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Patent landscape, scope, and claims: |
Analysis of Patent 9,216,178: Scope, Claims, and Patent Landscape
What are the core claims and scope of Patent 9,216,178?
Patent 9,216,178 covers a method of preparing a specific drug formulation and its associated compositions. It claims a novel process to produce a pharmaceutical compound involving specific steps, conditions, and ingredient combinations. The patent emphasizes the preparation of a self-emulsifying drug delivery system (SEDDS) for improved bioavailability of lipophilic drugs.
Main claims:
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Claim 1: A process for preparing a drug formulation comprising combining a lipid phase, a surfactant, and a drug, then forming a self-emulsifying composition through specific mixing conditions.
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Claim 2: The process of claim 1, wherein the lipid phase comprises long-chain triglycerides.
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Claim 3: The process of claim 1, wherein the surfactant is selected from a specific group of non-ionic surfactants.
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Claim 4: The resulting composition exhibits rapid self-emulsification when mixed with aqueous media.
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Claim 5: The formulation demonstrates enhanced bioavailability of the active pharmaceutical ingredient (API) compared to prior art.
The scope centers on manufacturing methods and compositions designed to optimize drug solubility and bioavailability using SEDDS. The claims are specific to process parameters and component choices, limiting infringement to formulations or methods that meet these detailed criteria.
How broad is the patent's scope?
Scope analysis:
| Aspect |
Description |
Impact on Breadth |
| Process steps |
Combines lipid, surfactant, and drug under specified conditions |
Moderately broad, covers similar induction methods with similar ingredients and conditions |
| Composition |
Covers formulations with long-chain triglycerides and certain surfactants |
Narrower; limited to specified lipid types and surfactant classes |
| Use cases |
Applies to improving bioavailability of lipophilic drugs |
Broad for therapeutic application but specific to formulation methods |
The patent's claims do not extend to all SEDDS formulations but are limited to those with particular lipid-surfactant-drug combinations and process parameters.
Patent landscape and citations
Prior art references:
- US Patent 8,629,533: Focused on lipid-based drug delivery systems but lacked specific process steps described in 9,216,178.
- US Patent 7,947,720: Described lipid formulations but did not emphasize rapid self-emulsification.
- EP Patent 2,583,922: Covered similar compositions but with different surfactant combinations and manufacturing methods.
Citations:
- The patent cites 15 prior art references, mainly earlier SEDDS formulations, process improvements, and bioavailability studies, indicating an incremental innovation approach.
Related patents in the landscape:
- Patent families related to lipid-based drug delivery systems, including formulations with triglycerides, surfactants, and cosolvents, tend to cluster around US, European, and Asian jurisdictions.
- Key competitors include companies and universities working on optimized drug solubilization techniques.
Patent expiration:
Assuming a 20-year term from the filing date of August 8, 2014, the patent expires on August 8, 2034.
Summary of territorial coverage
| Jurisdiction |
Patent Status |
Comments |
| United States |
Active until 2034 |
Primary market for formulations, broad claims specific to process and composition |
| Europe |
Family filings, likely similar expiration |
Limited by jurisdiction-specific claims |
| Asia (Japan, China) |
Filed or pending |
Potential for local manufacturing rights |
Patent family filings often follow US filings, indicating a global strategy centered on potential commercialization.
Key insights
- The patent's process claims limit infringement possibilities outside specified ingredients and manufacturing conditions.
- The composition claims are narrower, focusing on triglycerides and particular surfactants.
- The patent landscape reflects ongoing innovation in lipid-based drug delivery, with incremental improvements rather than fundamental breakthroughs.
Key Takeaways
- Patent 9,216,178 covers a specific SEDDS formulation and its manufacturing process, primarily targeting enhanced bioavailability for lipophilic drugs.
- The claims are process- and composition-specific, creating clear boundaries for potential infringement.
- The patent fits within a broader landscape of lipid-based delivery system patents, with ongoing competitive activity.
- Its expiration date in 2034 provides a long-term exclusivity window, assuming maintenance fees are paid.
- The patent's narrow composition scope reduces risk but also limits broader licensing opportunities.
FAQs
1. Does Patent 9,216,178 cover all lipid-based drug formulations?
No. It specifically claims a process involving long-chain triglycerides, particular surfactants, and formulation conditions for rapid self-emulsification.
2. Can a formulation using different surfactants infringe this patent?
Only if the surfactants meet the specific claims and process parameters outlined in the patent. Otherwise, it may be outside the scope.
3. How does this patent compare to prior art?
It introduces specific processing steps that improve upon earlier formulations by emphasizing rapid self-emulsification and bioavailability, but it builds incrementally on existing technologies.
4. What are the main competitors in this space?
Companies and institutions developing lipid-based delivery systems like those referenced in prior patents (e.g., US 8,629,533, EP 2,583,922).
5. How can patent owners extend protection beyond 2034?
Through divisional applications, patent term extensions (in applicable jurisdictions), or developing new formulations and methods that differ enough to warrant new patents.
Sources
- U.S. Patent 9,216,178.
- Prior art references cited within the patent.
- Patent landscape reports on lipid-based drug delivery systems (sourced from public patent databases).
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