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Exploring the latest in intellectual property law
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Exploring the latest in intellectual property law
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Corresponding disclosed structure? Only what’s necessary to perform a recited function

by | Mar 26, 2026 |

The US Court of Appeals for the Federal Circuit held that the disclosure of an added function in the specification of a patent should not affect the structure necessary to meet the recited function in a Section 112(f) claim element. Gramm v. Deere & Co., Case No. 24-1598 (Fed. Cir. Mar. 11, 2026) (Lourie, Reyna, Cunningham, JJ.)

Richard Gramm exclusively licensed Reaper Solutions rights to a patent directed to an apparatus for keeping the header of a crop harvester at a certain height above the ground as the harvester moves across a field. Gramm and Reaper sued Deere & Co., alleging that specific Deere header sensor kits infringed the patent. Deere challenged the validity of the patent in a partially successful inter partes review (IPR) proceeding, leaving one independent claim and some of the dependent claims asserted.

In connection with claim construction during the IPR proceeding, Reaper and Deere disputed the meaning of “control means” in the independent claim. At issue was whether the specification’s discussion of the “head controller 20” was sufficiently definite corresponding disclosed structure for the (§112(f)) means-plus-function claim element to satisfy the definiteness requirement of §112 (b). The function of the claimed “head controller” was to provide electrical control signals to another feature in the claimed apparatus to control the lateral position of the corn header and its height above the ground or soil. Deere argued that “head controller 20” was not sufficiently definite since it amounted to a general-purpose computer or processor, thus requiring disclosure of code or an algorithm to avoid being indefinite.

In 1997, the patent’s priority date, there were only three commercially available head controllers used in Deere combines: Dial-A-Matic Versions #1, #2, and #3. Deere argued that only Versions #2 and #3 could constitute corresponding structure for the “head controller 20,” as only those versions could control both header height and lateral position. Because Versions #2 and #3 used microprocessors to control header height, Deere argued that the patent specification was required to disclose an algorithm for performing the claimed function. In the alternative, Deere argued that the district court should hold Reaper to its argument in the IPR proceeding that the corresponding disclosed structure was the specific controller incorporated into Deere’s Dial-A-Matic Version #1, which “controlled header height through a series of diodes, switches and integrated circuits rather than a microprocessor.”

The district court found the independent claim indefinite and reasoned that the specification’s reference to Dial-A-Matic Versions #2 and #3 triggered the need for a disclosure of a general-purpose computer or microprocessor that the patent failed to satisfy. The district court accepted Deere’s argument that the specification did not disclose Dial-A-Matic Version #1 as a corresponding structure because it could not perform the function of controlling the lateral position of the corn header. Reaper appealed.

The Federal Circuit agreed with Reaper that the district court erred by identifying a corresponding structure for “control means” beyond what was necessary to perform the claimed function, leading the district court to incorrectly [...]

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Too late to help: Inventorship fix fails to revive forfeited argument

by | Mar 19, 2026 |

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board, concluding that the retroactive effect of a correction of inventorship under 35 U.S.C. § 256 does not bar the application of forfeiture principles in inter partes review (IPR) proceedings, and that a patent owner that fails to timely raise an antedating theory during an IPR may forfeit reliance on a later corrected inventorship to resurrect that theory. Implicit, LLC v. Sonos, Inc., Case Nos. 20-1173; -1174 (Fed. Cir. Mar. 9, 2026) (Taranto, Stoll, Cunningham, JJ.)

Implicit owns patents directed to content rendering that originally named Edward Balassanian and Scott Bradley as co-inventors. Sonos filed IPR petitions against both patents, asserting unpatentability under 35 U.S.C. §§ 102 and 103, primarily based on Janevski, which had an effective prior art date of December 11, 2001.

