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Exploring the latest in intellectual property law
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Code, copies, and consequences: $185 million verdict uninstalled!

by | Mar 26, 2026 |

Addressing patent eligibility, infringement, willfulness, enhanced damages, and the limits of patent damages tied to foreign software sales, the US Court of Appeals for the Federal Circuit vacated a $185 million jury award after finding that damages based on foreign sales were improperly included because the accused software copies were made and installed abroad. Trs. of Columbia Univ. v. Gen Digital Inc., Case No. 24-1243 (Fed. Cir. Mar. 11, 2026) (Dyk, Prost, Reyna, JJ.)

The Trustees of Columbia University sued Gen Digital, the Norton software brand marketer, for infringement of patents directed to detecting anomalous program execution in antivirus software. A jury found willful infringement and awarded approximately $185 million in damages, including more than $94 million attributable to foreign sales of Norton software products based on findings that the infringing product sold to foreign customers was made in and distributed from the United States. The district court denied Gen Digital’s post-trial motions, enhanced the damages, and awarded attorneys’ fees. Gen Digital appealed.

Patent eligibility: Abstract at Alice step one

The Federal Circuit determined that the asserted claims are directed to an abstract idea at step one of the Alice framework. The Court explained that the claims, at their core, involve comparing data (function calls) to a model – created using multiple computers – to identify anomalous behavior, which is a long-standing abstract concept in the context of virus detection. Although Columbia argued that the claims improved computer functionality through efficiency gains and the use of distributed models, the Court found that those purported improvements were either themselves abstract or not required by the claim language. The Court agreed with Columbia that factual disputes remain as to whether certain claimed features – particularly the “model of function calls” – were well-understood, routine, and conventional, precluding resolution of step two of the Alice framework. The Court remanded for further proceedings to perform an Alice step two analysis.

Willfulness: Affirmed by substantial evidence

The Federal Circuit found that substantial evidence supported a finding that Gen Digital knew or should have known of the asserted patents, including evidence that its personnel were aware of the underlying technology and related patent applications prior to issuance. The Court rejected Gen Digital’s argument that its litigation defenses precluded willfulness, explaining that post hoc reasonable defenses do not negate willfulness absent evidence that the defendant relied on those defenses at the time of the accused conduct. Because the record supported a finding that Gen Digital failed to adequately investigate potential infringement despite being aware of the patents, the Federal Circuit found no basis to disturb the district court jury’s willfulness determination.

No domestic infringement for foreign-made software copies

The Federal Circuit reiterated the general rule that US patent law does not apply to products made and sold abroad. Although the jury was instructed that damages could include foreign sales if the infringing product was “made in or distributed from the United States,” the Court found this instruction legally incorrect. The Court further explained that 35 U.S.C. § [...]

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Absent a client waiver, attorney-client relationship survives conflict

by | Mar 26, 2026 |

Reversing a district court order requiring the disclosure of attorney-client communications and holding a law firm in civil contempt, the US Court of Appeals for the Federal Circuit ruled that an attorney’s conflict of interest does not automatically terminate the attorney-client privilege and that an invalid order could not support civil contempt. Trs. of Columbia Univ. in City of New York v. Gen Digital Inc., Case No. 24-1243, (Fed. Cir. Mar. 11, 2026) (Dyk, Prost, Reyna, JJ.)

The Trustees of Columbia University sued Gen Digital, the Norton software brand marketer, for infringement of two patents and to correct the inventorship of one of the patents. Norton owned the patent on which inventorship correction was sought, and a Norton employee, Dr. Dacier, was listed as the sole inventor. Columbia alleged that two Columbia professors invented the subject matter.

On the inventorship issue, Norton and Dr. Dacier were both represented by Quinn Emanuel Urquhart & Sullivan. Dr. Dacier was deposed and testified about the development of the invention, including activities involving the Columbia professors. Dr. Dacier did not attribute any inventive contributions to the Columbia professors, but Columbia argued – and the district court agreed – that his testimony supported Columbia’s inventorship theory.

Before the district court, Columbia argued that this representation created an improper conflict of interest, particularly because Dr. Dacier had allegedly expressed views critical of Norton’s litigation positions. In Columbia’s view, Quinn Emanuel had improperly prevented Dr. Dacier from testifying at trial in support of Columbia’s inventorship claims. The district court agreed, finding that Quinn Emanuel’s representation of Dr. Dacier raised a conflict, and ruled that Quinn Emanuel’s current representation of Norton automatically terminated its representation of Dr. Dacier. The district court ordered Quinn Emanuel to release its communications with Dr. Dacier. Quinn Emanuel had previously asserted a claim of privilege over these communications. Quinn Emanuel refused the production order, and the district court found Quinn Emanuel in civil contempt. As a sanction, the district court imposed a negative evidentiary inference that Dr. Dacier would have testified to improper conduct by Quinn Emanuel – supporting Columbia’s motion for enhanced damages and attorneys’ fees in a companion case. Quinn Emanuel appealed.

On appeal, Quinn Emanuel argued that the district court’s order requiring the disclosure of communications with Dr. Dacier was invalid because it improperly compelled production of privileged communications and that the contempt finding should be reversed. Columbia argued that the disclosure order was proper because Norton did not raise the privilege issue response to Columbia’s motion for an order to show cause, Quinn Emanuel failed to request in camera review, Quinn Emanuel did not contact Dr. Dacier to determine if he wanted to assert privilege, and Dr. Dacier waived the privilege by emailing both Columbia’s counsel and Quinn Emanuel disclosing that he had been in contact with Columbia’s counsel.

The Federal Circuit rejected all four arguments, holding that there was “no question that Dr. Dacier retained Quinn [Emanuel] to represent him and that he did not terminate the relationship [...]

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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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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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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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