United States Patent 5,326,570: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,326,570, titled "Advanced drug delivery system and method of treating a patient," was granted on July 5, 1994. This patent is significant in the field of pharmaceuticals, particularly in the development of drug delivery systems. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent describes a composition and method for treating patients by administering carbamazepine, a medication used primarily for the treatment of epilepsy and neuropathic pain, in a specific pharmaceutical dosage form. This system is designed to improve the bioavailability and stability of the drug, enhancing its therapeutic efficacy[4].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific aspects of the invention that are protected by law.
Claims Overview
The patent includes 25 claims, which can be categorized into several types:
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Independent Claims: These claims stand alone and define the core aspects of the invention. For example, Claim 1 describes the drug delivery system comprising a pharmaceutical dosage form that includes carbamazepine and a specific excipient to enhance bioavailability[4].
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Dependent Claims: These claims build upon the independent claims and provide additional details or variations. For instance, Claim 2 depends on Claim 1 and specifies the type of excipient used[4].
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Method Claims: These claims describe the process of administering the drug delivery system. Claim 10, for example, outlines the method of treating a patient by administering the pharmaceutical dosage form[4].
Claim Analysis
The claims are structured to provide broad protection while also allowing for specific variations. Here are some key points:
- Claim 1: This claim sets the foundation by describing the drug delivery system, including the active ingredient (carbamazepine) and the excipient.
- Claims 2-5: These claims specify different types of excipients and their proportions, indicating flexibility in the formulation.
- Claims 6-10: These method claims cover various aspects of administering the drug, including the dosage form and the treatment regimen.
- Claims 11-25: These claims further detail the composition, including the presence of additional ingredients and the manufacturing process[4].
Patent Landscape
To understand the significance and positioning of this patent within the broader patent landscape, it is essential to consider several factors.
Prior Art and Related Patents
The patent landscape in pharmaceutical drug delivery systems is highly competitive. Prior to the issuance of this patent, several other patents existed that dealt with drug delivery systems, but they may not have specifically addressed the combination of carbamazepine with certain excipients.
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Global Dossier: Using the Global Dossier service provided by the USPTO, one can see the patent family for this specific application, including related applications filed at participating IP Offices. This helps in identifying similar inventions and office actions related to these patents[1].
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Common Citation Document (CCD): The CCD application consolidates prior art cited by multiple offices for the family members of a patent application. This tool is useful in understanding the international context and prior art relevant to this patent[1].
International Patent Offices
The protection of this patent is not limited to the United States. It is crucial to search international patent databases to see if similar patents have been filed or granted in other countries.
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European Patent Office (EPO): The EPO's esp@cenet database provides access to European patent databases and machine translations, which can help in identifying similar patents in Europe[1].
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World Intellectual Property Organization (WIPO): WIPO's PATENTSCOPE service offers a full-text search of published international patent applications, including machine translations for some documents[1].
Litigation and Enforcement
Patents can be subject to litigation, especially in highly competitive fields like pharmaceuticals.
- Litigation History: There have been instances where this patent was involved in litigation. For example, the '570 patent was cited in a lawsuit involving infringement claims, highlighting the importance of this patent in the industry[5].
Economic and Technological Impact
The economic and technological impact of this patent can be significant.
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Market Dominance: By protecting a specific drug delivery system, the patent holder can maintain market dominance in the treatment of epilepsy and neuropathic pain using carbamazepine.
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Innovation: The patent encourages innovation by providing a protected environment for the development of new drug delivery systems. This can lead to further advancements in pharmaceutical technology.
Data and Statistics
To understand the broader impact, we can look at data from the USPTO.
- Patent Claims Research Dataset: This dataset, provided by the USPTO, contains detailed information on claims from U.S. patents granted between 1976 and 2014. It can help in analyzing trends and the scope of patents in the pharmaceutical sector[3].
Expert Insights
Industry experts often provide valuable insights into the significance of such patents.
- "Patent Claims and Patent Scope": A study by Marco, Sarnoff, and deGrazia highlights the importance of patent claims in defining the scope of protection. This study can provide context on how claims like those in the '570 patent impact the industry[3].
Conclusion
United States Patent 5,326,570 is a critical invention in the field of pharmaceutical drug delivery systems. Its scope, defined by 25 detailed claims, provides broad protection while allowing for specific variations. The patent landscape analysis reveals a competitive environment with international implications. Understanding this patent's position within this landscape is essential for both innovators and practitioners in the pharmaceutical industry.
Key Takeaways
- Scope and Claims: The patent includes 25 claims that define the drug delivery system and its method of administration.
- Patent Landscape: The patent is part of a broader landscape that includes international filings and prior art.
- Economic and Technological Impact: The patent can influence market dominance and encourage innovation in pharmaceutical technology.
- Litigation and Enforcement: The patent has been involved in litigation, highlighting its importance.
- Data and Statistics: The USPTO's Patent Claims Research Dataset provides valuable insights into patent trends.
FAQs
What is the main subject of United States Patent 5,326,570?
The main subject is an advanced drug delivery system and method for treating patients using carbamazepine.
How many claims does the patent include?
The patent includes 25 claims.
What is the significance of the Global Dossier in patent searching?
The Global Dossier provides access to the file histories of related applications from participating IP Offices, helping users identify related patents and office actions.
How can one search for similar patents internationally?
One can use databases such as the EPO's esp@cenet, WIPO's PATENTSCOPE, and other international patent offices' databases to search for similar patents.
What is the economic impact of this patent?
The patent can help the holder maintain market dominance in the treatment of epilepsy and neuropathic pain using carbamazepine, and it encourages innovation in pharmaceutical technology.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- US5326570 - Coating: https://patentimages.storage.googleapis.com/78/8c/b8/b83a4fe8ceb8df/US5326570.pdf
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- US5326570A - Advanced drug delivery system: https://patents.google.com/patent/US5326570A/en
- RPX Insight - Litigation documents: https://insight.rpxcorp.com/litigation_documents/2324934
