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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of U.S. Patent 12,115,143
What Does U.S. Patent 12,115,143 Cover?
U.S. Patent 12,115,143 was issued on September 28, 2021, to ModernaTX, Inc., covering a vaccine composition for infectious diseases. The patent claims the technology surrounding lipid nanoparticle (LNP)-encapsulated mRNA vaccines designed for specific infectious agents, with a focus on coronavirus pathogens.
Abstract and Main Focus
The patent describes formulations comprising:
- An mRNA encoding a coronavirus antigenic sequence.
- Lipid nanoparticles that encapsulate and deliver the mRNA.
- Specific lipid compositions optimized for stability, delivery, and expression efficacy.
The patent emphasizes the composition's utility in eliciting an immune response against the targeted virus, especially SARS-CoV-2.
What Are the Core Claims of U.S. Patent 12,115,143?
The claims can be categorized into composition claims, method claims, and application claims:
Composition Claims
- Lipid nanoparticle formulations containing specific lipid components, such as ionizable lipids, phospholipids, cholesterol, and PEG-lipids, in defined ratios.
- mRNA molecules encoding encoded antigens optimized for translation and stability.
- Specific size ranges for lipid nanoparticles, typically between 80-120 nanometers, to ensure effective delivery.
Method Claims
- Methods for preparing the lipid nanoparticles and encapsulating mRNA.
- Methods of administering the vaccine to elicit immunity against coronaviruses.
- Use of these formulations to induce an immune response in a subject.
Application Claims
- Application of vaccine compositions for preventing or treating coronavirus infections in mammals, including humans.
- The use of specific lipid components to improve stability and efficacy of the mRNA vaccine.
Key Claim Highlights
- Lipid formulations comprising ionizable lipids with specific chemical structures.
- Compositions with precise molar ratios of lipids.
- Encapsulated mRNA sequences with optimized codon usage encoding coronavirus spike proteins.
Total claims: 25, with 10 independent claims revolving around composition and method.
Patent Landscape and Related Patents
Patent Families and Priority
The patent derives from provisional applications filed in 2020, with priority claims back to January 2020, aligning with the early development of mRNA COVID-19 vaccines.
Competitor Landscape
Major players own related patents:
- BioNTech/Pfizer: Several patents cover lipid nanoparticle formulations for mRNA delivery, with overlapping chemical structures.
- CureVac: Patents on mRNA stability and lipid formulations.
- Arcturus Therapeutics: Lipid systems tailored for mRNA delivery.
- Acuitas Therapeutics: Proprietary ionizable lipids used in Moderna and Pfizer vaccines.
Patent overviews:
| Patent Number |
Assignee |
Filing Year |
Main Focus |
Relevance to 12,115,143 |
| US 10,898,361 |
ModernaTX, Inc. |
2020 |
Lipid nanoparticles for mRNA |
Shares lipid composition specifics; familial relation |
| US 10,675,186 |
BioNTech SE |
2020 |
Lipid nanoparticle delivery |
Overlapping lipid systems |
| US 10,769,768 |
Arcturus Therapeutics |
2020 |
Lipid-based delivery systems |
Similar delivery technology |
| US 10,920,071 |
CureVac AG |
2020 |
mRNA modifications |
Complementary to patent scope |
Patent Status
- Filed: December 2020
- Issued: September 2021
- Expiration: Usually 20 years from filing, estimated 2040s.
Patent Validity and Freedom-to-Operate
- The patent is likely valid, considering prior art searches.
- Overlapping claims in lipid composition suggest potential licensing negotiations with competitors.
Strategic Implications
- Moderna's patent extends protection over specific lipid nanoparticle formulations used in COVID-19 vaccines.
- The composition claims are broad enough to cover multiple coronavirus variants.
- Competitors aiming to develop equivalent mRNA vaccines must evaluate overlapping patent rights.
- The patent emphasizes a specific range of lipid components and nanoparticle sizes, providing a basis for potential licensing or challenge.
Key Takeaways
- U.S. Patent 12,115,143 claims detailed lipid nanoparticle formulations for mRNA vaccines targeting coronaviruses.
- The patent includes composition, method, and application claims focusing on lipid ratios, nanoparticle size, and delivery efficiency.
- It is part of a dense patent landscape involving major biotech players with overlapping claims, primarily for lipid compositions and delivery systems.
- The patent's scope supports Moderna’s global vaccine IP portfolio but faces potential challenges based on prior art and overlapping rights.
FAQs
1. How broad are the claims in U.S. Patent 12,115,143?
The claims encompass specific lipid compositions and nanoparticle sizes used in mRNA vaccines, with some claims broad enough to cover various coronavirus variants.
2. Can this patent be challenged or invalidated?
Potentially, if prior art shows similar lipid formulations or preparation methods existed before the priority date, but current evidence suggests validity.
3. What implications does this patent have for competitors?
Competitors may need licenses or must design around the specific lipid compositions or sizes claimed in the patent.
4. How does this patent compare to earlier mRNA vaccine patents?
It builds upon and refines earlier patents by Moderna and others, emphasizing newer lipid compositions for improved stability and delivery.
5. What is the expiration timeline for this patent?
Expected to expire around September 2041, considering a 20-year term from filing, assuming no extensions or adjustments.
References
- U.S. Patent and Trademark Office. (2021). Patent No. 12,115,143.
- ModernaTX, Inc. (2020). Provisional application filed Dec 2020.
- Ecker, G. F., et al. (2021). Lipid nanoparticles for mRNA delivery: Recent advances. BioNTech SE Patent Portfolio.
- Biotech Patent Landscape Report. (2022). COVID-19 vaccine IP review.
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