To avoid Janevski as prior art, Implicit argued that the inventions were conceived and reduced to practice before December 11, 2001. It contended that Balassanian and Bradley conceived of the inventions and collaborated with another engineer, Guy Carpenter, to implement the invention prior to December 2001. Implicit argued that Carpenter’s work inured to the benefit of the named inventors, thereby antedating Janevski. The Board rejected Implicit’s argument and found the challenged claims unpatentable as anticipated or obvious over Janevski. The Board found Implicit’s evidence insufficient to establish conception and communication of the invention by Carpenter in a manner that would support an earlier reduction to practice.

Following the Federal Circuit’s and Supreme Court’s decisions in Arthrex v. Smith & Nephew addressing the Appointments Clause as applied to IPR proceedings, the case was remanded to permit Director review. While proceedings were ongoing, Implicit sought correction of inventorship under 35 U.S.C. § 256 to add Carpenter as a co-inventor. The United States Patent & Trademark Office (USPTO) granted the request and issued certificates of correction in August 2022. The Federal Circuit remanded the case to the Board to determine what impact, if any, the corrections had on the prior final written decisions. The Board concluded that equitable doctrines, including forfeiture, precluded Implicit from relying on the corrected inventorship to advance a new antedating theory. Implicit appealed.

The appeal presented two principal questions:

  • Whether the retroactive effect of a correction of inventorship under § 256 forecloses application of forfeiture principles in an IPR proceeding.
  • Whether the Board abused its discretion in finding that Implicit forfeited its right to assert a new antedating theory based on corrected inventorship.

Implicit argued that § 256 contains no temporal limitation and that corrections operate retroactively, requiring the Board to revisit its unpatentability determinations once Carpenter was added as an inventor. Sonos and the USPTO countered that Implicit had litigated the IPRs on a single inventorship theory and waited until after adverse final written decisions to change course.

The Federal Circuit affirmed on both grounds.

First, the Federal Circuit found that forfeiture principles may apply notwithstanding the retroactive effect of § 256. Although [...]

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USPTO signals new emphasis on US manufacturing in IPR and PGR institution decisions

by | Mar 19, 2026 |

The United States Patent and Trademark Office (USPTO) issued a Memorandum on March 11, 2026, signaling that the Patent Trial & Appeal Board may place increased weight on domestic manufacturing activity and the interests of small businesses when deciding whether to institute inter partes review (IPR) or post grant review (PGR).

The America Invents Act (AIA) established IPR and PGR proceedings as mechanisms for challenging the validity of issued patents before the Board. In establishing the framework for institution decisions, the statute directs the USPTO Director to consider broader policy concerns, including the impact on the US economy, the integrity of the patent system, and the efficient administration of the USPTO.

The Memorandum highlights concerns regarding the decline of US manufacturing, particularly in the electronics and computer sectors. Citing government studies, the USPTO notes that the offshoring of key industries has contributed to economic and national security vulnerabilities. According to the USPTO, these developments bear directly on the Director’s statutory obligation to consider the economic effects of Board institution decisions.

While some stakeholders contend that IPR and PGR proceedings protect US manufacturers and small businesses from weak patents, the USPTO observed that many of the most frequent petitioners are large companies that report little domestic manufacturing activity and have not made meaningful investments in US production. According to the Memorandum, this data prompted the USPTO to question whether the current discretionary institution framework adequately accounts for the interests of companies that do invest in domestic manufacturing.

As a result, the USPTO announced that certain factors related to US manufacturing and small businesses may now inform discretionary institution determinations. The USPTO encourages parties to address these considerations explicitly in their discretionary briefing.

When evaluating whether to institute an IPR or PGR, the Director may consider:

  • Whether the products accused of infringement in parallel litigation are manufactured in the United States or tied to domestic manufacturing investments.
  • Whether the patent owner produces competing products in the US.
  • Whether the petitioner qualifies as a small business that has been sued for patent infringement.

The Memorandum clarifies that manufacturing considerations are not limited to final assembly but may also encompass the production of components and situations in which products manufactured domestically are later processed abroad. For method claims, the relevant product for this analysis will be the device used to perform the claimed method.

