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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 8,178,519IntroductionUnited 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 PatentIssued 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 ClaimsScope and Breadth of the ClaimsThe 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:
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 StepThe 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 VulnerabilitiesPossible vulnerabilities include:
Patent Landscape and Competitive DynamicsKey Jurisdictional FilingsBesides 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:
Related Patents and Prior ArtA landscape search reveals numerous patents related to [subject area], including:
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 HistoryWhile 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 ImplicationsEntities 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
ConclusionThe '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
FAQs1. What is the primary innovation protected by the '519 patent? 2. How does the '519 patent compare to prior art? 3. Are the claims broad enough to cover future innovations? 4. What risks does the patent face in enforcement? 5. Should companies in the field consider licensing the '519 patent? References
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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 |
