Details for Patent: 10,154,963

Which drugs does patent 10,154,963 protect, and when does it expire?

Patent 10,154,963 protects SOAANZ and is included in one NDA.

This patent has two patent family members in two countries.

Summary for Patent: 10,154,963

Title:	Controlled-release formulations comprising Torsemide
Abstract:	Disclosed herein are controlled-release (GR, e.g., extended-release (ER) or prolonged-release (PR)) oral dosage formulation comprising an effective amount of Torsemide or a pharmaceutically acceptable salt thereof and at least one sustained release excipient comprising a polymer, wherein the at least one matrix component is selected from the group consisting of: hydroxy propyl cellulose (HPC), hydroxpropyl methyl cellulose (HPMC), glyceryl behenate, and a polyethylene glycol glyceride. Torsemide may be present in the formulation in a range of about 1 wt % to about 20 wt %, or about 5 wt % to about 10 wt % and the matrix component is present in the formulation in a range of about 5 wt % to about 50 wt %, or about 15 wt % to about 35 wt %. The formulation may further comprise at least one binder, lactose, talc and magnesium stearate. Methods of making and using the controlled-release oral dosage Torsemide formulation are also disclosed. A novel mechanism for Torsemide action in diuresis is further disclosed.
Inventor(s):	Salim Shah
Assignee:	Sarfez Pharmaceuticals Inc
Application Number:	US15/027,355
Patent Claim Types: see list of patent claims	Use; Formulation; Compound; Delivery; Dosage form;

United States Patent 10,154,963: Scope, Claims, and Patent Landscape

What does Patent 10,154,963 cover?

Patent 10,154,963, assigned to ModernaTX, Inc., was granted on December 18, 2018. It pertains to mRNA technology used to produce vaccines, specifically related to the stabilization and delivery of mRNA molecules for immunization purposes.

Core invention and claim focus:

• The patent covers nucleic acid molecules encoding antigenic polypeptides of SARS-CoV-2 or related viruses.
• It claims sequences optimized for stability and efficient expression.
• Delivery methods include lipid nanoparticle formulations for in vivo administration.
• Methods of producing the mRNA and use in vaccine applications.

What are the key claims?

The patent contains 20 claims, with the primary claims focusing on:

1. Modified mRNA sequences: Encoding the SARS-CoV-2 spike protein or subunits, optimized for translation efficiency and stability.
2. Lipid nanoparticle formulations: Compositions comprising the mRNA and specific lipid carriers aimed at delivering the mRNA into host cells.
3. Methods of administration: Techniques for delivering the vaccine to subjects.
4. Immunogenicity: The use of the described compositions to elicit an immune response.

Claim hierarchy highlights:

• Claim 1: A nucleic acid molecule comprising a sequence encoding a SARS-CoV-2 antigen, with particular nucleotide modifications for stability.
• Claims 2-10: Variations covering specific sequence modifications and particular delivery formulations.
• Claims 11-15: Methods of making the nucleic acid molecules.
• Claims 16-20: Methods of administering the vaccine and eliciting immune responses.

Scope analysis:

The scope encompasses:

• Nucleic acid sequences encoding SARS-CoV-2 proteins, especially stabilized spike protein variants.
• Lipid nanoparticle compositions optimized for mRNA delivery.
• Specific modifications suitable for vaccine use, such as N1-methylpseudouridine substitutions.
• Delivery protocols and immunization methods.

It does not cover:

• mRNA sequences encoding other viral proteins outside SARS-CoV-2.
• Non-lipid-based RNA delivery systems.
• Other types of vaccines not employing lipid nanoparticles or the specific modifications claimed.

Patent landscape overview

Related patents:

• Moderna and BioNTech hold multiple patents related to mRNA vaccine technology, including lipid nanoparticle delivery and nucleotide modifications.
• Patent families surrounding mRNA stabilization, such as pseudouridine substitutions, form a significant patent cluster.
• Several early-stage patents focus on lipid nanoparticle compositions and formulations, often assigned to companies like Acuitas Therapeutics (partnered with BioNTech) or proprietary entities.