These considerations apply to all to all IPRs and PGRs in which the due date for a patent owner discretionary brief has not yet elapsed.



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Separately recited structures must be separately present in accused device

by | Mar 19, 2026 |

The US Court of Appeals for the Federal Circuit explained (again) that when a claim separately recites multiple structural limitations, infringement requires separate corresponding structures. A single component that sequentially or multifunctionally performs the claimed functions is not enough. Magnolia Medical Technologies, Inc. v. Kurin, Inc., Case No. 24-2001 (Fed. Cir. Mar. 6, 2026) (Lourie, Hughes, Freeman, JJ.)

Magnolia Medical sued Kurin for infringement of two patents directed to devices designed to reduce contamination of blood samples by skin microbes during venipuncture. The claimed devices divert the initial portion of blood, which is most susceptible to contamination, into a separate reservoir before collecting the remainder of the sample. Kurin manufactures the Kurin Lock, which separates the initial blood sample from the remaining sample using a porous plug. That plug initially functions as a vent, allowing air to escape, and then expands as it absorbs blood, closing its pores and forming a seal.

The representative claim of one of the asserted patents recites a device comprising a fluid reservoir “at least partially defined by a seal member and a vent.” The representative claim of the other patent recites a “diverter.”

During claim construction, the district court construed “diverter” as a means‑plus‑function term under § 112(f). Because the Kurin Lock lacked a corresponding diverter structure, the parties stipulated noninfringement of that patent.

The district court did not expressly construe the “seal” and “vent” limitations of the other patent at Markman. At trial, however, the jury found that Kurin infringed that patent.

Kurin moved for judgment as a matter of law (JMOL), arguing that it did not infringe because the Kurin Lock did not include separate seal and vent structures. Instead, a single porous plug performed both functions at separate times. The district court agreed and granted JMOL of no infringement. Magnolia appealed.

The Federal Circuit affirmed, rejecting Magnolia’s argument that the district court had improperly adopted a new claim construction at the JMOL stage. While courts may not introduce a materially different construction after trial, they may elaborate on what is inherent in the plain and ordinary meaning of a claim. The Federal Circuit reiterated its prior holdings that when a claim separately lists structural limitations, the plain and ordinary meaning requires separate corresponding structures. Here, the district court merely clarified that requirement, it did not change the construction.

The Federal Circuit found that the asserted claim required separate structures. The use of “comprising,” the introduction of “a” before both “seal” and “vent,” and the use of “and” between them all pointed to distinct components. The specification further reinforced that the seal and vent were described as separate structures.

The Federal Circuit also affirmed the district court’s construction of “diverter” as a means plus function limitation. Although the claim did not use the word “means,” Kurin successfully showed that the term failed to recite sufficient structure, triggering § 112(f).

Practice note: This case is a reminder that when multiple structural elements are separately recited in a claim, courts are likely to require [...]

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Not so fast, Daubert: Expert report OK after all

by | Mar 19, 2026 |

The US Court of Appeals for the Federal Circuit reversed a district court’s exclusion of the plaintiff’s damages expert, finding that a proffered royalty base tied to unaccused products may be permissible when supported by a causal connection to the accused technology. The Federal Circuit vacated the resulting orders denying discovery and granting summary judgment for lack of a remedy. Exafer Ltd. v. Microsoft Corp., Case No. 24-2296 (Fed. Cir. Mar. 6, 2026) (Moore, Taranto, Stoll, JJ.)

Exafer sued Microsoft for patent infringement based on features of Microsoft’s Azure platform. After Exafer served its expert reports, Microsoft filed a Daubert motion, and the district court excluded Exafer’s damages expert because she used unaccused virtual machines as the royalty base. Exafer moved to reopen fact and expert discovery to present an alternative theory, which the district court denied. The district court subsequently granted Microsoft’s motion for summary judgment based on the absence of a remedy. Exafer appealed all three orders.

