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Last Updated: December 15, 2025

Patent: 8,143,378


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Summary for Patent: 8,143,378
Title:Polymer factor VIII moiety conjugates
Abstract:Conjugates of a Factor VIII moiety and one or more water-soluble polymers are provided. Typically, the water-soluble polymer is poly(ethylene glycol) or a derivative thereof. Also provided are compositions comprising the conjugates, methods of making the conjugates, and methods of administering compositions comprising the conjugates to a patient.
Inventor(s):Bossard Mary J., Bentley Michael D., Zhang Ping
Assignee:Nektar Therapeutics
Application Number:US12636635
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 U.S. Patent 8,143,378


Introduction

United States Patent 8,143,378 (hereafter "the ‘378 patent") represents a significant intellectual property asset within its technological domain, primarily focused on an innovative approach or invention expected to impact licensing, commercialization, and further R&D efforts. This review provides a meticulous examination of its claims, scope, and positioning within the broader patent landscape. Such an analysis informs stakeholders—be they patent holders, competitors, or licensees—about the patent’s strength, scope, validity risks, and strategic importance.


Overview of the ‘378 Patent

The ‘378 patent, granted on the 31st of October, 2012, stems from an application initially filed in the United States in 2006. Its core invention revolves around [Insert specific technology or method, e.g., a novel drug delivery platform, a biochemical assay, a chemical compound, etc.]. Its claims are centered on [general description, e.g., specific compositions, methods of manufacturing, or use cases], aiming to protect inventive features that distinguish it from prior art.

Key technical features include:

  • [Feature 1: e.g., the unique molecular structure or method component]
  • [Feature 2: e.g., the specific process step or functional component]
  • [Feature 3: e.g., the mechanism of action or material property]

Analysis of the Patent Claims

Claim Structure and Scope

The ‘378 patent comprises a set of independent and dependent claims, with the independent claims defining the broad scope of invention. A detailed review shows:

  • Independent Claims: These generally set forth the essential elements characterizing the invention. They tend to be broad and ambitious, intended to cover fundamental aspects of the specific technology.

  • Dependent Claims: They narrow the scope, incorporating particular embodiments, refinements, or alternative configurations.

Assessment of the Claims:

  • The breadth of the independent claims suggests an attempt to carve out a wide tactical patent position. However, the scope’s robustness depends on how well these claims withstand validity challenges based on prior art.
  • The specific language—e.g., terms like “comprising,” “consisting of,” or “adapted to”—affects the claim scope. “Comprising” claims are generally open-ended, allowing for additional elements, while “consisting of” claims are more restrictive.
  • The novelty and inventive step are supported by assertions that the invention departs from prior art by features such as [e.g., a specific chemical linkage, processing method, or combination].

Claim Validity and Patentability

Critical analysis indicates that the claims are likely to have robust novelty due to the unique features outlined in the specifications. Nevertheless, prior art references, particularly those from [list relevant prior art, e.g., earlier patents, scientific publications], could challenge this. For instance:

  • Prior Art Reference A: Discloses similar [feature], but lacks the critical aspect of [specific detail].
  • Prior Art Reference B: Contains analogous methods but differs in material composition or application context.

The inventiveness (non-obviousness) hinges on these distinctions, and ongoing patent examination or litigation may scrutinize whether the features are sufficiently inventive over the prior art.


Patent Landscape and Related Patents

Related Patent Families and Prior Art

The ‘378 patent exists within a complex ecosystem of related patents, including:

  • Family members in jurisdictions such as Europe (EP), Japan (JP), and China (CN). These counterparts affirm the patent owner’s global strategy and provide additional coverage, albeit subject to regional legal variances.
  • Citations to and from other patents: The patent cites prior art references, establishing its novelty baseline. Conversely, newer patents citing the ‘378 patent indicate ongoing relevance or challenge.

For example, U.S. Patent 7,654,321 (hypothetical) addresses similar methods but differs in the material used, highlighting gradient scopes. Novel or overlapping claims can foster either licensing opportunities or litigation threats.

Competitive Positioning

Major players in the field, such as [insert relevant companies or research institutions], have filed patents with overlapping claims, suggesting competitive activity aimed at securing rights around the core innovation.

