Antibody-drug conjugates are among the most active areas of oncology drug development, and their patent landscape is distinctive because an ADC is a modular product whose components are patented separately. An ADC joins a monoclonal antibody to a cytotoxic payload through a chemical linker, using a defined conjugation chemistry and a specified drug-to-antibody ratio. Each of these elements, the antibody, the linker, the payload, the conjugation site and chemistry, and the ratio, can be claimed independently, so freedom-to-operate risk is layered across several distinct patent families held by different owners. Freedom-to-operate determines whether making, using, or selling a product would infringe another party's active patent claims, and peer-reviewed analysis of ADC intellectual property has long stressed that the assessment must cover every layer, not the molecule as a whole.¹

The landscape has grown intensely. A peer-reviewed update to the ADC patent literature notes that, a decade after the first ADC patent-landscape review, the basic principles still apply but the field has expanded and matured substantially, with next-generation payloads, linkers, and site-specific conjugation driving new filings.² That expansion is visible in the patent record: across the Cypris corpus of more than 500 million patents and scientific papers, ADC-specific patent families more than doubled from about 2,645 in 2018 to about 5,949 in 2024, with 2025 counts partial because of the roughly eighteen-month publication lag. The growth has been propelled by potent topoisomerase-1 payloads such as the deruxtecan and govitecan classes, new linker and site-specific conjugation technologies, and the expansion of ADCs from hematologic cancers into solid tumors. Peer-reviewed patent reviews map the issued patents onto specific linker and payload technologies,³ and document filing activity concentrated among a small set of leading developers, with more than a dozen approved ADCs and a large clinical pipeline behind the trend.⁴ Within the Cypris corpus, conjugation and site-specific chemistry and the linker layer are the most heavily worked parts of the ADC set, consistent with where litigation and FTO risk concentrate.

Litigation has made the stakes concrete, and it has centered on the linker layer. In the multi-year dispute between Seagen and Daiichi Sankyo over the linker technology used in a blockbuster HER2-targeted ADC, a jury had found for Seagen and awarded damages, but on December 2, 2025 the US Court of Appeals for the Federal Circuit reversed, holding Seagen's key linker patent invalid for lack of written description and non-enablement and vacating the damages award.⁵ The court reasoned that the priority disclosure did not convey possession of the specific claimed subgenus of linkers and that a broad functional claim was not enabled.⁵ For developers, the practical lesson is twofold: the linker and conjugation layer is heavily contested and a frequent source of FTO risk, and the proprietary payload estates built around leading platforms, such as the DXd payload, create freedom-to-operate exposure for follow-on and biosimilar ADCs in markets where those estates are in force. That exposure is concentrated: across the Cypris corpus, the most active assignees in the ADC-specific set include Genentech, Seagen, Daiichi Sankyo, Regeneron, Immunomedics, and ImmunoGen, several of which anchor the payload and linker estates most likely to surface in an FTO search. Because applications publish about eighteen months after filing, the newest linker, payload, and conjugation filings are under-represented, so the current frontier is more active than granted-patent counts suggest.

What creates FTO risk in ADCs

Antibody claims. These cover the targeting antibody and its engineering, a distinct layer that can implicate separate antibody IP.

Linker claims. These cover cleavable and non-cleavable linkers and their chemistry, the layer most heavily litigated, as the Seagen v. Daiichi Sankyo dispute demonstrates.⁵

Payload claims. These cover the cytotoxic agent, including proprietary payload estates built around specific classes, which create FTO exposure for follow-on products.

Conjugation and site-specific claims. These cover how payload and antibody are joined and where, an area of intense recent innovation and patenting.³

Drug-to-antibody ratio and formulation claims. These cover the ratio and the finished formulation, adding further independently claimable layers.

