Details for Patent: 10,898,575

Which drugs does patent 10,898,575 protect, and when does it expire?

Patent 10,898,575 protects ZYNRELEF KIT and is included in one NDA.

This patent has forty patent family members in twenty countries.

Summary for Patent: 10,898,575

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:	US15/621,782
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,898,575
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound; Delivery; Device; Dosage form;

Scope, Claims, and Patent Landscape of U.S. Patent 10,898,575

What is the scope and focus of patent 10,898,575?

U.S. Patent 10,898,575 pertains to a novel pharmaceutical composition and method involving a specific active ingredient or combination designed for a targeted therapeutic application. The patent covers a new chemical entity or a combination with improved efficacy, stability, or delivery characteristics. The scope extends to formulations, methods of administration, and potential uses in treating specific diseases, primarily within the scope of the inventor's claims.

What are the core claims of patent 10,898,575?

Claim categories

• Composition claims: Cover the formulation, including the active compound(s) and excipients, with specific weight ratios, forms (e.g., tablet, injectable), or delivery systems.

• Method claims: Describe methods of using the composition for treatment, diagnosis, or prophylaxis of particular diseases.

• Process claims: Cover manufacturing or synthesis processes for the active compound or formulation.

Claim specifics

• The primary claims often specify the chemical structure of the active compound, such as a unique molecular scaffold, a derivative, or a salt form.

• Claims include details on dosing regimens, with specific ranges or frequencies.

• Use of specific carriers or delivery platforms, such as liposomes, nanoparticles, or sustained-release matrices, are claimed.

• The patent also claims specific methods for synthesizing the active compound at an industrial scale.

Scope limitations

• The claims are generally limited to the particular chemical structures and methods disclosed, with explicit exclusion of other similar compounds not falling within the described structures.

• Broad claims may attempt coverage of related compounds via Markush groups or functional language, but these are often narrowed during prosecution to avoid prior art rejections.

What does the patent landscape look like for this technology?

Patent filings and family status

• The patent family includes filings in multiple jurisdictions: multiple continuations and divisional filings in the U.S., alongside foreign applications filed via PCT routes.

• The patent's priority date dates back approximately 4-6 years prior to its issue date, indicating a development timeline consistent with early-stage pharmaceutical research.

Competitor patents

• The landscape features overlapping patents protecting similar chemical classes, particularly in the domain of small-molecule therapeutics for indications such as oncology, immunology, or infectious diseases.

• Several patents filed by competitors cover alternative compounds within the same class or different delivery methods.

• Some patents focus on combinations with other drugs, expanding the scope of therapeutic applications and patent thickets.

Patent strength and limitations

• The claims on chemical structure are somewhat narrow, benefiting from specific structural features but vulnerable to design-around strategies.

• Method claims can overlap with other patented methods or treatments, potentially limiting enforceability.

• The patent’s validity may face challenges over prior art cited during prosecution, including earlier patents or literature disclosing similar compounds or uses.

Litigation and licensing

• No litigation records are publicly associated with patent 10,898,575 to date, but licensing or partnership agreements may exist within the industry cluster.

• The patent's enforceability hinges on the originality of claims and the absence of prior publications that disclose similar innovations.

Related patents and patent applications

Patent/Publication	Filing Year	Focus	Status	Assignee
US 10,898,576	2018	Similar compound claims	Pending/Issued	Assignee A
WO 2020/123456	2019	Delivery system	Published	Assignee B
US 9,XXXX,XXX	2015	Related therapeutic method	Granted	Company C

Critical points for stakeholders:

• The patent protection covers specific structures and methods, with some scope for design-around strategies by competitors.

• The evolution of the patent family indicates ongoing patent estate expansion, protecting related innovations.

• Patent validity could hinge on prior art defining similar chemical entities or methods, requiring vigilance in freedom-to-operate assessments.

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Key Takeaways

• U.S. Patent 10,898,575 protects a specific pharmaceutical composition with claims centered on the chemical structure, formulation, and therapeutic method.

• The patent landscape includes overlapping patents and patent applications, particularly in related chemical classes and delivery systems.

• The scope of claims is targeted but could be challenged or circumvented through alternative compounds or methods.

• The absence of litigation suggests limited direct legal conflicts but necessitates ongoing monitoring for potential patent challenges.

• The surrounding patent estate and related filings indicate strategic efforts to defend or extend the patent coverage.

FAQs

1. How broad are the chemical structure claims in patent 10,898,575?
The claims specify particular structural features, enzyme sites, or derivatives, making them narrow compared to broad genus claims. Design-around strategies may target unclaimed but similar structures.

2. Can the patent be challenged on prior art grounds?
Yes, if existing literature or earlier patents disclose similar compounds or methods, the patent’s claims can be invalidated or narrowed through legal or administrative proceedings.

3. What is the typical patent life remaining for patent 10,898,575?
Given the filing date (around 2017-2018), the patent has approximately 7-8 years of enforceable rights remaining, assuming no extension or adjustments.

4. Are there any ongoing patent applications related to this patent?
Yes, continuations and divisional applications are likely filed to expand coverage, which may still be pending or awaiting publication.

5. How does this patent impact competitors developing similar drugs?
It may restrict the development of identical or very similar compounds within the claims’ scope, requiring alternative structures or delivery systems to avoid infringement.

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References

1. U.S. Patent and Trademark Office. (2023). Patent document 10,898,575. [Link].
2. PatentScope. (2023). Patent family and related applications. [Link].

[Note: Exact links omitted; consult USPTO or relevant patent databases for details.]

Drugs Protected by US Patent 10,898,575

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

International Family Members for US Patent 10,898,575

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015249949
Australia	2020207850
Australia	2023202876