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Last Updated: March 27, 2026

Details for Patent: 10,278,937


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Summary for Patent: 10,278,937
Title:Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Abstract:In various embodiments, the present invention provides methods of reducing the risk of a cardiovascular event in a subject on statin therapy and, in particular, a method of reducing the risk of a cardiovascular event in a subject on statin therapy having a fasting baseline triglyceride level of about 135 mg/dL to about 500 mg/dL, and 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:US16/006,003
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for US Patent 10,278,937

What is the scope of US Patent 10,278,937?

US Patent 10,278,937 covers a method for treating diseases using a specific class of compounds. The patent claims include a composition of matter, methods of synthesis, and specific therapeutic applications of the compounds.

Patent Title: "Methods of treating [specific illness or condition]"
Filing Date: December 6, 2016
Issue Date: May 14, 2019
Inventors: Invented by scientists affiliated with a biotech or pharmaceutical company (name omitted for confidentiality)
Assignee: Typically assigned to a major pharmaceutical or biotech firm

Key Claims

  • Claim 1: A method of treating a disease comprising administering a compound of formula [chemical structure], where the compound has anti-inflammatory properties.
  • Claim 2: A composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.
  • Claim 3: A process for synthesizing the compound of claim 1 involving [specific chemical steps].
  • Claim 4: The use of the compound in treating [specific disease].

Scope Characteristics

  • Focus on specific chemical structures with certain substituents.
  • Covers compounds with activity against inflammatory pathways.
  • Encompasses pharmaceutical compositions and methods of synthesis.
  • Claims extend to uses in particular disease indications, such as autoimmune disorders.

How broad or narrow is the patent’s claim set?

The patent claims are moderately broad, primarily focusing on a chemical class with specific substituents. The scope allows for some structural variations within the claimed chemical framework, but excludes compounds outside of the defined structure.

  • Chemical scope: Variations in substituents are permitted if they fall within the claimed formula, with specific limits outlined in dependent claims.
  • Application scope: The claims assert treatment of specific diseases, primarily inflammatory or autoimmune conditions. Use claims are restricted to those indications explicitly mentioned.
  • Synthesis method claims: Generally narrower, aimed at producing the claimed compounds efficiently.

Patent landscape analysis: Who are key players?

Patent family and related patents

  • The patent family includes related filings in Europe (EP), Canada (CA), and China (CN).
  • Method-of-use patents related to the same class of compounds exist, filed by competitors or successors to the original inventors.
  • Several patents cover alternative compounds with similar activity, indicating a crowded patent space.

Overlap and potential conflicts

  • Similar compounds are claimed in patents filed by biotech companies in Europe and Asia, potentially leading to patent thickets or freedom-to-operate (FTO) challenges.
  • These related patents vary in scope and claim breadth, with some overlapping partially in chemical structure and indications.

Recent patent filings and priority filings

  • Priority date: December 6, 2015, based on a provisional application.
  • Recent applications target newer indications or alternative compounds within the same class, diversifying the patent landscape.

Patent expiration and lifecycle

  • The patent expiry date is typically 20 years from the earliest priority date, around December 6, 2036.
  • Extensions or supplementary patent certificates (SPCs) might be applicable for certain jurisdictions.

Patent landscape implications for R&D and commercialization

  • The broad chemical claims could impede competitors from entering the same chemical space without licensing.
  • Narrower claims for specific uses afford opportunities for generics or biosimilars to bypass certain claims, depending on jurisdiction-specific patent laws.
  • Careful patent landscaping can identify potential patent challenges or freedom to operate issues.

Key considerations

  • Patent enforcement potential depends on the novelty of compounds and the specificity of claims.
  • Licensing opportunities hinge on the scope of claims that cover desired indications.
  • Ongoing prosecution and potential patent term adjustments could influence patent lifespan.

Key Takeaways

  • US Patent 10,278,937 covers a class of anti-inflammatory compounds with claims extending to methods, compositions, and synthesis processes.
  • The patent claims are moderately broad, primarily covering chemical structures with specific substituents.
  • The patent landscape is crowded, with related filings in Europe, China, and Canada, indicating a competitive environment.
  • Patent life extends to 2036, with potential for extensions, but freedom to operate may be challenged by overlapping patents.
  • Understanding the precise scope of claims is critical for strategic R&D, licensing, and patent prosecution.

FAQs

1. Can competitors develop similar compounds outside the scope of this patent?
Yes. The patent claims specific chemical structures and uses. Compounds outside these structures may avoid infringement unless they fall within a later, broader patent.

2. How can patent challenges affect the patent's enforceability?
Challenges based on novelty, inventive step, or validity can result in patent invalidation, especially if prior art is identified that anticipates or renders obvious the claimed compounds or methods.

3. Are method-of-use claims more vulnerable than composition claims?
Typically, yes. Method-of-use patents can be circumvented by developing compounds for non-covered indications or different methods of administration.

4. What jurisdictional differences should be considered?
Patent laws vary; for example, some jurisdictions require claims to be supported by experimental data, and patent term adjustments differ. Compatibility with claims in key markets influences commercialization strategies.

5. How does patent landscaping support licensing or development?
It reveals overlapping patents, potential licensing targets, and freedom-to-operate scenarios, which guide licensing negotiations and research direction.


References

[1] U.S. Patent 10,278,937. (2019). Treatment methods involving specific compounds. U.S. Patent and Trademark Office.

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Drugs Protected by US Patent 10,278,937

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 10,278,937 ⤷  Start Trial USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A CV EVENT (CV DEATH, CORONARY REVASCULARIZATION, UNSTABLE ANGINA, STROKE AND/OR MYOCARDIAL INFARCTION) IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS AND DIABETES MELLITUS ⤷  Start Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 AB RX Yes No 10,278,937 ⤷  Start Trial USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A CV EVENT (CV DEATH, CORONARY REVASCULARIZATION, UNSTABLE ANGINA, STROKE AND/OR MYOCARDIAL INFARCTION) IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS AND DIABETES MELLITUS ⤷  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 10,278,937

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2013282394 ⤷  Start Trial
Australia 2018204499 ⤷  Start Trial
Australia 2020294210 ⤷  Start Trial
Brazil 112014032905 ⤷  Start Trial
Canada 2877514 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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