BioTech IP Review

Assignee: ModernaTX, Inc.
Filed: August 30, 2024
Patent Issued: September 23, 2025
Patent Number: 12,419,957 B2
Inventors: Antonin De Fougerolles, Sayda M. Elbashir, et al.

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What It Covers

This patent protects novel compositions, delivery systems, and methods for formulating engineered nucleic acids—especially modified messenger RNA (mRNA)—and delivering them into cells efficiently to modulate protein expression. These technologies are central to Moderna’s core business of mRNA-based vaccines and therapeutics.

Key features include:

• Engineered nucleic acid formulations:
  The patent claims specific compositions of modified mRNA and other engineered nucleic acids that improve stability, translation efficiency, and therapeutic potency inside target cells.
• Lipid nanoparticle (LNP) delivery:
  It covers LNP or similar delivery vehicles optimized to encapsulate and protect the mRNA cargo, ensuring efficient cellular uptake and controlled release once inside the body—critical for vaccine and therapeutic performance.
• Methods of use:
  The patent includes methods for administering the formulated engineered mRNA to achieve desired protein expression for therapeutic applications, such as vaccines, gene replacement, or protein-based therapies.

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Why It’s Important

• Core to Moderna’s Platform Technology

This patent protects technology essential for delivering mRNA drugs into human tissues, which underpins Moderna’s entire product portfolio—from COVID-19 vaccines to RSV shots to future mRNA therapies for other diseases.

• Broad Therapeutic Scope

By covering both the formulation and delivery aspects of engineered nucleic acids, the patent supports Moderna’s efforts not just in vaccines but potentially in cancer vaccines, immunotherapies, enzyme-replacement strategies, and genetic disease treatments.

• Competitive IP Position

In an increasingly crowded mRNA therapeutics field, strong proprietary rights on delivery platforms and formulations differentiate Moderna from competitors and help defend its market share as older foundational patents face challenges.

• Commercial Impact

Effective delivery systems are critical to the commercial success and clinical performance of mRNA medicines. Owning strong patents in this area enables Moderna to license technology, defend products from infringement attacks, and capture long-term revenue from its expanding mRNA pipeline.

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Summary

U.S. Patent No. 12,419,957 B2, issued in September 2025 and filed in August 2024 by ModernaTX, Inc., is one of Moderna’s most strategically important biotech patents of 2025. It covers formulations and delivery methods for engineered nucleic acids (like mRNA)—core to the company’s vaccines and future therapeutic products. The patent strengthens Moderna’s intellectual property around one of the technology’s most commercialized innovation areas.