Understanding the Scope and Claims of United States Patent 5,023,252
Introduction
United States Patent 5,023,252, often referred to as the "Hsieh patent," is a significant patent in the field of pharmaceuticals, particularly in the development of enhancers for transdermal drug delivery. This article delves into the details of the patent's scope, claims, and its impact on the patent landscape.
Background of the Patent
The Hsieh patent, issued to inventor Tsung-Min Hsieh, pertains to cyclic enhancers used in pharmaceutical compositions to increase the rate of passage of drugs through the skin or other body membranes. This technology is crucial for improving the efficacy of transdermal drug delivery systems.
Patent Claims
The patent claims are the heart of any patent, defining the scope of protection granted to the inventor. Here are some key aspects of the claims in the Hsieh patent:
Independent Claims
The independent claims of the Hsieh patent describe specific cyclic enhancers, such as oxacylohexadecan-2-one, which are designed to enhance the permeability of the skin to drugs. For example, the claims specify the chemical structure and properties of these enhancers, ensuring that only these specific compounds are protected under the patent[1].
Dependent Claims
Dependent claims build upon the independent claims, often providing more detailed descriptions or specific applications of the invention. In the Hsieh patent, dependent claims may include variations of the cyclic enhancers or their use in combination with other ingredients to enhance drug delivery.
Scope of the Patent
The scope of the Hsieh patent is defined by its claims and the description provided in the patent specification.
Enhancers Described
The patent describes a class of cyclic enhancers, including oxacylohexadecan-2-one, which are capable of increasing the rate of passage of androgen through the skin. These enhancers are critical for the development of effective transdermal drug delivery systems, particularly for treating conditions like hypogonadism[1].
Applications
The patent's scope extends to various pharmaceutical compositions that incorporate these enhancers. This includes formulations for treating hypogonadism using testosterone gel, as seen in subsequent patents that claim priority to the Hsieh patent[1].
Impact on the Patent Landscape
The Hsieh patent has had a significant impact on the development of transdermal drug delivery systems.
Influence on Subsequent Patents
Patents such as those involved in the case of Auxilium Pharmaceuticals, Inc. v. Upsher-Smith Labs., Inc. claim priority to the Hsieh patent. These patents build upon the technology described in the Hsieh patent, further refining the formulations and applications of the cyclic enhancers[1].
Industry Standards
The Hsieh patent has set a standard for the development of transdermal enhancers. Pharmaceutical companies developing similar products must ensure that their formulations do not infringe on the claims of the Hsieh patent, driving innovation and differentiation in the field.
Patent Prosecution and Litigation
The prosecution and litigation history surrounding patents that rely on the Hsieh patent provide valuable insights into the challenges and strategies involved in protecting intellectual property.
Doctrine of Equivalents
In cases like Auxilium Pharmaceuticals, Inc. v. Upsher-Smith Labs., Inc., the doctrine of equivalents is often invoked to determine whether an accused device or formulation is equivalent to the claimed invention. The court's decision in such cases highlights the importance of precise claim drafting and the limitations of the doctrine of equivalents[1].
Global Patent Landscape
The Hsieh patent is part of a broader global patent landscape that includes similar technologies and innovations from various countries.
International Search Resources
To navigate this landscape, researchers and inventors can use resources such as the European Patent Office's esp@cenet, the Japan Patent Office's database, and the World Intellectual Property Organization's PATENTSCOPE® Search Service. These tools help in identifying prior art and ensuring that new inventions do not infringe on existing patents[4].
Economic and Research Implications
The Hsieh patent and similar patents contribute to the economic and research dynamics in the pharmaceutical industry.
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents, including those related to pharmaceuticals. This dataset helps in analyzing trends and scope measurements of patents, which can inform research and development strategies[3].
Key Takeaways
- Specific Enhancers: The Hsieh patent protects specific cyclic enhancers like oxacylohexadecan-2-one.
- Transdermal Drug Delivery: The patent is crucial for transdermal drug delivery systems, particularly for treating hypogonadism.
- Impact on Subsequent Patents: The patent has influenced numerous subsequent patents in the field.
- Global Landscape: Understanding the global patent landscape is essential for navigating and innovating in this field.
- Economic and Research Implications: The patent contributes to the economic and research dynamics in the pharmaceutical industry.
FAQs
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What is the main subject of the Hsieh patent?
The main subject of the Hsieh patent is cyclic enhancers used to increase the rate of passage of drugs through the skin or other body membranes.
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How does the Hsieh patent influence subsequent patents?
The Hsieh patent sets a foundation for subsequent patents by describing specific enhancers and their applications, which are then built upon and refined in later patents.
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What is the doctrine of equivalents, and how is it relevant to the Hsieh patent?
The doctrine of equivalents is a legal principle that allows patent holders to claim infringement against devices or formulations that are not literally described in the patent claims but are equivalent in function, way, and result. This doctrine is often invoked in litigation involving patents that rely on the Hsieh patent.
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Where can researchers find information on global patent landscapes?
Researchers can use databases such as the European Patent Office's esp@cenet, the Japan Patent Office's database, and the World Intellectual Property Organization's PATENTSCOPE® Search Service to navigate the global patent landscape.
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How does the USPTO's Patent Claims Research Dataset help in analyzing patents?
The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents, allowing researchers to analyze trends and scope measurements of patents, which can inform research and development strategies.
Sources
- Auxilium Pharms., Inc. v. Upsher-Smith Labs., Inc. - Casetext
- Desmopressin composition - Patent US-2010160214-A1 - PubChem
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- WO1999055855A2 - Neuropilin antisense ... - Google Patents
