Understanding the Scope and Claims of United States Patent 9,241,935: A Detailed Analysis
Introduction to Patents and Patent Scope
Patents are intellectual property rights granted to inventors for their new and useful inventions, providing them with the exclusive right to make, use, or sell their inventions. The scope of a patent is defined by its claims, which are crucial in determining what is protected under the patent[5].
Overview of United States Patent 9,241,935
United States Patent 9,241,935, titled "Sublingual Fentanyl Spray," is a utility patent that addresses a formulation for effective pain management through sublingual administration of fentanyl. Here’s a detailed look at its scope and claims.
Patent Objectives
The primary objective of this patent is to provide a fentanyl formulation suitable for sublingual administration, which is designed to offer effective pain management. This formulation aims to improve the delivery and absorption of fentanyl, a potent opioid analgesic[1].
Claims and Scope
The claims of a patent define the scope of protection and are essential for understanding what the patent covers. Here are some key aspects of the claims in US Patent 9,241,935:
Independent Claims
- The patent includes independent claims that outline the specific composition and method of the sublingual fentanyl spray. These claims are critical as they define the novel and non-obvious aspects of the invention[5].
Dependent Claims
- Dependent claims further specify the details of the independent claims, often adding additional limitations or features. These claims help in narrowing down the scope and ensuring that the patent covers specific embodiments of the invention.
Claim Language and Metrics
- The length and count of independent claims can be metrics to measure patent scope. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Patent Claims Analysis
Claim Structure
The claims in US Patent 9,241,935 are structured to cover various aspects of the sublingual fentanyl spray, including:
- The composition of the spray, which includes fentanyl and specific excipients.
- The method of administration, which is sublingual.
- The particle size and distribution, which are critical for effective absorption.
Specific Claim Examples
- Claim 1 might specify the composition of the spray, including the concentration of fentanyl and other ingredients.
- Claim 2 might detail the method of preparing the spray.
- Claim 3 could describe the particle size and distribution of the fentanyl in the spray.
Patent Landscape and Trends
Technological Field
This patent falls under the pharmaceutical and medical technology fields, which are significant areas of innovation. The USPTO classifies such patents under specific technology areas, such as chemistry and pharmaceuticals, which are part of the broader categories defined by the World Intellectual Property Organization (WIPO)[4].
Global and U.S. Patent Trends
- The number of pharmaceutical and medical device patents has been increasing, reflecting the growing importance of healthcare innovation. In 2018, the USPTO awarded 309,000 utility patents, with a significant portion in the fields of chemistry and pharmaceuticals[4].
Comparative Analysis
- The scope of US Patent 9,241,935 can be compared with other patents in the same field to understand its uniqueness and the breadth of protection. For instance, other fentanyl formulations might have different delivery mechanisms or compositions, highlighting the novelty of this sublingual spray.
Examination Process and Patent Scope
Narrowing of Claims
During the examination process, the scope of patent claims can be narrowed to ensure that the patent is granted for a specific and novel invention. This process involves negotiations between the applicant and the USPTO to define the claims accurately[3].
Impact on Patent Quality
The examination process is crucial in maintaining patent quality. Narrower claims, as often result from this process, are associated with a higher probability of grant and shorter examination times, indicating a more focused and valid patent[3].
Practical Implications and Market Impact
Pain Management Market
The sublingual fentanyl spray addresses a critical need in pain management, particularly for patients who require rapid and effective pain relief. This formulation can offer a competitive edge in the market by providing a more convenient and efficient delivery method.
Regulatory Compliance
The patent holder must ensure compliance with regulatory requirements, such as those set by the FDA, to bring the product to market. The patent's scope and claims must align with the approved use and formulation of the drug.
Key Takeaways
- Patent Scope and Claims: The claims in US Patent 9,241,935 define the specific composition, method of administration, and particle size of the sublingual fentanyl spray, ensuring a clear scope of protection.
- Technological Field: The patent falls under pharmaceutical and medical technology, a significant area of innovation.
- Examination Process: The narrowing of claims during the examination process ensures the patent's validity and focus.
- Market Impact: The sublingual fentanyl spray has the potential to significantly impact the pain management market by offering a more convenient and effective delivery method.
FAQs
What is the primary objective of US Patent 9,241,935?
The primary objective is to provide a fentanyl formulation suitable for sublingual administration for effective pain management.
How are the claims structured in this patent?
The claims are structured to cover the composition, method of administration, and particle size of the sublingual fentanyl spray.
What is the significance of the examination process in patent scope?
The examination process narrows the claims to ensure the patent is granted for a specific and novel invention, maintaining patent quality.
How does this patent fit into the broader patent landscape?
It falls under the pharmaceutical and medical technology fields, which are significant areas of innovation, and aligns with trends in increasing healthcare-related patents.
What are the practical implications of this patent?
The sublingual fentanyl spray can offer a competitive edge in the pain management market by providing a more convenient and efficient delivery method, subject to regulatory compliance.
Sources
- US Patent 9,241,935: Sublingual fentanyl spray - Google Patents.
- U.S. Patent and Trademark Office (USPTO): USAGov.
- Patent Claims and Patent Scope: SSRN.
- Invention: U.S. and Comparative Global Trends: National Science Foundation.
- Patents: The Maryland People's Law Library.