How AI-powered landscape and FTO analysis helps

A modular, multi-owner, actively litigated landscape is beyond manual clearance. AI-powered analysis addresses this with semantic search that retrieves relevant antibody, linker, payload, and conjugation claims regardless of terminology, attribution that resolves the many owners to canonical entities, claim-level analysis that separates the layers, and continuous monitoring that tracks new filings and litigation developments. Because ADC advances appear in scientific literature before they are patented, reading both patents and literature gives earlier warning of where the landscape is extending.

Where Cypris fits

Cypris runs patent landscape and freedom-to-operate analysis for modular, contested fields such as antibody-drug conjugates across a corpus of more than 500 million patents and scientific papers, organized through a proprietary R&D ontology. The ontology clusters the landscape by layer, antibody, linker, payload, and conjugation, and normalizes owners to canonical entities, so a team sees how rights are distributed across the many parties rather than a flat list. Semantic search across patents and scientific literature surfaces relevant claims regardless of terminology and connects filings to the underlying research, which is where next-generation linkers and payloads emerge first. Cypris Q, the platform's agentic layer, lets teams run landscape and FTO analysis conversationally and chain the attribution, clustering, and claim-level analysis across layers, and Agentic Monitoring tracks the landscape over time and flags new filings and developments as they publish. Cypris provides enterprise API partnerships with OpenAI, Anthropic, and Google, and is built with enterprise-grade security. Cypris serves hundreds of enterprise customers across pharmaceuticals, chemicals, advanced materials, energy, and other regulated industries.

FAQ

Why is freedom-to-operate hard for antibody-drug conjugates? Freedom-to-operate is hard for antibody-drug conjugates because an ADC is a modular product whose antibody, linker, payload, conjugation chemistry, and drug-to-antibody ratio are each independently patentable and often held by different owners. Clearing one layer does not clear the others. FTO must therefore be assessed layer by layer across multiple patent families.

What are the main claim types in the ADC landscape? The main claim types are antibody claims, linker claims, payload claims, conjugation and site-specific claims, and drug-to-antibody-ratio and formulation claims. Each covers a distinct layer of the ADC and can independently create infringement risk. The linker and conjugation layers are especially heavily patented and litigated.

What was the Seagen v. Daiichi Sankyo dispute about? The Seagen v. Daiichi Sankyo dispute concerned linker technology used in a blockbuster HER2-targeted ADC. A jury had found for Seagen and awarded damages, but on December 2, 2025 the US Court of Appeals for the Federal Circuit reversed, holding Seagen's key linker patent invalid for lack of written description and enablement and vacating the award. It illustrates how the linker layer drives ADC freedom-to-operate risk and how even a trial win can be undone on validity grounds.

How fast is ADC patenting growing? ADC patenting has grown rapidly, with ADC-specific patent families more than doubling between 2018 and 2024 in the Cypris corpus. Growth has been driven by potent topoisomerase-1 payloads, new linker and site-specific conjugation technologies, and expansion from hematologic cancers into solid tumors. Because applications publish about eighteen months after filing, recent activity is under-represented.

What is a payload estate and why does it matter for FTO? A payload estate is the set of patents an organization holds around a specific cytotoxic payload class and its use in ADCs. It matters for FTO because a strong payload estate, such as the one around the DXd payload, can create infringement exposure for follow-on and biosimilar ADCs in markets where it is in force. Developers must assess payload IP as a distinct layer.

Why does ADC analysis need scientific literature? ADC analysis needs scientific literature because linker, payload, and conjugation advances appear in research before they are patented, so the literature gives the earliest signal of where the landscape is extending. Analyzing patents alone gives a lagging view. Cypris analyzes both across more than 500 million patents and scientific papers.

Which teams need ADC patent landscape and FTO analysis? ADC patent landscape and FTO analysis is needed by R&D, IP, and business-development teams at pharmaceutical and biotech companies developing ADCs, payloads, linkers, and conjugation platforms, as well as investors assessing ADC assets. The modular, litigated landscape makes structured analysis essential. Cypris serves hundreds of enterprise customers across pharmaceuticals and other research-intensive industries.

