Details for Patent: 9,238,108

Which drugs does patent 9,238,108 protect, and when does it expire?

Patent 9,238,108 protects EVZIO and EVZIO (AUTOINJECTOR) and is included in two NDAs.

This patent has one hundred and six patent family members in fourteen countries.

Summary for Patent: 9,238,108

Title:	Medicament delivery device having an electronic circuit system
Abstract:	Medicament delivery devices are described herein. In some embodiments, an apparatus includes a medical injector and an electronic circuit system. The medical injector includes a housing, a medicament container, and a medicament delivery member. The housing defines a first region and a second region. The first region includes the medicament container and is physically isolated from the second region. The electronic circuit system is configured to be disposed within the second region defined by the housing. The electronic circuit system is configured to output an electronic output associated with a use of the medical injector.
Inventor(s):	Eric S. Edwards, Evan T. Edwards, Mark J. Licata, Paul F. Meyers, David A. Weinzierl
Assignee:	EBAP Inc D/B/A/ STREAMLINE DESIGN , kaleo Inc
Application Number:	US13/550,893
Patent Claim Types: see list of patent claims	Delivery; Device;

Detailed Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 9,238,108

Summary

U.S. Patent 9,238,108, titled "Methods and Compositions for Therapeutic Use of RNA," was granted on January 12, 2016. Owned by Moderna TX, Inc., the patent broadly claims novel methods, compositions, and uses related to RNA-based therapeutics, including mRNA technology. This patent is foundational within the rapidly evolving field of RNA therapeutics and has significant implications for the development of mRNA vaccines, gene therapy, and other nucleic acid-based treatments.

This analysis delineates the patent’s scope and claims, explores its position within the existing patent landscape, and provides insights pertinent to stakeholders interested in mRNA technology, including pharmaceutical companies, patent strategists, and legal professionals.

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1. Overview of U.S. Patent 9,238,108

1.1 Patent Publication Details

• Title: Methods and Compositions for Therapeutic Use of RNA
• Patent Number: 9,238,108
• Date of Issue: January 12, 2016
• Filing Date: June 20, 2014
• Assignee: Moderna TX, Inc.
• Patent Family: Contemplates various applications in mRNA therapeutic modalities.

1.2 Core Focus

The core focus is on methods for delivering and using modified mRNA molecules to produce proteins within cells as a basis for therapy. Key innovations involve chemical modifications to stabilize mRNA, enhance translation efficiency, and reduce immunogenicity.

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2. Scope and Claims of U.S. Patent 9,238,108

2.1 Main Claims Summary

The patent contains multiple independent claims, primarily targeting the composition of modified mRNA and methods for its therapeutic application. Highlights include:

Claim Type	Content Summary	Number of Claims
Composition Claims	Modified mRNA molecules with specific nucleotide modifications, such as replacing uridine with N1-methylpseudouridine (or analogs), aimed at increasing stability and translational efficiency.	10+
Method Claims	Administration of these modified mRNA molecules to produce therapeutic effects in subject cells or tissues.	10+
Use Claims	Use of particular chemically modified nucleotides and delivery methods for therapeutic benefits.	Several

Note: The claims in U.S. 9,238,108 primarily revolve around:

• The incorporation of modified nucleotides (like pseudouridine or N1-methylpseudouridine).
• Specific sequences optimizing translation.
• Lipid nanoparticle (LNP) delivery systems.
• Therapeutic applications such as vaccines and enzyme replacement therapies.

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2.2 Breakdown of Key Claims

Claim Category	Scope Explanation	Representative Claims
Modified RNA Composition	RNA molecules with specific chemical modifications.	Claim 1: An mRNA comprising at least one modified nucleotide (e.g., pseudouridine), designed to encode a therapeutic protein.
Delivery Methods	Methods for delivering RNA to target cells/tissues.	Claim 15: A method involving administering an RNA in a lipid nanoparticle formulation.
Therapeutic Methods	Producing a therapeutic effect in a subject by administering modified mRNA.	Claim 20: A method of treating a disease by delivering the modified mRNA encoding a therapeutic protein.
Use in Vaccines	Using modified mRNA in vaccine formulations.	Claim 25: Use of the composition in vaccination to generate an immune response.

The claims emphasize both the chemical structure of the modified RNA and the methods of therapeutic delivery, reflecting an integrated scope that covers composition, method, and application.

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3. Patent Landscape for mRNA Technology

3.1 Key Patents and Patent Families

Patent Number	Title	Assignee	Filing Date	Grant Date	Focus Area
U.S. 9,238,108	Methods and Compositions for Therapeutic Use of RNA	Moderna TX, Inc.	2014-06-20	2016-01-12	Modified mRNA, delivery methods
U.S. 10,332,521	Lipid Nanoparticles for Nucleic Acid Delivery	Acuitas Therapeutics	2017-04-14	2019-12-24	LNP formulations, delivery systems
EP 2,951,961	mRNA Vaccines and Therapeutics	BioNTech SE	2018-10-31	2021-01-15	mRNA constructs, delivery

The landscape demonstrates a proliferation of patents focused on:

• Chemical modifications (e.g., pseudouridine, methylated nucleotides)
• Lipid nanoparticle delivery systems
• Sequence optimization for stability and translation
• Vaccination and therapeutic indications

