United States Patent 8,324,266: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,324,266, titled "Compositions, methods and systems for respiratory delivery of two or more active agents via a metered dose inhaler," is a significant patent in the field of respiratory medicine. This patent, assigned to Pearl Therapeutics, Inc., covers innovative compositions, methods, and systems for delivering multiple active agents to the respiratory system. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Purpose
The patent addresses the need for effective and efficient delivery of respiratory medications, particularly for conditions such as chronic obstructive pulmonary disease (COPD) and asthma. The invention focuses on the use of metered dose inhalers (MDIs) to deliver two or more active agents, enhancing the therapeutic efficacy and patient compliance.
Scope of the Patent
Compositions
The patent describes compositions that include two or more active agents, such as long-acting muscarinic antagonists (LAMAs) and long-acting beta2 adrenergic receptor agonists (LABAs), formulated for pulmonary delivery. These compositions are designed to be stable, efficient, and easy to administer via MDIs[4].
Methods
The methods outlined in the patent involve the preparation and administration of these compositions. This includes the process of formulating the active agents, filling the MDIs, and ensuring the consistent delivery of the medication to the lungs[4].
Systems
The patent also covers systems for delivering these compositions, including the design and functionality of the MDIs. These systems are engineered to ensure accurate dosing and optimal drug delivery to the respiratory tract[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1: A composition for pulmonary delivery comprising a first active agent and a second active agent, where the first and second active agents are formulated to be delivered via an MDI.
- Claim 10: A method for preparing a composition for pulmonary delivery, involving the steps of formulating the active agents and filling the MDI.
- Claim 20: A system for delivering a composition for pulmonary delivery, including an MDI and a canister containing the composition[4].
Dependent Claims
The dependent claims further specify the characteristics of the composition, method, and system, such as the types of active agents, the formulation process, and the design of the MDI.
Patent Landscape
Related Patents
The patent landscape surrounding US 8,324,266 includes several related patents that cover similar technologies and compositions. For example:
- US 10,716,753 B2: This patent, also assigned to Pearl Therapeutics, Inc., covers compositions and methods for pulmonary delivery of LAMAs and LABAs, but with a focus on different formulations and delivery systems[1].
- US 9415009: This patent involves methods and systems for respiratory delivery of active agents, with a focus on different types of inhalers and formulations[2].
Patent Expiration and Maintenance
The patent US 8,324,266 is currently active, with maintenance fees having been paid to extend its term. The next maintenance fee is due in the 12th year after the patent's grant date, ensuring the patent remains in force until its expiration date[2].
Industry Impact
The invention covered by US 8,324,266 has significant implications for the treatment of respiratory diseases. By providing a more efficient and effective way to deliver multiple active agents, it enhances patient outcomes and compliance.
Market and Generic Launch
The expiration of this patent could lead to the introduction of generic versions of the medication, potentially increasing accessibility and reducing costs for patients. However, the exact timeline for generic launch will depend on various factors, including the expiration dates of related patents and regulatory approvals[2].
Legal and Regulatory Considerations
Patent Eligibility
The patentability of processes and compositions like those described in US 8,324,266 is subject to the criteria outlined in 35 U.S.C. § 101. The claims must be tied to a particular machine or apparatus or transform a particular article into a different state or thing to be considered patent-eligible[5].
Litigation and Enforcement
Patent holders must be vigilant in enforcing their rights against potential infringers. The landscape of patent litigation is complex, and cases like Prometheus Laboratories, Inc. v. Mayo Collaborative Services highlight the importance of ensuring that patent claims meet the statutory requirements for patentability[5].
Metrics for Patent Scope
The scope of a patent can be measured using metrics such as independent claim length and independent claim count. Narrower claims, as seen in the examination process, are often associated with a higher probability of grant and a shorter examination process[3].
Key Takeaways
- Comprehensive Coverage: The patent covers compositions, methods, and systems for delivering multiple active agents via MDIs.
- Significant Impact: The invention enhances the treatment of respiratory diseases by improving delivery efficiency and patient compliance.
- Patent Landscape: The patent is part of a broader landscape that includes related patents and ongoing maintenance fees.
- Legal Considerations: The patent must meet specific criteria for patent eligibility and is subject to enforcement and potential litigation.
Frequently Asked Questions (FAQs)
What is the main focus of US Patent 8,324,266?
The main focus of US Patent 8,324,266 is on compositions, methods, and systems for the pulmonary delivery of two or more active agents via metered dose inhalers (MDIs).
Who is the assignee of this patent?
The assignee of this patent is Pearl Therapeutics, Inc.
What are the key active agents covered in this patent?
The key active agents covered include long-acting muscarinic antagonists (LAMAs) and long-acting beta2 adrenergic receptor agonists (LABAs).
How does this patent impact the treatment of respiratory diseases?
This patent enhances the treatment of respiratory diseases by providing a more efficient and effective way to deliver multiple active agents, improving patient outcomes and compliance.
When is the patent set to expire?
The exact expiration date is not specified in the provided sources, but it will be determined by the patent's grant date and any subsequent extensions or adjustments.
Cited Sources:
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United States Patent - googleapis.com
Compositions, methods and systems for pulmonary delivery of long-acting muscarinic antagonists and long-acting beta2 adrenergic receptor agonists and associated methods and systems.
US 10,716,753 B2
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Bevespi Aerosphere patent expiration - Pharsight
Find out all the patents protecting Bevespi Aerosphere drug, its owner, and when it is going to expire, along with insights into its generic launch.
-
Patent Claims and Patent Scope - Search eLibrary :: SSRN
This paper explores two very simple metrics for measuring patent scope based on claim language: independent claim length and independent claim count.
-
US8324266B2 - Compositions, methods and systems for respiratory delivery of two or more active agents - Google Patents
Compositions, methods and systems are provided for pulmonary or nasal delivery of two or more active agents via a metered dose inhaler.
-
Prometheus Laboratories, Inc. v. Mayo Collaborative Services
The United States District Court for the Southern District of California granting summary judgment of invalidity of U.S. Patents 6,355,623 (“the ’623 patent”) and 6,680,302 (“the ’302 patent”) under 35 U.S.C. § 101.