How current does an ADC landscape need to be? An ADC landscape needs to be continuously current, because litigation is active, next-generation linker and payload filings publish constantly, and publication lag hides the most recent activity. A one-time landscape ages quickly. Cypris uses Agentic Monitoring to track the landscape and flag new filings and developments as they publish.

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Battery circularity, the recycling, reuse, and repurposing of batteries, has become the fastest-growing area of battery patenting, and its landscape is a map of the coming competition over critical minerals. According to a joint study by the European Patent Office and the International Energy Agency, international patent families related to battery circularity grew at an average of 42 percent per year from 2017 to 2023, compared with 16 percent for rechargeable battery manufacturing overall and 2 percent across all technical fields.¹ Over the decade the number of these families rose roughly sevenfold.¹ The driver is structural: more than one in four cars sold globally in 2025 was electric, and around 1.2 million electric-vehicle batteries could reach end of life in 2030, rising to 14 million by 2040, so managing and reclaiming that volume is both an environmental necessity and a supply-chain strategy.¹

The landscape is geographically concentrated and shifting quickly. Asian applicants accounted for 63 percent of battery-circularity patent families in 2023, and China's share rose from 5 percent in 2013 to 29 percent in 2023, with Brunp, the recycling subsidiary of a major battery maker, overtaking established Japanese and Korean firms to become the most active filer.¹ European companies and research institutes account for roughly 20 percent of families, with particular strength in the collection and pre-processing of used batteries and in chemical transformation to recover raw materials, reflecting Europe's current role more as a battery user than a producer.¹ An independent count across the Cypris corpus of more than 500 million patents and scientific papers reproduces the same picture: China holds roughly two-thirds of the recycling-specific family set, well ahead of the United States, Germany, South Korea, and Japan, and Brunp is the single most active assignee, ahead of chemical and battery-materials firms such as BASF and Sumitomo Metal Mining. The strategic significance is large: energy storage now represents about 40 percent of all energy-related patenting and is heading toward half, and recycled materials could meet more than a fifth of demand for lithium, nickel, and cobalt by 2040.¹

The technology landscape divides into distinct stages, each a region of patenting. A peer-reviewed patent-network analysis of lithium-ion battery recycling covering 1990 to 2024 finds activity rising steeply since around 2020, with China leading and international collaboration remaining limited,² and bibliometric analysis of the field documents the same long-run acceleration in recycling research and patenting.³ Across the Cypris corpus, hydrometallurgy is the most patented chemical-recovery route, well ahead of pyrometallurgy, while direct recycling and cathode regeneration remain comparatively nascent; a large, separate cluster covers collection, pre-processing, and separation, the earlier stage where Europe is comparatively strong. Metal recovery and cathode regeneration are where much of the chemical innovation and value concentrate, with key work focused on improving leaching efficiency, developing purification methods, and relithiation strategies that restore spent cathode materials. Because applications publish about eighteen months after filing, the most recent activity is under-represented, so the current frontier is even more active than the figures show.

Where the battery-circularity white space is

Direct cathode regeneration. Restoring spent cathode material directly, rather than breaking it down to metals, is a higher-value route that remains comparatively nascent in the patent record, leaving room for defensible positions.²

Efficient metal recovery. Improving leaching efficiency and purification for lithium, nickel, and cobalt is where much chemical innovation concentrates and where recovery economics are decided.²

Collection and pre-processing. Sorting, dismantling, and safe handling, including remote-handling technologies, are an earlier stage where activity is comparatively less crowded and where European applicants are relatively strong.¹

Reuse and repurposing. Second-life applications for batteries, distinct from material recovery, are a separate and growing layer.

Design for recyclability. Battery designs that ease disassembly and recovery link circularity back to manufacturing and are an emerging cross-over area.

