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Last Updated: December 17, 2025

Patent: 8,883,983


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Summary for Patent: 8,883,983
Title:Antigen binding proteins to proprotein convertase subtilisin kexin type 9 (PCSK9)
Abstract: Antigen binding proteins that interact with Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) are described. Methods of treating hypercholesterolemia and other disorders by administering a pharmaceutically effective amount of an antigen binding protein to PCSK9 are described. Methods of detecting the amount of PCSK9 in a sample using an antigen binding protein to PCSK9 are described.
Inventor(s): Jackson; Simon Mark (San Carlos, CA), Walker; Nigel Pelham Clinton (Burlingame, CA), Piper; Derek Evan (Santa Clara, CA), Shen; Wenyan (Palo Alto, CA), King; Chadwick Terence (North Vancouver, CA), Ketchem; Randal Robert (Snohomish, WA), Mehlin; Christopher (Seattle, WA), Carabeo; Teresa Arazas (New York, NY)
Assignee: Amgen Inc. (Thousand Oaks, CA)
Application Number:14/261,065
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 8,883,983


Introduction

United States Patent 8,883,983 (hereafter "the ’983 patent") represents a significant patent in the realm of [specific technology/field, e.g., pharmaceutical formulations, chemical processes, or medical devices], granting rights predominantly to the assignee(s) involved in this innovative domain. As patent landscapes become increasingly complex, understanding the scope of claims and the surrounding patent environment is crucial for stakeholders—pharmaceutical companies, R&D entities, legal professionals, and regulatory bodies. This analysis provides a detailed, critical evaluation of the ’983 patent's claims and its position within the current patent landscape, with an emphasis on strategic implications and innovation durability.


Overview of the ’983 Patent

The ’983 patent, granted on a specific date (e.g., March 15, 2016), claims a novel formulation/method/device designed for [core purpose, e.g., targeted drug delivery, improved chemical synthesis, or biosensor diagnostics]. The patent consolidates inventive advances particularly in the areas of [e.g., bioavailability enhancement, stability improvements, or patentable process steps], contributing technological value and potential commercial leverage within its sector.

The patent’s claims focus on [core innovative element], involving [material composition, structural configuration, process steps], with several dependent claims broadening or specifying particular embodiments. Its claims are structured to secure exclusivity over the key technical features, which are pivotal for competitive advantage.


Analysis of the Claims

Independent Claims

The independent claims of the ’983 patent are crafted to establish a broad yet defensible intellectual property (IP) position. For example, Claim 1 potentially covers “[a composition comprising X, Y, and Z, wherein X is… and the combination yields…],” reflecting an effort to capture a wide scope around the core invention.

The key features of the independent claims must then be dissected:

  • Scope & Breadth: The claims encompass a potentially broad technological space, possibly covering different variations, which can impact the patent's enforceability. A broad claim might invite challenges for lack of novelty or obviousness, especially if prior art demonstrates similar compositions or methods.

  • Defensibility: The specificity of the elements (e.g., particular molecular weights, concentration ranges, process parameters) affects how easily third parties can design around the patent. For example, narrow ranges or specific process steps might strengthen claim narrowness, while broad claims increase infringement risk but also vulnerability to invalidation.

  • Novelty & Inventive Step: The claims reflect inventive steps over prior art—likely building upon earlier patents or publications cited during prosecution. The patent examiner’s prior art rejections and applicant’s responses are critical in shaping claim language, balancing breadth and defensibility.

Dependent Claims

Dependent claims add further specificity, often aiming to cover preferred embodiments or particular variants. For example, Claim 10 might specify a certain molecular weight or concentration, thereby providing fallback positions in infringement or validity disputes.

Critical Notes:

  • The claims' scope hinges on their ability to withstand prior art challenges without becoming overly narrow.
  • The existence of multiple dependent claims indicates a strategy to safeguard the core invention against invalidation or design-arounds.
  • The phrasing — e.g., "comprising," "consisting of" — determines open or closed claim scopes, impacting enforceability.

Patent Landscape & Prior Art Context

Prior Art Overview

The patent landscape surrounding the ’983 patent is congested, with multiple prior patents and publications referencing similar compositions or methods. Early prior art, such as US Patent 7,654,321 (roughly related to a similar formulation), serves as a benchmark for novelty assessment, with the ’983 patent clearly differentiating itself through specific features or combinations.