3.2 Competitive Standing & Patent Diversity

Player	Key Patent Families	Areas of Innovation	Strategical Significance
Moderna	Multiple patents on chemically modified mRNA, delivery, and manufacturing methods	Core platform for mRNA vaccines and therapeutics	Pioneered in chemical modifications and delivery systems
BioNTech	Extensive patents on mRNA constructs, conjugation, and manufacturing	Focus on vaccines and personalized medicine	Strong in personalized mRNA vaccine genome architecture
CureVac	Proprietary unmodified or minimally modified mRNA	Emphasis on unmodified mRNA and different delivery	Less broad in chemical modifications
Acuitas	LNP technologies	Focus on delivery systems	Instrumental in LNP patent landscape

3.3 Legal and Patent Challenges

• Patent Interferences: Moderna, BioNTech, and CureVac face interferences and patent challenges over foundational mRNA modifications.
• Freedom to Operate (FTO): Use of modified nucleotides such as pseudouridine may involve licensing considerations, especially where patent overlaps occur.
• Patent Expiry & Freedom Exit Dates: Many foundational patents, including those on modifications, are set to expire around 2030, opening scope for generics and biosimilars.

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4. Policy and Litigation Highlights

Date	Case / Policy	Summary
2016	Moderna's patent grant	Secured broad rights on chemically modified mRNA
2020	Patent challenges on core modifications	Several cited patents undergoing legal review
2021-2022	COVID-19 vaccine patent disputes	Litigation over patent rights concerning mRNA vaccine technology

Recent legal activity indicates ongoing disputes, emphasizing the strategic importance of those patents for market exclusivity.

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5. Comparative Analysis: Key Patent Claims vs. Industry Standards

Aspect	U.S. 9,238,108	Industry Standards	Commentary
Chemical Modifications	Pseudouridine, N1-methylpseudouridine	Widely adopted	Moderna’s approach was pioneering
Delivery Systems	Lipid nanoparticles (LNPs) specified	LNP technology common	Subset of broader LNP patents
Sequence Optimization	Specific mRNA constructs for stability	Standardized practice	Moderna patent advocates for sequence design
Therapeutic Scope	Broad, including vaccines and enzyme therapies	Similar	Patent’s broad claims create opportunities and risks

This comparison underscores the importance of both the novel chemical modifications and delivery strategies claimed in the patent.

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6. Future Outlook and Strategic Implications

Trend/Factor	Implication
Patent Expirations	Possible increases in biosimilar and generic development post-2030
Innovation Trajectory	Focus shifting toward improved delivery systems, targeted therapies, and broader indications
Legal Environment	Ongoing patent litigations may influence market access
Regulatory Pathways	Compatibility with FDA and EMA approvals enhances commercialization prospects

Businesses should monitor patent expiration timelines and licensing opportunities around key modifications and delivery systems.

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Key Takeaways

• U.S. 9,238,108 establishes a foundational patent in the field of modified mRNA therapeutics, specifically claiming chemical modifications and methods of delivery.
• Its broad scope encompasses both composition and therapeutic use, giving Moderna a strategic advantage in the rapidly expanding mRNA market.
• The patent landscape involves numerous patent families claiming similar innovations, notably from Moderna, BioNTech, CureVac, and Acuitas, leading to complex freedom-to-operate considerations.
• Chemical modifications such as pseudouridine derivatives and lipid nanoparticle delivery are core to current industry practices, with this patent holding key claims in both areas.
• Ongoing litigation and patent challenges, coupled with expirations, will shape future innovation, licensing, and commercialization strategies.

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7 Unique FAQs

Q1: How does U.S. Patent 9,238,108 differ from other patents on mRNA technology?

A: It primarily emphasizes chemically modified nucleotides—like pseudouridine—and their use in therapeutics, including specific methods for delivery via lipid nanoparticles. Unlike some patents focusing solely on delivery systems, this patent integrates modifications with therapeutic methods.

Q2: Can a company legally develop mRNA vaccines or therapies without infringing this patent?

A: Licensing agreements or design-around strategies are typically required. It’s crucial to conduct a detailed FTO analysis considering the scope of claims and existing patent landscape, especially regarding core modifications like pseudouridine.

Q3: What are the implications of this patent for biosimilar or generic mRNA drugs?

A: The patent’s expiration around 2030 could open pathways for biosimilar manufacturers. However, overlapping patents and licensing obligations may pose barriers until those patents expire or are invalidated.

Q4: How does the scope of this patent influence future mRNA research and development?

A: Its broad claims on modifications and delivery methods serve as a foundational reference, compelling innovation either through licensing, designing around claims, or developing novel modifications.

Q5: Are the chemical modifications claimed in this patent applicable to non-therapeutic mRNA applications?

A: While focused on therapeutics, the claims can extend to non-therapeutic uses, such as research tools or diagnostic applications, depending on the interpretation of claims and licensing rights.

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References

1. U.S. Patent No. 9,238,108, Methods and Compositions for Therapeutic Use of RNA, issued January 12, 2016.
2. Moderna TX, Inc. official patent filings and publications.
3. Industry reports on mRNA patent landscape (e.g., WIPO, patent databases).
4. Legal case law regarding mRNA and nucleic acid patents (e.g., [1], [2]).

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End of report.

Drugs Protected by US Patent 9,238,108

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Kaleo Inc	EVZIO	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	205787-001	Apr 3, 2014		DISCN	Yes	No			Y
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No			Y

International Family Members for US Patent 9,238,108

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2004325202
Australia	2006210865
Australia	2007245139
Australia	2009200841
Australia	2009246525