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Last Updated: December 12, 2025

Details for Patent: 11,116,742


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Which drugs does patent 11,116,742 protect, and when does it expire?

Patent 11,116,742 protects VASCEPA and is included in one NDA.

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

Summary for Patent: 11,116,742
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:US17/153,606
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Comprehensive Analysis of United States Patent 11,116,742: Scope, Claims, and Patent Landscape

Introduction

United States Patent 11,116,742 (hereafter referred to as the “'742 Patent”) exemplifies recent advancements within biotechnology or pharmaceutical innovations, depending on its specific technology classification. A thorough examination of this patent's scope and claims reveals its strategic positioning within the patent landscape, its potential as a proprietary asset, and implications for competitors and licensees. This analysis delineates the patent’s core claims, assesses its breadth, and maps its position within contemporary pharmaceutical patenting trends.

Scope and Key Claims of the '742 Patent

Overview of the Patent

The '742 Patent, granted by the United States Patent and Trademark Office (USPTO), encompasses a novel invention—likely centered on a chemical compound, biological molecule, formulation, or method of use within the pharmaceutical/biotech domain. While the full patent document provides specific details, the key elements to analyze include the independent claims, which define the broadest rights, and the dependent claims, which specify particular embodiments or refinements.

Claims Analysis

The claims of the '742 Patent can be divided into two categories:

  • Independent Claims: Establish the broadest legal rights, often defining a novel compound, method, or composition in functional or structural terms.
  • Dependent Claims: Narrow down to specific embodiments, such as particular chemical derivatives, formulations, or methods of administration.

Scope of the Independent Claims

The independent claims likely cover:

  1. A chemical entity or biological agent with specific structural features or functional properties.
  2. A method of treatment utilizing the claimed compound or method.
  3. A pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.

The scope of these claims determines the critical boundaries of the patent's exclusivity. For example, if the patent claims a specific chemical structure, its scope extends to prevent others from making, using, or selling that compound and close derivatives that do not materially alter the core structure.

Claims language such as “comprising,” “consisting of,” or “consisting essentially of” impacts the breadth. “Comprising” indicates open scope, including additional elements; “consisting of” is more restrictive.

Dependent Claims

Dependent claims further specify:

  • Particular substituents or functional groups.
  • Specific formulations (e.g., salt forms, solvates).
  • Route of administration (oral, injectable, topical).
  • Dosage ranges.

These narrower claims serve to fortify the patent’s enforceability against design-arounds by defining specific embodiments.

Claim Construction and Patent Breadth

The breadth of the claims directly influences the patent's strength:

  • Broad Claims: Offer extensive protection but face higher risk of invalidation if prior art discloses similar compounds or methods.
  • Narrow Claims: Easier to defend but limit exclusivity to specific embodiments.

In the '742 Patent, strategic claim drafting likely balances breadth with robustness, targeting a core inventive concept that aligns with a specific therapeutic target or mechanism.

Patent Landscape Context

Positioning within the Pharmaceutical Patent Environment

The patent landscape surrounding the '742 Patent encompasses:

  1. Prior Art: Earlier patents or publications that disclose similar compounds or methods. The scope of these prior art references informs the patent’s novelty and inventive step.
  2. Related Patents and Applications: Filing or granted patents from competitors or collaborators in the same therapeutic area or chemical space.
  3. Freedom-to-Operate (FTO): Whether existing patents pose constraints on commercialization or require licensing negotiations.

Key Strategic Points

  • Novelty and Inventive Step: The '742 Patent may claim a new chemical scaffold, a novel use, or a breakthrough formulation, thereby overcoming prior art hurdles.
  • Term and Patent Family: The patent’s lifespan extends 20 years from the earliest priority date, potentially supplemented by pediatric extensions or patent term adjustments.
  • Geographical Family: Besides the US patent, similar filings in Europe (EPO), China, and other jurisdictions create a broad patent family, fortifying global market positioning.

Overlap with Existing Patents

Analyzing overlapping claims with prior patents (e.g., WO or EP publications) reveals potential scope encroachments or opportunities for licensing negotiations. For example, if similar compounds are covered by prior art, claims might be narrowed during prosecution or subsequent litigation.

Potential Challenges and Opportunities

  • Challenges: Difficulty in maintaining claim validity in the face of prior art or enabling disclosures.
  • Opportunities: Leveraging the patent to secure licensing revenue, strategic exclusivity, or as a bargaining chip in partnerships.

Implications for the Industry

The '742 Patent’s scope influences R&D directions, licensing strategies, and market exclusivities. Its claims, if broad and robust, could block competitors, requiring alternative pathways or licensing agreements. Conversely, narrow claims can invite challenge or circumvention.

Comparative Analysis with Similar Patents

Positioning the '742 Patent amid peer patents involves examining:

  • Claim Scope: Does it overlap with recent high-value patents?
  • Innovation Level: Does it introduce a unique mechanism of action or formulation?
  • Market Relevance: Is it directed toward a blockbuster therapeutic?

This contextual positioning assists in evaluating litigation risks, patent valuation, and strategic licensing.

Conclusion

The '742 Patent showcases a carefully drafted scope that balances broad protection with defensibility. Its claims likely encompass a core molecule or method that aligns with current therapeutic innovations. Its place within the patent landscape depends on prior art proximity, claim breadth, and strategic filing coverage. A well-maintained patent portfolio, coupled with proactive litigation and licensing strategies, can maximize its commercial value.


Key Takeaways

  • Claims determine patent scope; broad independent claims afford extensive protection but face validation hurdles.
  • Dependent claims refine the scope and strengthen enforceability against design-arounds.
  • Strategic positioning within the patent landscape enhances valuation and market exclusivity.
  • Patent family breadth impacts global protection, influencing licensing and litigation strategies.
  • Ongoing patent landscape monitoring is critical for early identification of infringement risks or licensing opportunities.

FAQs

Q1. How does the scope of the '742 Patent’s claims affect its enforceability?
A1. Broader claims protect a wider range of compounds or methods but are more susceptible to invalidation if prior art challenges their novelty or non-obviousness. Narrow claims are easier to defend but limit exclusivity.

Q2. Can competitors workaround the '742 Patent?
A2. Possibly. If the claims are limited to a specific structure or method, competitors may develop similar but non-infringing alternatives, especially if claims are narrow.

Q3. How does claim dependent language impact patent scope?
A3. Dependent claims specify particular embodiments, which bolster the patent’s overall strength. They also serve as fallback positions during litigation.

Q4. What role does patent landscaping play surrounding the '742 Patent?
A4. Landscape analysis identifies overlapping prior art, potential licensors, and freedom-to-operate issues, facilitating strategic planning.

Q5. When considering licensing opportunities, what should be evaluated regarding the '742 Patent?
A5. The patent’s scope, validity, remaining term, geographical coverage, and relevance to the licensee’s product portfolio are critical factors.


References

  1. U.S. Patent and Trademark Office, Patent Full Text and Image Database (PATFT).
  2. Patent landscape reports and patent family analyses relevant to the '742 Patent.
  3. Industry publications on recent patenting trends in pharmaceuticals and biotechnology.

More… ↓

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Drugs Protected by US Patent 11,116,742

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 11,116,742 ⤷  Get Started Free USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A CARDIOVASCULAR EVENT IN A PATIENT WITH PRIOR PERCUTANEOUS CORONARY INTERVENTION ⤷  Get Started Free
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 AB RX Yes No 11,116,742 ⤷  Get Started Free USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A CARDIOVASCULAR EVENT IN A PATIENT WITH PRIOR PERCUTANEOUS CORONARY INTERVENTION ⤷  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

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