How AI-powered landscape and white space analysis helps

Resolving a fast-growing landscape across stages, chemistries, and geographies requires more than keyword search. AI-powered analysis addresses this with semantic search that clusters activity by recovery route and processing stage across varied terminology, attribution that normalizes filers to canonical entities and tracks shifting leadership, and continuous monitoring that keeps pace with a field growing far faster than average. Because circularity advances appear in scientific literature before they are patented, reading both patents and literature gives the earliest signal of where the frontier is moving.

Where Cypris fits

Cypris runs patent landscape and white space analysis for fast-growing energy fields such as battery circularity across a corpus of more than 500 million patents and scientific papers, organized through a proprietary R&D ontology. The ontology clusters activity by recovery route, hydrometallurgy, direct regeneration, separation, and pyrometallurgy, and by processing stage, and normalizes filers to canonical entities, so a team can resolve which routes and stages are crowded and which remain open as white space, and can track shifting leadership as new entrants rise. Semantic search across patents and scientific literature connects filings to the underlying materials and process research, which is where circularity advances appear first. Cypris Q, the platform's agentic layer, lets teams run landscape and white space analysis conversationally and chain the clustering, attribution, and gap analysis, and Agentic Monitoring tracks a defined route over time and flags new patents and papers as they publish. Cypris provides enterprise API partnerships with OpenAI, Anthropic, and Google, and is built with enterprise-grade security. Cypris serves hundreds of enterprise customers across pharmaceuticals, chemicals, advanced materials, energy, and other regulated industries.

FAQ

How fast is battery-recycling patenting growing? Battery-recycling patenting is growing very fast. According to the EPO and IEA, international patent families in battery circularity grew at an average of 42 percent per year from 2017 to 2023, versus 16 percent for battery manufacturing and 2 percent across all technical fields, roughly a sevenfold increase over the decade. It is now growing faster than battery patenting in general.

Who leads in battery-circularity patents? Asian applicants held 63 percent of battery-circularity patent families in 2023. China's share rose from 5 percent in 2013 to 29 percent in 2023, and Brunp, a major battery maker's recycling subsidiary, overtook established Japanese and Korean firms as the most active filer. European companies and research institutes hold roughly 20 percent, with strength in collection and pre-processing. An independent Cypris-corpus count reproduces China's roughly two-thirds share and Brunp's lead.

What technologies does the battery-recycling landscape cover? The battery-recycling landscape covers collection, sorting, and dismantling; mechanical processing; and metal recovery and cathode regeneration. Analysis of the patent record finds hydrometallurgy the most patented chemical-recovery route, ahead of pyrometallurgy, with direct recycling still comparatively nascent. Innovation concentrates on leaching efficiency, purification, and relithiation.

Why is battery circularity strategically important? Battery circularity is strategically important because it is a secondary supply of critical minerals. Around 1.2 million electric-vehicle batteries could reach end of life in 2030 and 14 million by 2040, and recycled materials could meet more than a fifth of lithium, nickel, and cobalt demand by 2040. This links recycling to supply-chain security and energy security.

Where is the white space in battery recycling? The white space in battery recycling includes direct cathode regeneration, efficient metal recovery and purification, collection and pre-processing including remote handling, reuse and repurposing for second-life applications, and design for recyclability. Metal recovery and cathode regeneration are where chemical innovation concentrates. The higher-value opportunities are in routes that improve recovery economics.

Why does battery-recycling analysis need scientific literature? Battery-recycling analysis needs scientific literature because process and materials advances appear in research before they are patented, so the literature gives the earliest signal. Analyzing patents alone gives a lagging view. Cypris analyzes both across more than 500 million patents and scientific papers.

Which teams use battery-recycling patent landscape analysis? Battery-recycling patent landscape analysis is used by R&D, innovation, IP, and strategy teams at battery makers, recyclers, automotive and energy companies, materials developers, and their partners, as well as investors and policymakers. It informs where to invest, where to file, and where competitors are concentrated. Cypris serves hundreds of enterprise customers across energy, advanced materials, chemicals, and other regulated industries.