Exafer argued that the district court erred in excluding its damages theory, which relied on Microsoft’s virtual machine pricing rate to estimate the value Microsoft placed on the accused features. Exafer contended that the district court misapplied the Federal Circuit’s 2018 decision in Enplas Display Device v. Seoul Semiconductor by effectively creating a categorical bar against considering noninfringing activities in a reasonable royalty analysis.

The Federal Circuit agreed, explaining that in Enplas the unaccused products had no causal connection to the accused infringing products. Here, by contrast, the Court found such a connection: Microsoft’s own documents showed that Exafer’s royalty base was tied to a causal connection between the accused Azure features and the operation of virtual machines. The Court concluded that Exafer’s damages expert valued the accused features based on the incremental virtual machines Microsoft could host because of those efficiency gains.

The Federal Circuit rejected Microsoft’s argument that Enplas categorically precluded applying a royalty rate to sales of unaccused products to prevent a patent owner from “expanding its patent monopoly to unpatented products.” The Court explained that the analysis must be conducted on a case-by-case basis to determine how the parties would value the accused technology in the hypothetical negotiation. As an example, the Court noted that claims directed to methods of manufacture commonly use the unaccused product produced by the claimed method as the royalty base.



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German Federal Court of Justice reinforces strict willing licensee standard in SEP litigation

by and | Mar 19, 2026 | ,

The German Federal Court of Justice (FCJ) established requirements for a fair, reasonable, and nondiscriminatory (FRAND) defense against injunction claims based on standard-essential patents (SEPs). VoiceAge v. HMD, Case No. KZR 10/25 (FCJ Jan. 27, 2026) (Rol-off, Deichfuß, Tolkmitt, Vogt-Beheim, Kochendörfer, JJ.)

Consistent with its earlier decisions, the FCJ adopted an approach that imposes strict procedural and substantive obligations on implementers in FRAND licensing negotiations. This approach reinforces a demanding framework for implementers. The FCJ rejected the implementer’s FRAND defense in this case.

The case attracted considerable attention because the European Commission, acting as the EU competition law authority, intervened by submitting an amicus curiae brief and presenting oral argument before the FCJ. The Commission’s participation underscored the ongoing de-bate over the proper interpretation of FRAND obligations under Article 102 TFEU and, more particularly, the framework established by the Court of Justice of the European Union (CJEU) in Huawei v. ZTE.

Willing licensee standard and the obligation to provide security

The FCJ found the implementer to be an unwilling licensee since it unduly delayed its responses to the SEP owner’s license offers and failed to provide adequate security in a timely manner. According to the FCJ, the implementer must promptly enter into negotiations with the SEP owner regarding licensing terms and submit a counteroffer, even if the SEP owner’s initial license offer was not FRAND-compliant. During licensing negotiations, the implementer should actively and constructively engage in efforts to conclude a FRAND-compliant license agreement.

Similar to the recent Statement of Interest by the US Department of Justice and the United States Patent and Trademark Office in US patent litigation between Collision Communications and Samsung, the FCJ underscored the importance of injunctive relief, including for nonpracticing entities (NPEs) and with respect to SEPs. According to the FCJ, only exclusive rights allow an invention to be subject to market processes, and the availability of damages claims does not alter this fundamental principle.

The FCJ cited case law from the Unified Patent Court (UPC) and from national courts in the Netherlands and the United Kingdom to support its reasoning. Taken together, these authorities demonstrate a growing consensus within the European judiciary toward interpreting FRAND obligations as establishing a high threshold for a successful FRAND defense. Consequently, FRAND jurisprudence is developing across Europe in a direction that is increasingly strict for implementers.

The FCJ emphasized that if the SEP owner rejects the counteroffer, the implementer must promptly provide adequate security. In this case, the implementer did not adequately do so because it did not even provide security corresponding to the royalties under its own relatively low counteroffer. However, the FCJ did not provide specific guidance on how to determine the required amount of security. The lower court relied on the amount of the SEP owner’s last offer, but the FCJ did not comment on this offer because the security that the implementer provided was too low.

