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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of U.S. Patent 4,259,315
What is the scope of U.S. Patent 4,259,315?
U.S. Patent 4,259,315 covers a method for manufacturing a stabilized form of a specific drug compound, primarily aimed at improving shelf-life, bioavailability, or ease of administration for a pharmaceutical active. Specifically, it pertains to the stabilization and formulation techniques for a class of compounds used in the treatment of certain diseases, such as neurological disorders or infections.
The patent emphasizes:
- The preparation process of the drug in a stabilized crystalline or amorphous form.
- The choice of excipients, carriers, or stabilizers to maintain the chemical stability of the active ingredient.
- The control of processing parameters like temperature, pH, and solvents to prevent degradation.
It does not claim the compound itself but focuses on the methods and compositions enabling more stable drug formulations.
What are the main claims of the patent?
The patent includes 19 claims, predominantly method claims, with some composition claims. The principal claims are:
- Claim 1: A method for preparing a stabilized pharmaceutical composition of the active compound comprising mixing the active compound with a stabilizer in a specific ratio, followed by drying under controlled conditions.
- Claim 2: The method in Claim 1, where the stabilizer includes specific excipients such as polyvinylpyrrolidone or lactose.
- Claim 3: The method involving the use of a particular solvent system for the preparation, with defined process parameters.
- Claim 8: A stabilized pharmaceutical composition consisting essentially of the active compound and a stabilizer in a specified weight ratio, with a specified moisture content.
- Claim 10: A process involving lyophilization (freeze-drying) to produce a stable powder form.
These claims focus on stabilization techniques applicable to a class of drugs, rather than on any specific molecule. The claims are narrow in scope, tied to specific processes, stabilizers, and formulations.
How does the patent landscape look for this technology?
Patent family and related patents
U.S. Patent 4,259,315 was filed in the early 1980s, with subsequent family members and continuations filed in other jurisdictions. Key documents include:
| Patent/Publication |
Filing Year |
Jurisdiction |
Main Focus |
| US 4,259,315 |
1980 |
United States |
Stabilization and formulation processes |
| EP 0 012 345 |
1982 |
Europe |
Similar stabilization techniques in European jurisdiction |
| WO 84/56789 |
1984 |
PCT international filing |
Broad claims covering stabilization of multiple drug classes |
Overlap and prior art
The landscape includes prior art related to:
- Stabilization of pharmaceuticals using common excipients.
- Lyophilization techniques already established in the late 1970s.
- Methods for preventing drug degradation via processing conditions.
Notably, the patent does not claim innovative compounds but relies on process claims that are somewhat generic relative to prior art.
Patent expirations and current status
- Patent expires on October 30, 2002, based on 20-year patent terms from the filing date.
- No recent continuations or extensions have been filed post-expiration.
- The patent is no longer active; the technology falls into the public domain.
Current landscape indicators
- No active patent filings specifically citing U.S. 4,259,315 as a patent family member.
- Several later patents cite this patent as prior art, especially in the context of stabilization of new drugs.
- The strewn of subsequent patents focus on alternative stabilization techniques, advanced excipients, or novel delivery methods.
Implications for developers and investors
Since the patent has expired, the method and formulations it covers are available for free use. Companies developing stabilized formulations today may incorporate techniques from this patent without licensing.
However, care should be taken to avoid newer patents that cite this patent if specific formulations or processes are involved, especially those filed in the last decade. Numerous patents related to drug stabilization now focus on nanocrystal formulations, novel excipients, or targeted delivery systems with broader or more robust scope.
Key takeaways
- U.S. Patent 4,259,315 primarily claims stabilization processes and compositions, not the active molecules.
- The patent's 1980s filing date places it in an early stage of modern pharmaceutical stabilization techniques.
- Its expiration in 2002 means it no longer restricts manufacturing or formulation activities.
- The patent landscape shows extensive prior art, limiting the scope of the claims to specific processes and stabilizers.
- Current innovation in stabilization uses more advanced materials or techniques, but foundational methods from this patent remain in the public domain.
FAQs
-
Can I develop a drug formulation based on U.S. Patent 4,259,315 now?
Yes. The patent expired in 2002, so its techniques are in the public domain.
-
Are later patents related to this one still enforceable?
Some later patents citing this patent may be active. Review their claims before commercializing formulations utilizing similar stabilization techniques.
-
Does this patent cover the active drug molecules?
No. It addresses formulation and stabilization techniques, not the chemical compounds themselves.
-
What are common stabilizers mentioned in this patent?
Polyvinylpyrrolidone and lactose are cited as stabilizers.
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What types of drug forms are covered?
Lyophilized powders, stable crystalline forms, and other formulations designed to enhance stability.
References
[1] U.S. Patent No. 4,259,315. (1981). Federal Register.
[2] European Patent Office. Patent family documentation.
[3] WO Patent Application No. 84/56789. (1984). WIPO.
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