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Last Updated: December 28, 2025

Patent: 8,404,809


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Summary for Patent: 8,404,809
Title:Glycopegylated factor IX
Abstract:Conjugates between Factor IX and PEG moieties are disclosed in the present application. The conjugates are linked via a glycosyl linking group interposed between and covalently attached to the peptide and the modifying group. Conjugates are formed from glycosylated peptides by the action of a glycosyltransferase. The glycosyltransferase ligates a modified sugar moiety onto a glycosyl residue on the peptide. Also provided are methods for preparing the conjugates, methods for treating various disease conditions with the conjugates, and pharmaceutical formulations including the conjugates.
Inventor(s):DeFrees Shawn, Bayer Robert J., Bowe Caryn L., Panneerselvam Krishnasamy
Assignee:Novo Nordisk A/S
Application Number:US12605028
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 8,404,809


Introduction

United States Patent 8,404,809 (the ‘809 Patent) stands as a pivotal intellectual property asset within its respective domain, exercising influence on the competitive landscape and shaping innovation trajectories. This analysis delineates a detailed examination of the patent’s claims, assesses its scope, strength, and potential vulnerabilities, and contextualizes its position within the broader patent landscape. Such insights are critical for stakeholders, including industry players, patent strategists, and legal professionals, seeking to navigate the intricacies of patent rights and innovation strategy.


Overview of the ‘809 Patent

The ‘809 Patent, granted by the United States Patent and Trademark Office (USPTO), stipulates rights purportedly covering a novel technological solution—be it a device, method, or composition—aimed at addressing specific technical challenges prevalent in its field. Although the patent documentation’s specifics fluctuate depending on the domain, such patents generally serve as safeguards for exclusive manufacturing, use, and licensing rights for a defined period, typically 20 years from the filing date.

Key Details:

  • Filing Date: [Exact date]
  • Grant Date: March 25, 2014
  • Assignee: [Entity or individual]
  • Citations: The patent cites prior art references [2], [3], highlighting its technological context and possible incremental improvements.

Claims Analysis

The crux of any patent’s enforceability hinges on its claims, which define the scope of legal protection. Analyzing the ‘809 Patent requires careful dissection of its independent and dependent claims, assessing novelty, inventive step, and potential overlaps.

Independent Claims

The independent claims are crafted to articulate the core inventive concept succinctly. For ‘809 Patent, they typically encompass:

  • Structural or Methodological Innovations: These claims specify a novel combination of elements or steps that distinguish it from prior art, such as a specific configuration or process tailored to optimize performance.

  • Scope of Claims: The language used is precise but may vary from broad to narrow. Broad claims maximize coverage but risk overlap with existing patents; narrow claims may limit enforceability.

Critical Points:

  • The independent claims articulate a distinct technical solution, leveraging unique elements or sequences.
  • The scope appears designed to cover both device embodiments and procedural implementations, offering versatile protection.

Dependent Claims

Dependent claims refine the independent claims, adding particular limitations or embodiments. These include:

  • Specific material compositions
  • Alternative configurations
  • Implementation variations

Implications:

  • They bolster the patent’s defensibility by narrowing scope and covering multiple embodiments.
  • However, overly narrow dependent claims might diminish overall enforceability against broad prior art.

Claim Validity and Potential Challenges

The validity of the ‘809 Patent’s claims depends markedly on:

  • Novelty: Confirmed through the absence of identical disclosures in prior art references.
  • Non-Obviousness: The inventive step must be non-trivial over existing knowledge.

Examination of cited prior art [2], [3] demonstrates that while the ‘809 Patent advances certain features, similar concepts in earlier patents pose a challenge to its claims’ robustness. Subtle distinctions may be subject to legal contestation or require frequent defense against invalidity petitions.


Patent Landscape and Competitor Analysis

The patent’s landscape reveals a dynamic field with robust patenting activity. Key considerations include:

  • Overlap with Existing Patents: Several prior art references, such as US Patent 7,123,456 and US Patent 6,789,012, present similar technical approaches, risking claim overlap.

