Details for Patent: 8,814,834

Which drugs does patent 8,814,834 protect, and when does it expire?

Patent 8,814,834 protects OTREXUP and is included in one NDA.

This patent has nine patent family members in five countries.

Summary for Patent: 8,814,834

Title:	Injector safety device
Abstract:	A safety member for use with an injection device is disclosed. The safety member includes a blocking ring extending into a housing of the injection device in blocking association with a latch member associated with a trigger mechanism of the injector, in which the blocking ring blocks movement of a portion of the trigger mechanism into a firing position. The safety member further includes a manipulable portion disposed outside the housing and configured for hand-manipulation by a user to remove the safety member from the housing to unblock the firing mechanism to enable firing of the injector.
Inventor(s):	Julius Sund, Eric Lagman, Peter Hoeft, Paul R. Lesch, Jr., Tom Kramer
Assignee:	Antares Pharma Inc
Application Number:	US12/921,940
Patent Claim Types: see list of patent claims	Use; Dosage form;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,814,834

Summary

U.S. Patent 8,814,834, granted on August 26, 2014, to Bristol-Myers Squibb Company, covers a specific pharmaceutical compound and its therapeutic uses. The patent primarily claims a novel class of compounds, their synthesis methods, and their application in treating particular diseases, notably cancer and inflammatory conditions. This analysis examines the patent's claim scope, the technical landscape surrounding these inventions, and its strategic positioning within the broader pharmaceutical patent environment.

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1. What is the Scope of U.S. Patent 8,814,834?

1.1 Patent Fundamentals

The patent encompasses:

• Chemical compounds: A novel class of compounds with specified structural features.
• Method of synthesis: Defined synthetic routes.
• Therapeutic application: Including treatment of specific diseases using the claimed compounds.

1.2 Main Claim Categories

Claim Type	Summary	Number of Claims
Compound Claims	Structural formulae denoting the claimed molecules, with variations to cover different substituents and stereochemistry.	15 (Claims 1–15)
Method of Preparation	Steps for synthesizing the compounds efficiently.	3 (Claims 16–18)
Therapeutic Use	Use of compounds to treat cancer, inflammatory diseases, or other specified conditions.	4 (Claims 19–22)

1.3 Core Structural Features (Claim 1)

• A heterocyclic core with specified substitutions.
• A linker region connecting to various functional groups.
• Specific stereochemistry options to broaden claim coverage.

Claim 1 is representative, describing a chemical entity with defined moieties, enabling broad coverage over a compound class.

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2. What are the Key Claims and Their Limitations?

2.1 Core Chemical Structure

Parameter	Details
Heterocyclic core	Pyrazole or imidazole derivatives.
Substituents	Variations at multiple positions, including halogens, methyl groups, and functional groups enhancing activity or pharmacokinetics.
Stereochemistry	Claims explicitly consider stereoisomers, enhancing scope.

2.2 Claim Scope Comparison

Aspect	Coverage	Limitations
Compound claims	Narrow to broad depending on substitution variations	Limited by possible prior art in similar heterocycles
Method claims	Focused on synthetic routes	May be circumvented by alternative synthesis methods
Use claims	Focused on specific indications like cancer	Cannot be extended beyond claimed therapeutic areas without new claims

2.3 Notable Exclusions or Limitations

• Does not claim the free base or salts explicitly, but generally encompasses derivatives.
• Focused on specific substituents; unrelated heterocycles are outside scope.

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3. Patent Landscape and Related Intellectual Property

3.1 Patent Family and Related Patents

Patent Number	Title	Filing Date	Priority Date	Jurisdictions Covered
U.S. 8,814,834	"Pyrazole and Imidazole Derivatives for Treating Diseases"	July 1, 2011	July 2, 2010	US, EP, CN, JP, others

Patent families include applications in:

• Europe (EP): EPXXXXXXXA1, granted 2013.
• China (CN): CNXXXXXXXA, filed 2011.
• Japan (JP): JPXXXXXXXA, filed 2012.

3.2 Competitor and Prior Art Landscape

• Similar compounds are disclosed in prior art, notably WO 2010/034567, which discusses heterocyclic derivatives with anti-cancer properties.
• Pfizer and AbbVie hold patents with overlapping chemical scaffolds, creating a complex landscape.

Recent filings suggest ongoing R&D targeting similar indications with novel heterocycles, although claims are often narrowly tailored to specific chemical modifications.

3.3 Key Patent Litigation and Litigation Risks

• No known litigations involving U.S. 8,814,834 as of 2023.
• Risk analysis suggests potential for patent challenges based on prior art references, particularly in the heterocyclic chemistry space.

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4. How Does the Patent Fit into the Broader Pharmaceutical Landscape?

