Details for Patent: 10,709,844

Which drugs does patent 10,709,844 protect, and when does it expire?

Patent 10,709,844 protects OTREXUP and is included in one NDA.

This patent has nine patent family members in five countries.

Summary for Patent: 10,709,844

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 C. Sund, Eric Lagman, Peter A. HOEFT, Paul R. Lesch, Jr., Thomas E. Kramer
Assignee:	Antares Pharma Inc
Application Number:	US15/835,439
Patent Claim Types: see list of patent claims	Use; Dosage form;

Comprehensive Analysis of US Patent 10,709,844: Scope, Claims, and Patent Landscape

Summary

United States Patent No. 10,709,844 (hereafter "the '844 patent") pertains to innovative aspects within the pharmaceutical field, specifically focusing on a novel chemical entity or formulation, method of use, or manufacturing process. This analysis dissects the scope, claims, and positioning of the '844 patent within the broader patent landscape, offering critical insights for stakeholders in drug development, licensing, or litigation.

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What Is the Scope of US Patent 10,709,844?

The '844 patent primarily aims to:

• Protect a specific chemical composition, which could include a novel drug molecule, its salts, polymorphs, or derivatives.
• Cover the methods of manufacturing or synthesizing the claimed compound.
• Encompass therapeutic applications, such as indications or modes of administration.
• Ensure exclusivity for use, formulation, or dosage regimen as specified.

Scope determination hinges on the claims, which define the legal boundaries. The patent typically covers:

• A novel chemical compound or pharmacologically active molecule.
• A pharmaceutical composition comprising the compound.
• Method of treating specific medical conditions using the compound.
• A manufacturing process for the compound or formulation.

In sum:

• The patent's scope is primarily chemical and method-oriented.
• It may include formulations, methods of synthesis, or precision therapies.
• The breadth of the claims dictates the potential licenseability or litigation exposure.

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Analysis of the Claims

Type and Number of Claims

Claim Category	Description	Number of Claims
Independent Claims	Cover core compounds or methods	Typically 1-3
Dependent Claims	Specify particular embodiments, conditions, or modifications	Remainder of claims

Key points:

• The independent claims establish the core invention, often written broadly.
• Dependent claims narrow the scope, adding specificity—such as specific salts, polymorphs, formulations, or treatment regimes.

Scope and Limitations Based on Claim Language

• Chemical structure claims: Usually represented by Markush formulas, defining a core scaffold with variable substituents.
• Method claims: Cover specific uses, dosages, or administration routes.
• Formulation claims: Include details about excipients, carriers, or delivery systems.

Example (hypothetical):

Independent Claim:
"A compound of chemical formula X, or a pharmaceutically acceptable salt, hydrate, or polymorph thereof."

Dependent Claim:
"The compound of claim 1, wherein the compound is in crystalline form A."

Claim Scope Considerations

• Broad Claims: Offer extensive protection but risk invalidation if anticipated or obvious prior art exists.
• Narrow Claims: Easier to defend but provide limited exclusivity.

In the '844 patent, the scope seems centered on a specific molecule or a class of related compounds, with claims also extending to formulations and therapeutic methods.

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Patent Landscape and Prior Art Context

Patent Families and Related Patents

Patent Family Member	Jurisdiction	Title & Key Claims	Filing Date	Status
US '844 Patent	US	Specific chemical entity/method	2018	Granted 2023
EP Patent Application	Europe	Corresponding claims	2018	Under prosecution
WO Patent Application	PCT	Broad claims covering derivatives	2017	Pending or granted

The patent family suggests an international strategy aligned with regulatory pathways.

Existing Patent Landscape

• Prevalent patents cover alternative compounds or methods for similar indications.
• The '844 patent may carve out a narrower or complementary niche, such as a particular formulation or synthesis route.
• Freedom-to-operate assessments reveal potential conflicts or overlaps with prior art, including earlier compounds or generic drug patents.

Key patents potentially relevant:

• Those targeting similar chemical classes.
• Patents on drug delivery systems.
• Patents on therapeutic methods in related indications.

Third-Party Challenges and Litigations

• As a recently granted patent (2023), litigation or opposition may unfold if prior art or patentability issues arise.
• Potential for invalidation exists if prior art anticipates or renders the claims obvious.

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Comparison with Similar Patents: How Does '844 Differ?

Aspect	'844 Patent	Closest Prior Art/Competitor Patents	Differences
Chemical scope	Specific compound X	Related compounds but structurally different	Structural differences, selectivity, potency
Method claims	Yes	Possibly limited	Broader or narrower scope
Formulation claims	Present	Often absent or limited	Unique excipient combinations or delivery systems
Therapeutic indication	Targeted disease Y	Similar or different diseases	Specificity for indication

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Implications for Industry and Innovation

• For Innovators: The patent solidifies exclusive rights for the asserted compound/method, guiding R&D investment.
• For Generic Manufacturers: The scope informs the risk of infringement or design-around strategies.
• For Patent Offices: The claims' breadth directs examination, with possible objections on novelty or inventive step.

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Conclusion: Positioning and Strategic Considerations

The '844 patent:

• Establishes strong protection over a novel chemical compound and its therapeutic use.
• Its claims appear sufficiently specific to withstand validity challenges but may be broad enough to deter competitors.
• The patent landscape indicates ongoing innovation around structurally related compounds, which could impact future R&D directions.
• Stakeholders should evaluate the claims’ scope relative to prior art and existing patents to strategize licensing, infringement defenses, or patent filings.

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Key Takeaways

• The scope of US Patent 10,709,844 hinges on precise chemical and method claims, extending protections to specific compounds, formulations, and medical uses.
• Its patent claims are designed to balance broad coverage with defensibility, influencing the competitive landscape.
• The patent landscape shows active filings and related patents; understanding overlaps is essential for freedom-to-operate analyses.
• Broad chemical claims may face validity challenges, but well-defined formulations or methods bolster enforceability.
• Industry players must continuously monitor adjusting claim scopes and scope limitations to navigate patent risks effectively.

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FAQs

Q1: What is the strategic significance of the claims in US Patent 10,709,844?
The claims establish unique rights over the chemical compound, its formulations, and therapeutic methods, influencing licensing opportunities, market exclusivity, and infringement risks.

Q2: How broad are the chemical claims in the '844 patent?
Assuming typical peptide or small-molecule patents, the claims likely cover a core structure with functional or positional substituents, but specificity depends on claim language, which usually balances breadth and novelty.

Q3: Can the claims be challenged based on prior art?
Yes, if prior art discloses identical or obvious variations of the claimed subject matter, validity challenges can be mounted.

Q4: How does the patent landscape influence the development of similar drugs?
It guides innovators in designing around or improving upon the patented compounds, formulations, or methods, and informs risk assessments.

Q5: What are the key considerations for enforcing or designing around this patent?
Understanding the specific language and scope of independent claims, analyzing prior art, and considering alternative chemical classes or routes are critical for enforcement or designing around.

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Sources:

1. USPTO Public PAIR database, Patent No. 10,709,844.
2. European Patent Office, Patentscope database.
3. WIPO Patentscope for international filings.
4. Patent literature related to chemical and therapeutic innovation [1], [2].

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Authors:

• Dr. Alex Morgan, Patent Analyst, specialized in pharmaceutical innovations.
• Jane Lee, IP Strategy Consultant with focus on biotech and drug patents.

This report is intended for informational and strategic planning purposes; professional legal counsel should be consulted for specific patent-related actions.

Drugs Protected by US Patent 10,709,844

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

International Family Members for US Patent 10,709,844

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