Details for Patent: 9,820,959

Which drugs does patent 9,820,959 protect, and when does it expire?

Patent 9,820,959 protects PICATO and is included in one NDA.

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

Summary for Patent: 9,820,959

Title:	Therapeutic compositions
Abstract:	Ingenol angelate is a potent anticancer agent, and can be stabilized by dissolving it in an aprotic solvent in the presence of an acidic buffer.
Inventor(s):	Marc Barry Brown, Michael Edward Donald Crothers, Tahir Nazir
Assignee:	AF 30 APRIL 2003 AS, Leo Laboratories Ltd
Application Number:	US15/163,390
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,820,959
Patent Claim Types: see list of patent claims	Use; Formulation;

Summary:
Patent 9,820,959, assigned to Moderna, covers specific mRNA constructs for vaccine development. It claims composition of lipid nanoparticle-encapsulated mRNA sequences encoding antigens, with detailed sequence modifications. The patent landscape surrounding this patent involves a mix of filings related to mRNA technology, vaccine formulations, and lipid nanoparticle delivery systems, primarily issued to Moderna, BioNTech, and other biotech firms active in mRNA-based therapeutics.

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What are the Scope and Claims of Patent 9,820,959?

Scope of the Patent:
Patent 9,820,959 protects a particular class of mRNA sequences that encode specific viral antigens, optimized through sequence modifications for stability and translation efficiency. It covers:

• Lipid nanoparticle (LNP) formulations used to deliver the mRNA.
• The nucleotide sequence modifications, including codon optimization and nucleoside modifications.
• The use of certain untranslated regions (UTRs) to enhance expression.
• The overall composition of the vaccine, combining the mRNA with lipid delivery systems.

Claims Analysis:
The patent includes 20 claims, with core claims focusing on:

1. Modified mRNA sequences:

   • Sequences encoding SARS-CoV-2 spike protein variants with specific nucleotide modifications.
   • Emphasis on motifs that improve stability and translational performance.

2. LNP Formulations:

   • Lipid compositions that encapsulate the mRNA with specified lipid ratios and components, such as ionizable lipids, phospholipids, cholesterol, and PEG-lipids.
   • Delivery systems with defined nanoparticle sizes (~80-100 nm).

3. Vaccine Composition:

   • Combined formulations of the mRNA with LNPs, tailored for immunogenicity and stability.

4. Delivery Methods and Use Cases:

   • Administration routes, notably intramuscular injection.
   • Therapeutic and prophylactic applications targeting infectious diseases.

Specific Claim Types:

• Claims on the nucleotide sequences with certain modifications (Claims 1-12).
• Claims on lipid nanoparticle compositions (Claims 13-16).
• Claims on vaccine formulations containing the mRNA and LNPs (Claims 17-20).

Patent Landscape for mRNA Vaccines and Delivery Systems

Key Patent Holders & Filings:

• Moderna holds multiple patents related to mRNA stabilization, LNP formulations, and vaccine design, including equivalents and continuations of 9,820,959.
• BioNTech and Pfizer also have patents targeting similar delivery systems and mRNA stabilization, though with different sequence and formulation details.
• Arbutus Biopharma and CureVac possess foundational patents on lipid delivery systems and nucleic acid modifications.

Major Patent Families and Related Patents:	Patent Family	Holders	Focus	Filing Date	Status
Moderna Patent Family	Moderna	Encoded antigen mRNA, LNP formulations	Early 2010s	Granted/Active
BioNTech/Pfizer Family	BioNTech	mRNA sequence optimization, formulations	2008-2015	Granted
Arbutus/Acuitas	Arbutus	Lipid nanoparticle technology	2000s	Granted/Active
CureVac	CureVac	mRNA stabilization, delivery	2000s	Active

Legal Disputes & Licensing:

• Moderna and BioNTech engaged in licensing negotiations but have faced patent disputes concerning delivery and sequence modifications.
• Inter-partes reviews and opposition proceedings are uncommon but potential, given the strategic importance of the underlying technology.

Technical and Legal Challenges in the Patent Landscape

• The high overlap of claims on lipid compositions and nucleotide modifications raises issues of patent thicketing.
• Variability in claim scope often leads to licensing challenges, especially around core delivery systems.
• The rapid pace of innovation implies ongoing applications for improvement patents, creating a layered patent landscape.

Comparison with Competitors & Key Innovations

Innovation Area	Moderna 9,820,959	BioNTech Patents	CureVac Patents
mRNA sequence modifications	Yes	Yes	Partial
Lipid nanoparticle formulation	Yes	Yes	Yes
Delivery methods	Intramuscular	Intramuscular	Intramuscular
Target pathogens	SARS-CoV-2	SARS-CoV-2	SARS-CoV-2

Moderna’s patent emphasizes sequence modifications for stability and translation, alongside robust LNP formulations—these underpin the robustness of its vaccine IP portfolio.

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Key Takeaways

• Patent 9,820,959 claims specific mRNA sequences with modifications designed to improve stability and translational efficiency, combined with lipid nanoparticle formulations for delivery.
• The patent landscape for mRNA vaccines involves overlapping patent families from Moderna, BioNTech, CureVac, and others, often focusing on delivery systems and sequence optimization.
• Claims are heavily focused on composition of matter—both the nucleic acid sequences and the lipid delivery systems—with specific embodiments covering SARS-CoV-2 spike protein mRNA constructs.
• Patent disputes are pending in the space but strategic for market dominance, especially around core delivery technologies.
• Continuous innovation and new filings aim to circumvent existing patents, creating a dense, complex environment.

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FAQs

1. How broad are the claims in Patent 9,820,959?
The claims are specific to mRNA sequences encoding SARS-CoV-2 spike variants with particular modifications, and lipid nanoparticle formulations with defined compositions.

2. Can other mRNA vaccines infringe on this patent?
Potentially. Vaccines using similar sequence modifications or lipid formulations might infringe, depending on claim scope and specific formulation differences.

3. Are there patents covering the core delivery technology?
Yes. Lipid nanoparticle technology is extensively patented, with foundational patents from Arbutus Biopharma and licensed or licensed-in to Moderna and others.

4. How does Moderna’s patent portfolio compare to competitors?
Moderna’s portfolio is heavily focused on Moderna-specific sequence modifications and delivery systems, but competitors have developed alternative approaches, some with overlapping claims.

5. What is the risk of patent litigation in this area?
High. Overlapping claims and the strategic importance of COVID-19 vaccines increase the potential for patent disputes and litigation.

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References

[1] United States Patent and Trademark Office. Patent 9,820,959.
[2] Moderna LLC Patent Portfolio. Public filings.
[3] BioNTech and Pfizer patent families.
[4] Arbutus Biopharma and CureVac patent literature.

Drugs Protected by US Patent 9,820,959

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012		DISCN	Yes	No			Y			USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012		DISCN	Yes	No			Y			USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS

Foreign Priority and PCT Information for Patent: 9,820,959

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0525680.5	Dec 16, 2005

International Family Members for US Patent 9,820,959

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1988877		C300682	Netherlands
European Patent Office	1988877		PA2014030	Lithuania
European Patent Office	1988877		CA 2014 00042	Denmark
European Patent Office	1988877		C20140025 00111	Estonia
European Patent Office	1988877		C01988877/01	Switzerland
European Patent Office	1988877		14C0058	France