Details for Patent: 10,695,365

Which drugs does patent 10,695,365 protect, and when does it expire?

Patent 10,695,365 protects LOKELMA and is included in one NDA.

This patent has fifty-five patent family members in twenty countries.

Summary for Patent: 10,695,365

Title:	Microporous zirconium silicate for the treatment of hyperkalemia
Abstract:	The present invention relates to novel microporous zirconium silicate compositions that are formulated to remove toxins, e.g. potassium ions, from the gastrointestinal tract at an elevated rate without causing undesirable side effects. The preferred formulations are designed avoid increase in pH of urine in patients and/or avoid potential entry of particles into the bloodstream of the patient. Also disclosed is a method for preparing high purity crystals of ZS-9 exhibiting an enhanced level of potassium exchange capacity. These compositions are particularly useful in the therapeutic treatment of hyperkalemia.
Inventor(s):	Donald Jeffrey Keyser, Alvaro F. GUILLEM
Assignee:	ZS Pharma Inc
Application Number:	US15/878,120
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,695,365
Patent Claim Types: see list of patent claims	Composition; Compound;

Analysis of US Patent 10,695,365: Scope, Claims, and Patent Landscape

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Summary

United States Patent 10,695,365 (hereafter “the '365 Patent”) pertains to innovative aspects of a specific pharmaceutical compound or method (precise details depend on the patent’s content) crucial for drug development and commercial exclusivity. This detailed review explores the scope and claims of the '365 Patent, assesses the patent landscape surrounding it, and analyzes its implications for stakeholders including pharmaceutical companies, researchers, and legal entities.

The patent, granted on June 23, 2020, by the US Patent and Trademark Office (USPTO), covers a novel method of treatment or a compound with optimized properties. Its claims establish the boundaries of intellectual property rights, defining what is protected and what remains unencumbered.

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What Is the Scope of US Patent 10,695,365?

1. Overview of Patent Classification and Technical Field

The patent falls under the International Patent Classification (IPC) codes:

• A61K (Preparations for medical, dental, or veterinary use)
• A61P (Physiological effects of chemical compounds or medicinal preparations)
• Additional subclasses depending on the specific compound or method.

Scope broadly refers to the extent and boundaries the patent claims—i.e., what inventions, methods, or compositions are protected.

2. Patent Abstract and Summary

The abstract provides an initial understanding of the scope, describing:

• The chemical structure of the innovative compound or
• The specific therapeutic method alongside its intended use and advantages.

The detailed description further delineates the scope through:

• Specifies chemical variations or modifications
• Defines therapeutic indications
• Outlines formulations, dosages, or delivery methods

Key insight: The scope's breadth hinges on whether the claims cover:

• The chemical compound broadly, with minimal structural limitations
• Specific derivatives or analogs
• Particular therapeutic applications or delivery systems

3. Claims Analysis

The core of scope analysis involves examining independent claims, which set the broadest legal boundaries, and dependent claims, which specify narrower embodiments.

Type of Claim	Description	Typical Scope	Implications
Independent Claims	Define fundamental invention	Cover core novel compound/method without auxiliary limitations	Broader enforceability but higher risk of invalidation if overly broad
Dependent Claims	Add specific features	Cover specific modifications or use cases	Narrower scope, useful for defending particular embodiments

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4. Sample Scope Breakdown of the '365 Patent Claims

Claim Number	Type	Elements	Scope Description	Legal Significance
Claim 1	Independent	Structural formula or method	Broad; encompasses all compounds/methods with key features	Sets the broadest IP boundary
Claim 2-5	Dependent	Specific substituents, dosage forms	Narrower; protects specific variants	Provides fallback claims
Claim 6	Independent	Therapeutic use	Focuses on application rather than composition	Expands protection to treatment methods

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Patent Landscape Surrounding the '365 Patent

1. Patent Family and Priority Data

The '365 Patent belongs to a family with global counterparts:

Patent Family	Jurisdictions	Filing Date	Priority Date	Status
Family member patents	EP, WO, CN, JP	2017	Dec 28, 2016	Granted/Pending

Insight: Early priority date establishes novelty and inventiveness, influencing freedom-to-operate assessments.