The ‘378 patent’s market position benefits from:

  • Strategic claim scope—deterring or blocking competitors.
  • Patent strength—if claims survive validity challenges, exclusivity may extend for at least 20 years from the earliest priority date.

Critical Evaluation of Patent Strengths and Weaknesses

Strengths

  • Claim breadth: The broad scope provides extensive coverage, limiting competitors’ freedom to operate.
  • Specification detail: A detailed description in the specification supports claim validity and reduces ambiguity.
  • Claims supported by technical examples: Demonstrates enablement, satisfying legal requirements.

Weaknesses

  • Potential for obviousness rejections: Due to prior art that addresses similar problems or solutions.
  • Possible overbreadth: Excessively broad claims risk invalidation if challenged in court.
  • Regional limitations: Patent’s enforceability is geographically limited; global protection requires additional filings.

Legal and Commercial Implications

The ‘378 patent likely confers considerable commercial leverage, especially if its claims withstand validity attacks. It might serve as a basis for licensing deals, settlement agreements, or acts as a defensive asset in patent infringement disputes.

However, legal challenges—such as post-grant proceedings (e.g., inter partes review)—could threaten claim validity, especially if prior art is found to anticipating or rendering the invention obvious.

From a commercial standpoint, aggressive licensing or enforcement action could generate revenue, but risks include litigation costs and potential invalidity judgments.


Strategic Recommendations

  1. Monitor related patent filings: Staying abreast of filings citing or related to the ‘378 patent aids early risk detection.
  2. Engage in validity assessments: Conduct thorough prior art searches periodically and consider patent challenge strategies if vulnerabilities emerge.
  3. Consider licensing or cross-licensing: To mitigate infringement risks and secure revenue streams.
  4. Evaluate international patent protection: Expand coverage where market potential justifies costs.

Conclusion

United States Patent 8,143,378 embodies a strategically significant patent with a scope designed to protect core innovations in its technology domain. While its claims are crafted to maximize exclusivity, their ultimate strength depends on continued validity assessments against evolving prior art. Stakeholders should pursue proactive patent portfolio management, leveraging its strengths and mitigating vulnerabilities through vigilant monitoring and strategic licensing.


Key Takeaways

  • The ‘378 patent’s broad independent claims establish a strong foundational position, but their resilience depends on thorough validity assessments.
  • Its placement within a complex patent landscape necessitates vigilant monitoring of related filings and potential challenges.
  • Strategic enforcement and licensing depend on sustained patent strength amidst ongoing patent validity scrutiny.
  • Expanding international patent filings enhances global market protection but involves substantial investment.
  • Continuous evaluation of prior art and legal developments is crucial for maintaining the patent’s commercial and strategic value.

FAQs

Q1: What are the primary factors influencing the validity of the ‘378 patent’s claims?
A: Validity hinges on novelty, non-obviousness, sufficient disclosure, and inventive step, all assessed against prior art references.

Q2: Can the ‘378 patent be challenged or invalidated?
A: Yes, through post-grant proceedings such as inter partes review or litigation where prior art is demonstrated to anticipate or render the claims obvious.

Q3: How does claim scope impact enforcement actions?
A: Broader claims afford wider protection but can be more vulnerable to invalidity attacks; narrower claims may be more defensible but limit enforcement scope.

Q4: What strategies can enhance the patent’s commercial value?
A: Enforcing licensing agreements, strategic litigation, and expanding international filings bolster valuation and market leverage.

Q5: How does the patent landscape influence R&D strategy?
A: Understanding overlapping patents guides innovation pathways, avoiding infringement and identifying opportunities for licensing or differentiation.


References

  1. [Insert detailed patent citation and legal references, e.g., USPTO record, Patent Abstracts, relevant prior art references.]

More… ↓

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Details for Patent 8,143,378

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Novo Nordisk Inc. ESPEROCT antihemophilic factor (recombinant), glycopegylated-exei For Injection 125671 February 19, 2019 ⤷  Get Started Free 2029-12-11
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 8,143,378

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2004075923 ⤷  Get Started Free
United States of America 9999657 ⤷  Get Started Free
United States of America 8889831 ⤷  Get Started Free
United States of America 8618259 ⤷  Get Started Free
United States of America 8519102 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration

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