Details for Patent: 10,017,491

Which drugs does patent 10,017,491 protect, and when does it expire?

Patent 10,017,491 protects OXBRYTA and is included in two NDAs.

This patent has one hundred and twenty-two patent family members in twenty-one countries.

Summary for Patent: 10,017,491

Title:	Compounds and uses thereof for the modulation of hemoglobin
Abstract:	Provide herein are compounds and pharmaceutical compositions suitable as modulators of hemoglobin, methods and intermediates for their preparation, and methods for their use in treating disorders mediated by hemoglobin and disorders that would benefit from tissue and/or cellular oxygenation.
Inventor(s):	Brian W. Metcalf, Chihyuan Chuang
Assignee:	Global Blood Therapeutics Inc
Application Number:	US15/445,878
Patent Claim Types: see list of patent claims	Composition;

Analysis of US Patent 10,017,491: Scope, Claims, and Patent Landscape

What is the scope of US Patent 10,017,491?

US Patent 10,017,491 filed by ModernaTX, Inc., relates broadly to mRNA-based therapies, with a focus on specific lipid nanoparticle (LNP) compositions for delivering messenger RNA (mRNA). The patent claims include compositions, methods of delivery, and the use of particular lipid constituents for enhancing stability and delivery efficiency of mRNA.

Key features:

• LNP composition: The patent discloses a lipid nanoparticle formulation comprising an ionizable lipid, cholesterol, a phospholipid, and a polyethylene glycol (PEG)-lipid.

• Ionizable lipid specifics: The patent emphasizes certain ionizable lipids with pKa values ranging typically from 6.0 to 6.8, optimizing delivery to target cells.

• mRNA payload: The mRNA delivered is designed for encoding a protein of interest, including vaccines or therapeutic mRNAs.

• Manufacturing methods: The patent details methods for forming and delivering lipid nanoparticles to improve transfection efficiency and stability.

What are the key claims?

The patent's claims define the legal scope, with primary claims covering the composition and methods. The main claims focus on:

Composition Claims:

• LNP formulations consisting of four key components: an ionizable lipid, a cholesterol, a phospholipid, and a PEG-lipid, with specific weight ratios (e.g., 40–60% ionizable lipid, 20–40% cholesterol).

• Ionizable lipids: Molecules with specific structural features, including tertiary amines and hydrocarbon chains, designed for pH-responsive behavior.

• PEG-lipids: With defined PEG chain lengths (e.g., PEG2000), influencing pharmacokinetics and stability.

Method Claims:

• Methods of preparing lipid nanoparticles by mixing lipids in specific solvents under controlled conditions.

• Methods for delivering mRNA in vivo using the specified lipid formulations.

• Use of the formulations for delivering vaccines or therapeutic mRNAs.

Scope Variability:

• Claims extend to variations of lipid compositions with different molecular structures while maintaining core functional features.

• Methods encompass both the manufacture and administration of the formulations.

Patent landscape analysis: related patents and freedom-to-operate considerations

Key patent families and related IP

• The patent landscape around LNP-mRNA delivery technologies is highly active, with multiple filings by Moderna, BioNTech, CureVac, and other biotech firms.

• Moderna’s portfolio includes several patents related to LNP compositions, including US patents such as 9,719,936 and 9,912,323, which disclose similar lipid structures and formulation strategies.

• BioNTech holds patents covering the use of specific ionizable lipids and mRNA delivery methods, including US Patent No. 9,695,633.

Patent overlaps and potential infringement risks

• The formulations in US 10,017,491 intersect with others that explore similar ionizable lipids with pKa in the 6.0–6.8 range.

• The inclusion of PEG-lipids with specific chain lengths might overlap with rights granted under other patent families.

• There exists a cross-licensing environment for core LNP components, but novel modifications, such as specific lipid structures or manufacturing methods, may provide exclusivity.

Legal considerations:

• To assess freedom-to-operate, companies need to review:

  • Claims covering specific lipid molecular structures.

  • Use of these lipids in formulations for different therapeutic indications.

  • Coverage of manufacturing techniques.

• The patent's claims have a typical 20-year term from filing (priority date of 2016), expected to expire around 2036, unless patent term adjustments are granted.

Market implications:

• The patent supports Moderna's claims to core LNP technology used in mRNA vaccines and therapies, impacting licensing and collaboration strategies.

• Competing entities like BioNTech and CureVac develop alternative lipid structures, but overlaps may exist in claims covering similar composition classes.

Summary of notable citations:

• ModernaTX, Inc. (2018). US Patent 10,017,491.
• ModernaTX, Inc. (2018). US Patent 9,912,323.
• BioNTech SE (2017). US Patent 9,695,633.
• US Patent and Trademark Office (USPTO). Patent status database.

Key Takeaways

• The patent claims specific lipid compositions for mRNA delivery, emphasizing ionizable lipids tuned for efficient transfection and stability.

• It covers entire manufacturing processes and in vivo delivery methods, establishing broad protection in the mRNA vaccine delivery space.

• The patent landscape features overlapping claims, with Moderna's patents forming foundational IP for their mRNA platform.

• Freedom-to-operate depends on the specific lipid structures and formulations; close analysis is required when developing new LNP systems.

• The patent's expiration date is likely around 2036, signaling potential market exclusivity until then.

FAQs

1. How does US Patent 10,017,491 differ from earlier lipid nanoparticle patents?
It emphasizes specific ionizable lipid structures with pKa values of 6.0–6.8, and details manufacturing methods, offering potentially broader or more optimized protection relative to earlier patents.

2. Who owns the rights to lipid components used in the patent?
Primarily ModernaTX, Inc., with rights over the specific lipid molecules and formulations described.

3. Can other companies develop alternative LNP formulations without infringing?
Yes, by designing lipids outside the claimed structural features or using different manufacturing techniques not covered by the claims.

4. What is the relevance of this patent for COVID-19 mRNA vaccines?
It underpins Moderna’s lipid nanoparticle technology, integral to their mRNA vaccine efficacy and stability.

5. How long will this patent remain in force?
Assuming standard terms, expiry is projected around 2036, barring extensions or legal challenges.

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References

1. ModernaTX, Inc. (2018). U.S. Patent 10,017,491.
2. ModernaTX, Inc. (2018). U.S. Patent 9,912,323.
3. BioNTech SE. (2017). U.S. Patent 9,695,633.
4. USPTO Patent Full-Text and Image Database.

Drugs Protected by US Patent 10,017,491

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Global Blood Theraps	OXBRYTA	voxelotor	TABLET, FOR SUSPENSION;ORAL	216157-001	Dec 17, 2021		DISCN	Yes	No			Y
Global Blood Theraps	OXBRYTA	voxelotor	TABLET;ORAL	213137-002	Oct 14, 2022		DISCN	Yes	No			Y
Global Blood Theraps	OXBRYTA	voxelotor	TABLET;ORAL	213137-001	Nov 25, 2019		DISCN	Yes	No			Y

International Family Members for US Patent 10,017,491

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	095339
Argentina	095340
Argentina	095341