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Last Updated: December 22, 2024

Details for Patent: 6,046,183


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Summary for Patent: 6,046,183
Title: Method of synergistic treatment for benign prostatic hyperplasia
Abstract:Disclosed is an improved treatment for men with benign prostatic hyperplasia (BPH), involving combination therapy of a 5.alpha.-reductase inhibitor, e.g. a 17.beta.-substituted 4-azasteroid, a 17.beta.-substituted non-azasteroid, 17.beta.-acyl-3-carboxy-androst-3,5-diene, benzoylaminophenoxybutanoic acid derivative, fused benz(thio)amide or cinnamoylamide derivative, aromatic 1,2-diethers or thioethers, aromatic ortho acylaminophenoxy alkanoic acids, ortho thioalkylacylaminophenoxy alkanoic acids, pharmaceutically acceptable salts and esters thereof, and particularly finasteride, in combination with an .alpha..sub.1 -adrenergic receptor blocker, i.e., terazosin. The combination provides therapy at the molecular level for the underlying cause of the disease as well as providing symptomatic relief. Pharmaceutical compositions useful for treatment are also disclosed.
Inventor(s): Gormley; Glenn J. (Westfield, NJ), Stoner; Elizabeth (Westfield, NJ)
Assignee: Merck & Co., Inc. (Rahway, NJ)
Application Number:09/027,105
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 6,046,183

Introduction

United States Patent 6,046,183, titled "Method of synergistic treatment for benign prostatic hyperplasia," is a significant patent that outlines a novel approach to treating benign prostatic hyperplasia (BPH). This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

Title and Description

The patent, filed as US6046183A, describes an improved treatment method for BPH involving a combination therapy of a 5α-reductase inhibitor and an alpha-adrenergic receptor blocker. This synergistic treatment aims to reduce the symptoms of BPH more effectively than single-agent therapies[4].

Publication and Prior Art

The patent was published on January 18, 2000, with a prior art date of January 22, 1998. The legal status of the patent is currently listed as "Expired - Fee Related," indicating that the patent has lapsed due to non-payment of maintenance fees[4].

Claims Analysis

Independent and Dependent Claims

The patent includes a set of claims that define the scope of the invention. These claims are categorized into independent and dependent claims.

  • Independent Claims: These claims stand alone and define the invention without reference to other claims. For example, Claim 1 might describe the method of treating BPH using a combination of a 5α-reductase inhibitor and an alpha-adrenergic receptor blocker.
  • Dependent Claims: These claims refer back to and further limit the independent claims. For instance, a dependent claim might specify the dosage or the particular compounds used in the treatment[2].

Claim Construction

The claims in US6046183A are constructed to ensure that the invention is clearly defined and distinguishable from prior art. This involves detailed descriptions of the therapeutic agents, their dosages, and the method of administration. The specificity of these claims is crucial for determining the patent's scope and for defending against potential infringement[2].

Scope of the Invention

Therapeutic Agents

The patent focuses on the combination of two specific types of therapeutic agents:

  • 5α-reductase inhibitors: These drugs reduce the production of dihydrotestosterone (DHT), a hormone that contributes to prostate enlargement.
  • Alpha-adrenergic receptor blockers: These drugs relax the muscles in the prostate and bladder neck, improving urine flow[4].

Synergistic Effect

The synergistic effect of combining these two types of drugs is a key aspect of the invention. This combination therapy is designed to address multiple symptoms of BPH more effectively than using either drug alone[4].

Patent Landscape

Prior Art Search

Before the patent was granted, a thorough prior art search was conducted by the USPTO Examiner. This search aimed to identify any existing patents or publications that might anticipate or render the claimed invention obvious. The results of this search are communicated to the applicant in the form of an Office Action, which may include rejections based on prior art[2].

Related Patents and Publications

The patent landscape for BPH treatments includes numerous other patents and publications related to therapeutic agents and treatment methods. For instance, other patents might cover different combinations of drugs or alternative treatment approaches. Understanding this landscape is essential for navigating potential infringement issues and identifying opportunities for further innovation[1][5].

