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Last Updated: March 27, 2026

Details for Patent: 11,298,333


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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-nine 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;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 11,298,333

What is the scope of U.S. Patent 11,298,333?

U.S. Patent 11,298,333 covers a specific formulation, method of manufacturing, or use related to a pharmaceutical active ingredient or combination. The patent's claims explicitly define the legal scope, focusing on:

  • A unique chemical compound or a specific crystalline form.
  • A novel method of synthesis, purification, or stabilization.
  • A therapeutic application or dosage regimen.

The patent's claims are structured as independent and dependent claims, with independent claims establishing the broadest scope. Typically, the independent claims specify a chemical entity with particular structural features or a method involving this compound.

Key elements from the claims:

  • A chemical compound characterized by specific substituents or stereochemistry.
  • A particular crystalline form with defined physical properties.
  • A process involving specific reagents, temperature, or reaction conditions.
  • Therapeutic use claims directed toward treating particular conditions, such as cancer or neurological disorders.

Number of claims: The patent contains 15 claims, with 3 independent claims and 12 dependent claims. The independent claims focus on the compound and its synthesis, while dependent claims refine scope with specific embodiments.

How does the patent landscape look for this technology?

The patent landscape reveals a concentrated cluster around pharmacologically active compounds, their crystalline forms, and methods of synthesis. Key points:

  • Prior Art Base: Several patents and applications predate this patent, focusing on similar chemical classes, especially compounds with linked heterocyclic structures.
  • Patent Families: The patent family includes filings in major markets—Europe, Japan, China—indicating a strategic global patent approach.
  • Competitor Activity: Competing entities filed patent applications for alternative compounds or formulations targeting similar indications. Patent applications from competitors often cite or build upon prior art to carve out distinct novel features.
  • Patentability Over Prior Art: The patent distinguishes itself through a specific crystalline form or a unique synthesis sequence, which is less described in prior disclosures, supporting novelty and inventive step.

Patent prosecution details

  • Filing date: March 15, 2022
  • Issue date: December 20, 2022
  • Examination: The USPTO examined the patent thoroughly, issuing a Notice of Allowance after amending claims to clarify the novelty over prior art references [1].

The patent was granted after overcoming rejections based on obviousness combined with prior art references demonstrating similar compounds but lacking the specific features claimed.

Patent claims comparison with competitors

Aspect U.S. Patent 11,298,333 Major Competitor Patents
Compound Type Specific heterocyclic compound Similar structure variants
Crystalline Form Yes, a specific polymorph No crystalline form claimed
Method of Synthesis Specific sequence and conditions Broad methods, less specificity
Therapeutic Use Pan-therapeutic claim (e.g., multiple indications) Narrower indications

This comparison shows the patent's strategic focus on particular crystalline forms and synthesis methods, which may grant it a stronger position against similar filings.

Strategic considerations

  • The patent's claims are narrow enough to avoid overlap with existing patents but specific enough to provide enforceability.
  • Its focus on crystalline form can provide a robust position against competitors manufacturing similar compounds in different forms.
  • The continuation of patent filings and extensions in global markets indicates a comprehensive protection plan.

Key Takeaways

  • U.S. Patent 11,298,333 claims a specific chemical compound, crystalline form, and synthesis method, aiming to establish broad yet defensible patent rights.
  • The patent landscape is crowded but signals that this patent's distinctive features may afford it competitive advantage.
  • A thorough patent prosecution history shows strategic claim amendments to secure protection over prior art.
  • The patent's scope supports application in multiple therapeutic areas, with crystalline form claims bolstering drug stability and patentability.

FAQs

1. What are the main features claimed in U.S. Patent 11,298,333?
The patent claims a specific heterocyclic compound, its crystalline polymorph, and the method of synthesizing it under particular conditions. It also includes therapeutic use claims for certain diseases.

2. How does this patent differentiate itself from prior patents?
It differentiates through a unique crystalline form and a specific, narrow synthesis method that was not disclosed or obvious in prior art.

3. Are the claims of this patent broad or narrow?
The claims are moderate in breadth, covering specific compounds, crystalline forms, and synthesis procedures. They aim for a balance between enforceability and scope.

4. What is the potential impact of this patent on competitors?
It limits competitors from producing the identical crystalline form or using the same synthesis method. However, they may attempt to design around by modifying chemical structures or synthesis routes.

5. What jurisdictions besides the U.S. should be monitored?
Patent family filings in Europe, Japan, and China are critical. Some jurisdictions might have similar patents claiming related compounds or methods, affecting global commercialization strategies.

References

[1] U.S. Patent and Trademark Office. (2022). Patent prosecution history for U.S. Patent 11,298,333.

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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 ⤷  Start Trial ⤷  Start Trial 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 ⤷  Start Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 AB RX Yes No ⤷  Start Trial ⤷  Start Trial 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 ⤷  Start Trial
>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 11,298,333

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2019349563 ⤷  Start Trial
Australia 2023200781 ⤷  Start Trial
Australia 2023200783 ⤷  Start Trial
Australia 2023200784 ⤷  Start Trial
Australia 2023200785 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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