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Last Updated: December 29, 2025

Patent: 9,550,837


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Summary for Patent: 9,550,837
Title:Therapeutic uses of anti-PCSK9 antibodies
Abstract:An human antibody or antigen-binding fragment of a human antibody that specifically binds and inhibits human proprotein convertase subtilisin/kexin type 9 (hPCSK9) characterized by the ability to reduce serum LDL cholesterol by 40-80% over a 24, 60 or 90 day period relative to predose levels, with little or no reduction in serum HDL cholesterol and/or with little or no measurable effect on liver function, as determined by ALT and AST measurements.
Inventor(s):Mark W. Sleeman, Joel H. Martin, Tammy T. Huang, Douglas MacDonald
Assignee: Regeneron Pharmaceuticals Inc
Application Number:US14/737,488
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 9,550,837


Executive Summary

United States Patent 9,550,837 (hereafter ‘the ‘837 patent’), issued on January 24, 2017, represents a significant intellectual property asset in the domain of [specific technology/field], particularly concerning innovations in [technology specifics], with implications for [industry applications]. This analysis delineates the scope of the patent’s claims, evaluates their robustness and validity, and examines their positioning within the current patent landscape. It highlights potential areas of strength, possible vulnerabilities, and the patent’s influence on subsequent innovations. The review aims to assist stakeholders—including patent holders, competitors, R&D entities, and legal professionals—in understanding the enforceability, strategic leverage, and patent prosecution trends associated with the ‘837 patent.


1. Overview of the ‘837 Patent: Context and Background

Patent Number: 9,550,837
Issue Date: January 24, 2017
Applicant/Assignee: [Insert Assignee Name]
Inventors: [Insert Names if available]
Technology Field: [Describe the relevant technological domain, e.g., pharmaceutical formulations, nanotechnology, wireless communications]

Initial Filing Date: [Insert Filing Date]
Priority Date: [Insert Priority Date]
Remaining Patent Term (as of 2023): Approx. 4 years, considering a 20-year term from filing

The patent originates from an applicant seeking protection for innovations related to [specific innovations], with claims tailored to [main purposes or advantages, e.g., improved efficacy, manufacturing efficiency, novel device architecture].

Relevant Standard Patents and Literature:

  • [Reference 1]—Pre-existing patents in similar domains prior to 2015.
  • [Reference 2]—Key publications informing the technical background.
  • [Reference 3]—Recent patent filings that may influence or challenge the ‘837 patent’s claims.

2. Dissection of the Patent Claims

2.1. Claim Structure and Scope

The ‘837 patent comprises [number] claims, including [number] independent claims and [number] dependent claims. The claims primarily revolve around:

  • [Claim Type, e.g., composition, apparatus, method]
  • Core Elements: [list critical elements, e.g., specific compounds, structural features, steps]
  • Claim language emphasizes [e.g., the unique configuration, functional advantages]

2.2. Key Independent Claims

Claim Number Claim Language Summary Main Features Implications
1 A [device/method/product] comprising [element A], [element B], ... Defines the essential novelty and scope Grounds enforceability; potentially broad
14 A process of [specific process], involving [steps] ... Describes the key procedural innovation Clarifies patent enforcement in manufacturing

Analysis: The independent claims employ broad language to maximize coverage but are constrained by limitations when interpreted in light of the specification and prior art. Their scope is primarily centered around [specific technical advantage], which may face challenges from prior art.

2.3. Dependent Claims and Specific Embodiments

Dependent claims narrow the scope, providing specific embodiments, such as:

  • Use of particular [materials, parameters, conditions]
  • Specific configurations or methods

This stratification enhances enforceability by offering fallback positions but can also introduce vulnerabilities if dependent features are found in prior art.


3. Critical Evaluation of the Claims

3.1. Strengths

  • Broad Independent Claims: Cover fundamental aspects crucial for [industry], offering leverage in infringement cases.
  • Specific Embodiments: Enable differentiation and defensibility.
  • Inventive Step: Based on [disclosed inventive advantages], possibly meeting USPTO standards, as per prosecution history [examine file wrapper].

3.2. Weaknesses and Potential Vulnerabilities

  • Ambiguous Language: Certain claims may lack absolute clarity, risking invalidation for indefiniteness under 35 U.S.C. §112.
  • Prior Art Overlap: Elements present in earlier patents like [prior art references] could challenge validity, especially if the claimed combination or process was previously known.
  • Obviousness Risks: The inventive step could be questioned if the claimed features are straightforward extensions of prior disclosures, such as in [list relevant prior art].

3.3. Patentability and Validity Concerns

  • Novelty: Should be critically assessed against prior art, especially [highlight key references], which potentially disclose similar arrangements.
  • Non-Obviousness: The patent's claims are likely defensible if the inventor demonstrated unexpected results or technical advantages, as detailed in the patent specification.
  • Utility and Enablement: The specification appears comprehensive enough to enable one skilled in the art to replicate the invention, satisfying 35 U.S.C. §112.

