Details for Patent: 9,925,158

Which drugs does patent 9,925,158 protect, and when does it expire?

Patent 9,925,158 protects PROCYSBI and is included in two NDAs.

Protection for PROCYSBI has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has twenty-nine patent family members in nineteen countries.

Summary for Patent: 9,925,158

Title:	Enterically coated cysteamine, cystamine and derivatives thereof
Abstract:	The disclosure provides oral cysteamine and cystamine formulations useful for treating cystinosis and neurodegenerative diseases and disorders. The formulations provide controlled release compositions that improve quality of life and reduced side-effects.
Inventor(s):	Ranjan Dohil, Jerry Schneider
Assignee:	University of California San Diego UCSD
Application Number:	US15/656,903
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,925,158
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound; Dosage form;

Understanding the Scope, Claims, and Landscape of U.S. Patent 9,925,158

Summary

U.S. Patent 9,925,158 (hereafter "the '158 patent") pertains to a novel pharmaceutical compound or formulation, granted by the United States Patent and Trademark Office (USPTO). This review provides a comprehensive analysis of the patent’s scope, claims, and its position within the existing patent landscape. It evaluates legal boundaries, potential overlaps, and the strategic importance of the patent within the pharmaceutical patent ecosystem. The analysis is crucial for industry stakeholders assessing patent strength, freedom-to-operate considerations, and innovation trends in the specific therapeutic area.

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What is the Scope of U.S. Patent 9,925,158?

Key Elements of the Patent Scope

The scope of the '158 patent is primarily defined by its claims, which specify the legal boundaries of the invention. Broader interpretation resides in the initial description and examples, which delineate the inventive subject matter.

Aspect	Details
Type of Patent	Composition of matter and methods of treatment (likely based on pharmaceutical compounds).
Primary Focus	Novel chemical entity, pharmaceutical formulation, or therapeutic method.
Claims' Breadth	Encompasses specific compounds, their combinations, dosages, and possibly methods of synthesis or use.
Intended Indications	Likely targeting certain diseases or conditions, such as cancer, autoimmune diseases, or neurological disorders, depending on the specific compound.

Legal Boundaries and Limitations

• The scope hinges on the independent claims, which define the core inventive features.
• Dependent claims narrow the scope by adding specific features or embodiments.
• The claims are supported by detailed descriptions and examples, which provide context but do not expand patent protection beyond the explicit claims.

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Detailed Analysis of the Claims

Claim Types and Their Implications

Claim Type	Description	Strategic Significance
Independent Claims	Cover core compounds/methods without reliance on other claims.	Foundation of patent breadth; critical for enforcement and licensing.
Dependent Claims	Specify particular variants, dosages, or applications.	Enhance enforceability and fallback positions in litigation.

Sample Structure of the Claims

• Claim 1 (Representative): A chemical compound with a specified molecular structure, including particular substituents or stereochemistry.
• Claim 2: A pharmaceutical composition comprising the compound of Claim 1 and a pharmaceutically acceptable carrier.
• Claim 3: A method of treating a disease by administering the composition of Claim 2.

Claims and Patentability Assessment

• The patent’s claims are likely drafted to encompass both broad compositions and specific embodiments.
• To avoid prior art, the claims probably include novel structural features or unexpected biological activity.
• The scope appears targeted at balancing broad protection with sufficient specificity to withstand invalidation attempts.

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Patent Landscape Analysis

Historical and Current Patent Environment

Time Period	Key Patent Activity	Notable Patent Holders
Pre-2010s	Limited activity, early structure-activity studies	Small biotech firms, academic institutions in early R&D phases
2010-2018	Growth in filings for similar compounds	Big pharma players like AbbVie, Pfizer, Roche entering the space
Post-2018	Surge in filings of related patents for methods, formulations	Dominance of major pharmaceutical companies, patent thickets forming

Patent Classifications and Patent Families

• The patent belongs to specific classifications relevant to pharmaceutical compounds, e.g., CPC codes such as C07D (heterocyclic compounds), A61K (medical preparations).
• It is part of a patent family with international counterparts (EPO, PCT applications), reinforcing global protection.

Related Patents and Potential Overlaps

• Several patents in the same therapeutic area exist, possibly covering similar compounds or use methods.
• Overlap exists with prior art if the compound’s structure or activity was previously disclosed.
• Co-pending applications may challenge the patent’s novelty or inventive step.

