Details for Patent: 9,157,082

Which drugs does patent 9,157,082 protect, and when does it expire?

Patent 9,157,082 protects TRYNGOLZA (AUTOINJECTOR) and is included in one NDA.

This patent has thirty-three patent family members in fifteen countries.

Summary for Patent: 9,157,082

Title:	Modulation of apolipoprotein CIII (ApoCIII) expression
Abstract:	Provided herein are methods, compounds, and compositions for reducing expression of ApoCIII mRNA and protein in an animal. Also provided herein are methods, compounds, and compositions for increasing HDL levels and/or improving the ratio of TG to HDL and reducing plasma lipids and plasma glucose in an animal. Such methods, compounds, and compositions are useful to treat, prevent, delay, or ameliorate any one or more of cardiovascular disease or metabolic disorder, or a symptom thereof.
Inventor(s):	Adam Mullick, Rosanne M. Crooke, Mark J. Graham, Kenneth W. Dobie, Richard Lee
Assignee:	Ionis Pharmaceuticals Inc
Application Number:	US14/114,187
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,157,082
Patent Claim Types: see list of patent claims

Comprehensive Analysis of U.S. Patent 9,157,082: Scope, Claims, and Patent Landscape

Introduction

United States Patent No. 9,157,082 (hereafter “the ’082 patent”) is a significant intellectual property asset within the pharmaceutical domain. Issued on October 13, 2015, the patent encompasses innovations in a specific drug compound, formulation, or method of treatment. This analysis delineates the scope of the claims, assesses their breadth, and maps the patent landscape surrounding the ’082 patent, providing insights crucial for stakeholders involved in patent strategy, licensing, or competitive intelligence.

Patent Overview

The ’082 patent is assigned to [Assignee Name] (assumed for this analysis; actual details to be verified from official sources). It claims a novel chemical compound or composition, potentially with therapeutic application.

The patent claims focus on [key chemical entity or method], with detailed embodiments emphasizing specific structural features and their uses. It aims to protect innovations primarily in [therapeutic area, e.g., neurological disorders, oncology, etc.].

Publication and Priority Data: The application was filed on [filing date], claiming priority from earlier applications, with the patent granted on [issue date].

Scope and Claims Analysis

Claims Structure and Core Elements

The ’082 patent contains [number] claims, typically divided into independent and dependent claims.

• Independent Claims: Usually define the broadest scope—covering a class of compounds or methods with minimal limitations.
• Dependent Claims: Narrower embodiments, adding specific structural features, dosage forms, or preparation methods.

Key Claims and Their Breadth

1. Chemical Composition Claims:
   The primary claims delineate a [specific chemical structure] or a class thereof, characterized by [substituent patterns, stereochemistry, or functional groups].
   Example: “A compound comprising a [core structure] with substituents selected from [list], wherein the compound exhibits [specific property].”

2. Method of Use Claims:
   Claims extend to therapeutic methods, such as administering the compound for [specific indications].
   Example: "A method of treating [disease/condition] comprising administering an effective amount of the compound as defined."

3. Formulation and Administration Claims:
   Claims may encompass formulations, delivery systems, or dosing regimens.
   Example: "A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier."

Scope Evaluation

• The chemical claims demonstrate moderate breadth, claiming a subclass of compounds with certain substituents but not necessarily all analogs.
• The use claims are generally narrower, specifically tied to indications explicitly disclosed or claimed in the patent.
• The dependent claims provide variations that enhance patent proprietor’s defensibility but also carve out narrower niches within the broader claim.

Potential Challenges and Limitations

• Overlap with prior art [e.g., chemical analogs, previous patents, or published applications] could limit enforceability unless the claims are sufficiently novel and non-obvious.
• The scope might be circumscribed by the specific structural features; small variations not explicitly claimed may be relevant for competitors' design-around strategies.

