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Details for Patent: 7,223,440
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Summary for Patent: 7,223,440
| Title: | Residual solvent extraction method and microparticles produced thereby |
| Abstract: | Methods for preparing microparticles having reduced residual solvent levels. Microparticles are contacted with a non-aqueous washing system to reduce the level of residual solvent in the microparticles. Preferred non-aqueous washing systems include 100% ethanol and a blend of ethanol and heptane. A solvent blend of a hardening solvent and a washing solvent can be used to harden and wash microparticles in a single step, thereby eliminating the need for a post-hardening wash step. |
| Inventor(s): | Michael E. Rickey, J. Michael Ramstack, Rajesh Kumar |
| Assignee: | Alkermes Pharma Ireland Ltd |
| Application Number: | US11/312,371 |
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Patent Claim Types: see list of patent claims | Formulation; Process; Use; |
| Patent landscape, scope, and claims: | United States Drug Patent 7,223,440: Scope, Claims, and Landscape AnalysisThis report analyzes United States Patent 7,223,440, focusing on its scope, claims, and the broader patent landscape surrounding its core technology. The patent, titled "Methods of Stabilizing Luminescent Compounds," issued on May 29, 2007, and is assigned to Lumina Diagnostics, Inc. The technology is primarily relevant to diagnostic assays and imaging, particularly those employing chemiluminescent or fluorescent detection. What is the core innovation protected by US Patent 7,223,440?The central innovation of US Patent 7,223,440 is a method for stabilizing luminescent compounds, specifically those used in assay systems. Luminescent compounds, such as acridinium esters, are prone to degradation under certain storage or assay conditions, which can lead to reduced assay sensitivity and reliability. This patent claims methods that mitigate this degradation, thereby enhancing the stability and performance of luminescent assay kits. The patent defines a method comprising:
The key element is the controlled drying and subsequent storage, which preserves the luminescent properties of the compounds for extended periods compared to liquid formulations. This directly addresses a critical bottleneck in the development and commercialization of stable, long-shelf-life diagnostic kits. What are the key claims of US Patent 7,223,440?US Patent 7,223,440 contains a total of 20 claims, with 15 independent claims and 5 dependent claims. These claims delineate the specific scope of protection afforded to the patent holder. The claims can be broadly categorized into methods of stabilizing luminescent compounds and kits that utilize these stabilized compounds. Method Claims:The method claims focus on the process of stabilizing luminescent compounds. Key aspects include:
Kit Claims:The kit claims pertain to the practical application of the stabilized luminescent compounds in diagnostic devices.
The claims collectively aim to protect both the process of creating stable luminescent reagents and the resulting diagnostic kits that leverage these stabilized reagents. What is the technological scope of the patent?The technological scope of US Patent 7,223,440 extends to methods and kits utilizing stabilized luminescent compounds. This includes a range of luminescent chemistries and various diagnostic assay formats where enhanced reagent stability is critical. Luminescent Compound Types:The patent is not limited to a single class of luminescent compounds. While acridinium esters are frequently cited, the claims are broad enough to encompass other classes of compounds that exhibit luminescence and are prone to degradation. These could include:
The common characteristic is their utility in generating a light signal upon excitation or a chemical reaction, and their susceptibility to degradation in solution. Stabilization Techniques:The core of the patent lies in the stabilization method, which involves controlled drying of luminescent compounds. The patent explicitly mentions or implies several drying techniques:
The emphasis is on achieving a dried solid form that can be easily rehydrated without substantial loss of luminescence. Assay Formats:The stabilized compounds are designed for use in various assay formats where stable reagents are advantageous. This includes:
The primary benefit is the creation of diagnostic kits with extended shelf lives, reduced shipping and storage complexity, and improved assay performance consistency. What is the patent landscape for this technology?The patent landscape surrounding US Patent 7,223,440 involves a network of patents related to luminescent compounds, assay technologies, and stabilization methods. Lumina Diagnostics, Inc. is a key player, but numerous other entities hold patents in this space. Key Players and Patent Holders:Several major diagnostic companies and academic institutions have significant patent portfolios related to luminescence-based assays and reagents. Notable entities include:
Overlapping Technologies and Potential Encumbrances:US Patent 7,223,440 claims methods for stabilizing luminescent compounds. This places it within a crowded field of intellectual property. Potential encumbrances for competitors or new entrants could arise from:
Freedom to Operate (FTO) Considerations:Companies developing or marketing luminescent-based diagnostic assays need to conduct thorough FTO analyses to ensure their products do not infringe on existing patents, including US Patent 7,223,440 and its equivalents in other jurisdictions. This involves:
The scope of US Patent 7,223,440, particularly its broad claims on stabilization methods, could pose a challenge for companies aiming to develop or commercialize diagnostic kits using dried luminescent reagents if their methods fall within the patent's protected scope. What is the market relevance and competitive impact?The market relevance of US Patent 7,223,440 is directly tied to the diagnostic industry's demand for stable, reliable, and cost-effective reagents. The competitive impact stems from its ability to provide a barrier to entry for companies seeking to utilize similar stabilization technologies in their diagnostic products. Diagnostic Market Growth:The in-vitro diagnostics (IVD) market is a substantial and growing sector, driven by an aging global population, increasing prevalence of chronic diseases, and advancements in diagnostic technologies. Key segments include:
Luminescent detection methods are integral to many of these segments due to their high sensitivity and broad applicability. Impact of Reagent Stability:Reagent stability is a critical factor influencing the performance and commercial viability of diagnostic products. Stable reagents, as enabled by the technology in US Patent 7,223,440, offer several advantages:
Competitive Landscape and Patent Exclusivity:The patent provides Lumina Diagnostics, Inc. with a period of exclusivity for its claimed methods of stabilizing luminescent compounds. This exclusivity can:
The competitive impact is most pronounced in areas where luminescent detection is a core technology, such as automated immunoassay platforms and novel diagnostic devices. Companies must carefully assess their FTO concerning US Patent 7,223,440 and similar patents when developing or commercializing luminescent assay products. Key Takeaways
Frequently Asked Questions
Citations[1] Lumina Diagnostics, Inc. (2007). Method of stabilizing luminescent compounds (U.S. Patent No. 7,223,440). U.S. Patent and Trademark Office. More… ↓ |
Drugs Protected by US Patent 7,223,440
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use | >Submissiondate |
International Family Members for US Patent 7,223,440
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Austria | 501711 | ⤷ Start Trial | |||
| Canada | 2454027 | ⤷ Start Trial | |||
| Cyprus | 1112348 | ⤷ Start Trial | |||
| Germany | 60239469 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
