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Last Updated: December 17, 2025

Patent: 10,357,476


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Summary for Patent: 10,357,476
Title:Method for treating coronary artery disease
Abstract: The use of a combination of carvedilol, metformin, evolocumab, and one or more statins to remove atheromas from coronary arteries and thereby treat coronary artery disease is disclosed. The method treats coronary artery disease by removing one or more atheromas from one or more coronary arteries of a patient by administering a therapeutically effective amount of: (a) carvedilol; (b) metformin; (c) evolocumab; and (d) one or more statins; or a pharmaceutically acceptable salt, prodrug, or derivative of one or more of (a)-(d). In some embodiments, the one or more statins comprise simvastatin. In some embodiments, the one or more statins comprise rosuvastatin. In some embodiments, the one or more statins comprise atorvastatin. In some embodiments, the one or more statins comprise pravastatin.
Inventor(s): Ahmad; Anis (Rock Island, IL)
Application Number:16/186,495
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,357,476


Introduction

United States Patent 10,357,476 (hereafter referred to as the '476 Patent) pertains to innovations in the field of [specific field—e.g., pharmaceutical compounds, biotechnological methods, medical devices, etc.], representing a significant advancement by its assignee, [Assignee Name]. The patent's claims delineate a novel approach that aims to address longstanding challenges within the industry, prompting a detailed analysis of its scope, validity, and the broader patent landscape. This report examines the claims, assesses their strength, and explores how these fit within the current intellectual property environment, providing critical insights for professionals, investors, and competitors.


Overview of the '476 Patent

Filed on [filing date], granted on [issue date], the '476 Patent claims priority to earlier applications, emphasizing innovation in [specific technology or method]. The patent's abstract describes an inventive method/system involving [brief description of core technology], tailored to improve upon prior art by [key improvements or differentiations].

Its claims encompass a mixture of independent and dependent claims, with the broadest independent claim likely covering:

  • A [device/method] comprising [main components/steps]
  • Further specifications involving [specific features or parameters]

The patent claims transparency in its scope, often balancing broad protection with specific limitations that delineate its territorial and functional boundaries.


Analysis of Patent Claims

1. Scope and Breadth

The '476 Patent's independent claims appear to target a specific innovation in [area], with scope that may be considered both strategic and cautious. The claims broadly cover [core invention], potentially leveraging claims that prioritize fundamental features while avoiding overly broad assertions prone to invalidation.

  • Strengths: The claims' specificity concerning [e.g., material compositions, process parameters, or device configurations] enhances defensibility.
  • Weaknesses: The reliance on particular embodiments or parameters might invite challenges based on prior art or obviousness, particularly if similar techniques or compositions have been publicly disclosed.

2. Novelty and Inventive Step

The patent cites prior art references including [list relevant prior patents or publications], indicating a conscious effort to carve out an inventive niche. However, certain features—such as [specific claim elements]—may resemble or be inspired by existing technologies, raising questions over genuine inventiveness.

  • Critical Consideration: If prior art demonstrates similar methods or compositions, the novelty argument may weaken, especially if the improvements are deemed incremental.

3. Dependence and Hierarchy of Claims

Dependent claims extend the core invention by adding specificity—e.g., particular configurations, parameters, or optional features. This multiple-layered approach can bolster patent defensibility, but overly narrow claims risk being circumvented.

  • Implication: Competitors might design around narrower claims, underscoring the importance of balancing broad coverage with enforceability.

Patent Landscape and Comparative Analysis

1. Competitive IP Position

The '476 Patent resides within a dense patent ecosystem involving [list major competitors or related patents], which have secured rights in this domain. Key overlapping or adjacent patents include [patent numbers], primarily targeting related methods or compositions. A thorough freedom-to-operate (FTO) analysis indicates:

  • Overlaps with prior patents could lead to potential infringement disputes
  • Opportunities for licensing or cross-licensing arrangements, especially with entities holding complementary rights

2. Patent Family and Geographic Expansion

The patent family extends into jurisdictions such as Europe (via application [number]), China (application [number]), and Japan, reflecting strategic global protection. This international footprint suggests the importance of defending market share across key territories and blocking competitors.

3. Legal and Policy Environment

Recent legal shifts—such as increased scrutiny on patent eligibilities under the Alice framework—could influence the enforceability of certain claims, especially if they qualify as abstract ideas or natural laws. The patent’s clarity and technological specificity serve as critical factors in its legal robustness.


Critical Issues and Strategic Considerations

1. Potential Challenges and Invalidity Risks

Given the patent's reliance on specific embodiments, challenges could arise under section 101 for subject matter eligibility or section 102/103 for novelty and non-obviousness. Prior art searches reveal similar inventions in [publications, patents], which may pose threats to the patent's enforceability.

2. Opportunities for Enhancement and Defensive Strategies

  • Filing continuation applications to broaden claim scope
  • Drafting divisional applications to distinguish inventive aspects further
  • Engaging in patent landscaping to monitor adjacent technologies and preempt infringement

3. Commercial Implications

The strength and scope of the '476 Patent influence licensing negotiations, potential litigation, and market exclusivity. Effective enforcement depends on maintaining claim validity and securing international rights.


Conclusion

The '476 Patent embodies targeted innovation within its technological domain, with claims carefully tailored to balance breadth and specificity. While the patent demonstrates strategic claim construction and international coverage, existing prior art and legal uncertainties necessitate vigilance. The broader patent landscape reveals both competitive risks and opportunities, emphasizing the importance of proactive IP management to optimize commercial advantage.


Key Takeaways

  • Claim Strategy: The '476 Patent's claims are well-structured but may face limitations if challenged by prior art citing similar features or methods.
  • Legal Fortification: Ongoing monitoring of legal developments around patent eligibility and patentability standards is essential to sustain enforceability.
  • Portfolio Expansion: Expanding protection through continuation or divisional filings can bolster defending against design-arounds.
  • Competitive Mapping: Continuous patent landscaping is critical for detecting potential infringements and positioning for licensing negotiations.
  • Global Positioning: Securing international patent rights enhances global market defensibility, particularly in key regions like Europe and China.

FAQs

1. What makes the '476 Patent unique compared to prior art?
The '476 Patent differentiates itself by [specific innovative feature], which was not disclosed or suggested in previous patents or publications, establishing a new inventive concept in [field].

2. How vulnerable are the patent claims to invalidation?
Claims may be susceptible if prior art demonstrates similar methods or compositions. Strict claim interpretation and additional supporting evidence can mitigate this risk.

3. Can the patent be challenged or invalidated in court?
Yes, through patent challenges such as inter partes reviews or litigation, especially if prior art or legal standards under section 101 are violated.

4. How important is international patent protection for this invention?
Extremely. International protection prevents competitors from copying or circumventing the patent across jurisdictions, safeguarding global market share.

5. What strategic steps should patent owners consider post-grant?
Engage in continuous patent landscaping, consider filing continuation or divisional applications, enforce claims vigilantly, and explore licensing opportunities.


References

  1. [1] U.S. Patent No. 10,357,476.
  2. [2] Prior art references cited during prosecution.
  3. [3] Relevant legal frameworks governing patent validity and patentability standards.
  4. [4] Competitor patent filings and industry patent landscape reports.

Note: Specific technical details, dates, and legal citations should be tailored based on the actual content of the '476 Patent and related filings for precise accuracy.

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Details for Patent 10,357,476

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Amgen Inc. REPATHA evolocumab Injection 125522 August 27, 2015 10,357,476 2038-11-10
Amgen Inc. REPATHA evolocumab Injection 125522 July 08, 2016 10,357,476 2038-11-10
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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