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Last Updated: May 20, 2025

Details for Patent: 10,668,042


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Which drugs does patent 10,668,042 protect, and when does it expire?

Patent 10,668,042 protects VASCEPA and is included in one NDA.

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

Summary for Patent: 10,668,042
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): Soni; Paresh (Mystic, CT)
Assignee: Amarin Pharmaceuticals Ireland Limited (Dublin, IE)
Application Number:16/391,128
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

United States Patent 10,668,042: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 10,668,042, titled "Methods of reducing the risk of cardiovascular events in a subject," is a significant patent in the field of cardiovascular health. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

Publication Number and Authority

The patent, numbered US10,668,042B2, was granted by the United States Patent and Trademark Office (USPTO)[4].

Background and Purpose

This patent describes methods for reducing the risk of cardiovascular events in subjects who are on statin therapy. The invention involves administering specific compounds to enhance the cardiovascular benefits of statin treatment.

Scope of the Patent

Technical Field

The patent falls within the technical field of pharmaceuticals and cardiovascular health, specifically focusing on methods to reduce cardiovascular risk factors.

Key Components

  • Compounds Involved: The patent mentions the use of ethyl eicosapentaenoic acid (EPA) and other related compounds in conjunction with statin therapy to reduce cardiovascular events. Statins, such as rosuvastatin and atorvastatin, are commonly used to lower cholesterol levels[4].

  • Methods of Administration: The methods outlined include administering these compounds to subjects who are already on statin therapy. The goal is to enhance the protective effects against cardiovascular events such as myocardial infarction, unstable angina, and other related conditions[4].

Claims of the Patent

Independent Claims

The patent includes several independent claims that define the scope of the invention. These claims typically describe the method of administering the compounds, the specific compounds used, and the subjects to whom the method is applied.

  • Claim 1: This claim typically sets the broadest scope, describing the method of administering ethyl eicosapentaenoic acid to a subject on statin therapy to reduce the risk of cardiovascular events[4].

  • Dependent Claims: These claims further specify the method, including the dosage, timing, and specific combinations of compounds. For example, claims may specify the use of rosuvastatin or atorvastatin in combination with ethyl eicosapentaenoic acid[4].

Patent Claims Analysis

Metrics for Patent Scope

Research on patent scope often uses metrics such as independent claim length and independent claim count to measure the breadth of a patent. Narrower claims, as indicated by shorter independent claim lengths and fewer independent claims, are often associated with a higher probability of grant and a shorter examination process[3].

  • Claim Length and Count: The patent in question has multiple claims, with the independent claims being relatively detailed to ensure specificity and clarity. This approach helps in avoiding overly broad claims that might face challenges during the examination process.

Patent Landscape

Related Patents and Prior Art

The patent landscape in the field of cardiovascular health is extensive, with numerous patents related to statin therapy and omega-3 fatty acid supplements.

  • Prior Art: The patent cites various prior art documents, including other patents and scientific studies, to establish the novelty and non-obviousness of the invention. For example, other patents like US-7022713-B2 discuss hyperlipemia therapeutic agents that include pitavastatins and eicosapentaenoic acid, highlighting the ongoing research in this area[5].

  • Global Dossier and International Search: The Global Dossier service provided by the USPTO allows users to view the file histories of related applications from participating IP Offices, which can be useful in understanding the global patent landscape for similar inventions[1].

Search and Examination Process

Tools and Resources

Conducting a thorough search for prior art and related patents is crucial in the patent examination process. Tools like the USPTO's Patent Public Search, Global Dossier, and the Common Citation Document (CCD) application are essential for this purpose.

  • Patent Public Search: This tool provides enhanced access to prior art, allowing users to search through a vast database of patents and published patent applications[1].

  • Global Dossier: This service helps in identifying related applications filed at participating IP Offices, which can be critical in assessing the novelty and non-obviousness of the invention[1].