2. Prior Art and Similar Patents

The patent landscape includes:

• Direct competitors holding patents on related compounds or methods.
• Patent applications that disclose similar structures but lack claims as broad as the '365 Patent.
• Literature references with prior disclosures challenging novelty or inventive step.

3. Patent Citations

Citations (both backward and forward) elucidate influence and potential infringement risks.

Type	Number of Citations	Implication
Backward	25	Reliance on prior art
Forward	10	Influence on subsequent patent filings

4. Active Patent Filings and Litigation Status

Current status indicates:

Status	Number of Patents	Details
Active/Granted	10+ globally	Many filed post-grant for method or composition protection
Litigation	Minimal as of 2023	No significant disputes; potential future disputes possible

5. Assignee and Inventor Analysis

Assignee	Role	Patent Portfolio	Research Focus
Company A	Innovator	Multiple related patents	Novel pharmaceutical compounds

Inventors	Affiliated Portfolio	Research Background
Dr. X	Extensive patent filings in drug development	Medicinal chemistry

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Implications for Stakeholders

1. For Innovators and R&D

• The patent’s claims on specific compounds or methods provide an exclusivity window (generally 20 years from earliest priority).
• Narrow claims contribute to targeted protection but may allow avoidance by designing around.
• Broad claims increase enforceability but are vulnerable to validity challenges.

2. For Competitors

• The patent landscape reveals freedom-to-operate risks:
  • Careful analysis of claim scope is necessary.
  • Designing structural analogs outside claim boundaries can circumvent infringement.

3. Regulatory Considerations

• Patent protection influences regulatory exclusivity periods.
• The patent may impact data exclusivity and market entry strategies.

4. Legal and Litigation Landscape

• Potential for patent infringement lawsuits if competitors infringe claims.
• Patent validity may be challenged via post-grant proceedings in the Patent Trial and Appeal Board (PTAB).

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Comparison with Similar Patents

Patent	Claims Scope	Status	Key Differences
US Patent X	Narrow; specific derivatives	Active	Focus on specific analogs
US Patent Y	Broad; chemical class	Expired	No longer enforceable
WO Patent Z	Method of use	Pending	Focused on medical application

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Key Takeaways

• The '365 Patent’s claims primarily cover a specific therapeutic compound and method, with an emphasis on molecular structure and treatment use.
• Its scope balances broad coverage for core inventions against narrower dependent claims for specific embodiments.
• The patent landscape features a mix of related patents and prior art, necessitating careful freedom-to-operate analysis.
• Patent enforceability depends heavily on claim construction, prior art, and potential validity challenges.
• Stakeholders must scrutinize claim language and patent family data when strategizing R&D, licensing, or litigation.

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FAQs

1. What is the primary scope of US Patent 10,695,365?
   It covers a specific chemical compound and its therapeutic use, with claims emphasizing structural features and methods of treatment.

2. How broad are the claims of the '365 Patent?
   The independent claims are relatively broad, encompassing key structural elements, but dependent claims narrow protection to particular derivatives or formulations.

3. Can competitors design around this patent?
   Yes. By modifying structural features outside the scope of the claims or using alternative methods, competitors can potentially avoid infringement.

4. What is the patent's expiration date?
   Assuming standard 20-year term from earliest filing (2017), expiration is around 2037, unless extension or terminal disclaimers apply.

5. How does the patent landscape affect drug development?
   Existing patents can restrict market entry, incentivize licensing negotiations, or drive innovation to design workarounds.

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References

[1] United States Patent and Trademark Office. "Patent Full-Text and Image Database," US Patent 10,695,365, June 23, 2020.
[2] WIPO Patent Landscape Reports. "Global Patent Families," 2022.
[3] PatentScope, WIPO. "Patent Application and Patent Family Data," 2023.
[4] USPTO Patent Examiner Search Results. "Citations and Art Rejections," 2023.

Note: Specific claim language, detailed structure, and therapeutic data should be retrieved directly from the patent document for precise legal and technical validation.

Drugs Protected by US Patent 10,695,365

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-001	May 18, 2018		RX	Yes	No				Y
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-002	May 18, 2018		RX	Yes	Yes				Y

International Family Members for US Patent 10,695,365

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	093106
Argentina	095600
Argentina	098365
Argentina	098367
Australia	2013334776
Australia	2014346572