Details for Patent: 9,801,945

Which drugs does patent 9,801,945 protect, and when does it expire?

Patent 9,801,945 protects ZYNRELEF KIT and is included in one NDA.

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

Summary for Patent: 9,801,945

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):	Ottoboni; Thomas B. (Belmont, CA), Girotti; Lee Ann Lynn (San Bruno, CA)
Assignee:	Heron Therapeutics, Inc. (Redwood City, CA)
Application Number:	15/331,767
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound; Delivery; Device;

Understanding the Scope and Claims of United States Patent 9,801,945

Introduction

United States Patent 9,801,945, titled "Long-acting polymeric delivery systems," is a significant patent in the field of pharmaceutical delivery systems. This patent, issued to innovators in the medical and pharmaceutical industries, outlines a novel approach to drug delivery using polymeric systems. Here, we will delve into the details of the patent's scope, claims, and its position within the broader patent landscape.

Background and Context

The patent in question addresses the need for efficient and long-acting drug delivery systems. Traditional drug delivery methods often suffer from limitations such as short duration of action, variable drug release rates, and potential side effects. The invention described in US 9,801,945 aims to overcome these challenges by utilizing a specific polymeric composition.

Patent Scope

The scope of US 9,801,945 is defined by its claims, which describe the composition and functionality of the long-acting polymeric delivery systems.

Composition

The patent specifies a delivery system comprising:

• A polyorthoester polymer
• A polar aprotic solvent
• A solvent containing a triglyceride viscosity reducing agent[4][5].

This unique combination is designed to achieve low viscosity, which is crucial for the effective delivery of drugs over an extended period.

Claims Analysis

The claims of the patent are the heart of its intellectual property protection. Here’s a breakdown of the key claims:

Independent Claims

• Claim 1 typically describes the broadest scope of the invention, outlining the essential components of the delivery system, including the polyorthoester polymer, the polar aprotic solvent, and the triglyceride viscosity reducing agent.
• Subsequent claims may narrow down the scope by specifying particular types of drugs that can be delivered (e.g., meloxicam, bupivacaine), the duration of drug release (e.g., hours, days), or specific formulations[4].

Dependent Claims

• These claims build upon the independent claims, adding additional limitations or specifications. For example, a dependent claim might specify the concentration of the polyorthoester polymer or the type of triglyceride used[4].

Patent Landscape

To understand the position of US 9,801,945 within the broader patent landscape, it is essential to analyze related patents and the overall intellectual property strategy of the company.

Related Patents

• The patent is part of a larger family of patents related to drug delivery systems. Analyzing these related patents can reveal trends in innovation and areas where the company is focusing its research and development efforts.
• For instance, other patents may cover different types of polymers, solvents, or drug formulations, indicating a comprehensive approach to addressing various aspects of drug delivery[4].

Patent Analytics

Using patent analytics tools, such as those described by Schwegman, can help in categorizing and analyzing the claims and scope concepts of US 9,801,945 along with other related patents. This involves creating a Claim Coverage Matrix and interactive claim charts to identify gaps in coverage and potential future design opportunities[3].

Practical Applications

The practical applications of the invention described in US 9,801,945 are significant:

Improved Drug Delivery

• The long-acting polymeric delivery systems can provide sustained release of drugs, reducing the need for frequent dosing and improving patient compliance.
• The low viscosity of the delivery system enhances its ease of administration, making it more comfortable for patients[4].

Therapeutic Benefits

• The specified drugs, such as meloxicam and bupivacaine, can be delivered in a controlled manner, providing consistent therapeutic effects over an extended period.
• This can lead to better management of chronic conditions and reduced side effects associated with traditional delivery methods[4].

Legal and Regulatory Considerations

The patentability of inventions like those described in US 9,801,945 is subject to various legal and regulatory considerations.

Subject Matter Eligibility

• The USPTO's guidance on AI and software patents, while not directly applicable here, emphasizes the importance of integrating judicial exceptions into practical applications. Similarly, the claims in US 9,801,945 must demonstrate a practical application and technological improvement to be considered patent-eligible[1].

Obviousness and Double Patenting

• The patent must also pass the tests of obviousness and double patenting. For example, the Federal Circuit's decision in cases like In re Cellect highlights the importance of ensuring that patents do not overlap in a way that would render them unpatentable due to obviousness-type double patenting[2].

Key Takeaways

• Composition and Claims: The patent describes a specific composition for long-acting polymeric delivery systems, including a polyorthoester polymer, a polar aprotic solvent, and a triglyceride viscosity reducing agent.
• Practical Applications: The invention provides sustained drug release, improves patient compliance, and enhances the ease of administration.
• Patent Landscape: The patent is part of a broader intellectual property strategy focusing on drug delivery systems, and its claims can be analyzed using patent analytics tools.
• Legal Considerations: The patent must meet subject matter eligibility, non-obviousness, and avoid double patenting issues.

Frequently Asked Questions

Q: What is the main composition of the long-acting polymeric delivery system described in US 9,801,945? A: The main composition includes a polyorthoester polymer, a polar aprotic solvent, and a solvent containing a triglyceride viscosity reducing agent.

Q: How does the patent improve drug delivery? A: The patent provides a sustained release of drugs, reducing the need for frequent dosing and improving patient compliance.

Q: What are some of the therapeutic benefits of this invention? A: The invention can provide consistent therapeutic effects over an extended period and reduce side effects associated with traditional delivery methods.

Q: How can patent analytics tools help in understanding this patent? A: Patent analytics tools can help in categorizing and analyzing the claims and scope concepts, identifying gaps in coverage, and highlighting future design opportunities.

Q: What legal considerations are important for this patent? A: The patent must meet subject matter eligibility, non-obviousness, and avoid double patenting issues to remain valid.

Drugs Protected by US Patent 9,801,945

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	9,801,945		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	9,801,945		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	9,801,945		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	9,801,945		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 9,801,945

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