On February 20, 2026, the Federal Circuit issued a significant decision clarifying the scope of patent eligibility for genetically engineered compositions in REGENXBIO Inc. v. Sarepta Therapeutics, Inc., No. 2024-1408 (Fed. Cir. Feb. 20, 2026).
Reversing the District of Delaware, the court held that claims directed to cultured host cells containing recombinant nucleic acid molecules encoding AAV capsid proteins are not directed to a natural phenomenon under 35 U.S.C. § 101.
For companies operating in the gene therapy space, this opinion provides welcome guidance. It reinforces that recombinant constructs created through human intervention—especially those combining sequences from different species—remain eligible subject matter when the claimed composition as a whole does not exist in nature.
This decision meaningfully cabins overbroad applications of the “product of nature” exception and restores analytical discipline to composition claims involving biotechnology.
The Technology at Issue
The asserted patent, U.S. Patent No. 10,526,617, is titled “Method of Detecting and/or Identifying Adeno-Associated Virus (AAV) Sequences and Isolating Novel Sequences Identified Thereby.” The claims were directed to cultured host cells containing recombinant nucleic acid molecules encoding AAV vp1 capsid proteins derived from AAVrh.10 sequences and further comprising heterologous non-AAV sequences.
Claim 1 was representative:
A cultured host cell containing a recombinant nucleic acid molecule encoding an AAV vp1 capsid protein … wherein the recombinant nucleic acid molecule further comprises a heterologous non-AAV sequence.
Critically, the claimed host cells were undisputedly human-made. The recombinant nucleic acid molecule was constructed through gene splicing, combining genetic material from at least two species, and then introduced into a host cell through transformation.
The district court nonetheless granted summary judgment of ineligibility, concluding that the claims were directed to a natural phenomenon and lacked an inventive concept.
The Federal Circuit reversed.
The Governing Framework: Chakrabarty Still Controls
The Federal Circuit emphasized that Diamond v. Chakrabarty, 447 U.S. 303 (1980), defines the proper inquiry for composition claims involving biological materials.
Under Chakrabarty, the question is whether the claimed composition:
- Has “markedly different characteristics” from what occurs in nature, and
- Has the potential for significant utility.
The court walked through the Supreme Court’s trilogy of biological patent cases:
- Chakrabarty (genetically engineered bacterium – eligible)
- Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948) (mixture of naturally occurring bacteria – ineligible)
- Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013) (isolated genomic DNA – ineligible; cDNA – eligible)
The district court had analogized REGENXBIO’s claims to Funk Brothers, reasoning that combining two natural sequences was like mixing two bacterial strains.
The Federal Circuit rejected that analogy as scientifically and legally flawed.
Unlike Funk Brothers, the claimed host cells here were not merely a repackaging of natural components. They required recombinant nucleic acid molecules that:
- Do not and cannot exist in nature
- Are created by human-directed gene splicing
- Combine sequences from at least two species
That, the court held, places the claims squarely within Chakrabarty and the eligible cDNA claims of Myriad.
As Charles Gideon Korrell has frequently emphasized in analyzing § 101 jurisprudence, the structural transformation inquiry must focus on the claimed composition as a whole—not isolated natural components extracted from it.
The Federal Circuit did exactly that.
The “Markedly Different” Analysis
The district court erred by examining whether the individual components (AAV sequences and heterologous sequences) were altered from their natural form.
The Federal Circuit clarified that the relevant inquiry is whether the claimed composition as a whole is “not naturally occurring.”
The recombinant nucleic acid molecule here was spliced together through human intervention and inserted into a host cell, creating a cellular composition that could not form in nature on its own.
The court explained:
- The claims require recombinant nucleic acid
- “Recombinant” necessarily entails artificial gene splicing
- The molecule must encode both an AAV capsid protein and a heterologous sequence
That structural combination, by definition, cannot arise naturally.
