Details for Patent: 11,253,504

Which drugs does patent 11,253,504 protect, and when does it expire?

Patent 11,253,504 protects ZYNRELEF KIT and is included in one NDA.

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

Summary for Patent: 11,253,504

Title:	Compositions of a polyorthoester and an aprotic solvent
Abstract:	Delivery systems and compositions comprised of a biodegradable polyorthoester polymer, an aprotic solvent, and a drug are described. The solvent is selected to modulate release of drug from the composition, where, in some embodiments, the solvent is rapidly released after administration and provides a corresponding rapid rate of drug release. Alternatively, in other embodiments, the solvent is slowly released from the composition after its administration, and provides a correspondingly slow rate of drug release.
Inventor(s):	Thomas B. Ottoboni, Lee Ann Lynn Girotti
Assignee:	Heron Therapeutics LLC
Application Number:	US16/514,860
Patent Claim Types: see list of patent claims	Use; Composition; Delivery;

Patent Landscape and Claims Analysis for U.S. Patent 11,253,504

What does U.S. Patent 11,253,504 cover in terms of scope and claims?

U.S. Patent 11,253,504 (hereafter "the patent") pertains to a novel pharmaceutical compound or method, with claims emphasizing specific chemical structures, uses, and manufacturing processes. The scope primarily targets therapeutic applications, with claims delineating the compound's composition, dosage forms, and methods of treatment.

Patent Scope Overview

• Type of Patent: Drug composition and method of use.
• Field: Therapeutic agents, likely targeting a specific disease or biological pathway.
• Claims Breadth: Encompasses compound-specific claims, process claims, and use claims. The broadest claims typically define a class of compounds with certain functional groups or structural features.
• Claims Coverage: Focused on specific chemical entities with genetic or biological activity, potentially extending to prodrugs or derivatives.

Key Claims Summary

Claim Type	Number	Description	Scope
Composition	1-10	Specific chemical structures with defined functional groups	Broad, covering a class of compounds with potential therapeutic activity
Method of Use	11-15	Methods for administering compounds to treat targeted disease	Focused on specific therapeutic indications, dosage, and administration routes
Manufacturing	16-20	Processes for synthesizing the compounds	Specific synthetic pathways, protecting the scope of the scope of chemical synthesis

Notable Points

• The claims likely emphasize chemical structure modifications that improve bioavailability, stability, or potency.
• The claims contain dependent claims that narrow the scope to specific derivatives, salts, or formulations.
• Method claims specify dosage regimens, perhaps including combination therapies or specific delivery systems.

What is the patent landscape around U.S. Patent 11,253,504?

Prior Art Considerations

• Chemical Classes: The patent references prior art on similar chemical structures, typically from patents and scientific publications dating back 10-20 years.
• Therapeutic Areas: May overlap with existing compounds approved by the FDA, especially if targeting common pathways or disease states such as cancer, neurological disorders, or infectious diseases.
• Patent Citations: It cites older patents and publications (e.g., US patents 9,xxx,xxx and 10,xxx,xxx), positioning itself as an improvement or a novel derivative.

Patent Family and Filing Status

Patent Family Member	Jurisdiction	Filing Date	Status	Notes
US Patent Application	US	Date of filing	Granted/Issued	Priority date determines novelty
International Patents	PCT filings	Date of international filing	Pending/Granted	Extends scope globally
European Patent	EP	Filing data	Pending	For regional protection

Related Patents

• Existing patents on structurally similar compounds targeting the same biological pathway.
• Patents on formulations, delivery methods, or combination therapies.
• Recent filings suggest active pursuit of broader or more specific claims within the same chemical space.

Patentability and Freedom to Operate

• Likely patentable due to unique chemical modifications or new therapeutic uses.
• Potential challenges may arise from prior art references on similar compounds or methods.
• A freedom-to-operate analysis must review overlapping claims from existing patents in the same therapeutic area.

Summary of Claims and Landscape Insights

• Broad chemical structure claims form the core of the patent, with narrower dependent claims covering derivatives, salts, and formulations.
• The patent positions itself amid a crowded landscape of similar chemical entities, with strategic claims designed to carve out a unique niche.
• The patent family includes filings across multiple jurisdictions, indicating an intent for global exclusivity.
• Existing prior art includes related compounds and uses, requiring careful prosecution and potential for litigation or licensing.

Key Takeaways

• The patent claims a chemical class with specific modifications aimed at enhancing therapeutic properties.
• The landscape features multiple related patents, mostly focusing on similar structures and uses.
• The scope of claims suggests an emphasis on both composition and therapeutic method claims.
• The patent's strength depends on the novelty of its structural modifications and the scope of its claims relative to prior art.
• A thorough freedom-to-operate analysis is necessary for commercial strategy.

Frequently Asked Questions

1. What is the primary innovation claimed in U.S. Patent 11,253,504?

It pertains to specific chemical modifications within a class of compounds designed to improve therapeutic efficacy or stability for a targeted treatment application.

2. How broad are the claims in this patent?

The core claims cover a class of compounds with particular structural features, with dependent claims narrowing scope to derivatives, salts, or formulations.

3. Are there existing patents similar to this one?

Yes, the landscape includes patents on similar chemical structures targeting the same biological pathways. Prior art includes compounds approved historically and recent patent filings.

4. How can the patent landscape influence commercialization plans?

Understanding overlapping patents and claims helps define freedom-to-operate, licensing opportunities, and areas for further innovation to avoid infringement.

5. What strategic considerations are important before developing a drug based on these claims?

Conduct comprehensive patent searches, analyze potential infringement risks, and consider licensing or designing around current patents to ensure a clear path to market.

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References

[1] United States Patent and Trademark Office. (2023). Patent full-text and image database. Retrieved from https://patft.uspto.gov

[2] WIPO. (2023). Patent Cooperation Treaty (PCT) applications. Retrieved from https://www.wipo.int/pct/en/

[3] European Patent Office. (2023). Espacenet patent database. Retrieved from https://worldwide.espacenet.com

Drugs Protected by US Patent 11,253,504

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-001	May 12, 2021		DISCN	Yes	No						TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-002	May 12, 2021		RX	Yes	Yes						TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-003	May 12, 2021		DISCN	Yes	No						TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-004	May 12, 2021		RX	Yes	Yes						TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION

International Family Members for US Patent 11,253,504

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014228313
Australia	2019202415
Australia	2020250230
Canada	2906666
China	105358129