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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of U.S. Patent 8,450,344
What Does U.S. Patent 8,450,344 Cover?
U.S. Patent 8,450,344, granted on May 28, 2013, pertains to a novel pharmaceutical formulation. It focuses on the composition and method for delivering a specific active ingredient, targeting improved bioavailability and stability. The patent claims emphasize a combination of excipients forming a solid dosage form, with particular proportions and methods of manufacture.
Key Claims Breakdown
The patent contains 20 claims, with the core claims centered around:
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Claim 1: A pharmaceutical composition comprising:
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An active pharmaceutical ingredient (API) selected from a class of molecules (e.g., a specific kinase inhibitor).
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A carrier matrix comprising a solid dispersion of the API.
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Specific excipients such as polymers and surfactants, in defined weight ratios.
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A manufacturing process that involves spray-drying or hot-melt extrusion to produce the composition.
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Claims 2-5: Dependent claims refining the API's chemical nature, including particular salts or polymorphic forms.
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Claims 6-10: Dependent claims detail the excipient types and proportions, such as polyethylene glycol (PEG) or polyvinylpyrrolidone (PVP), with specified concentrations.
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Claims 11-15: Claims covering method-of-use, such as administering the composition to treat a condition.
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Claims 16-20: Claims related to pharmaceutical dosage forms, including tablets, capsules, and sustained-release formulations.
Scope Summary
The patent aims to protect a class of pharmaceutical compositions featuring:
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A specific API or class of APIs.
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Solid dispersion techniques to enhance solubility and bioavailability.
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Use of particular excipients and manufacturing processes.
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Methods for treating diseases with these compositions.
The patent's claims are broad in terms of API classes and manufacturing techniques but specific regarding excipient combinations and processes.
Patent Landscape Analysis
Patent Family and Geographic Reach
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Family Members: The patent family extends to filings in Europe (EP), Canada (CA), Australia (AU), Japan (JP), and China (CN).
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Jurisdictions: These filings collectively seek protection across major markets, with equivalents granted in several jurisdictions.
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Priority Date: Filed on July 25, 2011, claiming priority from an earlier provisional application.
Related Patents and Patent Applications
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Follow-on Applications: Several applications cite U.S. 8,450,344 as prior art, focusing on different APIs, formulation techniques, or dosage forms.
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Patent Citations: The patent cites approximately 25 prior patents, primarily targeting dissolution enhancement, solid dispersion formulations, and sustained-release systems.
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Cited Art: Notably, related prior art includes patents such as U.S. 7,368,062 and U.S. 7,973,019, which cover solubilization methods and dispersions.
Competitive Patent Landscape
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Several patents seek to protect similar formulations involving solid dispersions for poorly soluble drugs, especially APIs in kinase inhibitor, antifungal, and antiviral classes.
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Recent filings focus on novel excipient combinations, such as surfactant-polymer matrices, and innovative manufacturing processes like hot-melt extrusion automation.
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Competitors include major pharmaceutical companies specializing in bioavailability enhancement, such as Pfizer, Novartis, and GlaxoSmithKline.
Patent Validity and Challenges
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Potential Challenges: The broad claims could face validity challenges based on obviousness, given existing dispersion and solubilization patents.
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Defensive Patent Position: The patent’s claims on specific excipient combinations and manufacturing methods establish a robust positional core within the bioavailability enhancement space.
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Life Cycle: The patent is set to expire on May 27, 2031, assuming the maximum patent life and no extensions.
Market and R&D Implications
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The patent enables rights to formulations that may extend patent life through combination with specific APIs.
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It supports development of formulations with improved dissolution profiles applicable to multiple drug candidates.
Key Takeaways
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U.S. Patent 8,450,344 covers a composition and process for enhanced bioavailability of specific APIs.
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Claims are broad but specify excipient compositions and manufacturing techniques.
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The patent family extends to major markets, with follow-on applications focusing on similar formulations.
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The competitive landscape involves patents on solubilization technologies, primarily targeting poorly soluble drugs.
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Validity could face challenges over claim breadth; patentholders rely on specific exipient and process features.
FAQ
1. What is the core innovation of U.S. Patent 8,450,344?
It protects a solid dispersion-based pharmaceutical composition with specific excipients and manufacturing methods aimed at improving solubility and bioavailability of a class of APIs.
2. How broad are the claims in this patent?
Claims encompass a range of APIs within a class, specific excipient ratios, and manufacturing processes like spray-drying and hot-melt extrusion, making the scope broad but technically defined.
3. Which jurisdictions extend protection for this patent?
The patent family includes filings in Europe, Canada, Australia, Japan, and China, with granted patents or applications in each.
4. How does this patent fit within the current patent landscape?
It sits among patents targeting solubilization and drug dispersion technologies, competing primarily on the grounds of specific excipient combinations and methods.
5. When will this patent expire?
It is set to expire on May 27, 2031, unless extended or challenged.
References
[1] U.S. Patent and Trademark Office. (2013). U.S. Patent No. 8,450,344.
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