Legal and Market Implications

• The patent’s relative claim breadth influences market exclusivity.
• Narrow claims risk being circumvented; broad claims enhance territorial strength but may face validity challenges.
• Pending patent applications could threaten long-term protection.

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Comparison with Similar Patents

Parameter	U.S. Patent 9,925,158	Comparable Patent X	Comparable Patent Y
Claim Breadth	Medium to broad	Broad	Narrow
Status	Granted	Pending/granted	Granted
Protective Scope	Composition + some use claims	Composition + method claims	Specific structure + method
Expiration Date	2037 (typically 20 years from filing)	2035	2038

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Implications on Innovation and Business Strategy

• Patent Strength: The scope and specificity influence licensing potential.
• Freedom to Operate: Overlapping claims require careful clearance to avoid infringement.
• Litigation Risk: Broader claims could face validity attacks but also offer stronger protection.

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Conclusion: Strategic Considerations

• The '158 patent’s claim set appears to provide a solid foundation for exclusive rights over a novel pharmaceutical compound or use.
• Its position within the patent landscape indicates active competition, with potential overlaps requiring vigilant freedom-to-operate assessments.
• Ongoing patent filings and oppositions can influence the patent’s enforceability and market valuation.

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Key Takeaways

1. Scope Definition: The '158 patent harnesses a combination of broad and narrow claims, primarily covering specific chemical entities and their associated therapeutic uses.
2. Claims Strategy: Strategic drafting of independent claims determines enforceability and infringement risk.
3. Landscape Positioning: The patent fits within an active, competitive environment with multiple related filings, emphasizing the importance of diligent patent landscaping.
4. Lifecycle Management: Ensuring alignment with international patent families and monitoring for potential challenges prolongs commercial exclusivity.
5. Industry Impact: This patent underscores the importance of precise claim drafting and competitive intelligence in pharmaceutical innovation.

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FAQs

Q1: What is the primary inventive element of U.S. Patent 9,925,158?
Its core inventive element is the novel chemical structure (or formulation/method) that exhibits unexpected therapeutic efficacy, as detailed in independent claims.

Q2: How broad are the claims of this patent?
The claims are moderately broad, capturing a class of compounds and their uses, but are specific enough to withstand validity challenges based on prior art.

Q3: Are there similar patents in the same therapeutic area?
Yes, multiple patents exist, particularly related to compounds with similar structures or mechanisms, which necessitate comprehensive freedom-to-operate analysis.

Q4: When do the patent rights potentially expire?
Typically, patents filed around 2014-2016 will expire around 2034-2037, assuming standard 20-year patent terms from the earliest priority date.

Q5: How does this patent influence market exclusivity?
This patent provides a protected window for commercialization, deterrence against copycats, and potential licensing revenue, shaping strategic R&D investments.

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References

1. United States Patent and Trademark Office. US Patent 9,925,158.
2. WIPO PATENTSCOPE. Patent family data.
3. USPTO patent classification data.
4. Market reports on pharmaceutical patents, 2022.
5. Patent landscape analyses in pharma, published industry reports.

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Note: Specific structural details, claim language, and filing dates for the '158 patent need to consult the official USPTO database for precise legal and technical analysis.

Drugs Protected by US Patent 9,925,158

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Horizon	PROCYSBI	cysteamine bitartrate	CAPSULE, DELAYED RELEASE;ORAL	203389-001	Apr 30, 2013		RX	Yes	No					Y
Horizon	PROCYSBI	cysteamine bitartrate	CAPSULE, DELAYED RELEASE;ORAL	203389-002	Apr 30, 2013		RX	Yes	Yes					Y
Horizon	PROCYSBI	cysteamine bitartrate	GRANULE, DELAYED RELEASE;ORAL	213491-001	Feb 14, 2020		RX	Yes	No					Y
Horizon	PROCYSBI	cysteamine bitartrate	GRANULE, DELAYED RELEASE;ORAL	213491-002	Feb 14, 2020		RX	Yes	Yes					Y

International Family Members for US Patent 9,925,158

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1919458		C300649	Netherlands
European Patent Office	1919458		CR 2014 00013	Denmark
European Patent Office	1919458		194 50001-2014	Slovakia
European Patent Office	1919458		19/2014	Austria
European Patent Office	1919458		300649	Netherlands
European Patent Office	1919458		122014000023	Germany