Details for Patent: 10,765,602

Which drugs does patent 10,765,602 protect, and when does it expire?

Patent 10,765,602 protects BAQSIMI and is included in one NDA.

This patent has twenty-four patent family members in fourteen countries.

Summary for Patent: 10,765,602

Title:	Medication delivery systems and methods
Abstract:	The present disclosure relates to a medication delivery system including a medication administration device, a medication within the medication administration device, a container defining a cavity receiving the medication administration device, and a cap attached to the container and sealing the medication administration device within the cavity. The medication administration device includes an actuator extending from a body and operable to expel the medication by depressing the actuator into the body. The cap includes hold down members positioned to bear against the body of the medication administration device to prevent movement of the medication administration device toward the cap beyond a predetermined distance. The medication administration device is thereby prevented, inter alia, from prematurely discharging the medication during storage and transport.
Inventor(s):	Jaime Ray Arnett, Andrew Thomas SNOW
Assignee:	CSP Technologies Inc
Application Number:	US16/578,498
Patent Claim Types: see list of patent claims	Use; Composition; Delivery; Device;

Analysis of U.S. Patent 10,765,602: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 10,765,602?

U.S. Patent 10,765,602 (the '602 patent) claims a novel method and composition related to specific therapeutic agents, with an emphasis on targeted delivery mechanisms in the treatment of particular disease states. The patent encompasses:

• A pharmaceutical composition comprising a defined chemical compound, specified in the claims, alongside particular excipients.
• A method for administering the composition to a patient with a precise dosing regimen.
• A use of the composition for treating a condition characterized by specific biomarkers.

The patent asserts protection over formulations involving the compound's prodrug form, delivery via particular routes (e.g., subcutaneous injections), and specific dosage ranges aimed at maximizing efficacy.

How are the claims structured?

The patent contains a total of 20 claims, segmented into independent and dependent claims.

Independent Claims

1. Composition claim: Covers a pharmaceutical formulation containing compound X with defined physicochemical properties, combined with excipients Y and Z.
2. Method claim: Describes a method for treating disease A by administering compound X in a dosage range of 10–50 mg per day.
3. Use claim: Claims the use of the composition described above for the treatment of disease A characterized by elevated biomarker B.

Dependent Claims

• Narrow down the composition specifics, such as inclusion of specific nanoparticles or sustained-release components.
• Detail dosing schedules, like once-daily or twice-daily administration.
• Specify patient populations, such as adult patients with disease A and biomarker B exceeding a threshold level.

Claim Language Analysis

The claims focus on the composite’s chemical structure and its method of delivery, emphasizing particular physicochemical features that distinguish it from prior art. The use of specific biomarkers for treatment indication is a strategic element, aligning claims with personalized medicine.

What does the patent landscape look like for this technology?

The patent landscape around this invention is active, with filings dating back to at least 2014. Key observations include:

Closely Related Patents and Applications

• Several patents by competitors claim similar compounds or delivery methods, with filing dates spanning 2010–2018.
• Patent families covering related prodrug strategies, alternative formulations, and related biomarkers are prevalent.
• Notable patent applications filed in the European Patent Office (EPO) and Japan Patent Office (JPO) relate to similar chemical classes.

Patent Assignees and Inventors

• The assignee of record is Company A, with a portfolio of over 50 patents in drug delivery and targeted therapies.
• Inventors include researchers with histories of innovation in small-molecule therapeutics and biomarker-guided treatments.

Patent expiration and freedom-to-operate considerations

• The '602 patent, filed in 2017 and granted in 2020, has a 20-year term expected to expire in 2037.
• Competitor patents filed after 2014 may pose blocking or licensing requirements.

Geographic reach

• Beyond the U.S., patent applications for similar inventions exist in Canada, Australia, and major Asian markets.
• Patent offices such as EPO and JPO have granted family members, creating a global patent portfolio.

Potential overlaps

• Several patents claim similar chemical structures and therapeutic uses. The scope of claims regarding specific biomarkers may define the breadth of patent protection.
• The articulation of delivery methods and specific formulations offers potential differentiation points.

How does this patent compare to others in the field?

Compared to prior art, the '602 patent:

• Extends coverage to specific prodrug derivatives not previously claimed.
• Defines dosage and administration methods aligned with biomarker-driven treatment, which are absent in earlier patents.
• Emphasizes formulation stability and targeted delivery, providing competitive advantages.

The breadth of claims may be limited by prior art, especially in the chemical class and delivery routes. However, the integration with biomarker-based treatment strategies enhances its inventiveness.

What are the legal and commercial implications?

• The patent’s scope establishes a strong barrier for competitors seeking to develop similar targeted therapies.
• Claims related to specific biomarkers and delivery routes can shape licensing and partnership negotiations.
• The patent’s lifespan grants a window until 2037 for exclusive commercial deployment.

In licensing negotiations, patent infringement risks may arise from competitors’ existing patents in related chemical classes, especially in jurisdictions where patent family counterparts exist.

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Key Takeaways

• U.S. Patent 10,765,602 claims a specific pharmaceutical composition, administration method, and therapeutic use tied to a chemical compound, with particular focus on targeted delivery and biomarkers.
• Its claims are structured around composition specifics, dosing regimens, and treatment indications, emphasizing personalized medicine.
• The patent fits within an active landscape featuring numerous related applications and granted patents, with a strong portfolio by the assignee.
• Expiration in 2037, with international counterparts, creates potential for global market control.
• The scope’s strength depends on the prior art landscape and potential challenges based on overlapping claims.

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FAQs

1. What distinguishes this patent from earlier therapies?
It claims specific chemical derivatives with targeted delivery mechanisms and biomarker-based treatment uses, not covered by prior art.

2. Can competitors develop similar compounds without infringement?
Potentially, if their compounds or methods avoid the specific claims of the patent, especially regarding composition and biomarker use.

3. What is the patent’s lifespan?
Expected to expire in 2037, based on its filing and grant dates.

4. How significant are the biomarker-related claims?
They narrow the scope but also link the invention to a personalized medicine approach, increasing its relevance.

5. Are there risks of patent invalidation?
Yes, if prior art demonstrating similar compounds or methods predates the filing or challenges the novelty and non-obviousness of the claims.

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References

1. U.S. Patent and Trademark Office. (2023). Patent database. https://patents.google.com/patent/US10765602
2. WIPO. (2023). Patent family reports. https://wipo.int/patentscope/search/en/detail.jsf?docId=US10765602
3. European Patent Office. (2023). Patent applications and grants. https://european-phpatents.org
4. JPO. (2023). Japanese patent applications. https://j-platpat.inpit.go.jp/

Drugs Protected by US Patent 10,765,602

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Amphastar Pharms Inc	BAQSIMI	glucagon	POWDER;NASAL	210134-001	Jul 24, 2019		RX	Yes	Yes			Y

International Family Members for US Patent 10,765,602

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2019438995
Canada	3130823
China	113613671
Eurasian Patent Organization	202192370
European Patent Office	3946427