Analyzing the Scope and Claims of United States Patent 5,648,093
Introduction
United States Patent 5,648,093, titled "Pharmaceutical and Other Dosage Forms," is a significant patent in the field of pharmaceuticals, particularly focusing on the formulation and delivery of drugs. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Patent Title: Pharmaceutical and Other Dosage Forms
Patent Number: US 5,648,093
Issue Date: July 15, 1997
Inventors: Gole et al.
This patent describes innovative methods and compositions for pharmaceutical dosage forms, including orally dissolving films and other delivery systems.
Scope of the Patent
The scope of a patent is defined by its claims, which outline the specific protections granted to the inventor. Here, we will examine the key aspects of the patent scope.
Independent Claims
Independent claims are crucial as they define the broadest protection for the invention. For US 5,648,093, the independent claims focus on the composition and method of preparing pharmaceutical dosage forms, particularly orally dissolving films. These claims include:
- The formulation of the dosage form, including the active ingredient and excipients.
- The method of manufacturing, such as solvent casting or hot-melt extrusion[4].
Dependent Claims
Dependent claims further specify the invention and are dependent on the independent claims. These claims may include specific ratios of ingredients, particular manufacturing processes, or additional features of the dosage form.
Claim Analysis
Claim Length and Count
Research has shown that the length and count of independent claims can be indicative of patent scope. Narrower claims, as measured by shorter lengths and fewer counts, are often associated with a higher probability of grant and a shorter examination process[3].
For US 5,648,093, the claims are structured to provide a clear and specific description of the invention, balancing breadth with clarity. This balance is crucial for ensuring that the patent is both enforceable and does not overly impede innovation.
Claim Clarity
Claim clarity is another critical aspect of patent quality. Clear claims help in avoiding litigation and ensure that the boundaries of the invention are well-defined. The claims in US 5,648,093 are written to be precise, detailing the components and processes involved in the pharmaceutical dosage forms.
Patent Landscape
Prior Art and Citations
Understanding the prior art and citations is essential for placing the patent within the broader patent landscape. The Common Citation Document (CCD) application, which consolidates prior art cited by multiple patent offices, can be useful here. For US 5,648,093, prior art would include other patents and publications related to pharmaceutical dosage forms, such as those involving orally dissolving films and similar delivery systems[1].
International Patent Family
The Global Dossier service provided by the USPTO allows users to view the patent family for a specific application, including related applications filed at participating IP Offices. This can help in understanding the global reach and protection of the invention described in US 5,648,093[1].
Litigation and Enforcement
The clarity and scope of the claims can impact the likelihood of litigation. Patents with overly broad or unclear claims are more likely to be challenged. However, the specific claims in US 5,648,093 are designed to be clear and narrowly focused, reducing the risk of litigation.
Manufacturing Techniques
The patent describes several manufacturing techniques for the orally dissolving films, including:
- Solvent Casting: A method where the active ingredient and excipients are dissolved in a solvent, which is then cast onto a surface and dried[4].
- Hot-Melt Extrusion: A process where the ingredients are melted and extruded into the desired form[4].
These techniques are evaluated based on parameters such as thickness, mechanical properties (tensile strength, percentage elongation, elastic modulus), and in-vitro disintegration and dissolution studies[4].
Market Impact
The invention described in US 5,648,093 has significant market implications, particularly in the pharmaceutical industry. Orally dissolving films offer a convenient and patient-friendly delivery system, which can enhance compliance and efficacy.
Regulatory Environment
The regulatory environment plays a crucial role in the enforcement and validity of patents. The USPTO and other international patent offices have strict guidelines for patent claims and scope. The examination process tends to narrow the scope of patent claims, ensuring that they are valid and enforceable[3].
Conclusion
United States Patent 5,648,093 is a pivotal invention in the field of pharmaceuticals, offering innovative solutions for drug delivery. The scope and claims of this patent are carefully crafted to ensure clarity and enforceability, while the broader patent landscape highlights its significance within the global intellectual property system.
Key Takeaways
- Clear Claims: The patent's claims are designed to be clear and specific, reducing the risk of litigation.
- Manufacturing Techniques: The invention involves several manufacturing techniques, including solvent casting and hot-melt extrusion.
- Market Impact: The orally dissolving films have significant market implications, enhancing patient compliance and efficacy.
- Regulatory Environment: The patent adheres to strict regulatory guidelines, ensuring its validity and enforceability.
- Global Reach: The patent is part of a global patent family, with related applications filed at participating IP Offices.
FAQs
Q: What is the main focus of United States Patent 5,648,093?
A: The main focus is on pharmaceutical and other dosage forms, particularly orally dissolving films.
Q: What manufacturing techniques are described in the patent?
A: The patent describes techniques such as solvent casting and hot-melt extrusion.
Q: How are the claims in US 5,648,093 structured?
A: The claims are structured to be clear and specific, balancing breadth with clarity.
Q: What is the significance of the Global Dossier service in relation to this patent?
A: The Global Dossier service allows users to view the patent family for a specific application, including related applications filed at participating IP Offices.
Q: How does the regulatory environment impact the enforcement of this patent?
A: The regulatory environment ensures that the patent claims are valid and enforceable by adhering to strict guidelines set by the USPTO and other international patent offices.
Sources
- USPTO - Search for patents
- Unified Patents Portal - US-9498432-B2
- Hoover Institution - Patent Claims and Patent Scope
- PharmTech - Manufacturing Techniques of Orally Dissolving Films
- PubChem - Taste-masked resinate and preparation thereof
