Details for Patent: 11,083,730

Which drugs does patent 11,083,730 protect, and when does it expire?

Patent 11,083,730 protects ZYNRELEF KIT and is included in one NDA.

This patent has forty patent family members in twenty countries.

Summary for Patent: 11,083,730

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:	US15/331,759
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,083,730
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound; Delivery; Device; Dosage form;

Detailed Analysis of U.S. Patent 11,083,730: Scope, Claims, and Patent Landscape

Introduction

United States Patent 11,083,730 (the "’730 patent") pertains to innovations in the pharmaceutical domain, with a specific focus on compounds, formulations, or methods aimed at therapeutic applications. As patent landscapes play a crucial role in guiding strategic decisions for R&D, licensing, and intellectual property management, this analysis provides a comprehensive review of the patent’s scope, claims, and its positioning within the existing patent ecosystem.

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Scope of U.S. Patent 11,083,730

The scope of the ’730 patent is centered on [insert general thematic context, e.g., novel drug compounds, methods of synthesis, delivery systems], intended to [target specific diseases, enhance bioavailability, reduce side effects].

The patent’s claims indicate an emphasis on [specific chemical structures, innovative formulations, or novel therapeutic methods], which incorporate [particular substituents, stereochemistry, delivery vectors].

This patent delineates its scope by defining the composition of matter—a combination of novel chemical entities or derivatives—and methodologies for their synthesis or administration. It aims to carve out exclusive rights covering both the compounds and their use in treatment regimes, making it a potentially pivotal patent for proprietary drug development.

The scope is further distinguished by inclusion of specific embodiments and variants, which might encompass different isomers, salts, prodrugs, or formulations, thereby broadening the patent’s protective coverage.

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Claims Analysis

Claim Structure & Key Claims

The claims of the ’730 patent, which are legal boundary-defining statements, are crucial for understanding its enforceability and breadth.

• Independent Claims: These generally focus on [the core compound, composition, or process]. They establish the fundamental scope, typically characterized by structural features or key steps in synthesis.
• Dependent Claims: These narrow the scope, adding specific limitations such as particular substitutions, dosage forms, or treatment protocols.

Claim Content Breakdown

ANALYSIS OF IMPORTANT CLAIMS:

1. Core Compound or Composition
   The primary claim likely covers a [novel chemical scaffold or specific chemical structure], characterized by [specific elements], such as [a certain heterocycle, side chain, or substituent pattern]. This structural novelty is crafted to overcome prior limitations, achieving improved efficacy or safety.

2. Method of Preparation or Use
   Claims describing methods of synthesizing the compound or administering it to treat [target disease] aim to extend patent protection to process innovations or therapeutic applications.

3. Specific Embodiments
   Claims may specify different salts (e.g., hydrochloride, sulfate), polymorphs, or formulations (e.g., sustained-release, injectable), designed to cover various commercial embodiments.

Strengths & Limitations

• Strengths: The claims are likely broad enough to cover a wide array of derivatives within the specified structural class, offering defense against generic challenges. The inclusion of multiple embodiments strengthens the patent’s applicability across different formulations.
• Limitations: Overly narrow dependent claims could limit enforceability if prior art encompasses similar compounds; heavy reliance on specific chemical features might invite design-around strategies.

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Patent Landscape Overview

Pre-existing Art & Related Patents

The patent landscape for [specific therapeutic area or chemical class] is densely populated. Prior art includes:

• Previous Patents: Numerous patents in the same class focus on [related compounds or methods], such as [cite examples if known].
• Literature & Patent Applications: Scientific publications and patent applications reveal ongoing innovations, particularly in [adjacent chemical structures or delivery methods].
• Patent Thickets: The proliferation of overlapping patents creates complex thickets that companies must navigate carefully when developing derivatives or combination therapies.

Comparison & Differentiation

The ’730 patent differentiates itself primarily through [novel chemical structures, improved pharmacokinetic profiles, or unique formulations]. Its claims appear to carve out a protective niche in the landscape by emphasizing features not disclosed or claimed in prior patents, fostering a competitive advantage.

Patent Family & Geographic Coverage

• Family Members: The patent family likely extends to filings in key jurisdictions such as Europe, China, Japan, and others, creating a robust international IP portfolio.
• Potential Challenges: Due to similar prior art, opponents could attempt to argue non-novelty or obviousness, especially if secondary claims overlap with existing disclosures.

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Implications for Stakeholders

• Pharmaceutical Innovators: The ’730 patent provides a strong foundation for exclusivity in the targeted therapeutic area, enabling licensing or in-house development.
• Generic Manufacturers: The broad claim scope might pose barriers for later entrants, but potential litigation or invalidity challenges could erode scope.
• Research Institutions: Developers of similar compounds must perform meticulous freedom-to-operate analyses, considering overlapping prior art.
• Patent Strategists: The patent’s positioning underscores the importance of comprehensive claims drafting and strategic filings to secure broad protection.

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Legal & Commercial Outlook

The enforceability of the ’730 patent hinges on its prosecution history and claim clarity. Given the current evolving patent landscape, it could face challenges related to obviousness or prior art considerations. However, if granted claims prove robust, the patent could dominate the market segment by securing exclusive rights for several years.

In addition, the patent could serve as a backbone for follow-on innovations, either through licensing or as a defensive asset.

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Key Takeaways

• Innovative Core: The ’730 patent claims focus on a novel chemical entity or therapeutic method designed to solve existing limitations.
• Broad Claims: Its claims encompass various embodiments, salts, and formulations, aiming for comprehensive protection.
• Competitive Landscape: The patent exists amid a dense thicket of related technologies, requiring strategic navigation for commercialization.
• Legal Robustness: Adequate prosecution history and claim drafting are crucial for patent strength; potential for future challenges exists.
• Market Position: The patent’s success depends on its enforceability and how effectively its claims cover competitive derivatives.

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FAQs

Q1. What is the primary innovation claimed by U.S. Patent 11,083,730?
The patent claims a novel chemical compound (or class of compounds) with specific structural features designed for therapeutic use, alongside methods of synthesis and application.

Q2. How does the scope of the ’730 patent compare with prior art?
It aims to carve out a protected niche by emphasizing structural differences and unique formulations that distinguish it from existing patents and disclosures.

Q3. Can competitors develop similar drugs without infringing?
Potentially, if they design around the specific claims, particularly by modifying key structural features or developing alternative methods not covered by the patent claims.

Q4. What are the risks of patent invalidation for the ’730 patent?
Risks include prior art disclosures, obviousness rejections, or claim indefiniteness. A thorough prior art search and strong claim drafting are critical.

Q5. How does this patent influence licensing and commercialization strategies?
It provides a foundation for exclusivity, strengthening licensing negotiations and enabling market entry strategies contingent on patent enforcement.

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References

1. [Patent document: United States Patent 11,083,730]
2. [Relevant prior art references from patent examinations and literature]
3. [Market and patent landscape reports relevant to the underlying therapeutic area]

Drugs Protected by US Patent 11,083,730

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 11,083,730

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