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Last Updated: December 22, 2024

Details for Patent: 4,880,823


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Summary for Patent: 4,880,823
Title: Injection of nicardinpine hydrochloride and process for the production thereof
Abstract:An injectable composition of nicardipine hydrochloride comprising an aqueous nicardipine hydrochloride solution containing 2-7 w/v % of polyhydric alcohol. This injectable composition can maintain its desired concentration and can be stably stored for a long period of time.
Inventor(s): Ogawa; Katayasu (Saitama, JP), Ohtani; Go (Tokyo, JP), Yokota; Shoji (Tokyo, JP), Aruga; Masayoshi (Saitama, JP)
Assignee: Yamanouchi Pharmaceutical Co., Ltd. (Tokyo, JP)
Application Number:07/338,402
Patent Claim Types:
see list of patent claims
Composition; Formulation; Process;
Patent landscape, scope, and claims:

Analyzing the Scope and Claims of United States Patent 4,880,823

Introduction

United States Patent 4,880,823, titled "Injection of nicardipine hydrochloride and process," is a patent that describes an injectable composition of nicardipine hydrochloride and the process for its production. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape.

Patent Overview

Patent Number and Title

  • The patent number is 4,880,823, and the title is "Injection of nicardipine hydrochloride and process."

Invention Description

  • This patent relates to an injectable composition of nicardipine hydrochloride, which has cerebral vascular dilating activity, coronary dilator activity, and anti-hypertension activity. The invention also includes the process of producing this injectable composition, specifically focusing on the adjustment of the pH of the aqueous solution to enhance its effectiveness[4].

Scope of the Patent

Claims

  • The patent includes multiple claims that define the scope of the invention. Here are some key aspects:
    • Claim 1: This claim typically defines the broadest scope of the invention, which in this case would be the injectable composition containing nicardipine hydrochloride and a polyhydric alcohol.
    • Dependent Claims: These claims narrow down the scope by adding specific limitations, such as the concentration of the polyhydric alcohol (2 to 7 W/V%) and the pH adjustment of the aqueous solution (pH 2.5 to 5)[4].

Process Claims

  • The patent also includes claims related to the process of producing the injectable composition. These claims detail the steps involved in preparing the solution, including the adjustment of pH and the addition of specific components.

Patent Claims Analysis

Independent Claims

  • Independent claims are those that stand alone and do not depend on other claims. For example, Claim 1 might read: "An injectable composition comprising nicardipine hydrochloride and 2 to 7 W/V% of a polyhydric alcohol."

Dependent Claims

  • Dependent claims build upon the independent claims by adding additional limitations. For instance, a dependent claim might specify the pH range of the aqueous solution: "The composition of claim 1, wherein the pH of the aqueous solution is adjusted to 2.5 to 5."

Patent Landscape

Prior Art and Related Patents

  • The patent landscape includes prior art and related patents that were considered during the examination process. For US Patent 4,880,823, the application was a continuation of earlier abandoned applications, indicating a complex history of development and refinement[4].

Global Dossier and International Search

  • To understand the global patent landscape, tools like the Global Dossier can be used. This service provides access to the file histories of related applications from participating IP Offices, helping to identify similar inventions and prior art[1].

Economic and Commercial Impact

Commercial Value

  • The commercial value of the patent is significant, given the therapeutic applications of nicardipine hydrochloride. The cost of developing and maintaining a patent, including prosecution and potential appeals, can be substantial, often ranging from $30,000 to much higher over the patent's lifetime[5].

Licensing and Commercialization

  • Patents like this one can be licensed to pharmaceutical companies, which can then commercialize the invention. The licensing process involves negotiating terms that ensure the patent holder recovers their investment and potentially generates revenue[5].

Legal and Regulatory Aspects

Inventorship

  • Determining the true and only inventors is crucial in patent law. The Court of Appeals for the Federal Circuit has frequently addressed issues of proper inventorship, emphasizing the importance of correctly identifying those who conceived the idea and reduced it to practice[2].

Patent Prosecution

  • The patent prosecution process involves the review of the patent application by a patent examiner. This process can be lengthy, often taking two to five years, and may involve arguments and amendments to the claims to overcome rejections[5].

Search and Analysis Tools

Patent Public Search

  • Tools like the Patent Public Search provided by the USPTO offer enhanced access to prior art, allowing for a comprehensive search of existing patents and published patent applications. This is crucial for understanding the patent landscape and ensuring the novelty of the invention[1].

Common Citation Document (CCD)

  • The CCD application consolidates citation data from participating IP Offices, enabling a single-point access to prior art cited by multiple offices. This helps in visualizing the search results for the same invention across different jurisdictions[1].

Key Takeaways

  • Patent Scope: The patent covers an injectable composition of nicardipine hydrochloride and the process for its production, with specific claims related to the composition and process.
  • Claims Analysis: Independent and dependent claims define the scope of the invention, with a focus on the composition and pH adjustment.
  • Patent Landscape: The patent is part of a broader landscape that includes prior art and related patents, both domestically and internationally.
  • Commercial Impact: The patent has significant commercial value, with potential for licensing and commercialization.
  • Legal Aspects: Proper inventorship and patent prosecution are critical legal considerations.

FAQs

Q: What is the main subject matter of US Patent 4,880,823? A: The main subject matter is an injectable composition of nicardipine hydrochloride and the process for its production.

Q: How does the pH adjustment affect the composition? A: The pH adjustment to 2.5 to 5 enhances the effectiveness of the injectable composition.

Q: What are the typical costs associated with patenting a similar invention? A: The costs can range from $8,000 to $20,000 for a U.S. non-provisional patent application, and significantly more for international patents and prosecution costs.

Q: How long does the patent prosecution process typically take? A: The patent prosecution process can take two to five years.

Q: What tools can be used to analyze the global patent landscape for this invention? A: Tools such as the Global Dossier and the Common Citation Document (CCD) can be used to analyze the global patent landscape.

Sources

  1. USPTO - Search for patents
  2. Oregon State University - Determining Inventorship for US Patent Applications
  3. USPTO - Patent Claims Research Dataset
  4. Google Patents - US4880823A
  5. KU Office of Research - Intellectual Property Protection

More… ↓

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Drugs Protected by US Patent 4,880,823

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 4,880,823

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Japan59-102991May 22, 1984

International Family Members for US Patent 4,880,823

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 63810 ⤷  Subscribe
Canada 1240930 ⤷  Subscribe
Germany 3582954 ⤷  Subscribe
European Patent Office 0162705 ⤷  Subscribe
Spain 543343 ⤷  Subscribe
Spain 8700567 ⤷  Subscribe
Greece 851230 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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