Impact and Applications

Clinical Significance

The methods described in this patent have significant clinical implications. By reducing the risk of cardiovascular events, these methods can improve patient outcomes and quality of life.

  • Cardiovascular Events: The patent's focus on reducing the risk of myocardial infarction, unstable angina, and other cardiovascular events aligns with ongoing medical research aimed at improving cardiovascular health[4].

Market and Commercial Potential

The commercial potential of this patent is substantial, given the widespread use of statins and the growing awareness of the benefits of omega-3 fatty acids in cardiovascular health.

  • Market Demand: The demand for effective methods to reduce cardiovascular risk factors is high, making this patent a valuable asset in the pharmaceutical industry.

Key Takeaways

  • Specific Methods: The patent outlines specific methods for administering ethyl eicosapentaenoic acid in conjunction with statin therapy to reduce cardiovascular risk.
  • Claims Analysis: The claims are detailed and specific, indicating a narrower scope that enhances the patent's validity.
  • Patent Landscape: The patent is part of a broader landscape of research in cardiovascular health, with numerous related patents and ongoing scientific studies.
  • Clinical and Commercial Impact: The invention has significant clinical and commercial potential, improving patient outcomes and addressing a high-demand market.

FAQs

Q: What is the main focus of United States Patent 10,668,042?

A: The main focus is on methods to reduce the risk of cardiovascular events in subjects on statin therapy by administering specific compounds like ethyl eicosapentaenoic acid.

Q: What are the key compounds mentioned in the patent?

A: The key compounds include ethyl eicosapentaenoic acid, rosuvastatin, and atorvastatin.

Q: How does the patent contribute to cardiovascular health?

A: The patent describes methods that can enhance the protective effects of statin therapy against cardiovascular events such as myocardial infarction and unstable angina.

Q: What tools can be used to search for related patents and prior art?

A: Tools like the USPTO's Patent Public Search, Global Dossier, and the Common Citation Document (CCD) application are useful for searching related patents and prior art.

Q: What is the commercial potential of this patent?

A: The patent has substantial commercial potential due to the high demand for effective methods to reduce cardiovascular risk factors.

Sources

  1. USPTO - Search for patents: https://www.uspto.gov/patents/search
  2. U.S. Patent and Trademark Office (USPTO) | USAGov: https://www.usa.gov/agencies/u-s-patent-and-trademark-office
  3. Patent Claims and Patent Scope - Search eLibrary :: SSRN: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
  4. Methods of reducing the risk of cardiovascular events in a subject - Google Patents: https://patents.google.com/patent/US10668042B2/en
  5. US-7022713-B2 - Hyperlipemia Therapeutic Agent | Unified Patents: https://portal.unifiedpatents.com/patents/patent/US-7022713-B2

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Drugs Protected by US Patent 10,668,042

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 10,668,042 ⤷  Try for Free USE OF VASCEPA WITH HIGH INTENSITY STATIN THERAPY TO REDUCE THE RISK OF A CV EVENT IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS AND (1) ESTABLISHED CV DISEASE, OR (2) DIABETES MELLITUS AND TWO OR MORE ADDITIONAL RISK FACTORS FOR CV DISEASE ⤷  Try for Free
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 AB RX Yes No 10,668,042 ⤷  Try for Free USE OF VASCEPA WITH HIGH INTENSITY STATIN THERAPY TO REDUCE THE RISK OF A CV EVENT IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS AND (1) ESTABLISHED CV DISEASE, OR (2) DIABETES MELLITUS AND TWO OR MORE ADDITIONAL RISK FACTORS FOR CV DISEASE ⤷  Try for 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 10,668,042

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2019349563 ⤷  Try for Free
Australia 2023200781 ⤷  Try for Free
Australia 2023200783 ⤷  Try for Free
Australia 2023200784 ⤷  Try for Free
Australia 2023200785 ⤷  Try for Free
Australia 2023226708 ⤷  Try for Free
Brazil 112021005580 ⤷  Try for Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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