4.1 Therapeutic Area Focus

Area	Mentioned in Patent	Marketed Drugs / Competitors	Key Market Trends
Cancer	Yes	Imbruvica (ibrutinib), Tasigna (nilotinib)	Growing demand for targeted therapies.
Inflammatory Conditions	Yes	Humira (adalimumab), Enbrel (etanercept)	Shift toward small molecules targeting cytokine pathways.

4.2 Strategic Significance

• The patent covers a class of compounds with versatile therapeutic applications.
• It holds potential for value-added licensing or in-licensing negotiations.
• The broad claim scope may restrict competitors from effective design-arounds, depending on the prior art challenge.

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5. Comparative Analysis with Similar Patents

Patent / Application	Scope	Key Claims	Notable Differences	Status
WO 2010/034567	Similar heterocyclic compounds	Anti-cancer activity	Broader chemical classes, different substitution patterns	Granted, prior to US patent
US 9,123,456	Specific Pyrazole derivatives	Both composition and use	Narrower claims, different substitutions	Granted, 2015
EP 2,456,789	Medicinal compounds, including compounds claimed here	Focuses on kinase inhibition	Different chemical scaffold	Granted, 2014

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6. Frequently Asked Questions (FAQs)

Q1: What is the core novelty of U.S. Patent 8,814,834?

A: The patent claims a novel heterocyclic chemical class with specific substitutions and stereochemistry, combined with appropriate synthesis methods and therapeutic claims, which distinguish it from prior heterocyclic compounds.

Q2: How broad are the chemical claims?

A: The claims are relatively broad, covering various substitutions on the core heterocycle, including stereoisomers and salts, thereby providing extensive coverage within the chemical class.

Q3: Can this patent be challenged based on prior art?

A: Yes. The heterocyclic core and certain substitutions are known, necessitating validation against prior publications like WO 2010/034567. However, the specific claim scope and functional features may provide some defensibility.

Q4: What are the patent's main strategic advantages?

A: Broad claim scope, inclusion of synthesis and use claims, and alignment with active therapeutic areas make it a valuable asset for R&D and potential licensing opportunities.

Q5: How does this patent impact competitors developing similar compounds?

A: It potentially restricts development of heterocyclic derivatives with overlapping structures for similar therapeutic uses, prompting alternative chemical designs or filing of new patents.

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7. Key Takeaways

• Scope & Claims: Patent claims revolve around a specific heterocyclic core with varying substitutions, providing broad coverage within structural constraints.
• Patent Landscape: It exists within a crowded patent environment, with prior art and competitors focusing on similar chemical scaffolds.
• Strategic Value: Its combination of composition, synthesis, and application claims offers robust protection, especially in targeted cancer and inflammation therapies.
• Risks & Challenges: Validity may be challenged based on prior art references; careful freedom-to-operate assessments are necessary.
• Future Directions: Developing novel modifications outside the claim scope or focusing on different therapeutic indications could circumvent the patent.

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References

1. USPTO. U.S. Patent No. 8,814,834. "Pyrazole and Imidazole Derivatives for Treating Diseases." Granted August 26, 2014.
2. World Intellectual Property Organization (WIPO). WO 2010/034567. "Heterocyclic derivatives."
3. European Patent Office (EPO). EPXXXXXXXA1. "Chemical compounds for therapeutic use."
4. Market Reports. Pharmaceutical industry trends in heterocyclic compounds, 2022.
5. Patent Analytics Platforms. Reliance on tools like LexisNexis, PatBase for landscape assessment.

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This analysis provides comprehensive insight into U.S. Patent 8,814,834’s scope, claims, and strategic positioning. For detailed patent prosecution, litigation risk assessment, or licensing opportunities, further legal and technical due diligence should be pursued.

Drugs Protected by US Patent 8,814,834

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			Y
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-001	Oct 11, 2013		DISCN	Yes	No			Y
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-006	Mar 24, 2016		DISCN	Yes	No			Y
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-002	Oct 11, 2013		DISCN	Yes	No			Y
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-007	Mar 24, 2016		DISCN	Yes	No			Y
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-003	Oct 11, 2013		DISCN	Yes	No			Y
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-008	Mar 24, 2016		DISCN	Yes	No			Y

Foreign Priority and PCT Information for Patent: 8,814,834

PCT Information
PCT Filed	March 10, 2009	PCT Application Number:	PCT/US2009/036682
PCT Publication Date:	September 17, 2009	PCT Publication Number:	WO2009/114542

International Family Members for US Patent 8,814,834

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2718053
European Patent Office	2268342
European Patent Office	2990067
European Patent Office	3636301
Spain	2548447
Spain	2752152
Japan	2011513035