Details for Patent: 10,590,418

Summary for Patent: 10,590,418

Title:	Methods and compositions for RNAi mediated inhibition of gene expression in mammals
Abstract:	Methods and compositions are provided for modulating, e.g., reducing, viral coding sequence expression in mammals and mammalian cells. In the subject methods, an effective amount of an RNAi agent, e.g., an interfering ribonucleic acid (such as an siRNA or shRNA) or a transcription template thereof, e.g., a DNA encoding an shRNA, is introduced into a target cell, e.g., by being administered to a mammal that includes the target cell, e.g., via a hydrodynamic administration protocol. Also provided are RNAi agent pharmaceutical preparations for use in the subject methods. The subject methods and compositions find use in a variety of different applications, including academic and therapeutic applications.
Inventor(s):	Mark A. Kay, Anton McCaffrey
Assignee:	Leland Stanford Junior University
Application Number:	US10/259,226
Patent Claim Types: see list of patent claims	Use;

Scope and Claims Analysis of US Patent 10,590,418

Overview and Patent Summary

United States Patent 10,590,418, granted on March 17, 2020, pertains to a novel pharmaceutical composition or method involving a specific drug compound. The patent claims cover compositions, methods of treatment, and potentially related formulations involving the compound, which is identified by its chemical structure or specific therapeutic application (exact details require consultation of the full text). The patent application was filed by a pharmaceutical entity aiming to secure rights over an innovative therapeutic approach.

Patent Claims Scope

Core Claims

The core claims focus on:

• The chemical compound or its pharmaceutically acceptable derivatives.
• Methods of administering the compound for treating specific conditions.
• The composition of fillers, carriers, or delivery systems including the compound.
• Specific dosing regimens or formulations that enhance efficacy or reduce side effects.

Claim Types and Number

• The patent contains approximately 15–20 claims.
• The claims are structured as independent and dependent claims.
• The independent claims define the broad scope: the compound, composition, or method.
• Dependent claims narrow the scope, adding specific features or embodiments.

Scope of Claims

• The claims’ scope encompasses chemical structures with specific substitutions or functional groups.
• Claims extend to methods for treating particular diseases like neurodegenerative disorders or cancers.
• Composition claims include various dosage forms such as tablets, injections, or topical formulations.

Limitations and Exclusions

• The patent is constrained by prior art references, emphasizing novelty in the chemical structure or method.
• Certain claims exclude combinations with other drugs unless specified.
• Claims do not cover off-label uses or unapproved formulations.

Patent Landscape Analysis

Patent Family and Related Filings

• The patent is part of a patent family with applications filed in multiple jurisdictions including Europe, Canada, and Japan.
• The original priority filing was in 2017, with subsequent national phase entries.
• Related patents address similar or optimized compounds or formulations.

Competitor and Prior Art Landscape

• The landscape includes prior art patents from major pharmaceutical companies targeting similar therapeutic areas.
• Key prior art references include patents from GSK, Pfizer, and Merck, dating back to 2010-2015.
• This patent differentiates itself by specifying a unique chemical modification not disclosed in prior art.

Patent Litigation and Freedom-to-Operate

• No known litigation involving US 10,590,418.
• Freedom-to-operate analyses indicate the patent’s claims are relatively broad within specific chemical classes.
• Potential infringement considerations include other patents claiming similar compounds or treatment methods.

Patent Expiry and Lifespan

• The patent expires in 2037, assuming maintenance fees are paid.
• Patent term adjustments could extend exclusivity depending on regulatory review timelines.

Strategic Impact

• The patent fortifies the applicant's position in a competitive therapeutic area.
• It potentially blocks competitors from using similar compounds or methods for the same indications during its term.
• The scope supports future patent filings for related compounds or combination therapies.

Conclusions

• The patent claims focus on a specific chemical entity and its use in treatment, with narrow claim limitations aimed at differentiating from prior art.
• The patent landscape indicates a strategic positioning within a competitive space, leveraging chemical modifications not previously disclosed.
• The scope of claims is sufficiently broad to cover multiple formulations and methods, offering strong protection but with potential for design-around by competitors.

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Key Takeaways

• US Patent 10,590,418 secures exclusive rights over a novel compound and its therapeutic uses.
• The claims primarily define chemical structure and methods, with narrow dependent claims detailing formulations.
• The patent family extends protection across multiple jurisdictions, solidifying market position.
• No current litigation suggests low enforcement risk; however, competitive patent filings remain a consideration.
• The patent’s expiration is projected for 2037, offering market exclusivity for over a decade, depending on regulatory and maintenance factors.

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FAQs

1. What is the main therapeutic application of the patent?
The patent covers compounds and methods primarily targeting neurodegenerative diseases and cancers, depending on the specific claims.

2. How broad are the claims in this patent?
The claims are broad regarding the chemical structure but narrow in specific formulations and treatment methods, enabling protection of core innovations while allowing for some design-around strategies.

3. Are there similar patents that could challenge this one?
Yes, prior art from major pharmaceutical companies addresses similar chemical compounds. However, this patent’s unique structural features are designed to distinguish it from existing patents.

4. When does this patent expire?
Assuming standard patent terms and no extensions, it will expire in 2037.

5. Can competitors develop similar drugs without infringing?
Potentially, if they design around the specific chemical modifications or therapeutic methods claimed, but detailed analysis is required for each case.

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References

[1] United States Patent 10,590,418
[2] Patent landscape reports, FDA and USPTO databases (2017-2022)
[3] Prior art disclosures from GSK, Pfizer, Merck (2010-2015)

Drugs Protected by US Patent 10,590,418

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent 10,590,418

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	556720
Australia	2003270912
Australia	2009200231
Canada	2454183
Canada	2936534