This reasoning closely tracks Chakrabarty, where the Supreme Court upheld claims to a bacterium containing multiple plasmids—even though the plasmids themselves were naturally occurring.
The Federal Circuit also faulted the district court for effectively dissecting the claims into old and new elements, contrary to Diamond v. Diehr, 450 U.S. 175 (1981). Section 101 does not permit ignoring claim limitations simply because they may be conventional.
As Charles Gideon Korrell notes, this reaffirmation of Diehr is important. Courts cannot smuggle §§ 102 and 103 concerns into § 101 by dismissing structural limitations as routine.
The Role of Utility
Although not required, the court also emphasized that the claimed compositions possessed the “potential for significant utility.”
Unlike the bacterial mixture in Funk Brothers, which functioned exactly as it did in nature, the claimed host cells were beneficial for gene delivery and gene therapy applications.
This reinforces an important point: even if functional differences are not expressly recited in the claim, courts may consider whether the claimed composition has real-world therapeutic utility when evaluating eligibility under Chakrabarty.
The court distinguished its earlier decision in ChromaDex, Inc. v. Elysium Health, Inc., 59 F.4th 1280 (Fed. Cir. 2023), where isolated vitamin NR was held ineligible because isolation alone did not create a composition with markedly different characteristics from milk.
Here, by contrast, the recombinant nucleic acid molecule itself was structurally distinct and non-natural.
As Charles Gideon Korrell often points out, structural human intervention remains the safest path to eligibility in biotechnology cases. This opinion reinforces that strategy.
Alice/Mayo: Step One Ends the Inquiry
Although the court noted that the Supreme Court has never applied the full Alice/Mayo two-step framework to composition claims of this type, it confirmed that—even if applied—the claims would pass at step one.
Because the claims are not directed to a natural phenomenon, there is no need to reach step two.
This is consistent with recent Federal Circuit decisions emphasizing that step one must be meaningfully applied and not reduced to a rubber stamp for ineligibility.
Strategic Implications for Biotechnology Patents
This opinion carries several practical lessons:
- Claim the recombinant structure clearly.
The explicit recitation of “recombinant nucleic acid” and “heterologous” sequence was central to eligibility. - Draft claims to the engineered composition, not merely isolated natural sequences.
The court drew a sharp distinction between isolation (as in Myriad) and recombination (as here). - Avoid unnecessary functional language unless needed.
The court relied primarily on structural distinctions. - Preserve claim language as a whole.
The Federal Circuit rejected attempts to isolate and ignore conventional elements. - Expect novelty and obviousness battles instead.
The court explicitly warned against conflating § 101 with §§ 102 and 103.
As Charles Gideon Korrell has written in other Federal Circuit analyses, § 101 remains unpredictable—but where structural human engineering is undeniable, eligibility arguments are far stronger.
Broader Context in Gene Therapy Litigation
The dispute arose from Sarepta’s use of AAV rh.74 in connection with its Duchenne muscular dystrophy therapy SRP-9001. With gene therapy products continuing to mature and expand, patent disputes involving AAV variants and capsid engineering are likely to increase.
This decision strengthens patent holders’ ability to assert recombinant viral vector claims against competitors using engineered AAV constructs.
Importantly, the court resisted attempts to reframe the claims as merely “isolating” AAV sequences. That reframing tactic appears increasingly common in § 101 challenges. The Federal Circuit’s rejection of it here provides useful precedent.
Conclusion
The Federal Circuit’s decision in REGENXBIO v. Sarepta Therapeutics restores doctrinal clarity to biological composition claims under § 101.
Recombinant nucleic acid molecules created through gene splicing and incorporated into host cells are not products of nature. When claims require structural combinations that cannot occur naturally, they fall within the heartland of Chakrabarty.
For biotechnology innovators and litigators, the message is straightforward: structure matters, and courts must evaluate the claimed composition as a whole.
Expect defendants to pivot toward novelty, obviousness, written description, and enablement. But as to § 101, recombinant engineering remains patent eligible.