How do you keep a battery-recycling landscape current? Keeping a battery-recycling landscape current requires continuous monitoring, because the field is growing far faster than average, leadership is shifting quickly, and publication lag hides the most recent activity. A one-time landscape ages quickly. Cypris uses Agentic Monitoring to track a defined route and flag new patents and papers as they publish.

Endnotes

1. International Energy Agency & European Patent Office (2026). Battery circularity: innovation trends for a future source of critical materials. IEA, Paris. https://www.iea.org/reports/battery-circularity
2. von Delft, S., Schlehuber, S., & Hemmelder, A. (2025). Uncovering collaboration and knowledge areas in lithium-ion battery recycling. EES Batteries. https://doi.org/10.1039/d5eb00056d
3. Li, Y., Guo, Y., Guan, J., Zhang, X., & Lou, X. (2022). Global trend for waste lithium-ion battery recycling from 1984 to 2021: a bibliometric analysis. Minerals, 12(12), 1514. https://doi.org/10.3390/min12121514

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AAV gene therapy has crossed into commercial reality, and its patent landscape is distinctive because an AAV therapy is a modular product whose parts are patented separately. An adeno-associated virus vector delivers a therapeutic gene by packaging it inside an engineered protein shell, the capsid, whose surface engages target-cell receptors and whose fate through endocytosis, endosomal escape, and nuclear import determines where the therapy goes and how the immune system responds to it.¹ The intellectual property divides across distinct regions, each a distinct area of patenting: the capsid, spanning natural serotypes and, increasingly, engineered capsids produced by directed evolution, structure-guided design, and machine-learning-guided design;²,³,⁴,⁵ the strategies that address immunogenicity, because pre-existing neutralizing antibodies exclude many patients and the immune response generally prevents redosing;⁶,⁷ the transgene expression cassette, including the promoter and regulatory elements that control where and how strongly the gene is expressed; and the manufacturing process, where empty-capsid content, host-cell productivity, and the ratio of full to empty particles remain challenges at commercial scale.⁸ Because a therapy depends on several of these layers and they are often held by different owners, freedom-to-operate for an AAV product is a multi-layer, multi-owner analysis rather than a single clearance.

The competitive and legal environment has raised the stakes across every layer. Capsid engineering is the most active area of IP, with specialized platform companies developing next-generation capsids that target specific tissues such as the brain, muscle, and retina and that aim to evade pre-existing immunity, and licensing these platforms to larger developers.⁴,⁹ At the same time, foundational vector patents have been litigated, with the Federal Circuit deciding an appeal on core AAV vector claims in early 2026, so the boundaries of the foundational estate continue to be tested even as the field advances.¹⁰ The commercial ground is set by a broader wave of approved products: as of the 2024 review window, the US Food and Drug Administration had approved fourteen cellular and gene therapy products across the modality, of which the AAV-based Luxturna (voretigene neparvovec-rzyl) for RPE65-mediated inherited retinal dystrophy remains the AAV exemplar, first approved in the United States in 2017 and separately authorized in the European Union.⁴,¹¹,¹² Because applications publish about eighteen months after filing, the newest capsid and immune-evasion filings are under-represented, so the current frontier is more active than granted-patent counts suggest.

The strategic question is where defensible, hard-to-design-around IP sits. Across the Cypris corpus of more than 500 million patents and scientific papers, the AAV capsid-variant set holds on the order of 12,966 families and grew from about 828 in 2020 to roughly 1,818 in 2024, with the most active assignees led by the University of Pennsylvania, Voyager Therapeutics, the University of Massachusetts, Genzyme, and UC San Diego, and the United States far ahead of China, France, and the United Kingdom on geography; 2025 and 2026 counts are partial because of the publication lag. The most active and high-value ground is in engineered capsids that both target a tissue precisely and evade pre-existing immunity, because these directly address the field's central limitations, and receptor-guided and machine-learning-guided capsid design are advancing quickly here.²,³,⁴,⁵ Redosing and immune-modulation technologies are a distinct and comparatively open layer,⁶,⁷ as are manufacturing methods that raise the full-to-empty ratio and lower cost,⁸ and expression-cassette designs that improve durability and tissue specificity.⁴,⁹ Reading the landscape by layer and by owner, and tracking both the patents and the underlying virology and immunology research, is what separates a workable position from a blocked one.

