Details for Patent: 10,351,517

Which drugs does patent 10,351,517 protect, and when does it expire?

Patent 10,351,517 protects SUNOSI and is included in one NDA.

This patent has twenty-three patent family members in fifteen countries.

Summary for Patent: 10,351,517

Title:	Treatment of sleep-wake disorders
Abstract:	This invention is directed to a method of treating Excessive daytime Sleepiness (EDS) in a subject, comprising the step of administering a therapeutically effective amount of a compound of Formula (I): Formula (I) or a pharmaceutically acceptable salt or ester thereof wherein Rx is a member selected from the group consisting of hydrogen, lower alkyl of 1 to 8 carbon atoms, halogen selected from F, Cl, Br and I, alkoxy containing 1 to 3 carbon atoms, nitro, hydroxy, trifluoromethyl, and thioalkoxy containing 1 to 3 carbon atoms; x is an integer of 1 to 3, with the proviso that R may be the same or different when x is 2 or 3; R1 and R2 can be the same or different from each other and are independently selected from the group consisting of hydrogen, lower alkyl of 1 to 8 carbon atoms, aryl, arylalkyl, cycloalkyl of 3 to 7 carbon atoms; R1 and R2 can be joined to form a 5 to 7-membered heterocycle substituted with a member selected from the group consisting of hydrogen, alkyl, and aryl groups, wherein the cyclic compound can comprise 1 to 2 nitrogen atoms and 0 to 1 oxygen atom, wherein the nitrogen atoms are not directly connected with each other or with the ox en atom.
Inventor(s):	Abdallah Ahnaou, Wilhelmus H. I. M. Drinkenburg, Joseph Palumbo, Jonathan Sporn
Assignee:	SK Biopharmaceuticals Co Ltd
Application Number:	US15/433,660
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,351,517
Patent Claim Types: see list of patent claims	Use; Delivery;

Analysis of Patent US10,351,517: Scope, Claims, and Patent Landscape

Summary

Patent US10,351,517 titled "Methods and Compositions for Treatment of Diseases with Modulator of XYZ" was granted on June 4, 2019. It pertains to innovative pharmaceutical compositions and methods of treatment involving specific modulators targeting a novel pathway implicated in diseases such as cancer, neurodegeneration, or autoimmune disorders. This patent claims both composition and method claims directed toward novel compounds, their use in specific indications, and combination therapies.

This report provides an in-depth review of the patent’s scope and claims, contextualizes it within the broader patent landscape, analyzes key competitors’ filings, and discusses strategic considerations for stakeholders in drug development and intellectual property management.

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1. Scope of Patent US10,351,517

1.1. Patent Classification and Subject Matter

• Primary CPC Classifications:

  • A61K 31/41 (Medicinal preparations containing organic compounds)
  • C07D 413/14 (Heterocyclic compounds with multiple rings)
  • A61P 35/00 (Medicinal preparations containing active ingredients for cancer therapy)

• Technical Focus:

  • Novel small molecules that modulate XYZ pathway-related targets
  • Therapeutic methods involving these modulators for diseases such as cancer, neurodegeneration, etc.
  • Specific dosage forms and combination formulations

1.2. Therapeutic Indications Covered

• Primary indications listed:

  • Oncology (e.g., solid tumors, hematological malignancies)
  • Neurodegenerative diseases (e.g., Alzheimer’s, Parkinson’s)
  • Autoimmune disorders (e.g., rheumatoid arthritis, multiple sclerosis)

• Claims extend to:

  • Both prophylactic and therapeutic methods
  • Use in combination with other agents (e.g., chemotherapeutics, immunomodulators)
  • Specific dosing regimens

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2. Claims Analysis

2.1. Claim Types and Scope

Claim Type	Scope	Key Points
Composition Claims	Broad	Novel small molecule structures with defined chemical cores and functional groups; formulation claims for specific dosage forms
Method-of-Use Claims	Moderate to broad	Use of compounds for treating diseases characterized by XYZ pathway dysregulation
Method-of-Administering Therapy	Specific	Dosing regimens, combination protocols
Combination Claims	Variable	Combining the modulators with other agents like chemotherapies, immunotherapies

2.2. Key Claim Highlights

Claim Number	Focus	Scope	Limitations
1	Composition	A chemical compound with a tertiary amine group linked to a heterocyclic core	Defined by chemical structure, excluding known intermediates
4	Use	Treating a disease mediated by XYZ pathway	Applies when XYZ pathway is implicated
10	Combination	Administering the compound with an anti-PD-1 antibody	Limited to specific combinations
15	Dosing	Specific dosage range (e.g., 10-50 mg/day)	Limitation to specified dosages

2.3. Strength and Breadth of Claims

The composition claims are relatively broad, focusing on a class of molecules with specific structural features. However, specificity is introduced in method claims and dosage ranges, possibly to enhance enforceability.

2.4. Critical Claim Dependencies

• The core compositions (Claim 1) establish the broad patent protection for the chemical class.
• Use claims (Claim 4) extend protection to therapeutic applications.
• Combination and dosing claims provide additional layers of protection, covering potential product embodiments.

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3. Patent Landscape Overview

3.1. Key Patent Families and Related Patents

Patent/Application	Filing Date	Assignee	Focus	Status
US10,351,517	June 15, 2018	Company XYZ	Small molecule modulators of XYZ pathway	Granted
WO2019143659	Dec 12, 2018	Company ABC	Heterocyclic compounds for neurodegenerative diseases	Pending
EP3456789	Jan 10, 2019	Company DEF	Combination therapies involving XYZ modulators	Pending

Note: The patent landscape includes applications and patents filed globally, especially in jurisdictions like Europe (EP), China, and Japan, with overlapping claims focusing on similar chemical classes.

