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Patent landscape, scope, and claims: |
Scope and Claims of US Patent 11,673,898
US Patent 11,673,898 was granted to Moderna Therapeutics on July 4, 2023. This patent primarily covers proprietary compositions and methods related to lipid nanoparticle (LNP) formulations used for mRNA delivery, with potential applications in vaccines, therapeutics, and gene editing.
Patent Scope
The patent’s scope encompasses:
- Specific lipid nanoparticle compositions incorporating unique lipid components.
- Methods of preparing these lipid nanoparticles, including specific manufacturing conditions.
- Delivery techniques optimized for stability and targeted delivery of mRNA molecules.
- Application in prophylactic and therapeutic treatments, particularly vaccines.
The patent aims to protect a broad class of LNP formulations with defined lipid compositions and preparation methods, emphasizing improvements over previous delivery systems in stability, efficacy, and safety.
Claims Breakdown
The claims are divided into independent and dependent claims, with the core claims focusing on:
Independent Claims
- Claim 1: Describes an LNP composition comprising a specific mixture of lipids including an ionizable lipid, phospholipid, cholesterol, and a PEG-lipid, with specified molar ratios.
- Claim 9: Covers a method of preparing the LNPs involving mixing an aqueous phase containing mRNA with an ethanol-based lipid mixture under particular conditions.
Dependent Claims
- Variations on the molar ratios of lipids, including ranges for the ionizable lipid (e.g., 40-60 mol%), cholesterol (10-20 mol%), PEG-lipid (1-3 mol%), and phospholipid (20-30 mol%).
- Specific types of lipids used, such as proprietary ionizable lipids and PEG-lipids with particular structures.
- Modifications involving additional functionalities, like surface modifications for targeted delivery.
- Alternative methods for assembling the LNPs, including microfluidic techniques and extrusion processes.
Key Limitations
- Lipid compositions designed to improve particle stability, delivery efficiency, and biocompatibility.
- Specific molar ratios are central to the claims, aligning with certain formulations used in Moderna’s mRNA vaccines.
- The claims do not specify the exact mRNA sequences or payloads but focus on the delivery vehicle.
Patent Landscape
Examining the patent environment reveals:
Major Players
- Moderna Therapeutics: Holds multiple patents around LNP formulations, mRNA stabilizations, and delivery methods.
- Pfizer/BioNTech: Owns patents covering lipid formulations and mRNA stabilization techniques, often in overlapping technological space.
- CureVac and BioNTech: Also patenting varied lipid nanoparticle technologies, especially concerning lipid compositions and manufacturing processes.
Similar Patents
- The patent family around LNPs includes patents such as US Patent 10,927,592 (Moderna) and WO 2020/016057 (Pfizer/BioNTech). These emphasize lipid compositions with ionizable lipids, PEG-lipids, and specific manufacturing techniques.
- Several patents focus on PEG-lipid structure optimization for minimizing immunogenicity and enhancing circulation time.
Patent Counsel and Litigation Risks
- The lipid composition claims are broad, but patentability is supported by Moderna's specific lipid structures and manufacturing conditions.
- Infringement risks exist for formulations overlapping with claims, especially in jurisdictions with active LNP patent pools or multiple filings.
Geographic Coverage
- While primarily U.S.-based, related patents are filed in Europe, Japan, China, and other key markets, indicating plans for international protection.
Summary of Claims and Landscape Insights
| Aspect |
Details |
| Composition Claims |
Lipid ratios, specific ionizable lipids, PEG structure |
| Method Claims |
Mixing procedures, manufacturing conditions |
| Patent Overlap |
Similar formulations in Pfizer, BioNTech, CureVac |
| Key Variants |
Surface modifications, targeting strategies |
| Patent Strength |
Broad lipid claims supported by specific lipid structures |
| Risks |
Infringement potential; overlapping claims from competitors |
Key Takeaways
- The patent’s claims focus on lipid composition ratios and preparation methods that optimize delivery.
- Moderna's patent landscape is competitive, with overlaps existing across players like Pfizer/BioNTech.
- Patent scope emphasizes stability, delivery efficiency, and manufacturing techniques.
- Broad claims may lead to licensing or litigation in overlapping fields.
FAQs
-
What specific lipids are covered in the patent?
The patent claims include ionizable lipids, phospholipids, cholesterol, and PEG-lipids with particular structures and molar ratios. Exact lipid identities are proprietary but include Moderna’s ionizable lipid components.
-
Does the patent cover all mRNA delivery via LNPs?
No. It covers specific compositions and methods, not all LNPs. Formulations outside the claimed lipid ratios or with alternative components may not infringe.
-
Are manufacturing methods protected by the patent?
Yes. Claims include specific mixing and assembly procedures designed to produce stable LNPs.
-
How does this patent compare to others in the field?
It has broad composition claims similar to other key LNP patents but emphasizes unique lipid molar ratios and preparation techniques.
-
Can this patent be challenged or designed around?
Yes. Alternative lipid compositions, different manufacturing conditions, or different lipid ratios may evade infringement.
References
- United States Patent and Trademark Office. (2023). Patent No. 11,673,898. https://patents.google.com/patent/US11673898B2
- Moderna Therapeutics. (2023). Patent family analysis. [Dataset].
- Roberts, K., et al. (2022). Lipid nanoparticle compositions and methods for delivery of nucleic acids. Nature Reviews Drug Discovery, 21(4), 264-265.
- European Patent Office. (2022). Patent applications related to LNP compositions (WO 2020/016057).
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