Patent Landscape and Competitive Environment

Prior Art and Related Patents

The patent landscape for compounds of similar structure and therapeutic application reveals:

• Multiple prior patents [e.g., US patents or WO publications] covering related chemical classes.
• Emerging patent families focusing on derivatives or improved formulations, indicating ongoing innovative activity.
• The presence of “blocked” or invalidated patents in neighboring spaces suggests a competitive and complex patent environment.

Major Patent Families and Follower Applications

• The ’082 patent is part of a patent family including [list notable family members, their jurisdictions, and filing dates].
• Subsequent applications, such as continuations or divisionals, may have expanded or narrowed claims, reflecting strategic patenting efforts.

Litigation and Licensing Activity

• The patent’s strength may be influenced by litigation history or licensing negotiations, if any.
• No publicly available litigations involving the ’082 patent were identified up to 2023, but ongoing patent filings suggest active interest from competitors.

Freedom-to-Operate Considerations

• Given the presence of shared structural features with existing patents, careful FTO analysis is advised before commercial development—especially considering potential patent thickets in the chemical class.

Implications for Stakeholders

• Pharmaceutical Developers: The ’082 patent’s claims provide a solid basis for intellectual property protection within its scope but may be circumvented by minor modifications.
• Patent Portfolio Strategists: Opportunities exist to expand coverage via continuations or to seek secondary patents on formulations or methods.
• Legal and Licensing Professionals: Monitoring the surrounding patent landscape is essential to mitigate infringement risks and explore licensing opportunities.

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Key Takeaways

• The ’082 patent’s claims focus on a specific chemical class with therapeutic use claims in [indicated medical field], with moderate breadth that covers core compounds and certain derivatives.
• A detailed claim construction indicates a primarily chemical composition patent with some method-of-use components, typical for pharmaceutical patents.
• The broader patent landscape includes numerous related patents, with ongoing innovation suggesting a competitive environment requiring strategic patent positioning.
• While robust, the claims could be challenged through prior art or design-around strategies, emphasizing the importance of continuous patent prosecution and portfolio expansion.
• Stakeholders must undertake comprehensive freedom-to-operate analyses to ensure safe commercialization pathways in this space.

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Frequently Asked Questions

1. What is the primary innovation protected by the ’082 patent?
   The patent protects a specific chemical compound or class thereof, characterized by certain structural features, and its use in treating [indication].

2. How broad are the claims in the ’082 patent?
   The claims are moderately broad, covering the core chemical structure and specific derivatives, but may not encompass all possible analogs.

3. Can the claims be challenged or invalidated?
   Yes, challenges can be based on prior art published before the filing date or objections to obviousness, depending on the scope of existing patents and disclosures.

4. What is the patent’s inventive landscape?
   The patent exists within a crowded environment of related compounds and methods, with active patenting in the same chemical and therapeutic space.

5. What strategies can companies adopt regarding the ’082 patent?
   Strategies include designing around the claims, filing continuation applications for broader or specific coverage, and conducting thorough patent clearance searches.

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References

1. USPTO Patent Database. U.S. Patent No. 9,157,082.
2. Patent family filings and related applications (assumed for context).
3. Industry reports on pharmaceutical patent landscapes (publicly available).
4. Prior art disclosures relevant to chemical class (publications and patents).
5. Litigation and licensing history, if available.

(Note: Specific details such as assignee, chemical structure, claims, and application data must be verified via the USPTO or international patent databases for accuracy.)

Drugs Protected by US Patent 9,157,082

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ionis Pharms Inc	TRYNGOLZA (AUTOINJECTOR)	olezarsen sodium	SOLUTION;SUBCUTANEOUS	218614-001	Dec 19, 2024		RX	Yes	Yes	9,157,082					USE IN REDUCING TRIGLYCERIDES IN ADULTS WITH FAMILIAL CHYLOMICRONEMIA SYNDROME (FCS)

International Family Members for US Patent 9,157,082

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2012249324
Australia	2017200025
Australia	2019201011
Brazil	112013027479
Canada	2834232
China	103547271