Detailed Analysis of the Scope and Claims of United States Patent 9,301,948
Introduction
United States Patent 9,301,948, titled "Instantly Wettable Oral Film Dosage Form Without Surfactant or Polyalcohol," is a significant innovation in the field of pharmaceuticals. This patent, granted on April 5, 2016, addresses a critical need in oral drug delivery systems. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Purpose
The patent describes an oral film dosage form that is instantly wettable and rapidly disintegrating, without the use of surfactants or polyalcohols. This innovation is crucial because it enhances patient compliance, especially for those who have difficulty swallowing traditional tablets or capsules. The absence of surfactants and polyalcohols also makes the formulation more stable and less likely to cause adverse reactions[5].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific features and limitations of the invention. Here are the key aspects:
Claims
- The patent includes multiple claims that describe the composition and properties of the oral film dosage form.
- Claim 1 typically sets the broadest scope, defining the oral film as comprising a polymer matrix, an active ingredient, and optionally other components like flavoring agents or sweeteners.
- Subsequent claims narrow down the scope by specifying particular polymers (e.g., vinylpyrrolidone), the absence of surfactants and polyalcohols, and the film's physical properties such as thickness and disintegration time[5].
Independent and Dependent Claims
- Independent claims (e.g., Claim 1) stand alone and define the invention without reference to other claims.
- Dependent claims (e.g., Claims 2-10) build upon the independent claims, adding additional features or limitations that further define the invention. For example, Claim 2 might specify a particular concentration of the active ingredient[5].
Patent Claims Analysis
The analysis of patent claims is crucial for understanding the patent's scope and potential impact.
Claim Length and Count
Research suggests that the length and count of independent claims can be metrics for measuring patent scope. Patents with narrower claims at publication tend to have a higher probability of grant and a shorter examination process. In the case of US 9,301,948, the claims are relatively specific, indicating a well-defined invention with clear boundaries[3].
Examination Process
The examination process for this patent would have involved a thorough review of prior art to ensure the novelty and non-obviousness of the invention. The fact that the patent was granted suggests that the claims were deemed sufficiently distinct from existing technologies.
Prior Art and Citation Data
Understanding the prior art and citation data is essential for assessing the patent's novelty and impact.
Common Citation Document (CCD)
Tools like the Common Citation Document (CCD) can provide insights into the prior art cited by various patent offices for the same invention. This helps in visualizing the global patent landscape and identifying potential overlaps or conflicts[1].
Global Dossier
The Global Dossier service allows users to view the file histories of related applications from participating IP Offices, including the IP5 Offices. This can help in understanding how the invention was treated in different jurisdictions and any office actions that may have been taken[1].
Patent Landscape
The patent landscape in the pharmaceutical sector, particularly in oral drug delivery systems, is highly competitive and dynamic.
Technology Area
The patent falls under the broader category of chemistry and health, which is one of the largest categories in terms of USPTO patents. Within this category, medical technology is a significant sub-field, reflecting the ongoing innovation in healthcare[4].
Industry Trends
High-technology manufacturing and commercial knowledge-intensive services industries dominate the patent landscape in this sector. Companies like IBM, Samsung, and Google are among the top patent recipients, indicating a strong focus on R&D and innovation[4].
International Patent Offices
Given the global nature of pharmaceutical research, it is important to consider how this patent might be treated in other countries.
European Patent Office (EPO) and Other International Offices
Databases such as esp@cenet provided by the EPO, and PATENTSCOPE by WIPO, offer access to international patent collections. These resources can help in determining if similar patents have been granted or applied for in other jurisdictions[1].
Practical Implications
The practical implications of this patent are significant for both the pharmaceutical industry and patients.
Enhanced Patient Compliance
The instantly wettable and rapidly disintegrating oral film dosage form can improve patient compliance, especially for pediatric, geriatric, or patients with swallowing difficulties.
Market Impact
This innovation could lead to new product lines and market opportunities for pharmaceutical companies, potentially disrupting traditional oral dosage forms.
Key Takeaways
- Innovation in Oral Drug Delivery: The patent represents a significant advancement in oral drug delivery systems, enhancing patient compliance and stability.
- Specific Claims: The claims are specific and well-defined, indicating a clear scope of the invention.
- Global Relevance: The patent's relevance extends globally, with potential implications for pharmaceutical companies and patients worldwide.
- Competitive Landscape: The patent landscape in this sector is highly competitive, with major companies driving innovation.
Frequently Asked Questions (FAQs)
Q: What is the main innovation described in US Patent 9,301,948?
A: The main innovation is an oral film dosage form that is instantly wettable and rapidly disintegrating without the use of surfactants or polyalcohols.
Q: How does this patent improve patient compliance?
A: The oral film dosage form is designed to be easy to administer, especially for patients who have difficulty swallowing traditional tablets or capsules.
Q: What are the key components of the oral film dosage form?
A: The oral film comprises a polymer matrix, an active ingredient, and optionally other components like flavoring agents or sweeteners.
Q: How can one search for similar patents globally?
A: Tools like the Global Dossier, Common Citation Document (CCD), and databases from international patent offices such as the EPO and WIPO can be used to search for similar patents globally.
Q: What is the significance of the patent's classification under the WIPO classification system?
A: The patent is classified under the chemistry and health category, which is a significant area for pharmaceutical innovations, reflecting its relevance to medical technology.
Cited Sources
- USPTO - Search for patents.
- USA.gov - U.S. Patent and Trademark Office (USPTO).
- SSRN - Patent Claims and Patent Scope.
- NSF - Invention, Knowledge Transfer, and Innovation.
- Google Patents - US9301948B2 - Instantly wettable oral film dosage form without surfactant or polyalcohol.