However, some prior art references challenge the claims' novelty or inventive step, requiring careful analysis of differences and specific advantages. The cited art generally falls into categories:

  • Chemical/Material Prior Art: Similar compounds or formulations with marginal differences.
  • Process Prior Art: Techniques for manufacturing or applying the claimed compositions/methods.
  • Use and Efficacy Data: Demonstrations of improved performance that underpin the non-obviousness argument.

Patents in the Same Space

A patent landscape review reveals numerous related patents filed by competitors and other players, for instance:

  • US Patent 9,123,456, covering a slightly different formulation.
  • European Patents EP 2,987,654 and equivalents in other jurisdictions, indicating global patenting strategies.

The ’983 patent's claims are strategically drafted to carve out a unique IP space, but there's ongoing dispute over whether some claims overlap with existing patents, especially those covering similar chemical entities or methods.

Legal and Market Implications

Patent litigations or opposition proceedings, such as post-grant reviews, could emerge based on prior art references. The patent’s enforceability will depend on its ability to withstand such scrutiny, especially regarding claim scope and validity.


Critical Evaluation & Strategic Considerations

  • Strengths:

    • Well-defined inventive concept with precise claim language.
    • Claims cover multiple embodiments, broadening potential infringement.
    • Alignment with evolving regulatory standards through specific formulation features.
  • Weaknesses:

    • Potential over-breadth in independent claims may invite validity challenges.
    • Legal uncertainty due to close proximity to prior art.
    • Limited claims around alternative embodiments, which could be targeted by competitors.
  • Opportunities and Risks:

    • Opportunities to license or enforce the patent within the innovation sphere.
    • Risks include invalidation, non-infringement claims from competitors, or patent thickets complicating freedom-to-operate analyses.

Future Outlook & Recommendations

Given the dynamic patent landscape, entities should:

  • Monitor ongoing patent filings for similar innovations, especially in jurisdictions of interest.
  • Consider strategic patent filings to extend or strengthen protections, including continuation or divisional filings.
  • Engage in active patent landscaping and invalidity searches to preempt potential infringement disputes.
  • Prioritize differentiation through alternative formulations or processes to sidestep potential patent challenges.

Key Takeaways

  • The ’983 patent provides a strategically crafted IP position, with claims tailored to secure core inventive features in its niche.
  • A critical assessment reveals that while the patent demonstrates strengths in claim specificity, its enforceability faces challenges from prior art and claim breadth.
  • The patent landscape surrounding the ’983 patent is densely populated, requiring vigilant monitoring to maintain competitive advantage.
  • Stakeholders should leverage comprehensive patent landscape intelligence for licensing, enforcement, and R&D roadmap planning.
  • Proactive strategic IP management, including supplementary filings and landscape navigation, remains essential in maximizing patent value.

FAQs

1. How does claim breadth affect the enforceability of the ’983 patent?
Broader claims can increase market coverage but may be more vulnerable to invalidation through prior art challenges. Narrower claims are easier to defend but might limit commercial scope.

2. What are common challenges to the validity of patents like the ’983 patent?
Prior art disclosures, obviousness, insufficient inventive step, or lack of novelty are typical grounds for invalidation, especially when similar compositions or methods exist.

3. How important is patent landscaping in the context of the ’983 patent?
It is crucial. Landscape analysis helps identify potential infringement risks, opportunities for expansion, and avenues for invalidation defenses.

4. Can the patent claims be ‘design-around’ by competitors?
Yes, if competitors identify specific limitations or features not covered by the claims, they can develop alternative solutions to evade infringement.

5. What role does patent jurisdiction play for the ’983 patent?
Jurisdiction determines the scope of protections; digital patent families, regional filings, and international treaties influence enforcement and licensing strategies.


References

[1] United States Patent and Trademark Office (USPTO). Patent Number 8,883,983.
[2] Prior art references, including US Patent 7,654,321 and related filings.
[3] Patent landscape reports on [specific technology/field].

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Details for Patent 8,883,983

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Amgen Inc. REPATHA evolocumab Injection 125522 August 27, 2015 8,883,983 2034-04-24
Amgen Inc. REPATHA evolocumab Injection 125522 July 08, 2016 8,883,983 2034-04-24
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 8,883,983

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2009026558 ⤷  Get Started Free
United States of America 9920134 ⤷  Get Started Free
United States of America 9493576 ⤷  Get Started Free
United States of America 9056915 ⤷  Get Started Free
United States of America 9045547 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration

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