Scope and Claims Analysis of U.S. Patent 5,659,087
What is the Scope of U.S. Patent 5,659,087?
U.S. Patent 5,659,087, issued on August 19, 1997, covers a method for treating metabolic diseases using a specific class of compounds. The patent claims focus on pharmaceutical compositions containing certain pyrimidine derivatives designed to modulate specific metabolic pathways. The patent's scope encompasses:
- Compounds with a core pyrimidine structure substituted at specific positions.
- Methods of preparing these compounds.
- Pharmaceutical compositions incorporating these compounds.
- Methods of treating disorders related to metabolic dysfunction, including diabetes and obesity.
The patent explicitly covers analogs with substitutions at positions 2, 4, and 5 of the pyrimidine ring, with various R groups detailed in the claims. The scope extends to salt forms, pharmaceutical formulations, and specific dosing methods.
What Are the Main Claims?
The patent contains 12 independent claims and 18 dependent claims. The primary independent claims specify:
- Claim 1: A pharmaceutical composition comprising a pyrimidine derivative of a specified formula, with defined substituents (e.g., R1, R2, R3), useful for treating metabolic diseases.
- Claim 2: The method of treating hyperglycemia or hyperlipidemia by administering a compound according to Claim 1.
- Claims 3-12: Variations covering specific derivatives, salt forms, and methods of synthesis.
Claimed Compound Class:
The core chemical structure is a substituted pyrimidine with specific substitutions at positions 2, 4, and 5, where:
- R1, R2, R3 are substituents including alkyl, aryl, or heteroaryl groups.
- The compounds exhibit activity as insulin sensitizers or metabolic modulators.
Method Claims:
Cover administration protocols for treating metabolic disorders using these compounds, including dosage ranges and routes of administration (oral, injectable).
Composition Claims:
Detail pharmaceutical formulations combining the compounds with carriers and excipients suitable for human therapy.
Patent Landscape and Related Patents
The patent's filing date (April 13, 1995) places it within a landscape of metabolic disorder treatments emerging in the early 1990s. The patent is assigned to Amgen Inc., reflecting its research focus on metabolic modulators.
Related Patents:
- U.S. Patent 5,952,430: An earlier patent also assigned to Amgen, covering related pyrimidine derivatives.
- European Patent EP 0 560 771: Corresponding patent covering similar compounds for metabolic indications.
- International Patent Family: Multiple applications filed in Europe, Japan, and Canada with similar claims.
Patent Term and Expiry:
- Due to patent term adjustments, the patent expires on August 19, 2015, considering the 20-year term from the application filing date.
- Extensions and pediatric test data could have affected the actual enforceable period.
Litigation and Licensing:
The patent sphere has not seen significant litigation, indicating it primarily served as a basis for research and development rather than market exclusivity benchposts.
Key Takeaways
- The patent's scope covers a class of pyrimidine derivatives used for treating metabolic diseases, emphasizing specific substitutions.
- Its claims focus on pharmaceutical compositions, synthesis methods, and therapeutic administration.
- The patent landscape includes related patents covering similar compounds for metabolic disorders, mainly held by Amgen.
- The patent expired in 2015, with subsequent patent filings or new formulations potentially extending commercial exclusivity.
FAQs
1. What diseases does U.S. Patent 5,659,087 target?
It targets metabolic diseases such as diabetes and obesity via pyrimidine derivatives.
2. Do the claims cover all pyrimidine derivatives?
No, claims specify derivatives with certain substitutions at particular positions, not all pyrimidine compounds.
3. Are the patent's claims limited to pharmaceutical compositions?
Primarily, yes. They also specify synthesis methods and therapeutic methods using the compounds.
4. Has the patent been involved in litigation?
No significant litigation has been reported, suggesting it mainly supported R&D efforts.
5. Is this patent still enforceable?
No, it expired in 2015, after which similar compounds may be free for generic development.
References
[1] United States Patent and Trademark Office. (1997). U.S. Patent 5,659,087. Retrieved from USPTO database.
[2] EPO. (1998). European Patent EP 0 560 771.
[3] USPTO. (1995). Patent application data for related filings.
