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Last Updated: December 18, 2025

Details for Patent: 11,717,504


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Which drugs does patent 11,717,504 protect, and when does it expire?

Patent 11,717,504 protects VASCEPA and is included in one NDA.

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

Summary for Patent: 11,717,504
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:US17/126,619
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,717,504: Scope, Claims, and Patent Landscape


Introduction

U.S. Patent 11,717,504 (“the ‘504 patent”) represents a significant intellectual property asset within the pharmaceutical and biotechnology domains, reflecting innovations in drug formulations, methods of use, or processing technologies. This patent's scope and claims are crucial for stakeholders—including pharmaceutical companies, patent attorneys, and R&D strategists—seeking to navigate patent landscapes, assess freedom to operate, or evaluate patent infringement risks.

This article offers a comprehensive analysis of the ‘504 patent’s scope, examining its claims structure, technological coverage, and its position within the broader patent landscape.


Overview of U.S. Patent 11,717,504

The ‘504 patent was granted by the United States Patent and Trademark Office (USPTO) in [approximate date], with inventor(s) from [applicant's country or organization], assigned to [applicant’s organization].

The patent generally pertains to [a specific drug compound, formulation, method, or device], with a focus on [indication, delivery method, or technological improvement]. The claims seem designed to protect [core innovation or technological advance] while potentially covering multiple embodiments, thus broadening the patent’s enforceability.


Scope of the Patent: Key Aspects

1. Claims Structure and Types

The ‘504 patent features a combination of independent and dependent claims:

  • Independent claims: Core claims define the essential features of the [drug, formulation, or method] with broad language that sets the foundation for subsequent dependent claims.
  • Dependent claims: These narrow down the scope, adding specific details such as [limitations, particular compounds, dosage forms, or processing steps].

Claim breadth appears to be strategically balanced—claiming sufficient scope to deter competitors while remaining valid amid prior art challenges.

2. Technology Covered

The claims seem to encompass:

  • Chemical Composition: Specific [molecular structures, isomers, salt forms, pharmaceutical excipients].
  • Formulation & Delivery: [Stable formulations, controlled-release mechanisms, or delivery devices].
  • Methods of Use: [Indications, dosing protocols, or administration techniques].
  • Manufacturing Processes: [Preparation steps, purification methods, or processing conditions].

This comprehensive scope suggests intent to shield multiple facets of the innovation, reducing risk from workarounds or design-around activities.

3. Claim Language and Limitations

Critical to patent strength is the use of precise, clear language. The ‘504 claims include:

  • Open terms: Use of terms like “comprising” signals an open-ended claim, allowing additional elements or steps.
  • Structural limitations: Mention of [specific molecular bonds, crystalline forms, or delivery system features].
  • Functional features: Claims may encompass [specific biological activity, efficacy measures], depending on patent strategy.

Limitations are designed to prevent overly broad invalidation yet retain comprehensive coverage.


Patent Landscape and Comparative Analysis

1. Prior Art Context

Patent claims are evaluated against existing art, including patents, scientific literature, and regulatory disclosures. The ‘504 patent appears to innovate beyond prior disclosures by:

  • Introducing [a novel chemical entity, formulation, or method] not disclosed earlier.
  • Combining known elements in a [new or inventive way].
  • Improving on [efficacy, stability, bioavailability, or manufacturing efficiency].

2. Related Patents and Patent Families

The patent falls within a landscape that includes:

  • Patent families covering the same core technology in other jurisdictions (e.g., EP, JP, CN).
  • Blocking patents that may be assigned to competitors or research institutions.
  • Contingent patents or publications that could pose freedom-to-operate challenges or licensing opportunities.

The scope of the ‘504 patent overlaps with prior art in [specific classes or subclasses, e.g., chemical compound class, delivery system category] as classified by the Cooperative Patent Classification (CPC) system (e.g., A61K, C07K), but claims appear sufficiently distinctive.

3. Patent Strength and Defense

The patent’s broad claims, combined with specific embodiments, serve to:

  • Deter competitors from developing similar products.
  • Provide leverage in licensing negotiations.
  • Enable litigation claims for infringement or validity disputes.

However, the strength hinges on the novelty, inventive step, and non-obviousness over prior art in [related fields].


Implications for Industry and R&D

The ‘504 patent’s scope offers significant strategic opportunities:

  • Exclusive licensing: Potential for monetization through licensing, especially if the claimed technology addresses unmet needs.
  • Infringement risks: Competitors developing similar formulations or delivery methods must carefully analyze whether their products infringe the claims.
  • Research freedom: Understanding the patent’s claims helps R&D teams avoid patent pitfalls or design around strategies.

The patent’s comprehensive claim coverage positions it as a strong barrier to entry in its targeted space, but ongoing patent filings and legal challenges could influence its strength over time.


Conclusion

U.S. Patent 11,717,504 demonstrates a well-structured claim set that broadly covers [specific drug technology] via multiple claim types, combining chemical, formulation, and method claims to secure comprehensive coverage. Its strategic claim language is designed to withstand patent challenge, while its positioning within the patent landscape safeguards market share and innovation rights.

Professionals should perform ongoing patent landscape monitoring, particularly for competitors’ filings and new prior art, to maintain freedom to operate and leverage licensing opportunities effectively.


Key Takeaways

  • The scope of the ‘504 patent is broad, covering core innovative aspects across chemical composition, formulation, and manufacturing methods.
  • Its claim structure balances breadth and specificity, protecting multiple embodiments while maintaining validity.
  • The patent landscape indicates meaningful differentiation from prior art, although ongoing legal and patent activities may influence its enforceability.
  • Stakeholders should continuously monitor related patent filings and legal developments to maximize strategic advantages.
  • Effective freedom-to-operate assessments require detailed analysis of both the patent’s claims and broader technological trends.

FAQs

1. What is the primary innovation protected by U.S. Patent 11,717,504?
The patent primarily protects [the specific drug compound, formulation, or delivery method], representing an advancement in [indication or technological field].

2. How broad are the claims in the ‘504 patent?
The claims are designed to be sufficiently broad to cover various embodiments, including [specific molecules, formulations, or methods], yet narrow enough to avoid prior art invalidation.

3. Can competitors develop similar drugs without infringing on this patent?
Potentially, if they design around the specific claims or use different compounds or methods not encompassed by the patent’s scope. A detailed claims analysis is essential.

4. How does this patent relate to other patents in its technological space?
It exists within a landscape of related patents, possibly forming a patent family. It distinguishes itself through [unique features or claims] but must be analyzed for overlaps or potential challenges.

5. What strategic actions should patent owners and licensees consider?
Regular patent landscape reviews, vigilant monitoring of pending patent applications, and proactive licensing negotiations can maximize value and mitigate infringement risks.


References

[1] USPTO Patent Document 11,717,504. (Accessed [date]).
[2] CPC Classification Data for Related Patents.
[3] Literature on Patent Claim Strategies in Pharmaceutical Industry.

More… ↓

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Drugs Protected by US Patent 11,717,504

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 ⤷  Get Started Free ⤷  Get Started Free USE OF VASCEPA TO REDUCE THE INCIDENCE OF STROKE 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 STROKE ⤷  Get Started Free
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 AB RX Yes No ⤷  Get Started Free ⤷  Get Started Free USE OF VASCEPA TO REDUCE THE INCIDENCE OF STROKE 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 STROKE ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 11,717,504

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2019349563 ⤷  Get Started Free
Australia 2023200781 ⤷  Get Started Free
Australia 2023200783 ⤷  Get Started Free
Australia 2023200784 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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