK, Within Limits

by | Oct 31, 2024 |

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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