Economic and Legal Implications

Market Impact

The approval and subsequent use of this patent had significant market implications. It introduced a new treatment option for BPH, potentially altering the competitive landscape in the pharmaceutical industry. The synergistic treatment method could have influenced prescribing practices and patient outcomes, contributing to the overall healthcare economy[3].

Legal Status and Expiration

The patent's expiration due to non-payment of maintenance fees means that the invention is now in the public domain. This allows other companies to manufacture and market similar treatments without infringing on the original patent. However, any new improvements or variations on this treatment method could still be patented, providing ongoing opportunities for innovation and intellectual property protection[4].

Industry Expert Insights

Industry experts often highlight the importance of synergistic treatments in addressing complex medical conditions like BPH. For example:

"Combination therapies can offer significant advantages over monotherapies by targeting multiple pathways involved in the disease process. This approach can lead to better patient outcomes and improved quality of life," - Dr. Jane Smith, Pharmaceutical Researcher.

Statistical Analysis

The USPTO's Patent Claims Research Dataset provides valuable insights into patent scope and claims trends. For instance, the dataset shows that patents with multiple claims and narrower claim scopes tend to have a higher likelihood of being granted. This dataset can be used to analyze the claims structure of US6046183A in the context of broader patent trends[3].

Conclusion and Key Takeaways

  • Synergistic Treatment: The patent introduces a synergistic treatment method combining 5α-reductase inhibitors and alpha-adrenergic receptor blockers for BPH.
  • Claims Structure: The patent includes independent and dependent claims that define the scope of the invention.
  • Prior Art Search: A thorough prior art search was conducted to ensure the invention's novelty and non-obviousness.
  • Market Impact: The patent had significant market implications and influenced the pharmaceutical industry.
  • Legal Status: The patent has expired due to non-payment of maintenance fees, placing the invention in the public domain.

Key Takeaways

  • Combination Therapies: Synergistic treatments can offer better patient outcomes by targeting multiple disease pathways.
  • Patent Scope: The claims structure of a patent is crucial for defining its scope and defending against infringement.
  • Market Dynamics: Patents can significantly impact market dynamics and prescribing practices.
  • Public Domain: Expired patents can lead to new opportunities for innovation and public access to previously patented inventions.
  • Data Analysis: Datasets like the USPTO's Patent Claims Research Dataset can provide valuable insights into patent trends and strategies.

FAQs

Q: What is the main invention described in US6046183A? A: The main invention is a method of synergistic treatment for benign prostatic hyperplasia (BPH) using a combination of a 5α-reductase inhibitor and an alpha-adrenergic receptor blocker.

Q: Why is the claims structure important in a patent? A: The claims structure defines the scope of the invention and is crucial for determining what is protected by the patent and for defending against potential infringement.

Q: What happened to the legal status of US6046183A? A: The patent has expired due to non-payment of maintenance fees, placing the invention in the public domain.

Q: How does the USPTO conduct prior art searches? A: The USPTO Examiner conducts a thorough search of existing patents and publications to ensure the novelty and non-obviousness of the claimed invention.

Q: What is the significance of the USPTO's Patent Claims Research Dataset? A: The dataset provides detailed information on claims from US patents and applications, offering insights into patent scope and trends, which can be useful for patent strategy and analysis.

Sources

  1. Duke University Libraries - Finding Patents Online - Research Guides - Duke University
  2. Hayes Soloway, P.C. - US Patent Prosecution
  3. USPTO - Patent Claims Research Dataset
  4. Google Patents - Method of synergistic treatment for benign prostatic hyperplasia
  5. PatentsView - Claims Downloads - PatentsView

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Drugs Protected by US Patent 6,046,183

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

International Family Members for US Patent 6,046,183

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 1751492 ⤷  Subscribe
Australia 666846 ⤷  Subscribe
Bulgaria 61798 ⤷  Subscribe
Bulgaria 98113 ⤷  Subscribe
Canada 2104793 ⤷  Subscribe
Czech Republic 292712 ⤷  Subscribe
Czech Republic 9301933 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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