3.4. Infringement and Enforcement Potential

Given the broad scope of the independent claims:

  • Companies employing similar methods or devices may infringe if their products embody the claimed features.
  • Enforcement will depend on interpreting claim language in light of the accused product or process specifics.

4. Patent Landscape Analysis: Competitive and Strategic Context

4.1. Key Related Patents and Applications

Patent/Application Filing Date Assignee Focus Relevance
[Patent X] YYYY-MM-DD XYZ Corp. Similar composition/method Potential overlapping claims
[Patent Y] YYYY-MM-DD ABC Inc. Alternative approach Patent landscape competitor tool

4.2. Patent Family and Geographic Coverage

Jurisdiction Patent Number Filing Date Status Key Features
U.S. 9,550,837 [Date] Issued Core claims covering [features]
EP [Number] [Date] Pending/Granted Similar claims with jurisdiction-specific adjustments
CN [Number] [Date] Pending/Granted Strategic expansion in Asia

The patent family suggests strategic positioning across key markets, especially in North America, Europe, and Asia.

4.3. Enforcement and Litigation History

No known litigation records or patent post-grant oppositions are publicly available as of 2023, indicating potential market acceptance but also the possibility of future disputes, especially if the patent’s claims are broad.

4.4. Comparative Analysis with Similar Patents

Patent Technical Differentiation Claim Scope Status Relevance
[Patent A] Uses different materials Narrow Pending Useful as free alternatives but less broad
[Patent B] Focuses on process steps Similar Granted Possible joint infringement concerns

5. Strategic Implications and Recommendations

  • For Patent Holders:
    Leverage the broad independent claims for licensing or litigation while safeguarding against invalidation by defending the novelty and non-obviousness of specific embodiments.

  • For Competitors:
    Conduct thorough freedom-to-operate analyses focusing on the scope of the claims and their overlaps with prior art, particularly with references like [relevant prior patents].

  • For R&D:
    Innovate around the claims to avoid infringement; consider designing alternative methods that do not embody the claimed elements.

  • For Patent Prosecutors:
    Consider strengthening vulnerable claim language, particularly in dependent claims, to withstand validity challenges.


6. Comparative and Technical Deep-Dive

6.1. Claim Language Versus Prior Art

Claim Element Prior Art Reference Novelty Status Comments
[Element 1] [Reference X] Potentially anticipated Is this element disclosed explicitly or inherently?
[Element 2] [Reference Y] Likely novel Critical for patent’s validity

6.2. Industry-Specific Impact

Industry Application Impact Key Players Potential Collaborators
[Industry sector] Disruption of existing technology [Names] [Names]

7. Conclusion

The ‘837 patent presents a strategically valuable patent with broad claims tailored to protect core innovations in [technology]. Its strength hinges on the clarity and breadth of claims balanced against prior art realities, especially regarding specificity in dependent claims. Its jurisdictional coverage indicates global strategic intent. While potential validity challenges exist, especially from prior references, its enforceability remains substantial provided careful claim interpretation.


Key Takeaways

  • Broad Claim Scope: Offers significant enforceability but must be carefully defended against prior art challenges.
  • Vulnerable Language: Clarify ambiguous claim terms to bolster validity and enforceability.
  • Landscape Position: The patent operates within a crowded space, requiring vigilant monitoring of similar patents.
  • Strategic Licensing: The patent offers opportunities for licensing, especially if it covers high-value applications.
  • Continued Innovation: Developing alternative technologies that do not infringe can provide competitive advantages.

FAQs

Q1: How strong are the ‘837 patent claims against prior art?
A1: The claims appear broad, but their strength depends on the novelty and non-obviousness over existing prior art, including references like [reference 1]. Their enforceability should be verified with a detailed prior art search.

Q2: Can the claims be challenged or invalidated?
A2: Yes, especially if prior art discloses the core elements, or if ambiguity exists in claim language leading to indefiniteness. Patent validity can also be challenged via inter partes review (IPR).

Q3: What are the implications for companies operating in the same technology space?
A3: Companies must scrutinize the patent claims to assess infringement risks and consider designing around the claimed features or seeking licensing opportunities.

Q4: How does the patent landscape affect innovation in this technology area?
A4: A complex landscape with overlapping patents can either incentivize licensing or inhibit further innovation unless alternative methods circumvent existing claims.

Q5: How does jurisdictional coverage influence patent strategy?
A5: Strategic coverage across jurisdictions like Europe and China indicates an aim to protect key markets, but also raises the importance of regional validity and enforcement efforts.


References

  1. [Patent Literature and Prior Art]
  2. [USPTO Patent Examination and Prosecution Files]
  3. [Technical Journals and Industry Reports]
  4. [Legal and Patent Policy Resources]

More… ↓

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Details for Patent 9,550,837

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Regeneron Pharmaceuticals, Inc. PRALUENT alirocumab Injection 125559 July 24, 2015 9,550,837 2035-06-12
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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