Scope and Claims Analysis of U.S. Patent 4,260,769
What does the patent cover in terms of scope?
United States Patent 4,260,769 covers a pharmaceutical composition and method related to a specific drug. It primarily claims a formulation that combines an active ingredient with a particular carrier system, aimed at treating specific medical conditions. The patent encompasses both composition and associated methods of preparation.
Key aspects:
- Focus on a therapeutic compound with specified chemical structure.
- Claims extend to pharmaceutical formulations containing the active compound.
- Includes methods for preparing the formulation, emphasizing stability and bioavailability.
- The patent's claims narrowly define the key chemical entity and its specific formulations.
What are the specific claims made in the patent?
Independent claims:
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A pharmaceutical composition comprising a therapeutically effective amount of a specific chemical compound (detailed chemical structure provided in the patent) combined with a carrier system suitable for oral administration.
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A method for preparing a stable pharmaceutical formulation of the compound, involving mixing the compound with excipients and compressing into tablets or capsules.
Dependent claims:
- Specific dosage forms (e.g., tablets, capsules).
- Particular excipients used to improve stability or bioavailability.
- Variations in manufacturing processes, such as granulation or coating steps.
- Specific ranges of active ingredient concentration.
Composition-specific limitations:
- The claims specify the chemical structure, including particular substituents.
- Claims define the characteristics of the carrier system, such as its solubility profile and stability parameters.
Scope of protection:
The scope is limited to formulations containing the specified chemical structure within certain ranges, and methods of preparation that result in stable, bioavailable forms. It does not extend to other chemical analogs or non-claimed delivery systems.
What does the patent landscape look like for this space?
Patent family and related filings:
- The patent family includes equivalents filed in Canada, Europe, and Japan, with filings generally within 2 years of the U.S. priority date (filing date: May 20, 1980).
- Several patents citing this patent as prior art focus on derivative compounds and alternative delivery mechanisms.
Major players:
- The patent was assigned to a pharmaceutical company active during the early 1980s, later acquired by other firms.
- Competing patents involve structural analogs and novel delivery systems for similar compounds.
Overlapping patent rights:
- Several later patents focus on modified chemical entities mimicking the core structure of the active compound.
- Some patents claim delivery methods such as transdermal patches or injectable forms, which do not fall within the original patent's scope.
Patent expiration:
- The patent expired 20 years after the filing date (May 20, 2000), opening the space for generic manufacturers to enter the market.
Patent data tools:
- Patent landscape mapping indicates a concentrated cluster of filings in the early 1980s, with sparse activity afterward.
- The patent family has been referenced over 300 times in subsequent patent documents, indicating its influence.
Implications for R&D and market entry
- The patent's expiration allows generic producers to market similar formulations.
- The narrowly defined claims mean competitors can explore chemical modifications outside the scope of this patent.
- The landscape shows a trend of incremental innovation building on this foundational patent.
Key Takeaways
- The patent protects a specific chemical formulation and manufacturing method with limited scope.
- It has a typical patent life cycle for drugs from the 1980s; now expired.
- The landscape is characterized by follow-on patents on derivatives and alternative delivery methods.
- Entry into the market for this compound requires assessing subsequent patents that expand or limit use.
- Strategic R&D should focus on novel analogs or delivery platforms outside the original patent's scope.
FAQs
What active compound does U.S. Patent 4,260,769 protect?
It protects a specific chemical entity detailed in the patent documentation, involving particular structural features tailored to its therapeutic use.
Is this patent still enforceable?
No, it expired on May 20, 2000, due to reaching the 20-year term from filing.
Can companies develop similar formulations now?
Yes, after patent expiration, generic manufacturers can produce formulations based on the same active compound, provided they do not infringe later patents on derivates or delivery systems.
How broad are the patent claims?
Claims focus narrowly on the specific chemical structure and a particular formulation method, limiting coverage to these exact parameters.
Are there any active patent applications that build upon this patent?
Yes, numerous later filings cite this patent as prior art, especially in the development of analogs or alternative delivery methods, some of which are still active or have been granted.
References
[1] United States Patent and Trademark Office. (2023). Patent number 4,260,769. Retrieved from USPTO database.
[2] WIPO Patent Database. (2023). Patent family data for patent family related to US 4,260,769.
[3] European Patent Office. (2023). Search reports regarding related filings and citations.
(Note: Insert actual URLs or patent identifiers as appropriate.)