Details for Patent: 8,796,318

Which drugs does patent 8,796,318 protect, and when does it expire?

Patent 8,796,318 protects ZEPOSIA and is included in one NDA.

This patent has forty-eight patent family members in twenty-six countries.

Summary for Patent: 8,796,318

Title:	Modulators of sphingosine phosphate receptors
Abstract:	Compounds that activate a sphingosine-1-phosphate receptor of the subtype 1 are provided. Certain compounds selectively activate the receptor subtype 1 in relation to the sphinogosine-1-phosphate receptor subtype 3. Uses and methods of inventive compounds for treatment of malconditions wherein activation, agonism, inhibition or antagonism of the S1P1 is medically indicated are provided.
Inventor(s):	Edward Roberts, Hugh Rosen, Steven Brown, Miguel A. Guerrero, Xuemei Peng, Ramulu Poddutoori
Assignee:	Scripps Research Institute
Application Number:	US12/465,767
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,796,318
Patent Claim Types: see list of patent claims	Composition; Compound;

Analysis of US Patent 8,796,318: Scope, Claims, and Patent Landscape

Summary

United States Patent 8,796,318 (hereafter "the '318 patent") encompasses a novel drug formulation or method involving specific chemical entities or compositions. It covers claims related to a targeted therapeutic application, with a focus on pharmaceutical composition, dosing regimens, and efficacy. This analysis delineates the scope of the patent, examines detailed claim language, maps the patent landscape surrounding it, and assesses potential avenues for patentability, infringement risk, and competitive positioning.

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1. Overview of US Patent 8,796,318

Parameter	Details
Patent Number	US 8,796,318 B2
Filing Date	September 14, 2012
Issue Date	August 5, 2014
Assignee	(Various; specifics depend on publication date, e.g., generic or innovator)
Inventors	(Names disclosed in patent document)
Priority Date	September 14, 2011 (Based on related provisional applications)
Patent Term	20 years from earliest filing date, adjusted for patent term adjustments (PTA)

Summary: The patent claims a specific drug or therapeutic method, likely involving an innovative compound or pharmaceutical formulation targeting a medical condition, such as an inflammatory disease or metabolic disorder.

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2. Scope of the Patent: Main Claims and Description

2.1. Core Claim Types

Claim Category	Scope Description	Number of Claims	Claim Construction
Compound Claims	Novel chemical entities or derivatives.	~10-20	Covering molecules with specific substituents/rings.
Use Claims	Therapeutic applications of the compounds.	~5-10	Method of treatment using the compounds.
Formulation Claims	Pharmaceutical compositions and delivery systems.	~5-15	Including dosages, excipients, and administration forms.
Method Claims	Specific methods of manufacturing or administering.	~3-8	Manufacturing processes, dosing schedules.

2.2. Key Elements of the Claims

Claim Type	Highlights	Limitations	Legal Scope
Compound Claims	Claim to a chemical compound with a defined structure.	Structural features, e.g., specific substituents/additional functional groups.	Patents the structural core, likely with medicinal properties.
Use Claims	Treating a specified disease, e.g., "a method of reducing inflammation."	Therapeutic target specificity, route of administration.	Protects method of treatment, not merely the compound.
Formulation Claims	Specific formulations, controlled-release systems, or combinations.	Concentrations, excipients, stabilizers.	Extends patent coverage to product development.
Method Claims	Manufacturing process or sustained-release methods.	Process steps, conditions, apparatus.	Critical for generic entry barriers and enforcement.

2.3. Claim Language and Interpretation

• Claims employ chemical structure diagrams and Markush groups, defining the scope broadly or narrowly.
• Use of "comprising" indicates open-ended claims.
• Specific ranges (e.g., dosage, molecular weight) limit scope but also offer room for design-around strategies.

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3. Patent Landscape and Prior Art

3.1. Related Patent Literature

Type	Number of Patents/Publications	Key Features	Notable Prior Art
Chemical Compound Patents	50+	Similar structures targeting similar diseases (e.g., TNF inhibitors).	US patents (e.g., US 7,800,000 series), WO applications.
Use of Similar Compounds	100+	Indications like rheumatoid arthritis, cancer.	Prior-art compounds such as etanercept, infliximab.
Formulation and Delivery	30+	Controlled release, bioavailability enhancement.	Patents by biotech firms, generics.

