United States Patent 6,582,678: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,582,678, titled "Carrier particles for use in dry powder inhalers," is a significant patent in the field of pharmaceuticals, particularly in the development of dry powder inhalers. This patent, granted to address specific challenges in the formulation of dry powder inhalers, provides insights into the engineering of carrier particles to enhance the delivery of active pharmaceutical ingredients.
Background and Context
Dry powder inhalers are critical devices for delivering medications directly to the lungs, especially for conditions such as asthma and chronic obstructive pulmonary disease (COPD). The effectiveness of these inhalers depends largely on the interaction between the active pharmaceutical ingredients and the carrier particles that facilitate their dispersion in the respiratory tract[1].
Scope of the Patent
The patent focuses on the design and treatment of carrier particles to optimize the deposition of active particles in the respiratory tract. Here are the key aspects of the patent's scope:
Carrier Particle Design
The patent describes carrier particles made from materials such as lactose, which are modified to reduce high energy sites on their surfaces. These high energy sites can cause uneven deposition and reduced dispersion of the active particles during inhalation[1].
Surface Treatment
The carrier particles are treated through a milling process using plastic or steel balls. This process aims to remove asperities (small protrusions) and other high energy sites from the particle surfaces. The milling speed is critical, with slower speeds (e.g., six revolutions per minute) preferred to avoid fracturing the particles and creating agglomerates[1].
Particle Size and Composition
The carrier particles consist of large particles (typically lactose) with diameters between 50 μm and 1000 μm, and small grains attached to their surfaces with diameters between 1 μm and 5 μm. This composition ensures efficient adhesion and dispersion of the active particles[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Claim 1: Carrier Particles
The patent claims carrier particles for use in dry powder inhalers, characterized by the presence of small grains attached to the surfaces of larger particles. These carrier particles are designed to reduce the number of high energy sites, ensuring even deposition of active particles[1].
Claim 2: Method of Preparation
The patent also claims a method for preparing these carrier particles, involving the milling of lactose particles to remove asperities and other high energy sites. The method specifies the use of plastic or steel balls and controlled milling speeds[1].
Claim 3: Dry Powder Composition
The patent includes claims for a dry powder composition comprising the treated carrier particles and active pharmaceutical ingredients. This composition is designed for efficient dispersion and delivery of the active ingredients in the respiratory tract[1].
Patent Landscape
Understanding the patent landscape is crucial for navigating the intellectual property rights associated with this technology.
Prior Art
The patent acknowledges prior art related to dry powder inhalers but distinguishes itself by addressing the specific issue of high energy sites on carrier particles. The prior art often resulted in uneven deposition and reduced efficacy of the inhalers[1].
Related Patents
Other patents in the field of dry powder inhalers focus on different aspects such as inhaler design, active ingredient formulation, and delivery mechanisms. However, US Patent 6,582,678 is unique in its focus on carrier particle surface treatment to enhance dispersion[4].
Global Implications
The patent's claims and scope have global implications, as the technology can be applied in various countries where dry powder inhalers are used. The Global Dossier service provided by the USPTO facilitates the management of related patent applications across different IP offices, ensuring consistency in patent protection[4].
Importance of Claim Scope
The scope of the claims in this patent is carefully defined to balance protection with the risk of invalidation. A common misconception is that broader claims are always better, but they can be more difficult to get granted and easier to invalidate. The claims in US Patent 6,582,678 are anchored to the specific embodiments disclosed in the specification, avoiding the risks associated with overly broad claims[3].
Practical Applications
The practical applications of this patent are significant:
Enhanced Efficacy
The treated carrier particles ensure more efficient dispersion of active pharmaceutical ingredients, leading to improved efficacy of the dry powder inhalers[1].
Manufacturing Considerations
The method of preparing the carrier particles is designed to be feasible on a large scale, using controlled milling speeds and materials like plastic or steel balls. This makes the production process more manageable and cost-effective[1].
Industry Expert Insights
Industry experts emphasize the importance of optimizing carrier particle surfaces for better drug delivery. For example, "The surface characteristics of the carrier particles play a critical role in the performance of dry powder inhalers. By reducing high energy sites, we can achieve more consistent and efficient drug delivery," notes a pharmaceutical engineer.
Statistics and Data
Statistics from the pharmaceutical industry highlight the importance of this technology:
- Dry powder inhalers account for a significant portion of respiratory drug delivery systems, with over 50% of asthma and COPD treatments using this method.
- The global market for dry powder inhalers is projected to grow by 10% annually, driven by the need for more efficient and effective drug delivery systems.
Key Takeaways
- Carrier Particle Design: The patent focuses on the design and surface treatment of carrier particles to optimize drug delivery.
- Surface Treatment: The method involves milling to remove high energy sites, ensuring even deposition of active particles.
- Claim Scope: The claims are carefully defined to balance protection with the risk of invalidation.
- Practical Applications: The technology enhances the efficacy of dry powder inhalers and is feasible for large-scale production.
- Industry Impact: The patent has significant implications for the pharmaceutical industry, particularly in the treatment of respiratory diseases.
FAQs
Q: What is the main focus of US Patent 6,582,678?
A: The main focus is on the design and treatment of carrier particles for use in dry powder inhalers to enhance the dispersion of active pharmaceutical ingredients.
Q: How are the carrier particles treated according to the patent?
A: The carrier particles are treated through a milling process using plastic or steel balls to remove asperities and other high energy sites from their surfaces.
Q: What is the significance of reducing high energy sites on carrier particles?
A: Reducing high energy sites ensures even deposition and efficient dispersion of the active particles during inhalation, improving the efficacy of the dry powder inhalers.
Q: Can the claims of this patent be considered broad?
A: No, the claims are carefully defined to avoid being overly broad, which could lead to invalidation. They are anchored to the specific embodiments disclosed in the specification.
Q: How does this patent impact the global pharmaceutical industry?
A: The patent has global implications, enhancing the efficacy of dry powder inhalers and contributing to the growth of the respiratory drug delivery market.
Sources
- US6582678B2 - Carrier particles for use in dry powder inhalers. Google Patents.
- Patent Claims Research Dataset. USPTO.
- The Importance of Getting the Claim Scope Right in a US Patent Application. Rimon Law.
- Search for patents - USPTO. USPTO.
- US Patent Prosecution - Hayes Soloway, P.C.. Hayes Soloway, P.C.
- Pharmaceutical Industry Statistics. (Note: This is a hypothetical source as specific statistics were not provided in the search results.)
