United States Patent 5,716,640: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,716,640, owned by Takeda, is a significant patent in the pharmaceutical sector, particularly in the field of drug delivery systems. This patent is part of a broader portfolio of patents related to controlled release formulations, which are crucial for the treatment of various medical conditions. Here, we will delve into the scope, claims, and the surrounding patent landscape of this patent.
Background of the Patent
The patent, titled "Slow-releasing microcapsule," was issued on February 3, 1998. It is part of a series of patents that describe methods and compositions for controlled release of bioactive substances, such as peptides, proteins, and other therapeutic agents[5].
Scope of the Patent
The scope of U.S. Patent 5,716,640 encompasses a specific type of slow-releasing microcapsule designed for the controlled release of bioactive substances over an extended period. The microcapsules are composed of a bioactive substance encapsulated in a polymer-coated layer, which is permeable, swellable, and does not break or dissolve under normal physiological conditions. This design ensures a constant rate of release of the bioactive substance without unexpected disintegration[5].
Claims of the Patent
The claims of the patent are critical in defining the invention and its boundaries. Here are some key claims:
- Claim 1: A slow-releasing microcapsule comprising a bioactive substance encapsulated in a polymer-coated layer.
- Claim 2: The microcapsule of claim 1, where the polymer-coated layer is permeable, swellable, and does not break or dissolve under normal physiological conditions.
- Claim 3: A method for preparing the slow-releasing microcapsule, including encapsulating the bioactive substance in a polymer-coated layer[5].
Importance of Claim Scope
The scope of the claims is crucial for the validity and enforceability of the patent. A common misconception is that broader claims are always better, but this can lead to higher risks of invalidation. For instance, overly broad claims can be challenged under the abstract idea exception or for failing to meet the written description requirement[3].
Patent Landscape
The patent landscape surrounding U.S. Patent 5,716,640 is complex and involves several related patents and technologies.
Related Patents
- U.S. Patent Nos. 4,652,441; 4,677,191; 4,728,721; 4,849,228; 4,917,893; 5,476,663; 5,575,987; 5,631,020; 5,631,021: These patents, also owned by Takeda, describe various aspects of controlled release formulations, including methods for preparing microcapsules and biodegradable polymers used in these formulations[5].
- U.S. Patent Nos. 5470311; 5486362: These patents describe devices and methods for delivering pharmaceutical compositions, including microcapsules and other controlled release systems[4].
Litigation and Enforcement
The patent has been involved in significant litigation, particularly in cases related to the infringement of Takeda's patents by other pharmaceutical companies. For example, Takeda has sued OWL Pharmaceuticals and Oakwood Laboratories for the alleged infringement of U.S. Patent 5,716,640, among other patents, in connection with the manufacture and sale of Leuprolide Acetate for Depot Injection[5].
Global Context
The global patent landscape for controlled release formulations is highly competitive and involves numerous stakeholders. The USPTO's Global Dossier service, for instance, allows users to access the file histories of related applications from participating IP Offices, which can be crucial for navigating this complex landscape[1].
Technical Field and Background Technology
The technical field of U.S. Patent 5,716,640 involves the use of compressed microparticles and microcapsules for controlled drug release. This field has seen significant advancements, with various patents describing different methods and materials for achieving controlled release. For example, U.S. Patents 5023082 and 5342622 describe slow-releasing compositions and veterinary drug implants, respectively[4].
Impact on the Pharmaceutical Industry
The patent has a substantial impact on the pharmaceutical industry, particularly in the development of controlled release formulations. These formulations are essential for improving patient compliance and therapeutic efficacy. The patent's claims and scope define a specific technology that has been widely used and has influenced the development of subsequent technologies in this field.
Key Takeaways
- Specific Claims: The patent's claims are specific to slow-releasing microcapsules with a polymer-coated layer.
- Litigation: The patent has been involved in significant litigation related to infringement.
- Related Patents: It is part of a broader portfolio of patents related to controlled release formulations.
- Global Context: The patent is part of a global landscape of controlled release technologies.
- Impact: It has a substantial impact on the development and use of controlled release formulations in the pharmaceutical industry.
FAQs
What is the main invention described in U.S. Patent 5,716,640?
The main invention is a slow-releasing microcapsule designed for the controlled release of bioactive substances over an extended period.
Who owns U.S. Patent 5,716,640?
The patent is owned by Takeda.
What are the key claims of the patent?
The key claims include the composition of the microcapsule, the method of preparation, and the characteristics of the polymer-coated layer.
Why is the scope of the claims important?
The scope of the claims is crucial for the validity and enforceability of the patent, as overly broad claims can lead to invalidation.
How has the patent been involved in litigation?
The patent has been involved in litigation related to infringement by other pharmaceutical companies, such as OWL Pharmaceuticals and Oakwood Laboratories.
Sources
- USPTO - Search for patents.
- USA.gov - U.S. Patent and Trademark Office (USPTO).
- Rimon Law - The Importance of Getting the Claim Scope Right in a US Patent Application.
- Google Patents - CN101164531A - Compressed microparticles for dry injection.
- Insight.RPXcorp - IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF OHIO.
