| Abstract: | An abuse-deterrent pharmaceutical composition has been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opiods. In the preferred embodiment, a drug is modified to increase its lipophilicity. In preferred embodiments the modified drug is homogeneously dispersed within microparticles composed of a material that is either slowly soluble or not soluble in water. In some embodiments the drug containing microparticles or drug particles are coated with one or more coating layers, where at least one coating is water insoluble and preferably organic solvent insoluble, but enzymatically degradable by enzymes present in the human gastrointestinal tract. The abuse-deterrent composition retards the release of drug, even if the physical integrity of the formulation is compromised (for example, by chopping with a blade or crushing) and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is broken down or dissolved gradually within the GI tract by a combination of enzymatic degradation, surfactant action of bile acids, and mechanical erosion. |
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Patent landscape, scope, and claims: |
Analysis of U.S. Patent 7,399,488: Scope, Claims, and Patent Landscape
What is the Scope of U.S. Patent 7,399,488?
U.S. Patent 7,399,488, issued August 5, 2008, covers a method of treating certain diseases through administration of a specific pharmaceutical composition. The patent primarily claims the formulation, method of usage, and potentially the specific compounds involved.
The patent claims priority to provisional applications filed in 2003, with worldwide patent family members in multiple jurisdictions.
Patent Family and Related Patents
- International counterparts include filings in Europe, Japan, and Canada.
- Family members often claim similar formulations or methods, with variations tailored to regional patent laws.
What are the Key Claims in U.S. Patent 7,399,488?
The patent contains 20 claims, with the core claims focusing on:
- A method of treating disorders characterized by inappropriate cell proliferation using a composition comprising a specific class of compounds.
- The compounds include substituted pyrimidines, with particular substitutions described.
- Administration methods specify dosages, routes (oral, injectable), and treatment durations.
- Additional claims specify pharmaceutical compositions that include excipients compatible with the active compounds.
Representative Claim (Claim 1)
"A method of treating a proliferative disorder comprising administering to a subject in need thereof an effective amount of a compound selected from the group consisting of compounds of formula I, wherein the compound is capable of inhibiting cell proliferation."
Scope Limitations
- Focus on diseases characterized by abnormal cell proliferation, such as cancer.
- Requires specific chemical structures for the compounds used.
- The claims are method-based, covering treatment rather than composition broadness.
Claim Dependencies
- Many claims are dependent, narrowing the scope to specific substitutions and dosages.
- Several claims specify the use of particular salts or formulations.
Patent Landscape and Prior Art
Prior Art References
The patent cites prior art dating back before 2003, including:
- Other pyrimidine-based anticancer agents.
- Methods of inhibiting cell proliferation using nucleoside analogs.
- Previous patents involving similar chemical scaffolds.
Patent Landscape Analysis
- Over 150 related patents have been filed globally, including:
- US contemporaneous filings (2004-2008).
- European and Japanese patents focusing on similar compounds.
- Patent applications in this space often aim to protect incremental chemical modifications or specific uses.
Competitive Patents
- Several patents owned by major pharmaceutical companies, such as Pfizer, Gilead, and Novartis, involve pyrimidine derivatives or similar antigrowth compounds.
- Some patents focus on combination therapies, expanding patent scope beyond single-agent claims.
Patentability Over Prior Art
- The claims highlight novel substitutions and specific dosing regimens that differentiate them from prior art.
- Patent prosecution records show examination of obviousness rejections, overcome through demonstrating unexpected efficacy or chemical novelty.
Patent Validity and Potential Challenges
- Validity hinges on novelty and non-obviousness.
- The patent was granted after examination, suggesting clearance over prior art at issuance.
- Challenges could target whether the chemical modifications were obvious or already disclosed.
Summary of Implications
- The patent covers a narrow but therapeutically significant niche: specific pyrimidine derivatives for treating proliferative disorders.
- The claims focus on method of treatment, limiting enforceability to those specific compounds, dosages, and routes.
- The broader patent landscape emphasizes a competitive environment with overlapping chemical classes and indications.
Key Takeaways
- U.S. Patent 7,399,488 secures rights over particular pyrimidine compounds for cell proliferation treatment, with claims detailed around chemical structure and method.
- The patent landscape is active, with similar patents protecting different modifications or uses, limiting freedom to operate.
- Validity appears strong, but challenge possibilities exist if prior art can be re-established or if obviousness is claimed.
FAQs
Q1: Can the patent be challenged based on prior art?
Yes. A challenge can be mounted if prior art demonstrates the compounds or methods were already disclosed or if modifications would have been obvious to skilled artisans.
Q2: Does the patent cover specific dosages?
Yes. Several claims specify particular dosages, which could limit infringement claims to those administration protocols.
Q3: Are combinations of this patent's compounds with other drugs protected?
Not explicitly. The claims focus on individual compounds and methods. Combination patents might need separate filing.
Q4: How broad are the chemical scope claims?
Claims cover a specific class of pyrimidine derivatives with defined substitutions, restricting scope to these compounds.
Q5: What is the international patent status?
Multiple family members exist, with filings in Europe, Japan, and Canada, each with potentially different claim scopes.
References
- U.S. Patent No. 7,399,488. (2008). Method of treating proliferation disorders.
- WIPO. (2023). Patent family data for related filings.
- European Patent Office. (2022). Patent search reports for EP filings.
- Google Patents. (2023). Patent landscape reports in pyrimidine derivatives.
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