Understanding the Scope and Claims of United States Patent 7,214,683
Introduction
United States Patent 7,214,683, hereafter referred to as the '683 patent, is a significant intellectual property asset in the pharmaceutical industry, particularly related to the drug Clarinex® (desloratadine). This patent is owned by Sepracor (now part of Sunovion Pharmaceuticals) and the University of Massachusetts (UMass). Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape.
Background of the Patent
The '683 patent is associated with the development and commercialization of desloratadine, an antihistamine used to treat allergies. The patent protects specific formulations, methods of use, and other aspects related to this drug.
Patent Claims
The claims of a patent are crucial as they define the scope of the invention and what is protected under the patent. Here are some key aspects of the claims in the '683 patent:
Independent Claims
Independent claims in a patent are standalone claims that do not depend on other claims. For the '683 patent, these claims typically include:
- Composition Claims: These claims cover the specific formulations of desloratadine, including the active ingredient and any excipients.
- Method of Use Claims: These claims describe the methods by which the drug is administered and used to treat specific conditions, such as allergies.
Dependent Claims
Dependent claims build upon the independent claims and provide additional specificity. For example:
- Dosage Forms: Claims might specify particular dosage forms, such as orally disintegrating tablets.
- Dosage Regimens: These claims could outline the recommended dosages and frequency of administration.
Scope of the Patent
The scope of the '683 patent is defined by its claims and the description provided in the patent specification.
Product Protection
The patent protects the specific product formulations of desloratadine, ensuring that any generic versions must differ significantly to avoid infringement.
Method Protection
The methods of use and administration are also protected, which means that any generic drug maker must either use a different method or obtain permission from the patent holders.
Patent Landscape
The patent landscape surrounding the '683 patent involves several key elements:
Related Patents
Other patents related to Clarinex®, such as United States Patent Nos. 7,211,582 and 7,214,684, also owned by Sepracor and UMass, form a protective umbrella around the drug. These patents may cover different aspects of the drug, such as manufacturing processes or additional formulations[2].
Global Dossier and International Protection
The Global Dossier service provided by the USPTO allows users to view the patent family for a specific application, including related applications filed at participating IP Offices. This service helps in understanding the global protection landscape for the '683 patent and related patents[1].
Litigation History
The '683 patent has been involved in several patent infringement cases. For instance, Sepracor and UMass sued Orchid Pharmaceuticals for filing Abbreviated New Drug Applications (ANDAs) with the FDA, which allegedly infringed on the '683 patent among others. This highlights the active enforcement of the patent rights by the owners[2][5].
Economic and Strategic Impact
The '683 patent has significant economic and strategic implications:
Market Exclusivity
By protecting the specific formulations and methods of use, the patent ensures market exclusivity for the branded drug Clarinex®, allowing Sepracor and UMass to maintain a competitive edge in the market.
Generic Competition
The patent's expiration date is crucial as it determines when generic versions of the drug can enter the market. Generic drug makers must wait until the patent expires or obtain permission to market their versions, which can significantly impact the market dynamics[2].
Tools for Patent Analysis
Several tools and resources are available for analyzing patents like the '683 patent:
Patent Public Search
The USPTO's Patent Public Search tool provides enhanced access to prior art and allows users to search and analyze patent documents effectively[1].
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset offers detailed information on claims from US patents, including claim-level statistics and document-level statistics. This dataset can be used to analyze the scope and trends of patent claims[3].
Common Citation Document (CCD)
The CCD application consolidates citation data from participating IP Offices, enabling users to visualize the prior art cited by multiple offices for the same invention. This is particularly useful for understanding the global citation landscape of the '683 patent[1].
Conclusion
The '683 patent is a critical asset in the pharmaceutical industry, protecting the drug Clarinex® and its related formulations and methods of use. Understanding the scope and claims of this patent, along with its place in the broader patent landscape, is essential for both the patent holders and potential generic competitors.
Key Takeaways
- Patent Claims: The '683 patent includes composition and method of use claims that define its scope.
- Scope of Protection: The patent protects specific formulations and methods of use for desloratadine.
- Related Patents: Other patents related to Clarinex® form a protective umbrella around the drug.
- Litigation History: The patent has been involved in several infringement cases.
- Economic Impact: The patent ensures market exclusivity and affects generic competition.
- Tools for Analysis: Resources like Patent Public Search and the Patent Claims Research Dataset are crucial for analyzing the patent.
FAQs
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What is the '683 patent related to?
- The '683 patent is related to the drug Clarinex® (desloratadine), specifically its formulations and methods of use.
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Who owns the '683 patent?
- The '683 patent is owned by Sepracor (now part of Sunovion Pharmaceuticals) and the University of Massachusetts (UMass).
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What are the key claims of the '683 patent?
- The key claims include composition claims for the specific formulations of desloratadine and method of use claims for its administration.
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How does the '683 patent impact generic competition?
- The patent prevents generic versions of Clarinex® from entering the market until it expires or unless the generic drug maker obtains permission.
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What tools can be used to analyze the '683 patent?
- Tools such as the USPTO's Patent Public Search, Global Dossier, and the Patent Claims Research Dataset can be used to analyze the patent.
Sources
- USPTO - Search for patents
- Case 3:07-cv-04623-MLC-TJB Document 1 Filed 09/26/07
- USPTO - Patent Claims Research Dataset
- RaySearch Laboratories Annual Report 2020
- GenomeWeb - Sepracor, UMass Sue Generic Drug Maker For Allegedly Infringing Clarinex Patents