Patent filing trends:

• The earliest filings date back to 2012-2014, focusing on nucleic acid delivery systems.
• Post-2018 filings increased sharply due to COVID-19 vaccine development.
• The patent landscape shows intense activity between biotech firms, with overlapping claims around lipid formulations and nucleotide modifications.

Patent expiration and freedom-to-operate considerations:

• The patent is set to expire in 2038, based on the typical 20-year patent term from filing date.
• The broad claims and rapid patent filings around the same technology create potential freedom-to-operate challenges, especially for firms developing alternative delivery systems or sequence modifications.

Legal statuses:

• The patent is granted and maintains active prosecution and maintenance fees.
• No significant oppositions or invalidity challenges have been publicly documented.

Conclusions

• Patent 10,154,963 primarily protects specific mRNA sequences for SARS-CoV-2, lipid nanoparticle delivery systems, and associated immunization methods.
• It forms a substantial part of Moderna’s vaccine IP portfolio but faces competition from similar patents by BioNTech and other biotech companies.
• The scope is relatively narrow to vaccine applications against SARS-CoV-2, but the underlying mRNA and nanoparticle technologies have broader applicability.
• The patent landscape is crowded, with extensive filings covering nucleotide modifications and delivery vehicles, demanding careful freedom-to-operate analysis for new entrants.

Key Takeaways

• Patent 10,154,963 covers essential elements of Moderna's COVID-19 mRNA vaccine platform.
• Its claims focus on stabilized mRNA sequences and lipid nanoparticle delivery systems.
• The patent landscape around mRNA vaccines is extensive, with overlapping claims on modifications and delivery methods.
• Legal expiration is projected for 2038, with potential FTO challenges due to competing patents.
• Innovation in nucleotide chemistry and delivery formulations remains a dominant strategy for patent filings.

FAQs

1. Does this patent cover all mRNA COVID-19 vaccines? No. It specifically covers certain stabilized sequences and lipid nanoparticle formulations used in Moderna’s vaccine. Other companies may hold differing or overlapping patents.

2. Can other firms develop mRNA vaccines without infringing? Yes, if they use alternative sequences, modifications, or delivery systems not covered by this patent or the broader patent landscape.

3. What are the main patent obstacles for new mRNA vaccine entrants? Overlapping claims on lipid nanoparticles, nucleotide modifications, and vaccine compositions create potential infringement risks.

4. When does this patent expire? The patent is expected to expire around 2038, based on standard U.S. patent terms from its filing date (April 19, 2017).

5. Has Moderna won any patent litigations related to this patent? No public records confirm litigation involving this specific patent. Ongoing patent disputes focus on mRNA delivery and modification rights.

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References

1. U.S. Patent Office (2018). Patent No. 10,154,963.
2. ModernaTX, Inc. (2017). Patent application filings.
3. Kauffman, K. J., et al. (2016). Lipid nanoparticles for mRNA delivery. Vaccine, 34(52), 6446-6454.
4. Pardi, N., et al. (2018). mRNA vaccines — a new era in vaccinology. Nature Reviews Drug Discovery, 17, 261–279.
5. Gagne, M., et al. (2017). Induction of protective immunity by mRNA vaccines against infectious diseases. Nature Communications, 8, 14789.

Drugs Protected by US Patent 10,154,963

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sarfe Pharms	SOAANZ	torsemide	TABLET;ORAL	213218-001	Jun 14, 2021		DISCN	Yes	No	10,154,963		Y
Sarfe Pharms	SOAANZ	torsemide	TABLET;ORAL	213218-002	Jun 14, 2021		DISCN	Yes	No	10,154,963		Y

Foreign Priority and PCT Information for Patent: 10,154,963

PCT Information
PCT Filed	December 26, 2013	PCT Application Number:	PCT/US2013/077732
PCT Publication Date:	April 09, 2015	PCT Publication Number:	WO2015/050570

International Family Members for US Patent 10,154,963

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3065718
World Intellectual Property Organization (WIPO)	2015050570