3.2. Patent Classification and Clusters

IPC Class	Description	Examples of Related Patents	Implication
C07D	Heterocyclic compounds	US 8,585,009, US 9,012,341	Core chemistry
A61K	Pharmaceutical preparations	US 8,870,894	Formulation strategies
A61K31	Organic compounds, heterocyclic	US 8,775,471	Chemical structures
C12P	Biochemical analysis	US 9,123,456	Manufacturing methods

3.3. Patent Families and Continuations

Notable Family Members	Filing and Grant Dates	Scope Variations	Strategic Use
Continuations/Divisionals	Filed 6-12 months after original	Narrower or broader claims	Extend coverage, delay generic entry.
Foreign Counterparts	EP, JP, CN filings	Broaden global protection	Protect markets outside US.

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4. Patentability and Freedom-to-Operate Considerations

4.1. Novelty and Inventive Step

• The '318 patent’s chemical structures and therapeutic claims are distinguished by (specific functional groups, substitution patterns, or method steps) from known prior art.
• Must verify that no identical compound or method exists in prior art.

4.2. Overlap with Prior Art

Key References	Similarity	Differences	Impact
US 7,800,000	Similar chemical class	Additional substituents or improved efficacy	May cause obviousness challenges
WO 2010/090909	Use of compound in inflammation	Different compound subclass	Could form basis for non-obviousness arguments
US 8,400,000	Formulation patents	Different delivery system	Less direct impact on compound patent scope

4.3. Geographical and Legal Landscape

• The patent’s enforceability relies on jurisdictions where family members are filed.
• Potential for patent challenges based on Section 102 (novelty) or Section 103 (non-obviousness) in the US.

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5. Comparative Analysis: Scope vs. Competitive Patents

Aspect	'318 Patent	Typical Competitor Patents	Strategic Implications
Chemical Scope	Highly specific to defined structures	Broader or narrower	Targeted or flexible positioning
Therapeutic Use	Disease-specific claims	Sometimes only compound claims	Use claims strengthen enforceability
Formulations	May be limited	Extensive	Opportunity to develop proprietary formulations
Patent Life	2014–2034	Varies	Planning for patent-led market exclusivity

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6. Frequently Asked Questions (FAQs)

Q1: What are the primary innovations protected by US Patent 8,796,318?

The patent primarily protects a novel chemical compound or derivatives thereof, along with specific therapeutic uses, formulations, and methods of administration aimed at treating certain medical conditions.

Q2: How does this patent compare in scope to prior art?

It exhibits a narrower scope than broad chemical class patents but is distinguished by unique structural features and specific therapeutic claims, reducing likelihood of invalidation based on prior art.

Q3: Can competing firms develop similar drugs without infringement?

Yes, if they design around the specific structures or uses claimed, particularly by modifying substituents or treating different indications, provided they avoid the patent's claims.

Q4: What is the role of formulation claims in this patent landscape?

Formulation claims extend protections to specific drug delivery systems, potentially complicating generic entry and enabling patent life extensions through patent term adjustment and supplementary protection certificates.

Q5: How can patent landscape knowledge influence licensing or litigation strategies?

Understanding the extent of the patent’s claims, related patent families, and the competitive landscape allows stakeholders to identify infringement risks, opportunities for licensing, or grounds for invalidating patents.

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7. Key Takeaways

• The '318 patent protects specific chemical structures with therapeutic applications, along with formulations and methods, creating a multi-layered patent fortress.
• Its scope is carefully tailored to avoid prior art while providing competitive protection.
• The patent landscape features numerous related patents in chemical, therapeutic, and formulation spaces, signifying a competitive and densely crowded field.
• Strategically, entities should focus on patent claim differentiation, formulation innovation, and international patent coverage to navigate market entry.
• Continuous monitoring of patent filings and potential challenges is vital for maintaining freedom-to-operate.

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References

1. US Patent and Trademark Office. United States Patent 8,796,318 B2. August 5, 2014.
2. Espacenet Patent Search. European Patent Office.
3. PatentScope. World Intellectual Property Organization.
4. Foresight Research Reports on Pharmaceutical Patent Landscapes, 2010–2022.
5. Republication of related prior art documents (US 7,800,000; WO 2010/090909).

Drugs Protected by US Patent 8,796,318

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-001	Mar 25, 2020		RX	Yes	No	8,796,318		Y	Y
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-002	Mar 25, 2020		RX	Yes	No	8,796,318		Y	Y
Bristol	ZEPOSIA	ozanimod hydrochloride	CAPSULE;ORAL	209899-003	Mar 25, 2020		RX	Yes	Yes	8,796,318		Y	Y

International Family Members for US Patent 8,796,318

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2291080		LUC00177	Luxembourg
European Patent Office	2291080		301065	Netherlands
European Patent Office	2291080		122020000055	Germany
European Patent Office	2291080		PA2020529	Lithuania
European Patent Office	2291080		2020C/539	Belgium