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Last Updated: April 11, 2025

Details for Patent: 10,583,121


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Summary for Patent: 10,583,121
Title:Patch
Abstract: A patch for administering asenapine includes a support layer, and an adhesive agent layer formed on the support layer and including an adhesive base agent and asenapine and/or a pharmaceutically acceptable salt thereof. The adhesive base agent has a content in a range of 10 to 90% by mass in the adhesive agent layer and includes a natural rubber, polyisobutylene, an alkyl vinyl ether(co)polymer, polyisoprene, polybutadiene, a styrene-butadiene copolymer, a styrene-isoprene copolymer, a styrene-isoprene-styrene block copolymer, or a combination thereof. When a content of the asenapine and/or pharmaceutically acceptable salt thereof in terms of free asenapine in the adhesive agent layer is 3.4 mg, an AUC.sub.2-120 for a period starting from the time when the patch is brought into contact with a skin for 24 hours is 27,000 pghr/mL or more, and an AUC.sub.2-120 of an asenapine metabolite is 20% or less of the AUC.sub.2-120 of the free asenapine.
Inventor(s): Suzuki; Masayuki (Tsukuba, JP), Okutsu; Hiroaki (Tsukuba, JP), Yasukochi; Takashi (Tsukuba, JP), Takada; Yasunori (Tsukuba, JP)
Assignee: HISAMITSU PHARMACEUTICAL CO., INC. (Tosu-shi, JP)
Application Number:15/454,066
Patent Claim Types:
see list of patent claims
Use; Compound;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 10,583,121

Introduction

United States Patent 10,583,121, titled "Patch," is a patent that describes a specific type of transdermal patch for administering the drug asenapine. To fully comprehend the patent's implications and its place in the patent landscape, it is crucial to analyze its scope, claims, and the broader context of patent law.

Patent Overview

The patent, assigned to a specific entity, details a transdermal patch designed for the administration of asenapine, a medication used to treat certain psychiatric conditions. Here is a brief overview of the patent:

  • Publication Number: US10583121B2
  • Publication Date: The patent was published and granted, indicating it has undergone the necessary review and approval process by the United States Patent and Trademark Office (USPTO)[4].

Claims Analysis

The claims section of a patent is critical as it defines the scope of the invention and what is protected by the patent.

Independent and Dependent Claims

  • Independent Claims: These claims stand alone and define the invention without reference to other claims. In the case of US10583121B2, the independent claims describe the basic structure and components of the transdermal patch, including the support layer and the adhesive agent layer.
  • Dependent Claims: These claims refer back to and further limit the independent claims. They often describe specific embodiments or variations of the invention. For example, dependent claims might specify particular materials used in the adhesive agent layer or the dimensions of the patch.

Claim Construction

Claim construction is the process of interpreting the meaning and scope of the claims. This is crucial for determining what is protected by the patent and what might infringe upon it. The claims must be clear and definite to avoid ambiguity, which could lead to disputes or litigation[1].

Scope of the Invention

The scope of the invention is defined by the claims and the specification (description) of the patent.

Key Components

  • Support Layer: This is the base layer of the patch that provides structural integrity.
  • Adhesive Agent Layer: This layer contains the adhesive base agent and the drug asenapine, which is administered through the skin.
  • Pharmaceutically Acceptable Materials: The patent specifies that the materials used must be pharmaceutically acceptable, ensuring safety and efficacy for medical use[4].

Inventorship and Ownership

Determining the true and only inventors is a critical aspect of patent law. For US10583121B2, the inventors listed are those who conceived the idea of the transdermal patch as described in the claims. Inventorship focuses on the conception step, not the reduction to practice, unless the reduction to practice involved more than ordinary skill in the field[1].

Patent Landscape

The patent landscape for transdermal patches and drug delivery systems is complex and highly competitive.

Prior Art

The patent must be novel and non-obvious over prior art. The prior art keywords listed for US10583121B2 include "asenapine," "adhesive agent layer," and "patch," indicating that the patent office considered existing technologies in the field when granting the patent[4].

