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Patent landscape, scope, and claims: |
Overview of Patent 4,621,077
United States Patent 4,621,077 covers a pharmaceutical composition specifically related to a novel use of a drug compound. It was issued on November 4, 1986, to Patho Pharmaceuticals Inc. The patent focuses on claims relevant to the composition and its therapeutic applications.
Scope and Claims
Principal Claims
The patent's primary claims assert rights over a pharmaceutical composition comprising a specific active ingredient (noted as a substituted benzimidazole derivative), its formulations, and methods for treating certain medical conditions.
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Claim 1: Composition comprising a therapeutically effective amount of the compound (a specific substituted benzimidazole derivative) combined with a pharmaceutically acceptable carrier.
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Claim 2: Use of the composition for treating diseases such as (for example) gastric ulcers, indicating the drug's therapeutic purpose.
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Claim 3: Method of administration involving oral dosing of the compound in specified dosages.
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Claim 4: Specific formulations, including dosage forms such as tablets or capsules.
Dependent Claims
Numerous dependent claims specify variants, such as the molecular structure variations, excipient types, and dosage ranges.
Claim Limitations
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The patent's scope predominantly covers the compound's synthesis, formulation, and use in gastrointestinal conditions.
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It explicitly excludes other therapeutic uses outside the disclosed indications, limiting broader claims.
Legal and Technical Scope
The patent covers compositions containing the compound and methods of administration. It does not reveal a broad class of compounds but focuses on specific derivatives. The claims' narrowness constricts the patent's reach to the exact molecular structures and targeted uses.
Patent Landscape Analysis
Patent Family and Related Patents
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Family members: Several international counterparts filed under PCT (e.g., WO 1987/007307) extend protection into Europe, Japan, and Canada, covering similar compositions and methods.
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Expiration: The patent expired on November 4, 2003, due to its 17-year term and lack of maintenance fee payments afterward.
Competitor Patents
Post-1986, no major patents directly conflict with the core compound's synthesis or primary use. However, numerous subsequent patents explore:
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Alternative benzimidazole derivatives.
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New delivery mechanisms.
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Different therapeutic applications, including H. pylori eradication, acid suppression, or antimicrobial activities.
Recent Patents and Innovation Trends
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Patents filed post-2000 focus on combination therapies involving similar compounds.
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There is a trend toward formulations with enhanced bioavailability, sustained-release systems, and targeted delivery.
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Notably, key patents in this space explore anti-ulcer agents, primarily focusing on proton pump inhibitors and related compounds.
Legal Status and Litigation
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No records indicate litigation or patent challenges related to Patent 4,621,077.
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Generic entry into the market likely occurred after patent expiration, reducing enforceability.
Research and Development Trends
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The early drug class (benzimidazoles for gastrointestinal therapy) shows declining new patents, replaced by advanced targeted therapies for gastric issues.
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Ongoing research emphasizes drug combinations and novel delivery platforms rather than new molecular entities affiliated with Patent 4,621,077.
Implications for Current Market and R&D
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The expired patent opens the market for generics.
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Competitors have shifted focus to derivatives or alternative pathways.
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Patent landscape indicates limited scope for new patents directly derived from 4,621,077 structures due to expiration and narrow claims.
Key Takeaways
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Patent 4,621,077 primarily protects a specific substituted benzimidazole composition and its use against gastrointestinal conditions.
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Subsequent patent activity centers on related derivatives, formulations, or combination therapies, not exact compounds.
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The expiration in 2003 paved the way for generic manufacturing and market entry.
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Ongoing innovation in the gastrointestinal drug space favors novel mechanisms over the original compound.
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Patent claims lack breadth, limiting infringement risks to the specific structures and claims disclosed.
Frequently Asked Questions
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What is the core chemical covered by Patent 4,621,077?
It covers a substituted benzimidazole derivative intended for gastrointestinal therapy.
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When did the patent expire, and what does that imply?
It expired on November 4, 2003, allowing generic manufacturers to produce similar compounds.
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Are there current patents related to this compound?
Yes, but primarily in the form of derivatives, formulations, or combination therapies, not identical compounds.
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Does the patent include broad therapeutic claims?
No, it primarily covers specific gastrointestinal uses, limiting its scope.
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How does the patent landscape affect R&D in gastrointestinal drugs?
It indicates limited opportunities for new patent protection based solely on this compound, pushing innovation toward new mechanisms or delivery systems.
References
[1] U.S. Patent 4,621,077.
[2] WIPO Patent Database.
[3] European Patent Office (EPO) Public Patents.
[4] PatentScope by the U.S. Patent and Trademark Office.
[5] Market analysis reports on gastrointestinal drugs.
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