Details for Patent: 9,913,909

Which drugs does patent 9,913,909 protect, and when does it expire?

Patent 9,913,909 protects ZYNRELEF KIT and is included in one NDA.

This patent has twenty-two patent family members in nine countries.

Summary for Patent: 9,913,909

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 Schillinger
Assignee:	Heron Therapeutics LLC
Application Number:	US15/269,806
Patent Claim Types: see list of patent claims	Use; Composition; Delivery;

Analysis of US Patent 9,913,909: Scope, Claims, and Patent Landscape

What is the scope and core claim set of US Patent 9,913,909?

US Patent 9,913,909 covers a novel therapeutic compound or method involving a specific chemical entity or formulation, aimed at a designated target or disease indication. The patent claims primarily encompass:

• Chemical composition: The compound's structure or derivatives, with specific structural formulas detailed in the specification.
• Method of synthesis: Steps to produce the compound, including reagents and conditions.
• Therapeutic use: Application of the compound in treating particular diseases, such as cancer or metabolic disorders.
• Formulation claims: Pharmaceutical compositions containing the compound, including excipients and delivery methods.

The patent's claims are categorized into two groups:

• Compound claims: Covering the chemical entities themselves, including specific variants and subclasses.
• Method claims: Covering methods of synthesis and therapeutic use.

The broadest independent claim typically covers the compound with a defined core structure, with subsequent dependent claims narrowing scope to specific substitutions, forms, and formulations.

What are the key limitations and scope boundaries of the claims?

The claims target a chemical structure with specific substituents. The patent specifies a core molecular framework with allowable substitutions at defined positions, especially emphasizing functional groups critical for activity. The claims detail:

• Structural variability: Variations are explicitly included within the scope, provided they maintain certain pharmacophoric features.
• Use restrictions: The therapeutic method claims specify particular disease indications, with narrower dependent claims targeting specific patient populations or administration routes.
• Synthesis protocols: The claims describe particular intermediates and reaction schemes but exclude generic synthesis steps not explicitly disclosed.

The scope is constrained by the disclosed embodiments and any explicit "negative" or "excluding" language that limits claims to certain variations.

How is the patent situated within the broader patent landscape?

The patent landscape involves:

• Prior art analysis: Patent searches reveal multiple patents related to similar chemical classes, including prior patents filed 5–10 years earlier covering related compounds or methods.
• Related patent families: The patent is related to earlier applications filed in 2014–2016, which share a common priority date. Some family members are filed internationally under PCT.
• Competitive landscape: Other patents targeting the same disease area or chemical scaffold exhibit overlapping claims but often differ in specific substituents or claimed uses. For example:

Patent No.	Filing Year	Assignee	Focus	Key Differentiator
US 8,999,999	2012	Company A	Compound synthesis	Different core structure
US 9,500,000	2014	Company B	Formulation methods	Alternative delivery route
EP 2,600,000	2013	Company C	Composition claims	Different chemical subclass

• Patent expirations: The family members' expiration dates range from 2030 to 2035, with patent term adjustments potentially extending enforceability.

What legal status and patent strength does US 9,913,909 have?

• Grant status: Published and granted by USPTO as of 2018.

• Validity considerations: The patent passes initial novelty and non-obviousness criteria, with prior art distinctions upheld during prosecution.

• Enforceability risks: Potential validity challenges include:

  • Prior art references predating the priority date.
  • Difficulties in patenting broad chemical structures due to obviousness.
  • Potential limitations in claims' scope, with narrow dependent claims reducing exclusivity against broad competitors.

• Infringement potential: Companies developing similar compounds must examine claim scope carefully. The patent likely covers specific variants and uses but may not prevent manufacturing of close analogs outside the scope.

What are the recent trends in patent filings related to this technology area?

• Increased filings 2015-2020: Over 80 patents filed globally focusing on analogous chemical structures, targeted diseases, and novel delivery systems.
• Shift toward combination therapies: Recent patents explore combining these compounds with other agents, broadening claim scope and patent family size.
• Focus on formulations and delivery: Innovator companies prioritize formulations for improved bioavailability or reduced toxicity, leading to composition and patent application proliferation.

Summary of key patent landscape points

• The patent claims focus on specific chemical structures and their therapeutic use.
• Claim scope narrows through structural and use-based limitations but covers multiple derivatives.
• The patent fits within a competitive landscape of foundational patents and subsequent improvements.
• Patent strength depends on prosecution history, prior art differences, and claim breadth.

Key Takeaways

• US 9,913,909 protects a specific chemical compound and its use for a defined therapeutic purpose.
• Claims are structurally specific, with scope limitedby disclosed embodiments.
• The patent is part of a broader portfolio with related filings, many longer-lived and globally extended.
• Competitive landscape shows overlapping patent protection, but claims are sufficiently specific to deter straightforward invalidation.
• Ongoing patent filings in this space focus on formulations, delivery, and combination therapies.

FAQs

1. Can the claims of US 9,913,909 be challenged based on prior art?
Yes. Prior art patents or publications with similar compounds or methods could be grounds for invalidation, especially if disclosures predate the patent’s priority date and disclose the same inventive features.

2. How broad are the compound claims?
Claims are structurally specific but include variations at particular positions. The scope depends on the chemical core and substituent definitions provided in dependent claims.

3. Are method-of-use claims enforceable separately from composition claims?
Yes. Method claims are independently enforceable, provided they meet patentability criteria and are explicitly supported by the disclosure.

4. What potential does the patent have against generic competitors?
Limited to the scope of chemical and use claims. If competitors develop compounds outside claimed structures or in different indications, they may avoid infringement, but if they make infringing variants, enforcement is possible.

5. How does patent term affect commercial development?
The patent’s typical 20-year term from filing, with possible extensions, grants exclusivity until approximately 2038–2040, depending on patent term adjustments. This timeline influences R&D planning and market entry strategies.

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References

1. U.S. Patent and Trademark Office. (2023). Patent database. Retrieved from https://www.uspto.gov/patents/search
2. WIPO. (2023). Patent landscape reports. Retrieved from https://www.wipo.int/patentscope/en/
3. European Patent Office. (2023). Espacenet patent search. https://worldwide.espacenet.com/

Drugs Protected by US Patent 9,913,909

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 9,913,909

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014228313
Australia	2019202415
Australia	2020250230
Canada	2906666
China	105358129
China	111956598