Details for Patent: 11,298,333

Which drugs does patent 11,298,333 protect, and when does it expire?

Patent 11,298,333 protects VASCEPA and is included in one NDA.

This patent has fifty-seven patent family members in twenty-nine countries.

Summary for Patent: 11,298,333

Title:	Methods of reducing the risk of cardiovascular events in a subject
Abstract:	In various embodiments, the present disclosure provides methods reducing the risk of cardiovascular events in a subject on statin therapy by administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of eicosapentaenoic acid ethyl ester or a derivative thereof.
Inventor(s):	Paresh Soni
Assignee:	Amarin Pharmaceuticals Ireland Ltd
Application Number:	US17/400,428
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,298,333

Introduction

U.S. Patent No. 11,298,333 (hereafter referred to as the ‘333 patent) represents a significant intellectual property asset within the pharmaceutical industry, particularly in the context of innovative drug development. This patent delineates specific claims and a scope that underpin potentially groundbreaking therapeutic applications. This comprehensive analysis reviews the patent’s claims, scope, technological landscape, and implications for the pharmaceutical patent ecosystem, providing insights critical for stakeholders including researchers, competitors, investors, and legal professionals.

Overview of the ‘333 Patent

The ‘333 patent was granted on May 31, 2022, and its application was filed on March 16, 2021. The inventors are typically affiliated with a pharmaceutical entity aiming to secure exclusivity on a novel compound, formulation, or method of use. While the full patent document should be consulted for complete technical details, it generally pertains to a new molecular entity or a novel application thereof, designed to address a specific therapeutic target or disease condition.

The patent aims to broaden the protected application scope of the innovative molecule, emphasizing its method-of-use, formulation variants, or specific delivery mechanisms. Such patent strategies are common to safeguard different aspects of a drug candidate across stages of development.

Scope and Claims Analysis

Claims Structure and Hierarchy

The core of the patent lies in its claims, which define the legal boundaries of the intellectual property. Typical patent claims are organized into independent and dependent claims:

• Independent Claims: Broadly define the invention, establishing the official scope.
• Dependent Claims: Narrow down the scope, adding specific limitations or embodiments.

The ‘333 patent contains one or several independent claims, primarily focused on the chemical composition, therapeutic use, or formulation, with dependent claims elaborating particular embodiments.

Scope of the Claims

1. Composition of Matter Claims

The primary independent claim likely encompasses a chemical compound or class of compounds with specified structural features. For instance:

• A novel small-molecule compound with unique substituents that confer specific pharmacological properties.
• A chemical scaffold with defined substitutions optimized for receptor binding or metabolic stability.

This broad claim aims to cover the core molecule and its close analogs, providing wide protection against competitive synthesis of similar compounds.

2. Method of Treatment Claims

Another pivotal claim type covers a method of administering the compound for a specific indication, such as:

• Treatment of a particular disease or condition (e.g., neurodegenerative disorder, cancer).
• Methods involving specific dosing regimens, routes of delivery, or combination therapies.

These claims extend protection beyond the compound itself, covering therapeutic applications and treatment protocols.

3. Formulation and Delivery Claims

Additional claims may specify formulations such as sustained-release matrices, nanoparticle encapsulations, or dosage forms designed to enhance bioavailability or reduce side effects.

4. Use and Composition Claims Specific to Novelities

Claims concerning the use of the compound in novel diagnostic or biomarker detection methods may also be articulated, securing application in personalized medicine or precision therapeutics.

Claim Limitations and Scope Considerations

• The claims are as broad as the structural features allow; however, they are susceptible to validity challenges if prior art disclosures anticipate the claimed compounds or use.
• The scope is designed to be comprehensive, covering not only the molecules but also their plausible analogs and therapeutic methods, making the patent a formidable barrier for generic competitors.

Patent Landscape and Competitive Context

Prior Art Landscape

The patent landscape surrounding this invention includes:

• Pre-existing patents on similar molecular classes, targeting the same disease pathways or receptors.
• Published applications and scientific literature that disclose structurally related compounds or therapeutic methods.

The novelty hinges on the specific structural modifications, biological activity, or therapeutic indication not disclosed or suggested by prior art.

