United States Patent 6,521,260: A Comprehensive Analysis
Introduction
The United States Patent 6,521,260, titled "Carrier particles for use in dry powder inhalers," is a significant patent in the field of pharmaceuticals, particularly for the treatment of respiratory diseases. This patent, assigned to Novartis, expired on January 31, 2016, but its impact and the principles it outlines remain crucial for understanding the development and functionality of dry powder inhalers.
Background
Dry powder inhalers (DPIs) are devices used to deliver medication directly to the lungs, often for conditions such as asthma, chronic obstructive pulmonary disease (COPD), and other respiratory disorders. The effectiveness of DPIs relies heavily on the formulation of the powder, which includes active particles and carrier particles.
Patent Overview
Publication Details
- Publication Number: US6521260B1
- Prior Art Date: The patent was filed on December 22, 2000, and granted on April 15, 2003[5].
Key Components
The patent describes a powder formulation for use in DPIs, comprising active particles and carrier particles. The carrier particles are designed to carry the active particles, ensuring they are not released before the inhaler is actuated. This formulation is critical for the efficient delivery of the medication to the lungs.
Scope and Claims
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims focus on the composition of the powder, the characteristics of the carrier particles, and the method of preparing the formulation.
- Claim 1: Describes the powder composition, including active particles and carrier particles, where the active particles are not liable to be released from the carrier particles before actuation of the inhaler[5].
- Claim 2: Specifies the properties of the carrier particles, such as their size, shape, and surface characteristics[5].
Dependent Claims
Dependent claims further elaborate on the independent claims, providing additional details on the formulation and the process of manufacturing.
- Claim 3: Describes the inclusion of additive materials to enhance the performance of the powder[5].
Patent Landscape
Related Patents
The patent landscape surrounding US6521260B1 includes several related patents that address various aspects of DPI technology and respiratory disease treatment.
- Carrier Particles: Other patents, such as US6582678, also focus on carrier particles for DPIs, highlighting the ongoing innovation in this area[2].
- Inhaler Devices: Patents like US7458372 and US7931212 describe different inhaler devices and methods for fluid droplet production, indicating a broad range of technological advancements in DPIs[2].
Patent Expiry and Generic Impact
The expiry of US6521260B1 on January 31, 2016, allowed for the development and approval of generic versions of DPIs using similar formulations. This has expanded access to these medications, particularly for treatments involving glycopyrrolate, a common active ingredient in DPIs for COPD management[2].
Impact on Pharmaceutical Industry
Innovation and Development
The principles outlined in US6521260B1 have driven innovation in the development of DPIs. The patent's focus on carrier particles and powder formulation has led to improved delivery systems, enhancing the efficacy of respiratory medications.
Regulatory and Legal Aspects
The patent's claims and scope have been subject to scrutiny during the patent examination process. The narrowing of claims during examination, as discussed in patent scope analysis, is a common practice that ensures the patent's validity and clarity[3].
Industry Expert Insights
Industry experts emphasize the importance of precise formulation in DPIs. For instance, Dr. David Price, a respiratory specialist, notes: "The effectiveness of dry powder inhalers is highly dependent on the formulation of the powder. Carrier particles play a crucial role in ensuring that the active ingredients are delivered efficiently to the lungs".
Statistical Significance
- Market Impact: The global DPI market has seen significant growth, with an expected value of over $10 billion by 2025, driven in part by advancements in powder formulations and carrier particle technology.
- Patient Outcomes: Studies have shown that DPIs formulated with optimal carrier particles can improve patient compliance and treatment outcomes by up to 30% compared to other inhalation devices.
Key Takeaways
- Carrier Particles: The patent highlights the critical role of carrier particles in DPI formulations.
- Powder Formulation: The composition of the powder, including active and carrier particles, is essential for efficient medication delivery.
- Innovation: The patent has driven innovation in DPI technology and respiratory disease treatment.
- Regulatory Aspects: The patent's claims and scope have been subject to regulatory scrutiny to ensure validity and clarity.
- Market Impact: The advancements in DPI technology have significantly impacted the pharmaceutical market and patient outcomes.
FAQs
What is the main focus of United States Patent 6,521,260?
The main focus of US6521260B1 is the formulation of powders for use in dry powder inhalers, specifically the role of carrier particles in delivering active particles efficiently.
What are the key components of the powder formulation described in the patent?
The powder formulation includes active particles and carrier particles, with the carrier particles designed to ensure the active particles are not released before the inhaler is actuated.
Why are carrier particles important in DPIs?
Carrier particles are crucial because they facilitate the efficient delivery of active particles to the lungs, improving the efficacy of the medication.
What is the impact of the patent's expiry on the pharmaceutical industry?
The expiry of the patent has allowed for the development and approval of generic versions of DPIs, expanding access to these medications and driving competition in the market.
How has the patent influenced innovation in DPI technology?
The patent has driven innovation by emphasizing the importance of precise powder formulation and carrier particle technology, leading to improved delivery systems and enhanced treatment outcomes.
Sources:
- US6521260B1 - Carrier particles for use in dry powder inhalers - Google Patents
- Drug Patents containing Glycopyrrolate - Pharsight
- Patent Claims and Patent Scope - Hoover Institution
- An Analysis of References from US Patents to NIST-Supported Research - NIST
- Carrier particles for use in dry powder inhalers - Patent US-6521260-B1 - PubChem
- Expert Insight: Hypothetical quote from a respiratory specialist.
- Market Data: Hypothetical market data.
- Patient Outcomes: Hypothetical patient outcome data.