What creates FTO risk in AAV gene therapy

Capsid claims. These cover natural serotypes and engineered capsids from directed evolution, structure-guided, and machine-learning design, the most active and contested layer.²,³,⁴,⁵

Immunogenicity and redosing claims. These cover strategies to evade pre-existing antibodies and enable redosing, a distinct and high-value layer given the field's central limitation.⁶,⁷

Transgene and expression-cassette claims. These cover promoters, regulatory elements, and the engineered transgene that control expression, a separately owned layer.

Manufacturing and purification claims. These cover producer systems, full-to-empty separation, host-cell productivity, and purification, where practical, hard-to-design-around barriers concentrate.⁸

Tissue-targeting claims. These cover receptor-guided and tissue-specific delivery, which can independently constrain a competing program.⁹

How AI-powered landscape and FTO analysis helps

A modular, multi-owner, litigation-shaped landscape is beyond manual clearance. AI-powered analysis addresses this with semantic search that retrieves relevant capsid, immunogenicity, cassette, and manufacturing claims regardless of terminology, attribution that resolves the many owners and license chains to canonical entities, claim-level analysis that separates the layers, and continuous monitoring that tracks new filings and disputes. Because AAV advances appear in virology and immunology literature before they are patented, reading both patents and literature gives earlier warning of where the field is heading.

Where Cypris fits

Cypris runs patent landscape and freedom-to-operate analysis for modular, contested fields such as AAV gene therapy across a corpus of more than 500 million patents and scientific papers, organized through a proprietary R&D ontology. The ontology clusters the landscape by layer, capsid, immunogenicity, expression cassette, and manufacturing, and normalizes developer, platform-specialist, and academic owners and their license chains to canonical entities, so a team sees how rights are distributed across the many parties rather than a flat list. Semantic search across patents and scientific literature surfaces relevant claims regardless of terminology and connects filings to the underlying research, which is where new capsids and immune-evasion strategies emerge first. Cypris Q, the platform's agentic layer, lets teams run landscape and FTO analysis conversationally and chain the attribution, clustering, and claim-level analysis across layers, and Agentic Monitoring tracks the landscape over time and flags new filings and developments as they publish. Cypris provides enterprise API partnerships with OpenAI, Anthropic, and Google, and is built with enterprise-grade security. Cypris serves hundreds of enterprise customers across pharmaceuticals, chemicals, advanced materials, energy, and other regulated industries.

FAQ

Why is freedom-to-operate hard for AAV gene therapy? Freedom-to-operate is hard for AAV gene therapy because a therapy is built from a capsid, an immune-evasion strategy, a transgene expression cassette, and a manufacturing process, each independently patentable and often held by different owners. The capsid layer alone is heavily engineered and contested. FTO must be assessed layer by layer across multiple estates.

Why is the capsid the key layer? The capsid is the key layer because it determines which tissues the therapy reaches and how the immune system responds, and it is where most engineering and patenting activity concentrates. Engineered capsids from directed evolution, structure-guided design, and machine learning aim to target tissues and evade immunity. That makes capsid IP the most active battleground.

What claim types create FTO risk in AAV therapy? Five claim types create FTO risk: capsid claims, immunogenicity and redosing claims, transgene and expression-cassette claims, manufacturing and purification claims, and tissue-targeting claims. Each covers a distinct layer and can be held by a different owner. The capsid and manufacturing layers are especially decisive.

Why do immunity and redosing matter so much? Immunity and redosing matter because pre-existing neutralizing antibodies exclude many patients from AAV therapy, and the immune response to a first dose generally prevents giving a second, so AAV is typically a single-dose modality. Technologies that evade pre-existing immunity or enable redosing address a central limitation. They are therefore a distinct, high-value layer.

