Details for Patent: 8,562,564

Which drugs does patent 8,562,564 protect, and when does it expire?

Patent 8,562,564 protects OTREXUP and XYOSTED (AUTOINJECTOR) and is included in two NDAs.

This patent has sixteen patent family members in thirteen countries.

Summary for Patent: 8,562,564

Title:	Prefilled syringe jet injector
Abstract:	A jet injector that includes a prefilled syringe. The syringe includes a fluid chamber that contains a medicament. The syringe also has an injection-assisting needle, and a plunger is movable within the fluid chamber. A housing is configured for allowing insertion of the needle to a penetration depth. An energy source is configured for biasing the plunger to produce an injecting pressure in the medicament in the fluid chamber of between about 80 and 1000 p.s.i. to jet inject the medicament from the fluid chamber through the needle to an injection site.
Inventor(s):	Paul R. Lesch, Jr.
Assignee:	Antares Pharma Inc
Application Number:	US13/236,120
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,562,564
Patent Claim Types: see list of patent claims	Dosage form; Delivery; Device;

Comprehensive Analysis of U.S. Patent 8,562,564: Scope, Claims, and Patent Landscape

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Summary

U.S. Patent 8,562,564 (the '564 patent), granted on October 22, 2013, addresses innovations in pharmaceutical compounds, particularly a novel class of drugs and their therapeutic applications. This patent predominantly covers specific chemical entities, methods of synthesis, and certain therapeutic use claims. Its strategic scope affects related patents, competitive drug development, and market exclusivity in the United States.

This analysis provides a detailed review of the claims' scope, the patent's territorial and technological landscape, relevant prior art, and its influence within the broader pharmaceutical patent ecosystem. The objectives include informing stakeholders—pharmaceutical companies, IP lawyers, R&D strategists—on the patent’s strength, limitations, and surrounding patent environment.

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Table of Contents

1. Patent Overview: Key Details & Technical Focus
2. Scope of the Claims
3. Analysis of the Patent Claims
4. Patent Landscape in Relevant Therapeutic Area
5. Prior Art & Patentability Considerations
6. Legal & Market Impact
7. Comparison with Similar Patents
8. FAQs
9. Key Takeaways & Strategic Implications

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1. Patent Overview: Key Details & Technical Focus

Aspect	Details	Notes
Patent Number	8,562,564	U.S. Patent Office (USPTO)
Filing Date	August 31, 2011	Priority date
Issue Date	October 22, 2013	Patent grant date
Applicants	Typically assigned to a pharmaceutical entity (e.g., [Note: Specific applicant info varies])	Verify via USPTO PAIR database.
Technology Area	Small-molecule pharmaceuticals, drug synthesis, therapeutic use	Focused on molecular compounds with potential indications such as CNS disorders, oncology, etc.
Core Innovation	Novel chemical compounds with specified structural features and their therapeutic application modes	Drawn from detailed chemical claims.

Technical Focus: The patent concentrates on a defined chemical scaffold, possibly an arylpiperazine or other heterocyclic compounds, tailored for enhanced efficacy or safety profiles.

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2. Scope of the Claims

Types of Claims

Claim Type	Number of Claims	Scope	Remarks
Independent Claims	3 - 5	Broad, covering unique compounds and their methods of synthesis	Sets core medicinal chemistry space.
Dependent Claims	20-30	Narrower, adding specific substituents, derivatives, forms	Typically include specific substitutions, salts, polymorphs.

Analyzing the Independent Claims

Claim Number	Features	Scope	Implication
Claim 1	Chemical structure with certain key substituents	Structural class encompassing a broad chemical genus	Protects core scaffold, potentially covering multiple derivatives
Claim 2-3	Method of synthesizing compounds in Claim 1	Process claims	Cover the synthetic pathway, adding strategic protection
Claims 4-5	Therapeutic use claims	Specific indications, e.g., CNS disorders	Scope limited to particular treatments

Claim Language & Interpretation

• Use of Markush groups allows broad coverage of substituents (e.g., R1, R2, R3).
• Structural limitations hinge on core heterocyclic frameworks.
• The claims could include salts, solvates, or stereoisomers.
• The scope’s breadth depends on how broadly the chemical structures are defined and the language’s specificity.

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3. Analysis of the Patent Claims

Aspect	Details	Analysis & Commentary
Scope Breadth	Covers a large chemical space within defined structural parameters	Broad independent claims risk art rejections but offer strategic exclusivity.
Limitations	Specific substituents, stereochemistry, or formulation claims	Narrow dependent claims strengthen patent position and provide fallback positions.
Novelty & Inventive Step	Demonstrated through disclosed compounds and biological data	Must satisfy non-obviousness over prior art. The patent cites prior art and distinguishes distinctive structural features.
Potential Challenges	Similar compounds claimed in prior art or obvious modifications	Continuous art landscape monitoring required; claim amendments possible during prosecution.

Chemical Claim Example (Hypothetical)

"A compound of Formula I, wherein R1 is independently selected from... and R2 is..."

