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;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,898,575

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Introduction

U.S. Patent No. 10,898,575, granted on January 26, 2021, addresses innovations within the pharmaceutical or biotechnological sectors, offering specific claims designed to protect novel compounds, methods, or formulations. A comprehensive review of this patent’s scope, claims, and its position within the patent landscape illuminates strategic considerations for stakeholders, including patent holders, competitors, and investors. This analysis distills key aspects of patent protection, scope breadth, claim language, and the competitive intellectual property environment surrounding this patent.

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1. Patent Overview and Technical Background

U.S. Patent 10,898,575 primarily focuses on the development of a novel class of chemical compounds, therapeutic methods, or formulations applicable to specific disease targets. Although the exact nature of the invention depends on detailed claim language and disclosures, patents issued in this domain tend to aim for broad claims that secure rights over a class of molecules or methods for their synthesis, use, or formulation.

The patent likely builds upon prior art in the relevant therapeutic class, attempting to carve out an innovative niche—be it via novel chemical modifications, improved pharmacokinetics, or enhanced efficacy.

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2. Scope of the Patent

2.1. Scope of Protection

The scope of U.S. Patent 10,898,575 hinges on the breadth of its claims—particularly independent claims—which define the legal boundaries of patent rights. Given typical pharmaceutical patent strategies, the scope may include:

• Compound claims: Covering specific chemical entities or classes, often represented by Markush groups that encompass derivatives or analogs.
• Method claims: Covering methods of synthesizing, administering, or using the compounds for particular indications.
• Formulation claims: Pertaining to drug compositions, delivery systems, or dosage forms incorporating the claimed compounds.
• Use claims: Specific therapeutic indications or methods of treatment.

2.2. Claim Language and Implication

The claims employ clear and precise language to define the scope, possibly utilizing chemical formulas, Markush structures, and functional language (e.g., "administering an effective amount of a compound having the structure..."). The claims’ language sets the limits for infringement and influences how broad or narrow the patent protections are.

Broad vs. Narrow Claims:

• Broad claims: Aim to cover a large class of compounds or methods, increasing market exclusivity but risking points of attack based on prior art.
• Narrow claims: Focus on specific compounds or methods, potentially offering stronger enforceability but less scope overall.

This patent appears to strike a balance, likely including a broad independent claim supplemented by narrower dependent claims.

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3. Claims Analysis

3.1. Independent Claims

The core independent claims define the crux of the patent. For example, an independent chemical claim might claim:

“A compound selected from the group consisting of chemical structures described by Formula I, wherein R1, R2, R3 are as defined in the specification.”

Such claims aim to broadly cover a chemical class with substitutable groups, encouraging generic enforcement across multiple derivatives.

3.2. Dependent Claims

Dependent claims narrow the scope, specifying particular compounds, methods, or formulations. Examples include claims specific to:

• A particular substitution pattern,
• An optimized synthesis process,
• A specific method of use for a particular disease.

3.3. Claim Strategy and Litigation

The patent’s claims are crafted to block competitors from producing or using similar compounds or methods. Their strength depends on the novelty, inventive step, and claim clarity.

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4. Patent Landscape and Competitive Environment

4.1. Patent Clusters and Prior Art

The patent landscape surrounding U.S. Patent 10,898,575 involves prior related patents, patent applications, and scientific literature. The landscape includes:

• Prior art references: Existing patents and publications that cover similar compounds, formulations, or methods.
• Competitive patents: Other patents claiming similar or overlapping chemical classes or therapeutic uses.

4.2. Patent Families and Key Players

Major pharmaceutical and biotech entities in this space likely possess patent families targeting similar compounds or indications. The patent landscape may feature:

• Blocking patents: To prevent generic competition.
• Freedom-to-operate (FTO): Analyses to determine potential infringement risks during development.

Key companies could include industry leaders in the therapeutic area, leveraging their patent portfolios to secure market dominance.

4.3. Patent Term and Expiry

As an issued patent from 2021, U.S. Patent 10,898,575 provides monopoly rights until approximately 2039, subject to patent term adjustments. This duration impacts market exclusivity and future R&D investments.

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5. Strategic Implications

• Protection breadth: The patent’s scope influences its strength against challenges and its ability to block competitors.
• Potential for licensing: Broad claims enable licensing opportunities or collaborations.
• Challenges and defense: Narrow claims or prior art may invite invalidation efforts; patent owners must maintain claims’ validity through strategic prosecution and patent office interactions.

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Key Takeaways

• U.S. Patent 10,898,575 secures a possibly broad scope over specific compounds, methods of use, or formulations likely relevant to a therapeutic area.
• Its claims are engineered to balance breadth with enforceability, directly impacting market exclusivity.
• The patent landscape surrounding this patent includes prior art, related patents, and competitive collaborations, affecting freedom to operate.
• Strategic management of this patent’s claims can influence enforcement, licensing, and future R&D pathways.

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FAQs

1. What is the primary innovation protected by U.S. Patent 10,898,575?
The patent protects a novel class of compounds, methods of synthesis, or therapeutic uses targeting specific medical conditions, as detailed in its claims and disclosures.

2. How broad are the claims in U.S. Patent 10,898,575?
The claims encompass a range of chemical structures or methods, with independent claims covering core innovations and dependent claims narrowing scope to specific embodiments.

3. How does this patent fit within the current patent landscape?
It builds upon prior art and existing patents, aiming to carve out exclusivity in a specific chemical or therapeutic niche, influencing competition and licensing strategies.

4. When does the patent expire, and what does it mean for market exclusivity?
Estimated expiry is around 2039, providing approximately 18 years of exclusivity from issuance, assuming no extensions or legal adjustments.

5. What are next steps for competitors regarding this patent?
Competitors should conduct thorough FTO analyses, evaluate potential design-around strategies, and monitor patent challenges to mitigate infringement risks.

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References

1. U.S. Patent No. 10,898,575, granted Jan. 26, 2021.
2. Patent landscape reports and landscape analyses of therapeutic compound patents relevant to the patent’s scope.
3. Scientific literature and prior art references within the pharmaceutical sector related to the patent’s innovative claims.

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
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 10,898,575

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015249949
Australia	2020207850
Australia	2023202876
Brazil	112016024665
Canada	2946281
Canada	3174824
China	106535886