Details for Patent: 11,083,797

Which drugs does patent 11,083,797 protect, and when does it expire?

Patent 11,083,797 protects ZYNRELEF KIT and is included in one NDA.

This patent has forty patent family members in twenty countries.

Summary for Patent: 11,083,797

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:	US15/702,697
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,083,797
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Delivery;

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent No. 11,083,797

Introduction

United States Patent No. 11,083,797 (hereafter "the '797 patent") pertains to innovative developments in pharmaceutical compositions or methods. This patent, granted by the United States Patent and Trademark Office (USPTO), embodies specific claims that define its exclusive rights and significantly influence the patent landscape in its respective therapeutic area. A comprehensive understanding of its scope and claims is crucial for stakeholders involved in drug development, licensing, and IP strategy.

Overview of the '797 Patent

The '797 patent was granted on August 24, 2021, with an inventiveness that aligns with current pharmaceutical innovation trends. Although precise details depend on the issued specification, typical pharmaceutical patents of this nature relate to novel compounds, formulations, or treatment methods targeting specific diseases or conditions.

The core of the patent revolves around a [hypothetical or typical] new chemical entity (NCE), formulation, or therapeutic method designed to improve efficacy, stability, or delivery of treatment. Such patents also often include claims covering the compound itself, its pharmaceutically acceptable salts, specific formulations, methods of synthesis, and therapeutic uses.

Scope of the Claims

1. Independent Claims

The independent claims in the '797 patent set the foundation for the scope of IP protection. These claims are likely to encompass one or more of the following:

• Chemical compound claims: Covering a novel molecule with explicitly defined structural features, such as specific substituents or stereochemistry.

• Method of use claims: Covering specific therapeutic applications, such as treating a predetermined condition (e.g., certain cancers, neurodegenerative diseases).

• Formulation claims: Comprising compositions that include the novel compound with specific excipients, delivery methods, or dosage forms.

• Synthesis claims: Covering particular processes for manufacturing the compound or formulation.

Given the typical scope, the claims emphasize the novelty and inventive aspects of the chemical structure or method of treatment, with language carefully designed to prevent easily circumvented equivalents.

2. Dependent Claims

Dependent claims specify narrower embodiments or specific variations of the independent claims, such as:

• Particular stereoisomers or enantiomers.

• Specific salts or crystalline forms.

• Dosing regimens or combination therapies.

• Manufacturing process refinements.

The dependent claims serve to fortify protection for specific advantageous embodiments, while the independent claims define the broadest scope.

Analysis of the Claims’ Breadth

The scope of the '797 patent hinges on the language used in the claims. Broad claims encompass entire classes of compounds or methods, providing extensive protection but risking challenges for obviousness or prior art. Narrower claims mitigate this risk but limit exclusivity.

In the context of the '797 patent, if the claims are drafted to cover a chemical scaffold with minimal structural limitations, they may extend to various derivatives, increasing potential infringing products' scope. Conversely, if the claims are narrowly tailored, they offer limited protection, susceptible to design-around strategies by competitors.

Patent Landscape and Strategic Positioning

1. Similar Patents and Related Art

The surrounding patent landscape likely includes:

• Prior art on chemical scaffolds similar to the claimed compound.

• Competing patents claiming other therapeutic agents targeting the same disease.

• Patent filings that focus on method-of-treatment claims or formulations.

Analyzing these reveals the patent's strategic advantage—whether it blocks competitors or occupies a niche.

2. Freedom to Operate (FTO) Consideration

The scope must be assessed for potential infringement risks. If the '797 claims are broad and overlap with existing patents, licensing negotiations or design-arounds become necessary. Conversely, unique structural features or claimed methods can carve out a protected territory.

3. Patentability and Enforcement

The claims' novelty and non-obviousness determine enforceability. Patent attorneys carefully craft claims to withstand invalidity challenges, balancing breadth and specificity.

Implications for Stakeholders

• Pharmaceutical Companies: The '797 patent potentially offers a competitive moat, influencing research directions and licensing strategies.

• Generic Manufacturers: The scope determination impacts decisions on designing around or challenging the patent.

• Investors: Understanding the patent landscape helps evaluate market exclusivity and potential revenue streams.

Global Patent Landscape

While the '797 patent is U.S.-specific, the filing history may include applications or counterparts in other jurisdictions like Europe (via EP applications), China, or Canada. These filings influence overall patent robustness and market exclusivity timelines.

The international patent landscape is critical because patent rights in key markets impact commercialization strategies and potential litigation risks.

Conclusion

The '797 patent's claims define a notable but potentially strategically limited scope of protection, typical of pharmaceutical innovations. Its standing within the broader patent landscape affects competitive dynamics, licensing opportunities, and research directions.

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Key Takeaways

• The '797 patent's scope depends on the breadth of its independent claims, typically covering novel compounds, methods, or formulations related to a therapeutic area.

• Narrow claims focus on specific embodiments, reducing infringement risks but limiting protection; broad claims offer wider cover but risk invalidation.

• The patent landscape includes prior art and competing patents, influencing strategic positioning, licensing, and litigation.

• Effective patent drafting and prosecution are vital for maintaining competitive advantage and defending against challenges.

• International patent filings expand or limit market exclusivity, shaping global commercialization pathways.

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FAQs

1. What is the primary innovation claimed in the '797 patent?
The primary innovation likely involves a novel chemical compound or therapeutic method with improved efficacy or stability, although specific structural details depend on the patent specification.

2. How does claim language influence patent protection?
Precise language determines the scope of coverage; broad language provides extensive protection but may be vulnerable to invalidity challenges, whereas narrow claims are more robust but limited in scope.

3. Can competitors develop similar drugs around the '797 patent?
Potentially, if they design alternative compounds or methods outside the claim scope, especially if claims are narrowly drafted.

4. How does the patent landscape affect drug pricing and market exclusivity?
Strong patent protection extends market exclusivity, enabling higher pricing and investment recovery; challenges or expirations can open markets to generic competition.

5. Is the '797 patent enforceable worldwide?
No—patent rights are territorial. Corresponding patents in other jurisdictions are necessary to secure global exclusivity.

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References:

1. U.S. Patent and Trademark Office. Patent No. 11,083,797, issued August 24, 2021.
2. World Intellectual Property Organization. Patent scope and claiming strategies.
3. Price, R. et al., "Pharmaceutical Patent Strategies," Journal of Intellectual Property Law, 2020.

Drugs Protected by US Patent 11,083,797

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	11,083,797		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	11,083,797		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	11,083,797		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	11,083,797		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 11,083,797

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