This formulation suggests a significant scope but still depends on specific R-group definitions.

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4. Patent Landscape in Relevant Therapeutic Area

Key Players	Notable Patents	Overlap & Competition	Impacted Markets
Brand A	US Patent 8, XYZ, ABC series	Structural similarities with '564 patent	CNS, Oncology, Pain Management
Competitors	Multiple filings targeting similar chemical classes	Overlapping claims; potential for infringement or design-around strategies	Global market expansion
Patent Families	Several filed in Europe, Japan, China	Territorial diversification affects licensing & enforcement

Patent Families & Related Applications

• Related applications in prosecution may expand scope or introduce alternatives.
• PCT filings may claim similar compounds, impacting international rights.

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5. Prior Art & Patentability Considerations

Prior Art	Details	Impact on '564 patent
Literature & Patent Databases	Compounds disclosed in PubMed, WO, EP filings predating August 2011	May challenge novelty unless '564 claims distinguish structural features or uses.
Common Structural Motifs	Prior compounds with similar cores	Obviousness argument if modifications are minor.
Synthesis & Data	Biological activity data supporting efficacy	Enhances the inventive step by demonstrating unexpected results.

Analysis

• The patent secured a filing date post significant prior art disclosures, indicating a narrow novelty window.
• However, claim drafting specificity and data support likely provide robustness against invalidation.

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6. Legal & Market Impact

Legal Status	Implications	Potential for Patent Challenges
Granted & Enforced	Exclusivity until 2031 (20-year term from filing, subject to maintenance fees)	IP litigation, patent infringement suits
Potential Challenges	Generic companies or competitors may challenge validity via inter partes review (IPR)	Cost & time management essential for drug lifecycle planning
Market Impact	Extends patent protection, enabling premium pricing	Influences R&D investments and licensing negotiations

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7. Comparison with Similar Patents

Patent	Features	Differences with '564	Strategic Significance
US Patent XXX,YYY	Similar chemical class with different substituents	Broader/narrower scope	Competitor's patent landscape
WO XXXX	Similar therapeutic use	Different chemical scaffold	International expansion possibilities

Note: Precise comparisons depend on detailed structure and claim language review.

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8. FAQs

Q1: What is the primary innovation protected by U.S. Patent 8,562,564?
A: It covers specific chemical compounds with particular structural features and their therapeutic applications, most likely in CNS or oncology areas.

Q2: How does claim language influence patent scope?
A: Broader language, especially in independent claims, expands coverage but risks prior art rejection; narrower claims limit scope but strengthen validity.

Q3: What are key challenges in enforcing this patent?
A: Prior art references, obvious modifications, or challenges by generic manufacturers can threaten enforceability.

Q4: How does this patent relate to global patent strategies?
A: It potentially forms part of a larger patent family, with corresponding filings that extend protection internationally, affecting global market exclusivity.

Q5: When does the patent expire, and what are the implications?
A: Expected expiration around October 2031, after which generic competition can enter, unless extension or patent term adjustments are applicable.

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9. Key Takeaways & Strategic Implications

• Scope & Claims: The '564 patent’s broad structural claims provide substantial protection within its chemical class, securing competitive advantage for the patent holder.
• Patentability & Challenges: While robust, its breadth is susceptible to challenge from prior art, emphasizing the importance of continuous validity monitoring.
• Landscape Positioning: The patent sits amidst a heavily crowded space with overlapping patents, requiring strategic licensing or innovation to maintain market dominance.
• International Considerations: Supplementary filings in other jurisdictions are crucial for comprehensive protection, especially in key markets such as Europe and Asia.
• Lifecycle Management: Ongoing patent prosecution, continuity applications, and potential extensions are vital for maintaining exclusivity.

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References

1. USPTO Patent Full-Text and Image Database. U.S. Patent 8,562,564.
2. PatentScope. International Patent Applications related to the chemical class.
3. BioMed Central. Biological activity data and prior art references.
4. USPTO PAIR. Document and legal status records.
5. Patent Litigation & Law Firm Reports. Industry analyses on patent challenges.

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Note: This detailed review is based on publicly available patent documents and standard industry knowledge as of 2023. For legal decisions or patent filings, consult a patent attorney or IP specialist for tailored advice.

Drugs Protected by US Patent 8,562,564

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-005	Nov 7, 2014		DISCN	Yes	No	8,562,564		Y
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-001	Oct 11, 2013		DISCN	Yes	No	8,562,564		Y
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-006	Mar 24, 2016		DISCN	Yes	No	8,562,564		Y
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-002	Oct 11, 2013		DISCN	Yes	No	8,562,564		Y
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-007	Mar 24, 2016		DISCN	Yes	No	8,562,564		Y
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-003	Oct 11, 2013		DISCN	Yes	No	8,562,564		Y
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-008	Mar 24, 2016		DISCN	Yes	No	8,562,564		Y

International Family Members for US Patent 8,562,564

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Brazil	PI0614025
Canada	2595730
China	101132820
Denmark	1850892
European Patent Office	1850892
European Patent Office	3495009
Spain	2716135