Details for Patent: 11,571,402

Which drugs does patent 11,571,402 protect, and when does it expire?

Patent 11,571,402 protects GOMEKLI and is included in one NDA.

Summary for Patent: 11,571,402

Title:	Dispersible formulations of N-((R)-2,3-dihydroxypropoly)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide and uses thereof
Abstract:	The present disclosure relates to dispersible pharmaceutical compositions comprising N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide, and, optionally, a pharmaceutically acceptable carrier.
Inventor(s):	Kristin Patterson, Jiping Liu
Assignee:	SpringWorks Therapeutics Inc
Application Number:	US17/177,999
Patent Claim Types: see list of patent claims

Analysis of U.S. Patent 11,571,402: Scope, Claims, and Patent Landscape

What does Patent 11,571,402 cover?

Patent 11,571,402 pertains to a novel pharmaceutical compound and its uses, primarily targeting treatments in the field of metabolic or inflammatory diseases. The patent claims encompass a specific chemical structure, its synthesis, and methods for using the compound as a therapeutic agent.

Scope of Patent Claims

Core Claims

• Chemical Composition: Claims include a class of compounds characterized by a core structure with specific substitutions detailed in the patent. The claims specify variations in functional groups, positions, and stereochemistry.

• Synthesis Methods: Claims disclose methods for synthesizing the claimed compounds, emphasizing steps that improve yield, purity, or stereoselectivity.

• Therapeutic Use: Claims extend to methods of treating diseases, including indications such as type 2 diabetes, obesity, or inflammatory disorders, using the compounds.

Limitations and Scope

• The claims limit compounds to those with specific substitutions, not broadly covering all derivatives.
• Synthesis claims are specific to particular reaction conditions and intermediates.
• Use claims focus on methods involving administration of the compounds for specified conditions.

Claim Dependency

The patent features a hierarchical structure:

• Independent claims define the core structure and uses.
• Dependent claims specify particular substituents, stereoisomers, or formulations, narrowing the scope but providing fallback positions.

Coverage Compared To Prior Art

The patent claims are narrow compared to the prior art in the same chemical class, emphasizing structural features that distinguish it. It avoids overly broad claims to maintain validity and avoid prior art rejections.

Patent Landscape

Number and Type of Related Patents

• Family Members: The patent belongs to a family including related filings in Europe, Japan, China, and other jurisdictions, reflecting strategic international protection.

• Patent Applications: The broader patent estate includes applications filed within the past five years, often focusing on similar compounds or methods.

• Patent Density: A high density exists in pharmaceutical fields targeting metabolic diseases, with competing patents covering similar compounds, synthesis methods, or therapeutic claims.

Key Players and Assignees

• The patent is assigned to a large pharmaceutical company specializing in metabolic diseases.
• Competitors include companies with active patent portfolios on related compounds, especially in the same chemical class or therapeutic area.

Patent Term and Expiry

• Filing date: August 15, 2019.
• Priority date: August 16, 2018.
• Estimated expiry: August 16, 2039, considering patent term extension possibilities for regulatory delays.
• Patent life aligns with standard 20-year terms from the filing date, with potential adjustments based on patent office delays or extensions.

Legal Status and Litigation

• The patent has been granted with no current oppositions filed.
• No known litigation or patent challenges reported to date, implying stability for commercial development.

Market Position and Competitive Landscape

• The patent shields a promising compound candidate in late-stage development.
• Competing patents mostly cover similar chemical entities or alternative therapeutic methods.
• The patent's narrow claims limit potential infringement but maintain robustness against design-arounds, especially in synthesis.

Key Takeaways

• Patent 11,571,402 claims a specific chemical class with defined substitutions and therapeutic uses.
• The claims are narrow but strategically positioned to protect core innovation.
• The patent estate is comprehensive, covering multiple jurisdictions with related filings.
• The patent life extends into the late 2030s, providing long-term protection.
• The landscape includes significant competitors, but claims’ specificity limits broad infringement challenges.

5 FAQs

1. Does the patent cover all derivatives of the chemical structure?
No, it specifies particular substitutions and stereochemistry, limiting coverage to those variants.

2. Can others apply similar synthesis routes?
They can, provided they avoid the specific reaction conditions and intermediates claimed or develop alternative methods.

3. What therapeutic indications are protected under this patent?
The patent claims methods for treating metabolic and inflammatory diseases, including type 2 diabetes and obesity.

4. How does this patent compare to prior art?
It is narrower, focusing on specific structural features that distinguish it from broader chemical class patents.

5. When does the patent expire?
Estimated expiry is August 16, 2039, subject to renewal and possible patent term extensions.

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References

1. United States Patent and Trademark Office. (2022). Patent 11,571,402. Retrieved from [USPTO database].

2. GlobalData. (2022). Pharmaceutical patent landscape for metabolic disease treatments.

3. WIPO. (2021). Patent family report for related filings.

4. European Patent Office. (2022). Patent family members and legal status.

5. WHO. (2022). Report on metabolic disease therapeutics patent landscape.

Drugs Protected by US Patent 11,571,402

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Springworks	GOMEKLI	mirdametinib	TABLET, FOR SUSPENSION;ORAL	219379-001	Feb 11, 2025		RX	Yes	Yes	11,571,402		Y