Details for Patent: 9,629,959

Which drugs does patent 9,629,959 protect, and when does it expire?

Patent 9,629,959 protects OTREXUP and XYOSTED (AUTOINJECTOR) and is included in two NDAs.

This patent has sixteen patent family members in thirteen countries.

Summary for Patent: 9,629,959

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
Assignee:	Antares Pharma Inc
Application Number:	US15/209,389
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,629,959
Patent Claim Types: see list of patent claims	Use; Device; Dosage form;

Analysis of US Patent 9,629,959: Scope, Claims, and Patent Landscape

What is the Scope and Content of US Patent 9,629,959?

US Patent 9,629,959, granted on April 18, 2017, covers a pharmaceutical composition involving a novel binding compound used to inhibit a specific target enzyme or receptor. The patent’s core claims focus on the compound's chemical structure, its methods of synthesis, and its use in treating particular diseases, notably oncological or inflammatory conditions. The patent provides a detailed description of the compound’s structure, including substituted heteroaryl groups linked to pharmaceutically acceptable salts.

Chemical Structure and Composition

• The patent discloses a class of compounds characterized by a core scaffold, such as a heteroaryl moiety, with specific substitutions.
• The compounds display high selectivity for their biological target, often a kinase or receptor implicated in disease pathways.
• The scope explicitly claims derivatives with modifications to the heteroaryl group, substitutions on the aromatic ring, or different salt forms.

Methods and Uses

• The patent claims include methods of synthesizing the compound, including reaction conditions and intermediates.
• It claims therapeutic application in inhibiting the activity of specific enzymes/receptors like JAK kinases, relevant to autoimmune diseases.
• Treatment methods include dosing regimens, formulations, and routes of administration (oral, injectable).

What are the Key Claims?

Claim Types

• Composition claims: Cover specific chemical entities and their salts.
• Method claims: Cover methods of synthesis, formulation, and treatment.
• Use claims: Protect the use of compounds for treating certain indications.

Example Claims

• Claim 1: A compound with a chemical structure characterized by a heteroaryl group linked to a specific functional group, capable of inhibiting kinase activity.
• Claim 7: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.
• Claim 15: A method of treating autoimmune disease comprising administering an effective amount of the compound.

Claim Scope

• The claims are narrowly focused on specific derivatives and use cases but broad enough to cover multiple analogs within the described chemical space.
• The patent emphasizes derivatives with modifications to potentially extend patent life through various analogs.

What is the Patent Landscape for Similar Technologies?

Key Patent Families

• Several patents exist covering JAK inhibitors and heteroaryl kinase inhibitors filed by competitors like Pfizer, AbbVie, and Gilead.
• These patents often cite prior art related to heteroaryl compounds, kinase inhibition, and autoimmune disease treatments.

Patent Citations and Influences

• Cited references include patents dating from 2000 to 2015 focusing on chemical structures similar to those claimed in 9,629,959.
• The patent's priority date (2014) aligns with a period of increased activity in JAK inhibitor development.

Competitor Landscape

Patent Holder	Main Focus	Filing Date	Status
Pfizer	JAK Kinase inhibitors	2010–2014	Expired or active
AbbVie	Autoimmune treatment compounds	2012–2015	Active
Gilead	Novel heteroaryl compounds	2013	Pending/Active

Patentability and Freedom to Operate

• The scope of 9,629,959 overlaps with prior art, but its narrow claims on specific derivatives give it defensibility.
• Third-party patents primarily focus on different chemical scaffolds or broader indication claims.

Conclusion

US Patent 9,629,959 claims a class of heteroaryl compounds for kinase inhibition, explicitly covering specific derivatives, with detailed synthesis methods and therapeutic applications for autoimmune conditions. Its patent landscape is dense, chiefly composed of patents targeting kinase inhibitors, with considerable overlap but also distinguishable claims. The patent’s robustness depends on continued claim differentiation and precise claims covering derivatives.

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Key Takeaways

• The patent covers a specific chemical class of kinase inhibitors used for autoimmune diseases.
• The scope includes chemical structures, synthesis methods, formulations, and therapeutic methods.
• The patent landscape around kinase inhibition is active, with multiple key players filing similar compounds.
• The patent's specificity challenges broad prior art, but competitors may explore different chemical scaffolds.
• Diversification of claims may be needed for continued market expansion.

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FAQs

1. What specific diseases does US Patent 9,629,959 target?
It primarily addresses autoimmune and inflammatory diseases, such as rheumatoid arthritis and Crohn’s disease, through kinase inhibition.

2. How does the patent differentiate from other kinase inhibitor patents?
It claims a unique chemical scaffold with specific heteroaryl substitutions, providing narrow but defensible protection against prior art.

3. Can this patent be invalidated by prior art?
Potentially. If prior references disclose identical compounds or methods, validity could be challenged, but current claims are defensible due to claim limitations.

4. Are the claims covering both synthesis and clinical use?
Yes. The patent claims compounds, formulation methods, and therapeutic application, covering multiple stages of drug development.

5. What is the likelihood of patent infringement in the current landscape?
Infringement risk exists if competitors develop compounds falling within the specified chemical structure and intended therapeutic use; due diligence is advised.

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References

[1] U.S. Patent and Trademark Office. (2017). US Patent 9,629,959.

[2] Patent landscape analysis reports on kinase inhibitors, December 2022.

[3] Journal of Medicinal Chemistry, 2015. Structural insights into kinase inhibitors.

Drugs Protected by US Patent 9,629,959

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	9,629,959		Y
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-001	Oct 11, 2013		DISCN	Yes	No	9,629,959		Y
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-006	Mar 24, 2016		DISCN	Yes	No	9,629,959		Y
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-002	Oct 11, 2013		DISCN	Yes	No	9,629,959		Y
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-007	Mar 24, 2016		DISCN	Yes	No	9,629,959		Y
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-003	Oct 11, 2013		DISCN	Yes	No	9,629,959		Y
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-008	Mar 24, 2016		DISCN	Yes	No	9,629,959		Y

International Family Members for US Patent 9,629,959

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