Detailed Analysis of the Scope and Claims of United States Patent 5,262,169
Introduction
United States Patent 5,262,169, titled "Pharmaceutical Forms for Oral Administration," is a patent that describes specific formulations and methods for preparing pharmaceuticals, particularly those containing mesna. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention Overview
The patent, granted to Sauerbier et al., pertains to pharmaceutical forms designed for oral administration. These forms include tablets, film-coated tablets, pellets, and granules, with a focus on compositions containing a high percentage of mesna, a drug used to prevent urothelial toxicity caused by certain chemotherapy agents[2].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific embodiments and limitations of the invention. Here are the key aspects:
Composition
- The patent describes pharmaceutical forms that contain at least 88% of mesna, produced by granulation with up to 15% water based on the amount of solid employed.
- It also covers forms containing at least 80% of mesna, produced by direct compression or compaction without the use of organic solvents[2].
Forms of Administration
- The invention includes various forms such as tablets, film-coated tablets, pellets, and granules, all designed for oral administration[2].
Claims Analysis
The patent includes six claims that detail the specific aspects of the invention:
Claim 1
- This claim describes a pharmaceutical form for oral administration, comprising at least 88% of mesna, produced by granulation with up to 15% water based on the amount of solid employed[2].
Claim 2
- This claim covers a pharmaceutical form containing at least 80% of mesna, produced by direct compression or compaction without the use of organic solvents[2].
Claims 3-6
- These claims further specify the methods of production and the composition of the pharmaceutical forms, including the use of specific excipients and the process of film-coating[2].
Patent Landscape
To understand the position of this patent within the broader patent landscape, it is essential to consider related patents and the evolution of pharmaceutical formulations.
Prior Art and Related Patents
- The patent cites several prior art documents, including U.S. Patents 5,252,341 and 5,503,845, which describe similar pharmaceutical formulations but with different compositions and methods of production[2].
International Patent Landscape
- Similar patents and applications can be found in international databases such as the European Patent Office (EPO) and the World Intellectual Property Organization (WIPO). These databases provide insights into global trends and innovations in pharmaceutical formulations[4].
Economic and Legal Implications
The patent's economic and legal implications are significant:
Market Impact
- The patent protects a specific formulation and method of production, giving the patent holder a competitive advantage in the market for mesna-containing pharmaceuticals.
- This protection can influence pricing and availability, as competitors may need to develop alternative formulations or negotiate licensing agreements[3].
Legal Considerations
- The patent's validity and enforceability are subject to legal scrutiny. For instance, issues like obviousness-type double patenting (ODP) can arise if similar patents are granted with overlapping claims, as seen in cases like In re Cellect LLC[1].
Search and Analysis Tools
For professionals conducting patent searches related to this invention, several tools are available:
USPTO Resources
- The USPTO's Patent Public Search tool and the Patent Claims Research Dataset are invaluable resources for analyzing patent claims and understanding the scope of existing patents[3][4].
International Databases
- Databases from other intellectual property offices, such as the EPO and WIPO, provide a global perspective on similar inventions and can help in identifying potential prior art or conflicting patents[4].
Conclusion
United States Patent 5,262,169 is a specific and detailed patent that covers unique pharmaceutical forms containing mesna. Understanding its scope, claims, and the broader patent landscape is crucial for both legal and market strategies.
Key Takeaways
- The patent describes pharmaceutical forms with high mesna content, produced through granulation or direct compression.
- The claims are specific and detailed, covering various forms of administration.
- The patent's economic implications include market protection and potential licensing agreements.
- Legal considerations involve validity and enforceability, including issues like ODP.
- Various tools are available for conducting thorough patent searches and analyses.
FAQs
What is the main subject of United States Patent 5,262,169?
The main subject is pharmaceutical forms for oral administration, specifically those containing a high percentage of mesna.
What are the different forms of administration covered by the patent?
The patent covers tablets, film-coated tablets, pellets, and granules.
How are the pharmaceutical forms produced according to the patent?
The forms are produced either by granulation with up to 15% water or by direct compression or compaction without organic solvents.
What is the significance of the patent in the market?
The patent provides the holder with a competitive advantage in the market for mesna-containing pharmaceuticals.
Where can one find related international patents?
Related international patents can be found in databases such as the EPO's esp@cenet and WIPO's PATENTSCOPE.
What tools are available for conducting patent searches related to this invention?
Tools include the USPTO's Patent Public Search, Patent Claims Research Dataset, and international databases like those from the EPO and WIPO.
