Details for Patent: 10,098,957

Which drugs does patent 10,098,957 protect, and when does it expire?

Patent 10,098,957 protects ZYNRELEF KIT and is included in one NDA.

This patent has forty patent family members in twenty countries.

Summary for Patent: 10,098,957

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. (San Diego, CA)
Application Number:	15/644,715
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Delivery; Device;

Understanding the Scope and Claims of United States Patent 10,098,957

Introduction

United States Patent 10,098,957, titled "Long-acting polymeric delivery systems," is a significant innovation in the field of medical science, particularly in the development of drug delivery systems. This patent, granted to address the need for efficient and long-lasting drug delivery, is crucial for understanding the current landscape of pharmaceutical technology.

Patent Overview

The patent describes a composition for long-acting polymeric delivery systems, which are designed to release therapeutic agents over an extended period. This system is particularly useful for delivering anesthetics and nonsteroidal anti-inflammatory drugs (NSAIDs) such as meloxicam and bupivacaine[1].

Key Components of the Patent

Polymeric Composition

The delivery system consists of a polyorthoester polymer, a polar aprotic solvent, and a solvent containing a triglyceride viscosity-reducing agent. This combination ensures a low viscosity of the composition, which is essential for easy administration and effective drug delivery[1].

Viscosity Measurements

The patent specifies that the composition has a viscosity of less than 10,000 mPa-s when measured at 37°C using a viscometer. In some embodiments, the viscosity ranges from about 2500 mPa-s to 10,000 mPa-s, making it suitable for various medical applications[1].

Therapeutic Agents

The composition includes an NSAID, preferably meloxicam, in varying concentrations. For example, meloxicam can be present in amounts ranging from 0.005% to 1% by weight of the composition. This flexibility allows for tailored therapeutic effects depending on the specific medical need[1].

Release Profiles

The patent outlines different release profiles for the therapeutic agents. In some embodiments, the delivery vehicle is an immediate-release vehicle, while in others, it is a sustained-release vehicle. The release of the anesthetic and NSAID can be determined through in vitro dissolution tests at 37°C, ensuring that at least 80% of the drugs are released within a specified time frame (e.g., 15 minutes to 2 hours)[1].

Claim Structure and Scope

Independent and Dependent Claims

The patent application likely includes a strategic mix of independent and dependent claims to maximize the scope of protection. Independent claims define the broadest scope of the invention, while dependent claims narrow down the scope by adding specific limitations. This structure is crucial for ensuring comprehensive protection of the invention[5].

Claim Management

Effective claim management, as highlighted in patent strategy discussions, involves ensuring that the patent utilizes its full entitlement of claims. This could include up to 3 independent claims and a total of 20 claims, as allowed by the initial patent application filing fee in the United States. Strategic addition and adjustment of claims can enhance the patent’s defensive capabilities and value in licensing discussions or infringement disputes[5].

Patent Landscape and Implications

Patent Scope Metrics

The scope of a patent, such as US 10,098,957, can be measured using metrics like independent claim length and independent claim count. These metrics have been shown to have explanatory power for correlates of patent scope, including patent maintenance payments, forward citations, and the breadth of patent classes. Narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].

Economic and Legal Implications

The patent landscape is influenced by economic and legal factors. The granting of patents with well-defined and narrow claims can reduce licensing and litigation costs, thereby promoting innovation. The strategic management of claims within a patent application can significantly enhance the patent’s effectiveness and value, making it a critical aspect of intellectual property strategy[3][5].

Industry Impact and Applications

Medical Applications

The long-acting polymeric delivery systems described in this patent have significant implications for medical practice. They can provide sustained analgesia for up to 24 hours, which is particularly beneficial for post-surgical pain management. For example, bupivacaine, an anesthetic mentioned in the patent, is commonly used for postsurgical analgesia following procedures like open inguinal hernia repair[4].

Pharmaceutical Innovation

This patent contributes to the advancement of pharmaceutical technology by offering a versatile and efficient drug delivery system. The ability to tailor the release profiles and therapeutic agent concentrations makes it a valuable innovation in the field of pharmacology.

Key Takeaways

• Polymeric Composition: The patent involves a polyorthoester polymer, a polar aprotic solvent, and a triglyceride viscosity-reducing agent.
• Viscosity and Release Profiles: The composition has a controlled viscosity and various release profiles, including immediate and sustained release.
• Therapeutic Agents: The system can deliver NSAIDs like meloxicam and anesthetics like bupivacaine.
• Claim Structure: Effective claim management is crucial for maximizing the scope of protection.
• Industry Impact: The innovation has significant implications for medical applications, particularly in post-surgical pain management.

FAQs

1. What is the primary purpose of the long-acting polymeric delivery systems described in US Patent 10,098,957?

   • The primary purpose is to provide a sustained release of therapeutic agents, such as anesthetics and NSAIDs, over an extended period.

2. What are the key components of the polymeric composition in this patent?

   • The key components include a polyorthoester polymer, a polar aprotic solvent, and a solvent containing a triglyceride viscosity-reducing agent.

3. How is the viscosity of the composition measured and what are the specified ranges?

   • The viscosity is measured at 37°C using a viscometer, and it ranges from about 2500 mPa-s to 10,000 mPa-s.

4. What therapeutic agents can be delivered using this system, and in what concentrations?

   • The system can deliver NSAIDs like meloxicam in concentrations ranging from 0.005% to 1% by weight of the composition.

5. Why is strategic claim management important in patent applications like US 10,098,957?

   • Strategic claim management ensures that the patent utilizes its full entitlement of claims, enhancing its defensive capabilities and value in licensing discussions or infringement disputes.

Sources

1. US10098957B2 - Long-acting polymeric delivery systems - Google Patents
2. Patent Claims Research Dataset - USPTO
3. Patent Claims and Patent Scope - SSRN
4. Bupivacaine: Uses, Interactions, Mechanism of Action - DrugBank
5. Maximizing Patent Value: A Strategic Approach to Claim Management - Harrity LLP

Drugs Protected by US Patent 10,098,957

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	10,098,957					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	10,098,957					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	10,098,957					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	10,098,957					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 10,098,957

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