Analyzing the Scope and Claims of United States Patent 4,539,333
Introduction
United States Patent 4,539,333, titled "Stable Prostacyclin Solutions," is a significant patent in the pharmaceutical field, particularly for the treatment of pulmonary arterial hypertension. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
The patent, issued to the assignee Glaxo Inc., covers the formulation, composition, and method of use of epoprostenol sodium, marketed as FLOLAN®. Epoprostenol is a prostacyclin analogue used to treat severe pulmonary arterial hypertension.
Scope of the Patent
The scope of the patent encompasses several key aspects:
Composition
The patent describes stable solutions of prostacyclin, specifically epoprostenol sodium, which are crucial for maintaining the potency and stability of the drug. These solutions are formulated to prevent degradation, ensuring the active ingredient remains effective over time[4].
Method of Use
The patent includes methods for administering the prostacyclin solutions, which are designed to treat pulmonary arterial hypertension. This involves specific dosing regimens and delivery methods to ensure the therapeutic efficacy of the drug[4].
Stability
A critical aspect of the patent is the stability of the prostacyclin solutions. The inventors developed formulations that prevent the degradation of epoprostenol, which is highly susceptible to hydrolysis and oxidation. This stability is essential for the clinical use of the drug[4].
Claims
The claims of the patent are the legal boundaries that define the invention and distinguish it from prior art. Here are some key claims:
Claim 1
The first claim typically defines the broadest scope of the invention. For U.S. Patent 4,539,333, this would involve a stable solution of epoprostenol sodium, including specific pH ranges and stabilizing agents to prevent degradation[4].
Dependent Claims
Subsequent claims are dependent on the first claim and provide more detailed specifications. These might include specific concentrations of the active ingredient, types of stabilizing agents, and methods of preparation and administration.
Patent Landscape
Understanding the patent landscape around U.S. Patent 4,539,333 involves analyzing related patents, competitors, and technological advancements in the field.
Related Patents
Other patents related to prostacyclin analogues and their use in treating pulmonary arterial hypertension include international patents such as WO2004017993A1. This patent describes a combination of prostacyclin or prostacyclin analogues with endothelin receptor antagonists, highlighting the ongoing research and development in this therapeutic area[5].
Competitors
Companies like Actelion Pharmaceuticals (now part of Johnson & Johnson) have developed competing treatments for pulmonary arterial hypertension, such as bosentan. These competitors often have their own patents and formulations, which can impact the market and intellectual property landscape[5].
Technological Advancements
The field of pulmonary arterial hypertension treatment is continuously evolving. New formulations, delivery systems, and combination therapies are being developed. For instance, the use of Global Dossier services provided by the USPTO allows for the tracking of related applications across different IP offices, helping to stay updated on global patent developments[2].
Patent Analytics and Claim Coverage
To fully understand the value and coverage of U.S. Patent 4,539,333, patent analytics tools can be employed. These tools help in categorizing patents by claims and scope concepts, making it easier to identify gaps or opportunities in the patent portfolio.
Claim Coverage Matrix
A Claim Coverage Matrix can show which patents and claims are actively protecting the intellectual property related to epoprostenol sodium. This matrix helps in identifying whether the claims cover the intended technology and where there might be gaps in coverage[3].
Interactive Claim Charts
Tools like ClaimScape® generate interactive claim charts that can be reviewed by technical experts to determine the applicability of specific scope concepts to target products or methods. This helps in spotting areas where claim coverage is lacking and highlights future design opportunities[3].
Key Takeaways
- Stable Formulations: U.S. Patent 4,539,333 focuses on stable solutions of epoprostenol sodium, crucial for maintaining the drug's potency.
- Method of Use: The patent includes specific methods for administering the drug to treat pulmonary arterial hypertension.
- Patent Landscape: The landscape includes related patents, competitors, and ongoing technological advancements in the field.
- Patent Analytics: Tools like Claim Coverage Matrix and interactive claim charts are essential for understanding the patent's value and identifying gaps in coverage.
FAQs
Q: What is the main subject of U.S. Patent 4,539,333?
A: The main subject is the formulation, composition, and method of use of stable prostacyclin solutions, specifically epoprostenol sodium.
Q: How does the patent ensure the stability of epoprostenol sodium?
A: The patent describes specific pH ranges and the use of stabilizing agents to prevent degradation of the active ingredient.
Q: What is the therapeutic use of the invention described in the patent?
A: The invention is used to treat severe pulmonary arterial hypertension.
Q: How can patent analytics help in understanding the value of U.S. Patent 4,539,333?
A: Patent analytics tools help in categorizing patents by claims and scope concepts, identifying gaps or opportunities in the patent portfolio, and generating interactive claim charts for review by technical experts.
Q: Are there other related patents in the field of pulmonary arterial hypertension treatment?
A: Yes, there are other patents such as WO2004017993A1 that describe combination therapies involving prostacyclin analogues and endothelin receptor antagonists.