Unlike lower instance courts, however, the FCJ emphasized in an obiter dictum that providing security is sufficient [...]

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Coiled in controversy: Summary judgment on Walker Process claim unwound

by | Mar 12, 2026 |

The US Court of Appeals for the Federal Circuit vacated a district court’s grant of summary judgment on inequitable conduct and a Walker Process antitrust claim arising from allegations that a patent owner withheld material prior art during patent prosecution and sought to enforce the patents against a competitor in the coiled tubing market. Global Tubing v. Tenaris Coiled Tubes, Case Nos. 23-1882; -1883 (Fed. Cir. Feb. 26, 2026) (Taranto, Hughes, Stark, JJ.)

Global Tubing filed a declaratory judgment action seeking a ruling that its coiled tubing product did not infringe Tenaris’ patents. After uncovering a document in discovery that it characterized as evidence that Tenaris attempted to withhold material information during patent prosecution, Global Tubing amended its complaint to assert inequitable conduct and Walker Process fraud, alleging that Tenaris sought to use fraudulently obtained patents to monopolize the market. Following the completion of discovery, the parties filed cross-motions for summary judgment. The district court granted summary judgment of inequitable conduct to Global Tubing and summary judgment of no liability for Walker Process fraud to Tenaris. As to the Walker Process fraud claim, the court determined that because Tenaris was such a small market player, Global Tubing could not prove it had the market power sufficient to achieve a monopoly. Both parties appealed.

The Federal Circuit determined that the district court erred in granting summary judgment to Global Tubing, finding that genuine disputes of material fact remained as to whether the single most reasonable inference was that the inventor acted with specific intent to deceive the United States Patent and Trademark Office (USPTO), making summary judgment on inequitable conduct inappropriate.

Addressing the Walker Process fraud claim, the Federal Circuit likewise vacated the district court’s grant of summary judgment in favor of Tenaris, finding that the record contained genuine disputes of material fact that precluded judgment as a matter of law. The Court explained that the evidence could support a finding that the inventor knowingly withheld a material prior art reference from the USPTO with intent to deceive, and that Global Tubing had raised a triable issue as to the first prong of its Walker Process claim: whether Tenaris obtained and enforced the patent through knowing and willful fraud on the USPTO.

Turning to the second prong of a Walker Process fraud claim (attempted monopolization), the Federal Circuit observed that the parties advanced competing definitions of the relevant market. The Court concluded that the district court erred by characterizing Tenaris as a small market participant with no dangerous probability of achieving monopoly power without first defining the relevant product and geographic markets or determining whether genuine disputes of material fact existed on those issues.

The Federal Circuit also concluded that genuine disputes of material fact remained as to whether Tenaris engaged in predatory or otherwise anticompetitive conduct. The Court noted that there may have been a triable issue regarding the appropriate date at which to measure Tenaris’ share of the relevant yet undefined market. Considering these unresolved factual questions, the Court [...]

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Tree-mendous award: Damages expert royalty opinions are lit

by | Mar 5, 2026 |

The US Court of Appeals for the Federal Circuit affirmed a damages verdict amounting to tens of millions of dollars. The Court found that the patentee’s damages expert correctly apportioned value to the patented feature and rejected challenges to her methodology. Willis Electric Co., Ltd. v. Polygroup Ltd., Case No. 24-2118 (Fed. Cir. Feb. 17, 2026) (Moore, Stark, Oetken, JJ.)

Willis sued Polygroup for infringing its patent related to pre-lit artificial trees with decorative lighting. In response, Polygroup filed multiple inter partes review (IPR) petitions challenging the asserted claims. Following extensive IPR proceedings, only a dependent claim that required coaxial trunk connectors remained for trial.

A jury found the claim infringed and not obvious, and awarded about $42.5 million in damages, equating to a $4-per-tree royalty. Polygroup moved for judgment as a matter of law of obviousness or, alternatively, for a new trial on damages. The district court denied both motions. Polygroup appealed.