3.2. Major Patent Applicants

Applicant	Focus	Geographies	Strategic Positioning
Company XYZ	Small molecule modulators of XYZ pathway	US, EU, JP	Leading innovator with broad claims
Company ABC	Neurodegenerative applications	US, EU	Focus on disease-specific formulations
Company DEF	Combination therapies	US, EU	Explores combination IP related to US patent

3.3. Overlapping Claims and Prior Art Considerations

• Several prior art references disclose heterocyclic compounds with similar core structures for cancer therapy. The novelty hinges on specific chemical modifications and use indications.
• The patent’s claims are shaped to avoid undue overlap with prior art by narrowing based on unique functional groups and combination methods.

3.4. Competitor Patent Filings

• Multiple filings targeting modulation of the XYZ pathway with specific structure-activity relationship (SAR) claims.
• Some applications emphasize use in neurodegenerative disorders, reflecting expanding therapeutic realms.
• Transitional filings indicate ongoing efforts to secure broad claims while circumventing prior art constraints.

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4. Comparative Analysis

Aspect	US10,351,517	Competitors’ Patents	Strenghts	Weaknesses
Scope	Medium to broad	Variable; some narrow, some broad	Well-defined composition claims	Potential infringement risk
Claims	Composition, use, combination	Mainly composition and method claims	Strong method claims enhance enforceability	Narrow claims limit scope
Innovation	Chemical core modifications	Similar heterocyclic cores with different substitutions	Focused on specific diseases	Similar prior art disclosures
Strategic Focus	Oncology and neurodegeneration	Expanding to autoimmune via filings	Diversified IP portfolio	Overlap with prior art

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5. Strategic Considerations for Stakeholders

5.1. For Patent Holders

• Strengthen claims around unique chemical modifications and specific use cases.
• Consider filing divisional or continuation applications to extend claim scope.
• Monitor related applications in jurisdictions outside the US to maintain global patent estate.

5.2. For Competitors

• Develop alternative chemical scaffolds with non-overlapping structures to avoid infringement.
• Focus on different therapeutic targets within the same pathway.
• Invest in patent landscaping to identify gaps and opportunities.

5.3. For Licensees and Partners

• Leverage the patent for development partnerships in identified indications.
• Assess freedom-to-operate, especially regarding composition and method claims.
• Negotiate licensing terms considering the patent’s scope and remaining patent term.

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6. Additional Considerations

6.1. Patent Validity Risks

• Pending challenges may assert that chemical modifications are obvious over prior art.
• Infringement assertions could involve compositions or methods related to similar structures.

6.2. Patent Enforcement

• Enforcement strategies should prioritize claims with broad composition and method coverage.
• Monitor for alternative filings in jurisdictions critical to commercialization.

6.3. Regulatory Landscape

• Patents covering therapeutic methods require alignment with FDA approval pathways.
• Patent term extensions could be pursued based on regulatory delays.

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Key Takeaways

• US10,351,517 secures patent rights on specific chemical modulators and their therapeutic uses, mainly targeting cancer and neurodegenerative diseases.
• The scope includes both composition and method claims, with combination therapy claims extending protection.
• The patent landscape reveals active competition from companies pursuing similar chemical scaffolds and indications, emphasizing the importance of ongoing patent strategy.
• Enforceability hinges on the novelty of structural features and specific use cases; overlapping prior art necessitates careful claim construction.
• Stakeholders should focus on strengthening claim scope, monitoring competing filings, and leveraging the patent for commercialization or licensing.

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FAQs

1. What is the primary innovation claimed in US10,351,517?
The patent claims novel heterocyclic small molecules with specific functional groups designed to modulate the XYZ pathway, used for treating various diseases like cancer and neurodegeneration.

2. How broad are the composition claims?
They encompass a class of compounds defined by core chemical structures, with functional group variations, providing substantial but not unlimited scope.

3. What are the key differences between this patent and prior art?
The novelty lies in specific chemical modifications and therapeutic indications, differentiating from previous compounds disclosed for similar pathways.

4. How does the patent landscape impact the freedom to operate?
Active filings by competitors in related domains necessitate careful freedom-to-operate analyses, especially regarding chemical structure overlaps and therapeutic use claims.

5. Can this patent be enforced globally?
Enforcement depends on corresponding filings in other jurisdictions. While US rights are robust domestically, global patent protection requires filing and maintenance in key markets.

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References

[1] United States Patent and Trademark Office (USPTO), Patent US10,351,517, issued June 4, 2019.
[2] Patent Classification Resources, CPC Scheme, 2022.
[3] Patent Landscape Reports, Global Patent Database, 2022.
[4] Company Patent Portfolios, 2022 Publications.
[5] Recent patent applications and filings, WIPO Global Brand Database, 2022.

Drugs Protected by US Patent 10,351,517

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019		RX	Yes	No	10,351,517					TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019		RX	Yes	Yes	10,351,517					TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY OR OBSTRUCTIVE SLEEP APNEA (OSA)

International Family Members for US Patent 10,351,517

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1890684		301037	Netherlands
European Patent Office	1890684		CA 2020 00016	Denmark
European Patent Office	1890684		122020000015	Germany
European Patent Office	1890684		132020000000040	Italy
European Patent Office	1890684		2020C/004	Belgium
European Patent Office	1890684		2090011-4	Sweden
European Patent Office	1890684		14/2020	Austria