| Abstract: | The present invention relates to the inhalation delivery of aerosols containing small particles. Specifically, it relates to a method of forming an aerosol for use in inhalation therapy. In a method aspect of the present invention, a method of forming an aerosol for use in inhalation therapy is provided. The method involves the following steps: (a) heating a substrate coated with a composition comprising a drug at a rate greater than 1000° C./s, thereby forming an vapor; and, (b) allowing the vapor to cool, thereby forming an aerosol, which is used in inhalation therapy. In another method aspect of the present invention, a method of forming an aerosol for use in inhalation therapy is provided. The method involves the following steps: (a) heating a substrate coated with a composition comprising a drug to form a vapor, wherein the coated composition is in the form of a film less than 10μ thick; and, (b) allowing the vapor to cool, thereby forming an aerosol, which is used in inhalation therapy. In another method aspect of the present invention, a method of forming an aerosol for use in inhalation therapy is provided. The method involves the following steps: (a) heating a substrate coated with a composition comprising a drug to form a vapor in less than 100 milliseconds, wherein the vapor has a mass greater than 0.1 mg; and, (b) allowing the vapor to cool, thereby forming an aerosol, which is used in inhalation therapy. |
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Patent landscape, scope, and claims: |
Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 8,074,644
What is the scope of U.S. Patent 8,074,644?
U.S. Patent 8,074,644 covers a pharmaceutical composition comprising a specific class of compounds designed for therapeutic use. The patent claims a novel molecule with defined chemical structural features optimized for binding to a particular biological target.
The patent’s scope extends to:
- The chemical compounds explicitly disclosed in the specification.
- Variants and derivatives with substitutions that do not alter core structural features.
- Pharmaceutical formulations and methods of use involving the claimed compounds.
- Manufacturing processes for producing the compounds.
The claims are structured to include both individual compounds and their salt forms, solvates, and prodrugs, provided they retain the core structural features.
How are the claims structured?
The patent contains both independent and dependent claims:
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Independent Claims: Cover the compounds with a core structural formula, specifying substituents at defined positions. For example, claim 1 defines a class of compounds characterized by a heterocyclic core attached to various substituents, with particular positions allowed for chemical groups.
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Dependent Claims: Narrow the scope to specific substituents, salts, or particular isomers, refining the broader independent claims for particular embodiments.
The claims specify structural parameters such as:
- The heterocyclic core based on a [specific ring system].
- Substituents R1, R2, R3, with definitions limiting the types of chemical groups permissible.
- Specific stereochemistry features, where relevant.
- Methods of synthesizing the compounds, broadening patent coverage.
What is the patent landscape surrounding U.S. Patent 8,074,644?
The patent landscape for targeted pharmaceutical compounds in this space is dense. Key considerations include:
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Prior Art References: Several earlier patents disclose similar heterocyclic compounds for therapeutic purposes, including U.S. patents and foreign equivalents. These references typically focus on particular chemical subclasses with known biological activity.
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Related Patents: Multiple patent families claim similar chemical scaffolds with variations in substituents, corresponding to the target mechanism or enhanced pharmacokinetics.
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Freedom to Operate (FTO): The scope of the claims in 8,074,644 overlaps with several existing patents, requiring careful analysis to avoid infringement, especially with closely related compounds.
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Patent Term and Expiry: Filed in 2008, with a typical 20-year term from filing, excluding patent term adjustments. The patent is expected to expire around 2028, after which generic versions may be developed.
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Global Patent Coverage: Patent applications have been filed in multiple jurisdictions, including Europe, Japan, and China. These counterparts may offer similar or broader protection, depending on the claims.
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Patent Challenges and Litigation: No notable litigations or reexaminations are publicly documented, but opportunistic patent challenges are common in this field.
Critical patentability considerations
- The novelty of the chemical structure is maintained by the specific substitution pattern.
- Inventive step hinges on the unexpected biological activity or improved pharmacological profile over prior art.
- The claims' breadth is balanced against the prior art landscape; overly broad claims risk invalidation.
- The patent covers both compounds and their therapeutic methods, broadening commercial utility.
Summary table of claim features and patent status
| Aspect |
Details |
| Patent number |
8,074,644 |
| Filing date |
March 14, 2008 |
| Issue date |
December 6, 2011 |
| Expiry (expected) |
December 6, 2028 |
| Claim type |
Composition of matter, method claims |
| Core chemical class |
Heterocyclic compounds with substituted groups |
| Patent family extensions |
Filed in EP, WO, JP, CN, AU |
| Literature references |
Multiple prior patents, scientific publications |
Key Takeaways
- The patent protects a broad class of heterocyclic compounds with therapeutic potential.
- Claims are structured to encompass both the compounds and their preparation or use.
- The patent landscape is crowded; existing patents may limit freedom to operate.
- Similar patents in global jurisdictions require comprehensive review for international commercialization.
- The patent will likely expire in 2028, opening opportunities for generic development.
FAQs
1. What are the core structural features covered by the patent?
The patent claims compounds with a heterocyclic core, specific substitution patterns at defined positions, and their salts, prodrugs, or solvates.
2. Can the patent be challenged based on prior art?
Yes. Despite its novelty, prior art references disclose similar compounds, which could be grounds for validity challenges if claims are overly broad.
3. Are method-of-use claims included?
Yes. The patent includes claims for therapeutic methods involving administering the claimed compounds.
4. Is international patent protection available?
Yes. Patent families have been filed in key jurisdictions such as Europe, Japan, China, and Australia, providing similar protection.
5. What is the risk of infringement on this patent?
Any compound or method that falls within the scope of the claims may infringe. A detailed legal analysis is essential before developing or commercializing similar compounds.
References
[1] U.S. Patent 8,074,644. (2011).
[2] European Patent Application. (2012).
[3] Japan Patent Application. (2012).
[4] International Patent Application (WO). (2012).
[5] Patent Landscape Analysis Reports. (2022).
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