Effect of prior IPR ruling

Polygroup argued that because the independent claim from which the asserted claim depended was held unpatentable, damages should be limited to only the incremental value of the coaxial connectors recited in the asserted dependent claim. The Federal Circuit rejected that argument, explaining that the IPR applied the broadest reasonable interpretation standard, while the district court construed the independent claim under the Phillips standard. Under the district court’s construction, the independent claim required forming simultaneous mechanical and electrical connections regardless of rotational orientation, a feature that was not required under the IPR construction. Because the independent claim had not been held unpatentable under the district court’s construction, the Federal Circuit reasoned that the IPR ruling did not preclude Willis from relying on that one-step functionality in calculating the value attributable to the coaxial connectors recited in the dependent claim.

The Federal Circuit emphasized that what value was attributable to the claimed coaxial connectors was a question of fact for the jury. Substantial evidence supported the jury’s finding that the value included rotationally independent, simultaneous connection functionality, not merely the physical presence of coaxial connectors.

Rule 702 and damages methodology

Willis’ damages expert presented two independent apportionment analyses.

Under an income-based approach, the expert compared profit margins for Willis’ “One Plug” trees and Polygroup’s Quick Set trees against comparable noninfringing trees to derive a royalty range. Under a market-based approach, she analyzed several license agreements to establish a reasonable royalty range, which she combined with her income approach to arrive at an expanded reasonable royalty range. She then applied the Georgia-Pacific factors to select a $5-per-tree royalty, resulting in a jury award of $4 per tree.

Polygroup argued that the expert failed to adequately apportion value and relied on non-comparable licenses and improper averaging methods. The Federal Circuit disagreed, emphasizing the district court’s gatekeeping role under Federal Rule of Evidence 702 while reinforcing the distinction between admissibility and weight.

The Federal Circuit explained that reasonable royalty determinations inherently involve approximation and uncertainty. Where an expert’s methodology is grounded in record evidence, including internal sales [...]

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Did you account for the entire corresponding disclosed structure?

by | Mar 5, 2026 |

The US Court of Appeals for the Federal Circuit affirmed the district court’s grant of summary judgment of noninfringement of a means-plus-function claim element, emphasizing that a patentee must compare the accused product to the entire disclosed structure, not just a selected subset. Genuine Enabling Tech. v. Sony Group Corp., et al., Case No. 24-1686 (Fed. Cir. Feb. 19, 2026) (Dyk, Taranto, Chen, JJ.)

Genuine Enabling Technology (GET) sued Sony for patent infringement, alleging that Sony’s PlayStation 3 and 4 infringed its patent related to synchronizing data streams from multiple input devices. The district court ruled in favor of Sony, granting summary judgment of noninfringement and excluding the infringement conclusion of GET’s expert. GET appealed.

The Federal Circuit affirmed. The parties agreed that the term “encoding means” for synchronizing two separate streams, present in each asserted claim, was a means-plus-function limitation under 35 U.S.C. § 112(f). Neither party disputed that the corresponding structure consisted of the entirety of a logic block disclosed in the patent specification.

GET’s expert focused solely on the bit-rate clock appearing in the logic block, neglecting most of the other disclosed components, and did not provide an explanation for these omissions in his “way” analysis. The Federal Circuit explained that this approach failed to satisfy the function-way-result test for structural equivalence, which requires demonstrating that the accused product is equivalent to the disclosed structure by showing that both the accused and corresponding disclosed structures perform the identical function in substantially the same way to achieve substantially the same result. The Court clarified that while a component-by-component examination is not necessary, the analysis must consider all components of the identified structure or justify any omissions. GET’s expert did not meet the burden of describing the “way” the “encoding means” structure in the patent performed its function.

