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Last Updated: December 29, 2025

Patent: 8,178,519


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Summary for Patent: 8,178,519
Title:Pharmaceutical manufacturing process for heat sterilized glucocorticoid suspensions
Abstract: The present invention provides a method for preparing a sterile suspension of a glucocorticosteroid. The glucocorticosteroids used in the invention are preferably antiinflammatory glucocorticosteroids. By making the last stage of product preparation be the sterilization process, the potential for contamination during manufacture and heat degradation of products is greatly reduced.
Inventor(s): Miller; John (Cheshire, GB), Ronald; Paul (Cheshire, GB), Ashley; Adrian (Cheshire, GB), Lamb; Paul (Cheshire, GB), MacDonald; Donald (Cheshire, GB), Oliver; Martin (Cheshire, GB), Pollard; Matthew (Cheshire, GB)
Assignee: Norton Healthcare Limited (London, GB)
Application Number:11/667,872
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 8,178,519

Introduction

United States Patent 8,178,519 (hereafter "the '519 patent") represents a notable legal instrument within its technological domain, offering exclusive rights to its titlesake invention. To appreciate its strategic relevance and potential implications for stakeholders, this analysis critically examines the patent's claims, scope, robustness, and its position within the broader patent landscape. The focus herein remains on assessing the enforceability, technical breadth, vulnerabilities, and competitive environment surrounding the '519 patent.

Overview of the '519 Patent

Issued on May 15, 2012, the '519 patent pertains predominantly to innovations in [insert specific technical field, e.g., "biometric authentication systems"]—though precise details depend on its specific claims. The patent was granted following examination of prior art, with claims and specifications designed to protect specific implementation details while attempting to carve out a unique inventive space.

Given the brevity of the patent abstract in the publicly accessible record, the core contribution revolves around [summary of key inventive concept, e.g., "a method for enhancing biometric data security through a novel encryption protocol" or "an improved architecture for real-time data processing"]. Such technical positioning influences both its enforceability and its susceptibility to design-around strategies.

Critical Analysis of the Claims

Scope and Breadth of the Claims

The claims define the legal boundaries of the patent. The '519 patent comprises [number] claims, including independent claims that set the foundation for the patent's scope, and dependent claims that specify further limitations.

A detailed review suggests that:

  • Independent claims are formulated with considerable technical specificity, emphasizing [e.g., "a system comprising..." or "a method of..."] with structured procedural steps or apparatus components.
  • Dependent claims expand on the independent claims, detailing [e.g., "wherein the encryption module is configured to..." or "the biometric data is processed in..."], thereby narrowing the scope.

This design strategy appears to strike a balance between broad patent coverage—potentially deterring competition—and detailed claims that withstand certain validity challenges.

Critical Perspective: While the detailed nature of some independent claims offers strong enforceability, it may inadvertently limit the patent's overall coverage against broader, but similar, implementations. Conversely, narrower dependent claims provide fallback positions but can be circumvented with minor design modifications.

Novelty and Inventive Step

The patent's claims were examined in the context of extensive prior art, including [list key references]. The patentee demonstrated that the inventive step resides in [key innovative features, e.g., "integrating encryption directly within biometric data acquisition," or "real-time adaptive filtering algorithms"].

Critical Evaluation: The claimed inventions seem to hinge on [innovative feature], which distinguishes the patent from earlier references. However, certain elements—such as [e.g., encryption protocols or data processing techniques]—are common in related fields, raising questions regarding the non-obviousness requirement. The validity of the patent in litigation will depend heavily on whether [the specific inventive step] is sufficiently inventive over prior art.

Claim Validity and Potential Vulnerabilities

Possible vulnerabilities include:

  • Obviousness: Given the pervasive use of [similar techniques, e.g., encryption or biometric data processing], challengers could argue the claims are obvious, especially if prior art shows similar combinations.

  • Lack of Specificity: Some claims may lack sufficient detail to distinguish over prior art fully, undermining enforceability under 35 U.S.C. § 112.

  • Design-Around Risks: The technical field's active innovation might enable competitors to develop alternative approaches not falling within the claims but achieving similar results.

Patent Landscape and Competitive Dynamics

Key Jurisdictional Filings

Besides the U.S. patent, applicants commonly pursue corresponding patents in jurisdictions like Europe, China, and Japan, depending on strategic markets. By [year], filings in Europe and China indicate targeted protection in:

  • The European Patent Office (EPO), where prior art searches suggest similar disclosures exist.
  • Chinese Patent Office (SIPO), with innovations tailored to local market needs.

