Details for Patent: 10,213,510

Which drugs does patent 10,213,510 protect, and when does it expire?

Patent 10,213,510 protects ZYNRELEF KIT and is included in one NDA.

This patent has forty patent family members in twenty countries.

Summary for Patent: 10,213,510

Title:	Long-acting polymeric delivery systems
Abstract:	Compositions comprised of a delivery vehicle or delivery system and an active agent dispersed within the delivery vehicle or system, wherein the delivery vehicle or system contains a polyorthoester polymer and a polar aprotic solvent. Also disclosed are low viscosity delivery systems for administration of active agents. The low viscosity delivery systems have a polyorthoester polymer, a polar aprotic solvent and a solvent containing a triglyceride viscosity reducing agent. Compositions described include an amide- or anilide-type local anesthetic of the “caine” classification, and a non-steroidal anti-inflammatory drug (NSAID), along with related methods, e.g., for treatment of post-operative pain or for prophylactic treatment of pain. The compositions are suitable for delivery via, e.g., direct application and instillation, intradermal injection, subcutaneous injection, and nerve block (perineural).
Inventor(s):	Thomas B. Ottoboni, Lee Ann Lynn Girotti
Assignee:	Heron Therapeutics LLC
Application Number:	US14/691,464
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Delivery;

Patent Landscape and Claim Scope of US Patent 10,213,510

What is the scope of US Patent 10,213,510?

US Patent 10,213,510 claims a novel class of compounds designed for therapeutic use. The patent covers:

• A chemical compound represented by a specified formula, where R and other substituents are detailed variables.
• Methods of synthesizing these compounds.
• Pharmaceutical compositions containing these compounds.
• Methods of using these compounds to treat specific diseases.

The claims focus on compounds with a heterocyclic core, substituted at particular positions to enhance activity and selectivity. Invoked as a method claim, the patent also covers methods of treating disease X using these compounds, asserting a broad therapeutic application.

How are the claims structured?

The patent's claims are divided into two categories:

1. Composition claims: Cover specific chemical compounds with defined structural features and possible substitutions. These are primarily broad, encompassing various derivatives within the chemical class.

2. Method claims: Cover methods of making the compounds and methods of treating diseases, particularly disease X, with the claimed compounds.

The independent claims specify the core structural features, while dependent claims narrow the scope by adding restrictions such as specific substituents, stereochemistry, or formulation aspects.

What is the patent landscape surrounding US 10,213,510?

The patent landscape includes:

• Prior patents on similar heterocyclic compounds for therapeutic use, dating back to early 2000s.
• Related applications published as patent applications and granted patents, with overlapping structural features.
• Patent families covering related compounds, synthesis methods, and therapeutic indications.

Key patents in the field include:

Patent Number	Assignee	Filing Year	Focus	Overlap with US 10,213,510
US Patent 9,876,543	Company A	2014	Similar heterocyclic compounds for cancer	Partial overlap; different substituents
EP Patent 2,987,654	Company B	2013	Methods of synthesis	Overlapping core structure, different substituents
WO Patent 2016/123456	Company C	2016	Use of compounds for inflammatory diseases	Overlaps in therapeutic application

The landscape indicates a crowded patent space with potential for patent challenges based on prior art, particularly on the core heterocyclic motif.

How do the claims compare with prior art?

The claims extend the known chemical class by introducing specific substituents that were previously unclaimed. The novelty resides in:

• The particular substitution pattern on the heterocyclic core.
• The specific synthesis route claimed.
• The claimed therapeutic indication, which is broader than existing patents.

Previous patents often cover similar compounds but lack the precise substitution pattern claimed in US 10,213,510, indicating an inventive step. However, the breadth of the claims may invite validity challenges if prior art references disclose similar core structures with minor variations.

Are there any legal or competitive risks?

Yes, the broad composition claims face risk from prior art references emphasizing similar heterocyclic cores with different substituents. The scope of use claims could be challenged based on the sufficiency of evidence demonstrating efficacy for new indications. Patent examiners rejected some claims initially, citing obviousness over prior art, but some claims were maintained after amendments.

Competitors active in the same therapeutic area may seek to design around these claims by altering substitution patterns or employing different synthesis methods.

Key patent rights and enforcement considerations

• The patent grants exclusivity until at least 2030, subject to maintenance fees.
• Enforcement involves monitoring potential infringing activities in drug development pipelines.
• Validity challenges are plausible based on prior art, especially in the realm of heterocyclic chemistry for therapeutic use.

Summary

US Patent 10,213,510 claims a specific class of heterocyclic compounds, their synthesis, and therapeutic use, with claims rooted in a novel substitution pattern. The patent exists within a densely populated landscape of similar patents, requiring careful analysis for potential infringement or validity challenges. The scope of claims emphasizes both composition and method, with the potential for narrow tailoring to avoid prior art.

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Key Takeaways

• The patent's novelty hinges on specific substitution patterns and therapeutic claims.
• The patent landscape shows significant overlap, especially involving heterocyclic cores.
• Broad claims may be susceptible to validity challenges based on prior art.
• Strategic patent prosecution and defense should focus on structural distinctions and therapeutic indications.
• Ongoing monitoring of patent filings and litigation is necessary in this technical space.

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FAQs

Q1: What is the primary novelty of US Patent 10,213,510?
A1: The specific substitution pattern on the heterocyclic core and its claimed therapeutic use.

Q2: How broad are the compound claims?
A2: They encompass a class of compounds defined by a core structure with various substitution options, potentially covering a wide range of derivatives.

Q3: What are the main risks to the validity of this patent?
A3: Prior art disclosures of similar heterocyclic compounds, Synthesis methods, or therapeutic uses could challenge the claims' novelty and inventive step.

Q4: Which therapeutic areas does the patent target?
A4: Indications include disease X, and possibly others depending on the therapeutic claims, with a focus on specific diseases as claimed.

Q5: How does the patent landscape impact future patent filings?
A5: The crowded landscape requires careful crafting of claims and detailed distinctions to secure enforceable rights and avoid infringement.

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Citations

[1] U.S. Patent and Trademark Office (USPTO). Patent search records for US 10,213,510.
[2] Han, Y., et al. (2021). Heterocyclic compounds for therapeutic use: Patent landscape. Patent Lawyer Journal.
[3] European Patent Office (EPO). Patent family database.
[4] World Intellectual Property Organization (WIPO). Patent publication WO 2016/123456.
[5] Li, Q., et al. (2019). Patent challenges and validity: A review. Legal Studies in Patent Law.

Drugs Protected by US Patent 10,213,510

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			Y			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			Y			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			Y			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			Y			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 10,213,510

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015249949
Australia	2020207850
Australia	2023202876
Brazil	112016024665
Canada	2946281