GET’s expert attempted to simplify structural equivalence to “anything that synchronizes to a clock.” The Federal Circuit explained that this approach improperly reduced the function-way-result test to function-result alone, contradicting the patent’s specific synchronization scheme. Because of the lack of analytical support for the expert’s structural-equivalence conclusion, the Federal Circuit upheld the district court’s exclusion of the expert’s opinion.

Since GET did not seek discovery of the accused product’s Bluetooth schematics until the end of fact discovery, GET’s expert never examined the internal design of the accused Bluetooth modules. Instead, his infringement theory relied solely on assumptions about generic Bluetooth behavior, which the Federal Circuit found to be conclusory, legally insufficient, and inconsistent with the patent’s detailed circuitry disclosed in the specification. The Federal Circuit affirmed the district court’s partial exclusion of GET’s expert’s testimony.

Practice note: When litigating means-plus-function claims under 35 U.S.C. § 112(f), an opining expert must address the entirety of the corresponding structure disclosed in the specification. Selectively focusing on only one or two elements without explaining omissions can be fatal.



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Manufactured host cells markedly different from naturally occurring cells may be patent eligible

by | Mar 5, 2026 | ,

Addressing subject matter eligibility in the life sciences context, the US Court of Appeals for the Federal Circuit reversed a district court’s summary judgment ruling that certain claims directed to genetically engineered host cells were patent ineligible as directed to a natural phenomenon. The Federal Circuit found that the claimed cells contained recombinant nucleic acid molecules that were markedly different from anything occurring in nature and therefore were patent eligible under 35 U.S.C. § 101. REGENXBIO Inc. v. Sarepta Therapeutics, Inc., Case No. 24-1408 (Fed. Cir. Feb. 20, 2026) (Dyk, Hughes, Stoll, JJ.)

REGENXBIO owns a patent directed to genetically engineered host cells containing a recombinant nucleic acid molecule (adeno-associated virus (AAV) rh.10 sequences). These host cells are human made and do not exist in nature. The recombinant nucleic acid molecule is created by chemically splicing together nucleic acid sequences from two different organisms. REGENXBIO sued Sarepta, alleging infringement of its patent. Both parties moved for summary judgment on whether the asserted claims were patent eligible under Section 101. The parties did not assert that claims were ineligible as an abstract idea but rather debated whether the claims disclosed natural products.

The district court analogized the claims to those considered in the 1949 Supreme Court decision in Funk Brothers Seed v. Kalo Inoculant, where two strains of bacteria from two different organisms were merely put together. The district court concluded that the invention, “taking ‘two sequences from two different organisms and put[ting] them together,’” amounted to merely packaging natural products together and found the asserted claims ineligible. REGENXBIO appealed.

The Federal Circuit reversed. Relying on the Supreme Court’s decisions in Diamond v. Chakrabarty (1980) and Association for Molecular Pathology v. Myriad Genetics (2013), the Federal Circuit explained that the relevant inquiry was whether the claimed composition as a whole possessed “markedly different characteristics” from what occurs in nature. The Court emphasized that the claimed recombinant nucleic acid molecules were not naturally occurring and cannot form in nature without human intervention. The claims required a recombinant molecule encoding both an AAV vp1 capsid protein and a heterologous sequence, created by combining genetic material from different sources.

The Federal Circuit explained that like the engineered bacterium in Chakrabarty, the claimed host cells here were “not nature’s handiwork” but a product of human ingenuity. And like the cDNA claims upheld in Myriad, the recombinant molecules represented something “distinct from” naturally occurring DNA. In contrast to Funk Brothers, where the bacteria performed exactly as they did in nature and were merely packaged together, the claimed host cells here contained a newly engineered molecule that did not exist in nature and that enabled gene therapy applications.

The Federal Circuit also noted that the claimed compositions had the potential for significant utility, specifically in gene delivery and gene therapy, further distinguishing them from the ineligible claims in Funk Brothers. Although the claims did not expressly recite a specific therapeutic use, the Court explained that potential utility may be considered in evaluating whether a composition is markedly [...]

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