Sustained-release Composition and Method for Producing the Same: A Detailed Analysis of US Patent 8,921,326
Introduction
The United States Patent 8,921,326, titled "Sustained-release composition and method for producing the same," is a significant patent in the pharmaceutical industry, particularly in the field of drug delivery systems. This patent, assigned to Takeda Pharmaceutical Company Limited, was issued on December 30, 2014. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
Sustained-release compositions are designed to release a drug over an extended period, improving patient compliance and therapeutic efficacy. The patent in question addresses a specific method and composition for achieving this sustained release, particularly for water-soluble physiologically active peptides.
Patent Scope
Definition and Coverage
The patent scope defines the boundaries of the invention, outlining what is protected and what is not. For US Patent 8,921,326, the scope includes a sustained-release composition where a water-soluble physiologically active peptide is substantially uniformly dispersed in a microcapsule. This dispersion ensures a controlled and sustained release of the peptide over time[1].
Claim Structure
The claims of a patent are crucial as they define the invention and the rights of the patentee. This patent includes multiple claims, each detailing different aspects of the composition and method:
- Independent Claims: These claims stand alone and define the core of the invention. For example, Claim 1 might describe the composition itself, while Claim 2 could detail the method of producing the microcapsules.
- Dependent Claims: These claims build upon the independent claims, providing additional details or limitations. For instance, a dependent claim might specify the type of peptide or the material used for the microcapsules[1].
Claim Analysis
Independent Claim Length and Count
Research has shown that the length and count of independent claims can be indicative of patent scope. Shorter independent claims and fewer claims generally suggest a narrower scope, which can be associated with a higher probability of grant and a shorter examination process[3].
Claim Clarity and Breadth
The clarity and breadth of claims are critical for patent quality. Clear and specific claims reduce the likelihood of litigation and ensure that the patent owner's property rights are well-defined. In the case of US Patent 8,921,326, the claims are detailed enough to specify the uniform dispersion of the peptide within the microcapsule, ensuring clarity and precision[3].
Method of Production
Microcapsule Formation
The method for producing the sustained-release composition involves encapsulating the water-soluble peptide within microcapsules. This process ensures that the peptide is released in a controlled manner, which is essential for maintaining therapeutic levels over an extended period. The inventors, Futo Tomomichi, Saito Kazuhiro, Hoshino Tetsuo, and Hori Masuhisa, have detailed a specific process to achieve this uniform dispersion[1].
Patent Landscape
Related Patents and Exclusivities
The patent landscape for sustained-release compositions is complex, with multiple patents covering various aspects of drug delivery systems. The USPTO's Orange Book lists patents associated with drug products, including those related to sustained-release formulations. For example, a drug product might be covered by multiple patents, each with different expiration dates and scopes, affecting the timing of generic competition[4].
Litigation and Enforcement
Patent litigation is a significant aspect of the pharmaceutical industry. Companies like Novartis have been involved in extensive litigation to protect their patents, including those related to sustained-release formulations. The construction of claims and the scope of patents are often at the heart of these legal battles, highlighting the importance of clear and well-defined claims[2].
Market Impact
Generic Competition
The expiration of patents can lead to generic competition, which significantly impacts the market. For sustained-release compositions, the expiration of key patents can allow generic manufacturers to enter the market, potentially reducing prices and increasing access to these drugs. However, the presence of multiple patents with different expiration dates can delay generic entry, as seen in cases like IMBRUVICA and LIPITOR[4].
Regulatory Considerations
FDA and USPTO Coordination
The FDA and USPTO work together to ensure that patents associated with drug products are properly listed and that exclusivity periods are respected. This coordination is crucial for maintaining the integrity of the patent system and ensuring that generic drugs are approved only after the relevant patents have expired or are no longer infringed[4].
Key Takeaways
- Patent Scope: The patent defines a sustained-release composition with a water-soluble peptide uniformly dispersed in microcapsules.
- Claim Structure: The patent includes independent and dependent claims that specify the composition and method of production.
- Method of Production: The method involves encapsulating the peptide within microcapsules to achieve controlled release.
- Patent Landscape: The patent is part of a complex landscape with multiple related patents and exclusivities.
- Market Impact: The expiration of this patent could lead to generic competition, affecting market dynamics.
FAQs
What is the main invention described in US Patent 8,921,326?
The main invention is a sustained-release composition where a water-soluble physiologically active peptide is substantially uniformly dispersed in a microcapsule.
Who are the inventors of this patent?
The inventors are Futo Tomomichi, Saito Kazuhiro, Hoshino Tetsuo, and Hori Masuhisa.
What is the significance of the microcapsule in this patent?
The microcapsule ensures the controlled and sustained release of the peptide over time, which is crucial for maintaining therapeutic levels.
How does this patent fit into the broader patent landscape?
This patent is part of a complex landscape involving multiple patents related to drug delivery systems, including sustained-release formulations.
What is the potential market impact of this patent's expiration?
The expiration of this patent could lead to generic competition, potentially reducing prices and increasing access to the drug.
Sources
- US8921326B2 - Sustained-release composition and method for producing the same - Google Patents
- Patent Litigation : No. 20-md-2930-LPS Stringham - GovInfo
- Patent Claims and Patent Scope - Hoover Institution
- Drug patent and exclusivity study - USPTO
- Generic Lupron Depot Availability - Drugs.com