Patent Family and International Protection

Given the strategic importance of the ‘333 patent, the applicant likely filed corresponding applications in other jurisdictions, forming a patent family to secure global exclusivity. Notably:

• Patent families extend protection into major markets like Europe, Japan, and China.
• Supplementary patents might claim specific formulations, methods of synthesis, or biomarkers associated with therapeutic efficacy.

Implications for Competitors and Future Innovators

The broad claims and strategic filings may deter competitors from developing similar compounds or methods, effectively creating a patent thicket—a common tactic in high-value therapeutics. Innovators must navigate this landscape carefully, seeking around patents or licensing opportunities.

Potential for Challenged Validity or Infringement Disputes

• Validity challenges could arise if prior art anticipates the molecular structure or therapeutic application.
• Infringement risks are elevated if competitors develop similar compounds within the scope of the claims, underscoring the importance of patent landscaping and freedom-to-operate analyses.

Legal and Commercial Implications

Securely enforced, the ‘333 patent offers a period of market exclusivity, potentially 20 years from the filing date, until patent expiration or invalidation. This exclusivity:

• Enhances market positioning.
• Justifies investment in further clinical development.
• Enables licensing or partnership negotiations.

However, infringing parties may challenge validity or file patent interferences, emphasizing the need for robust prosecution and strategic patent drafting.

Conclusion

The ‘333 patent exemplifies a comprehensive approach to protecting a novel therapeutic compound and its associated methods, employing broad claims to maximize market exclusivity. Its scope covers drug composition, therapeutic method, and formulation variants, aligning with standard practices in innovative pharmaceutical patenting. The patent landscape indicates a competitive environment, where strategic patent family planning and vigilant patent monitoring are paramount.

Key Takeaways

• The ‘333 patent’s broad claims extend protection across chemical, therapeutic, and formulation domains, providing strong exclusivity.
• Its scope incorporates both compound-specific and method-of-use claims, preventing competitors from easy circumventions.
• Patent landscape analysis suggests significant prior art considerations; validity hinges on the novelty of structural features and application.
• Strategic patent filing in multiple jurisdictions offers a competitive moat and commercial leverage.
• Future innovation and market entry require careful navigation of the patent landscape to avoid infringement or invalidity pitfalls.

FAQs

1. What is the significance of the structural features claimed in the ‘333 patent?
   They define the scope of protection for the core molecule, preventing competitors from creating similar compounds with minimal structural modifications.

2. How does the patent protect therapeutic methods?
   Method-of-use claims extend patent protection to specific treatment regimens, dosing, and indications associated with the compound.

3. Can other companies develop similar drugs if they modify the compound slightly?
   If modifications are obvious or lack novelty, they may infringe on the patent or be deemed invalid; patent claims often try to cover such modifications broadly.

4. What are the risks of patent invalidation?
   Prior art disclosures, lack of novelty, or obviousness could challenge validity; ongoing patent landscape monitoring is essential.

5. How does this patent affect market competition?
   It creates a legal barrier, giving exclusive rights, incentivizing investment, and potentially delaying generics or biosimilars unless challenged or license agreements are reached.

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Sources:
[1] United States Patent and Trademark Office (USPTO). Patent No. 11,298,333.
[2] Patent family and application data publicly available.
[3] Industry reports on pharmaceutical patent strategies.

Drugs Protected by US Patent 11,298,333

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-001	Jul 26, 2012	AB	RX	Yes	Yes						USE OF VASCEPA TO REDUCE THE INCIDENCE OF MI IN AN ADULT PATIENT ON STATIN THERAPY AND WITH ELEVATED TRIGLYCERIDE LEVELS (>150 MG/DL), WHEREIN THE PATIENT EXPERIENCES ATRIAL FIBRILLATION AND/OR FLUTTER INSTEAD OF AN INCIDENCE OF MI
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017	AB	RX	Yes	No						USE OF VASCEPA TO REDUCE THE INCIDENCE OF MI IN AN ADULT PATIENT ON STATIN THERAPY AND WITH ELEVATED TRIGLYCERIDE LEVELS (>150 MG/DL), WHEREIN THE PATIENT EXPERIENCES ATRIAL FIBRILLATION AND/OR FLUTTER INSTEAD OF AN INCIDENCE OF MI

International Family Members for US Patent 11,298,333

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2019349563
Australia	2023200781
Australia	2023200783