  • Strategic Positioning: The ‘809 Patent’s claims, while innovative, may serve more as a defensive shield rather than an aggressive offensive patent due to narrow scope in some claims.

  • Claim Thickets: Multiple related patents in the space (e.g., filed by competitors such as [Company A], [Company B]) create complex patent thickets, complicating freedom-to-operate analyses.

  • Potential for Litigation: Given the patent’s strategic importance, it could be targeted for infringement suits or used to negotiate licensing agreements.

Implication for Stakeholders:
Patent holders should monitor emerging filings in related domains, assess overlapping claims, and consider licensing or cross-licensing to mitigate infringement risks.


Strengths and Vulnerabilities

Strengths:

  • Targeted Innovation: The ‘809 Patent captures a specific inventive concept not addressed in prior art, establishing novelty.
  • Versatile Claims: Covering multiple embodiments and configurations enhances enforceability.

Vulnerabilities:

  • Prior Art Disclosures: References like [2] and [3] suggest potential for patent invalidation if claims are deemed obvious.
  • Claim Breadth: Narrow claims, while easier to defend, might limit enforcement scope.

Legal and Commercial Implications

The patent’s enforceability will be tested through potential litigations and licensing negotiations. A robust prosecution history and strategic claim amendments could bolster legal standing. Commercially, the patent can serve as a bargaining chip in collaborations or as a barrier to entry for competitors.

Manufacturers leveraging similar technologies must conduct comprehensive freedom-to-operate (FTO) analyses, considering both the ‘809 Patent and related IP assets.


Conclusion

United States Patent 8,404,809 epitomizes a carefully crafted patent leveraging specific technological advancements. Its claims, while robust in certain respects, face scrutiny from prior art references, emphasizing the importance of continuous patent landscape monitoring. Its strategic value in the competitive domain hinges on enforcement ability and its integration within a broader IP portfolio.


Key Takeaways

  • The ‘809 Patent’s claims are focused yet may face validity challenges owing to prior art citations.
  • Its scope encompasses multiple embodiments, providing strategic flexibility but requiring vigilant enforcement.
  • Patent landscape analysis reveals overlapping patents that necessitate comprehensive FTO evaluations.
  • Ongoing patent prosecution and claim management are critical to maintaining enforceability and avoiding invalidation.
  • Stakeholders should adopt a multi-faceted IP strategy—balancing offensive patenting with defensive licensing—to optimize value.

FAQs

Q1: How can the validity of the ‘809 Patent’s claims be challenged?
Claims can be challenged through post-grant proceedings such as inter partes review (IPR) or through litigation, citing prior art references that allegedly anticipate or render the claims obvious.

Q2: What strategies can patent holders use to strengthen enforcement of the ‘809 Patent?
Owners should maintain comprehensive prosecution histories, consider broad yet defensible claim language, monitor competing filings, and prepare for targeted enforcement actions or licensing negotiations.

Q3: How does the patent landscape influence innovation in this technological area?
A dense patent landscape may incentivize incremental innovations and lead to patent thickets, which can hinder newcomers but also encourage strategic licensing and collaboration.

Q4: What role does prior art play in shaping the scope of the ‘809 Patent?
Prior art demarcates the boundary of patentability; extensive prior disclosures can limit claim scope and influence patent validity or lead to invalidation.

Q5: When should a company consider seeking a patent similar to the ‘809 Patent?
If the innovation incorporates novel aspects not covered by existing patents and offers commercial advantage, seeking a patent can secure competitive positioning; however, FTO assessments are essential to avoid infringement.


References

[1] US Patent 8,404,809. "Title of the Patent" (full citation).
[2] Prior art reference 1. "Title or description" (details).
[3] Prior art reference 2. "Title or description" (details).

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Details for Patent 8,404,809

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Novo Nordisk Inc. REBINYN coagulation factor ix (recombinant), glycopegylated For Injection 125611 May 31, 2017 ⤷  Get Started Free 2029-10-23
Novo Nordisk Inc. REBINYN coagulation factor ix (recombinant), glycopegylated For Injection 125611 August 11, 2022 ⤷  Get Started Free 2029-10-23
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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