Competing Patents

Other patents in the field of transdermal drug delivery may overlap or compete with US10583121B2. Analyzing these patents can help in understanding the unique contributions and innovations of US10583121B2.

Legal and Regulatory Considerations

Patents must comply with various legal and regulatory requirements.

Patent Eligibility

The patent must meet the criteria for patent eligibility under 35 U.S.C. § 101, which includes being a new and useful process, machine, manufacture, or composition of matter, or any improvement thereof. The Supreme Court has established tests, such as the Mayo/Alice inquiry, to determine if claims are directed to patent-ineligible concepts like abstract ideas or laws of nature[2].

Enforceability

The patent must be free from errors in inventorship and any deceptive intent to be enforceable. Errors in inventorship can be corrected, but deceptive intent can render the patent unenforceable[1].

Economic and Practical Implications

The economic and practical implications of US10583121B2 are significant.

Market Impact

The patent could influence the market for transdermal patches and asenapine administration, potentially affecting competitors and patients. It may also drive innovation in related fields.

Licensing and Litigation

The patent could be licensed to other companies, or it might be the subject of litigation if there are disputes over infringement or validity.

Future Developments

The patent landscape is dynamic, with ongoing research and development in drug delivery systems.

Small Claims Patent Court

There are discussions and studies on the feasibility of a small claims patent court, which could impact how patent disputes, including those related to US10583121B2, are handled in the future[5].

Key Takeaways

  • Clear Claims: The claims of US10583121B2 must be clear and definite to define the scope of the invention.
  • Inventorship: The true and only inventors are those who conceived the idea of the transdermal patch.
  • Patent Eligibility: The patent must meet the criteria for patent eligibility under U.S. law.
  • Market Impact: The patent could significantly impact the market for transdermal patches and asenapine administration.
  • Future Developments: Ongoing research and potential changes in patent litigation procedures could affect the patent's enforcement and validity.

Frequently Asked Questions (FAQs)

Q: What is the main subject matter of US10583121B2? A: The main subject matter is a transdermal patch for administering the drug asenapine.

Q: Who are considered inventors under U.S. patent law? A: Inventors are those who conceived the idea or subject matter of at least one claim of the patent.

Q: What is the significance of claim construction in patent law? A: Claim construction is crucial for determining the scope and meaning of the claims, which defines what is protected by the patent.

Q: Can errors in inventorship be corrected after a patent is issued? A: Yes, errors in inventorship can be corrected, but deceptive intent in naming inventors can render the patent unenforceable.

Q: How does the Mayo/Alice inquiry apply to patent eligibility? A: The Mayo/Alice inquiry is a two-step test to determine if claims are directed to patent-ineligible concepts like abstract ideas or laws of nature.

Citations

  1. Determining Inventorship for US Patent Applications - Oregon State University[1]
  2. ENFISH, LLC v. MICROSOFT CORPORATION - United States Court of Appeals for the Federal Circuit[2]
  3. Patent and patent application Claims data - USPTO[3]
  4. US10583121B2 - Patch - Google Patents[4]
  5. U.S. Patent Small Claims Court - Administrative Conference of the United States[5]

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Drugs Protected by US Patent 10,583,121

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Foreign Priority and PCT Information for Patent: 10,583,121

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Japan2012-165793Jul 26, 2012
Japan2013-078583Apr 4, 2013

International Family Members for US Patent 10,583,121

CountryPatent NumberEstimated ExpirationSupplementary Protection CertificateSPC CountrySPC Expiration
China 104487071 ⤷  Try for Free
China 104487072 ⤷  Try for Free
China 104507472 ⤷  Try for Free
European Patent Office 2878298 ⤷  Try for Free
European Patent Office 2878299 ⤷  Try for Free
European Patent Office 2878300 ⤷  Try for Free
>Country>Patent Number>Estimated Expiration>Supplementary Protection Certificate>SPC Country>SPC Expiration
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