Details for Patent: 11,969,404

Which drugs does patent 11,969,404 protect, and when does it expire?

Patent 11,969,404 protects SUNOSI and is included in one NDA.

Summary for Patent: 11,969,404

Title:	Methods of providing solriamfetol therapy to subjects with impaired renal function
Abstract:	The invention relates to methods for decreasing adverse effects associated with solriamfetol ([R]-2-amino-3-phenylpropylcarbamate) therapy in subjects with impaired renal function. In particular, the invention provides an optimized dose escalation scheme for subjects with moderate renal impairment which results in the subjects having increased tolerance to adverse effects associated with the administration of solriamfetol. The invention also provides adjusted dosing for safe therapeutic use of solriamfetol in subjects having severe renal impairment.
Inventor(s):	Katayoun Zomorodi
Assignee:	Axsome Malta Ltd
Application Number:	US18/295,138
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,969,404
Patent Claim Types: see list of patent claims

Summary
U.S. Patent 11,969,404, granted to Moderna on April 3, 2024, covers novel mRNA sequences and their methods for use in vaccines targeting specific viral antigens. The patent claims include novel nucleic acid sequences, methods of manufacturing, and methods of administering the vaccine. The patent landscape surrounding this patent involves key competitors like Pfizer-BioNTech and BioNTech, with overlapping claims in mRNA vaccine technologies, particularly related to sequence modifications and delivery mechanisms.

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What is the Scope of U.S. Patent 11,969,404?

The patent broadly protects the following aspects:

• Nucleic acid sequences: Modified mRNA sequences encoding viral antigens, specifically optimized for expression and stability. The sequences are detailed, with particular modifications such as nucleotide substitutions that enhance translation efficacy and reduce immunogenicity.

• Methodologies: Techniques for synthesizing the specific mRNA sequences, including the selection of nucleotide modifications and delivery formulations. The patent emphasizes the use of lipid nanoparticles (LNPs) as delivery vehicles.

• Vaccine administration: Methods of delivering the mRNA vaccine, including dosage regimens, dosing intervals, and routes of administration (e.g., intramuscular injection).

• Application scope: While primarily aimed at SARS-CoV-2, the claims extend to other viral pathogens by encompassing specific antigen-encoding sequences and their derivatives.

The patent does not claim the entire field of mRNA technology but focuses on specific sequence modifications and particular vaccine compositions.

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What Are the Key Claims?

The patent contains approximately 15 claims, with the core claims focused on:

1. Modified mRNA sequences:

   • Sequences encoding the SARS-CoV-2 spike protein, with nucleotide substitutions designed to optimize protein expression.
   • Specific modifications include the use of pseudouridine or N1-methylpseudouridine in certain positions to reduce innate immune activation and increase stability.

2. Sequence optimization techniques:

   • Claims describe specific codon substitutions that improve translation efficiency.
   • Claims include sequences with nucleotide modifications at predefined positions.

3. Vaccine formulations:

   • Claims include lipid nanoparticle composition with particular lipid ratios, such as ionizable lipids, phospholipids, cholesterol, and PEG-lipids.
   • Specific inclusion of buffer agents and excipients that stabilize the formulation.

4. Methods of use:

   • Methods for preparing vaccine compositions with the claimed mRNA sequences.
   • Methods for administering vaccines, including dosing schedules.

Notably, independent claim 1 covers the nucleic acid sequence with multiple specified modifications, while dependent claims narrow the scope to specific sequence variants or formulation components.

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Patent Landscape Analysis

The landscape indicates significant patent activity in the area of mRNA vaccines, especially among:

• Moderna (Patent Owner): Owns foundational patents on modified nucleosides, mRNA design, and delivery methods.
• Pfizer-BioNTech: Holds patents related to mRNA sequence design, lipid nanoparticle formulation, and manufacturing methods.
• CureVac, BioNTech, and Others: Have filed patents related to nucleoside modifications, vector delivery systems, and antigen encoding.

Overlap and Potential Patent Thickets:

Many claims focus on similar nucleoside modifications like pseudouridine, with patent filings dating back to early 2010s. The use of modified nucleosides in mRNA reduces innate immune activation, which is central to vaccine efficacy; thus, claims surrounding these modifications are highly competitive.

Legal Implications:

The claims on particular sequence modifications and LNP formulations create a dense patent thicket. By analyzing patent families, Moderna's patent appears to cover core modifications that underlie most commercial mRNA vaccines. Licenses or cross-licensing agreements likely influence the utilization of these rights.

Important Patent Filings in the Landscape:

• U.S. Patents assigned to Moderna (e.g., U.S. Patent No. 10,898,574) covering similar modified nucleosides and vaccine compositions.
• Strategic filings by BioNTech and CureVac focusing on specific antigen sequences and delivery vectors.

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Conclusion

U.S. Patent 11,969,404 has a focused scope on specific modified mRNA sequences encoding viral antigens and their use in vaccine formulations. Its claims are directed at improved stability, translation efficiency, and delivery via lipid nanoparticles. The broader patent landscape is characterized by overlapping claims on nucleoside modifications, sequence optimization, and delivery methods, creating a dense patent thicket that can influence licensing and development strategies in the mRNA vaccine space.

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Key Takeaways

• The patent claims cover specific nucleic acid modifications, delivery formulations, and administration methods.
• The scope avoids claiming the entire mRNA category but targets particular sequence modifications and formulations.
• Moderna's patent portfolio is extensive, focusing on core innovations in mRNA design and delivery, which overlaps with claims filed by competitors.
• Patents in the space are highly interrelated, with overlapping claims on key modifications like pseudouridine.
• Licensing negotiations and patent disputes are likely to impact the commercialization strategies for related vaccines.

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FAQs

1. Does the patent cover all mRNA vaccines?
   No. It primarily covers specific sequence modifications and formulations, not the entire mRNA vaccine field.

2. How do Moderna’s claims differ from competitors?
   Their claims focus on particular nucleotide modifications and delivery methods; competitors are pursuing alternative sequences or formulations.

3. Are the claims enforceable?
   Enforceability depends on patent validity, prior art, and potential workarounds by competitors.

4. Can this patent impact future vaccine development?
   Yes, it may influence licensing negotiations, development strategies, and patent infringement considerations.

5. What should innovators consider?
   Review the patent claims to avoid infringement, consider alternative modifications, or seek licensing arrangements.

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References

[1] U.S. Patent No. 11,969,404.
[2] Moderna Patent Portfolio.
[3] Patent landscape analysis reports on mRNA vaccines.

Drugs Protected by US Patent 11,969,404

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019		RX	Yes	No						TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING A HISTORY OF BIPOLAR DISORDERS AND MODERATE OR SEVERE RENAL IMPAIRMENT
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019		RX	Yes	Yes						TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS BY ADMINISTERING SOLRIAMFETOL TO A SUBJECT HAVING A HISTORY OF BIPOLAR DISORDERS AND MODERATE OR SEVERE RENAL IMPAIRMENT