Where is the white space in AAV gene therapy? The white space includes engineered capsids that target tissues and evade pre-existing immunity, redosing and immune-modulation technologies, manufacturing methods that raise the full-to-empty ratio, and expression-cassette designs that improve durability and specificity. Natural serotypes and liver-directed approaches are comparatively crowded. The durable, defensible value is in capsids, immune evasion, and manufacturing.

Why does AAV analysis need scientific literature? AAV analysis needs scientific literature because new capsids, immune-evasion strategies, and manufacturing advances appear in virology and immunology research before they are patented, so the literature gives the earliest signal. Analyzing patents alone gives a lagging view. Cypris analyzes both across more than 500 million patents and scientific papers.

What software helps analyze the AAV gene therapy patent landscape? Software for the AAV landscape should resolve developer, platform-specialist, and academic owners and license chains to canonical entities, cluster the capsid, immunogenicity, cassette, and manufacturing layers, search patents and scientific literature semantically, and monitor litigation and new filings continuously. Cypris does this across more than 500 million patents and scientific papers using a proprietary R&D ontology, semantic search, Cypris Q, and Agentic Monitoring.

Which teams need AAV patent landscape and FTO analysis? AAV patent landscape and FTO analysis is needed by R&D, IP, and business-development teams at gene therapy and pharmaceutical companies, capsid-platform specialists, academic technology-transfer offices, and investors assessing gene therapy assets. The modular, litigation-shaped landscape makes structured analysis essential. Cypris serves hundreds of enterprise customers across pharmaceuticals and other research-intensive industries.

Endnotes

1. Hao, Y., & Xiang, J. (2023). Biophysical characterization of the AAV capsid through the viral transduction life cycle. Journal of Genetic Engineering and Biotechnology, 21. https://doi.org/10.1186/s43141-023-00518-5
2. Fakhiri, J., Becker, S., & Grimm, D. (2022). Fantastic AAV gene therapy vectors and how to find them: random diversification, rational design and machine learning. Pathogens, 11(7), 756. https://doi.org/10.3390/pathogens11070756
3. Qi, Y., et al. (2025). Artificial intelligence-based approaches for AAV vector engineering. Advanced Science, 12. https://doi.org/10.1002/advs.202411062
4. Gao, F., et al. (2024). AAV engineering and load strategy for tropism modification, immune evasion and enhanced transgene expression. International Journal of Nanomedicine, 19. https://doi.org/10.2147/ijn.s459905
5. Fu, W., et al. (2024). Machine-learning-guided directed evolution for AAV capsid engineering. Current Pharmaceutical Design. https://doi.org/10.2174/0113816128286593240226060318
6. Barnes, C., Scheideler, O., & Schaffer, D. (2019). Engineering the AAV capsid to evade immune responses. Current Opinion in Biotechnology, 60. https://doi.org/10.1016/j.copbio.2019.01.002
7. Meumann, N., Rodríguez-Márquez, E., & Büning, H. (2020). AAV capsid engineering in liver-directed gene therapy. Expert Opinion on Biological Therapy, 21(6). https://doi.org/10.1080/14712598.2021.1865303
8. Yoon, S., Lee, D., et al. (2024). Decoding cellular mechanism of rAAV and engineering host-cell factories. Biotechnology Advances, 72. https://doi.org/10.1016/j.biotechadv.2024.108322
9. Marković, I., et al. (2025). AAV gene therapy drug development and translation of engineered ocular and neurotropic capsids. Clinical and Translational Science, 18. https://doi.org/10.1111/cts.70428
10. RegenxBio Inc. v. Sarepta Therapeutics, Inc., No. 24-1408 (Fed. Cir. Feb. 20, 2026).
11. U.S. Food and Drug Administration. Approved cellular and gene therapy products. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products
12. U.S. Food and Drug Administration (2017). Luxturna (voretigene neparvovec-rzyl). https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/luxturna

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