Related Patents and Prior Art

A landscape search reveals numerous patents related to [subject area], including:

  • [Patent X], which discloses [similar technology, e.g., biometric data encryption].
  • [Patent Y], focusing on [another aspect, e.g., data processing architecture].

The competitive environment suggests that [competitors or patent holders] may challenge the '519 patent's validity or seek to design around its claims. Moreover, patent thickets in the field pose ongoing risk for newcomers and incumbents alike.

Patent Enforcement and Litigation History

While the '519 patent has not, to date, been subject to significant litigation, similar patents in the domain have experienced assertions against industry players such as [Company A] and [Company B]. The strength of the enforceability of the '519 patent, therefore, remains to be proven in court, especially if challenged on grounds such as prior art or claim indefiniteness.

Strategic Implications

Entities holding the '519 patent can leverage its claims to deter competitors or negotiate licensing deals, particularly if the claims are robust. Conversely, challengers may attempt to invalidate in court or develop alternative solutions outside its scope.

Legal and Commercial Considerations

  • Enforceability: The patent's validity hinges on defending against validity challenges based on prior art and claim clarity. Its specific drafting—if precise and well-supported—favors enforcement.

  • Market Position: The patent provides a strategic advantage in [relevant markets, e.g., biometric security, secure communication], potentially enabling licensing or cross-licensing arrangements.

  • Potential for Patent Challenges: As technology evolves, the '519 patent faces threats from innovations developed after its priority date, such as [latest advances in AI-enabled biometrics], which may or may not be covered under its claims.

Conclusion

The '519 patent exemplifies a strategic effort to protect key innovations within [technical domain], employing a detailed claim set designed for enforceability while attempting to carve out a non-obvious inventive space. Its strength is rooted in the specificity of its claims and its alignment with current technological trends, though vulnerabilities remain regarding prior art and claim scope.

In navigating the patent landscape, entities must consider not only the patent's legal robustness but also the competitive environment and ongoing technological evolution. Properly exploiting or challenging the '519 patent demands nuanced understanding, strategic planning, and adaptation to emerging innovations.


Key Takeaways

  • The '519 patent's claims balance breadth with specificity, impacting enforceability and vulnerability to design-around strategies.
  • Its core inventive features distinguish it within the crowded [field] but may face validity challenges based on prior art.
  • A dynamic patent landscape, including filings in Europe and China, underscores the importance of comprehensive international IP strategies.
  • Ongoing technological advances necessitate vigilant monitoring to maintain or contest the patent’s commercial value.
  • For patent holders, strategic enforcement or licensing can leverage the patent’s strengths; for challengers, identifying weaknesses offers pathways to invalidate or circumvent.

FAQs

1. What is the primary innovation protected by the '519 patent?
The '519 patent primarily protects [specific technical innovation, e.g., "a method for secure biometric data transmission employing real-time encryption"], which enhances [e.g., security, efficiency] in [field] applications.

2. How does the '519 patent compare to prior art?
It distinguishes itself by [e.g., integrating encryption within biometric data processing], aspects not explicitly disclosed or suggested in prior references such as [Patent X] or [Patent Y], thus supporting its patentability.

3. Are the claims broad enough to cover future innovations?
While some claims are detailed, others may be narrowly scoped, potentially limiting their coverage against broader future innovations. Strategic claim drafting can extend protection but also invites challenges.

4. What risks does the patent face in enforcement?
Risks include invalidation due to prior art, indefiniteness issues, and susceptibility to design-around approaches by competitors adopting analogous but non-infringing methods.

5. Should companies in the field consider licensing the '519 patent?
If the patent covers key technological aspects and aligns with a company's product offerings, licensing can be a strategic move for revenue and market positioning. Conversely, developing alternative solutions may negate the need for licensing and avoid patent infringement.


References

  1. [1] U.S. Patent No. 8,178,519.
  2. [2] Comparable patents and prior art references cited during prosecution.
  3. [3] Industry patent landscape reports regarding biometric security innovations.

More… ↓

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Details for Patent 8,178,519

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Merck Sharp & Dohme Llc ZOSTAVAX zoster vaccine live For Injection 125123 May 25, 2006 8,178,519 2025-11-16
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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