United States Patent 9,919,050: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,919,050, titled "Compositions comprising azelastine," is a significant patent in the pharmaceutical industry, particularly in the field of allergic and non-allergic condition treatments. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Invention Description
The patent, issued to Bayer HealthCare LLC and Meda Pharmaceuticals Inc., pertains to pharmaceutical compositions that include azelastine or its pharmaceutically acceptable salts or esters, such as azelastine hydrochloride. These compositions are formulated for various delivery methods, including nasal sprays, ocular solutions or drops, and oral and pulmonary delivery systems[4][5].
Key Components
- Active Ingredient: Azelastine, a well-known antihistamine used to treat allergic conditions.
- Formulations: The patent covers a range of formulations, each designed to enhance the therapeutic efficacy and patient acceptance of azelastine.
- Taste-Masking Agents: A crucial aspect of the invention is the inclusion of taste-masking agents to reduce or eliminate the bitter taste associated with azelastine, thereby improving patient compliance[4].
Scope of the Patent
Therapeutic Applications
The patent encompasses compositions for treating, alleviating, or preventing symptoms associated with various allergic and non-allergic conditions. This includes but is not limited to allergic rhinitis, conjunctivitis, and other respiratory disorders[4].
Delivery Methods
The scope extends to multiple delivery methods:
- Nasal Sprays: Formulations designed for intranasal administration.
- Ocular Solutions/Drops: For treating eye-related allergic conditions.
- Oral and Pulmonary Delivery: Formulations for oral ingestion or inhalation[4].
Claims Analysis
Independent Claims
The patent includes several independent claims that define the core aspects of the invention. These claims typically cover the composition itself, the method of preparation, and the therapeutic uses.
Dependent Claims
Dependent claims further specify the independent claims by detailing specific formulations, concentrations of azelastine, and the types of taste-masking agents used. For example, claims may specify the use of sucralose as a taste-masking agent[4].
Claim Coverage Matrix
To understand the full scope of the patent, a Claim Coverage Matrix can be useful. This matrix categorizes the patents and claims by scope concepts, helping to identify which claims cover specific technologies and where gaps or opportunities exist in the patent landscape[3].
Patent Landscape
Global Context
The patent is part of a broader global patent landscape, particularly within the IP5 Offices (the United States, Europe, Japan, Korea, and China). Tools like the Global Dossier and Common Citation Document (CCD) facilitate the analysis of related applications and prior art across these jurisdictions[1].
Competitive Landscape
The pharmaceutical industry is highly competitive, and patents like US 9,919,050 play a crucial role in protecting intellectual property. Companies like Bayer and Meda must continuously monitor and enforce their patents to prevent infringement. For instance, the patent was involved in a litigation case against Amneal Pharmaceuticals LLC, which sought to manufacture a generic version of the patented nasal spray[2].
Litigation and Enforcement
The patent has been subject to legal challenges, as seen in the case against Amneal Pharmaceuticals. This highlights the importance of robust patent enforcement strategies to protect the intellectual property rights associated with this patent[2].
Technical and Legal Aspects
Classification
The patent is classified under various categories in the International Patent Classification (IPC) system, including A61K45/06, A61K47/00, and A61P11/00. These classifications help in identifying similar patents and prior art[4].
Office Actions and Citations
Tools like the Office Action Indicators and the Common Citation Document (CCD) are essential for tracking office actions and citations related to this patent. These tools provide insights into how different patent offices have treated similar inventions and help in anticipating potential challenges[1].
Strategic Implications
Patent Analytics
Using patent analytics tools, companies can track the claims and scope concepts of their patents, including US 9,919,050. This helps in identifying gaps in coverage, future design opportunities, and the overall value of their patent portfolio[3].
Claim Charts and Scope Concepts
Interactive claim charts generated by tools like ClaimScape® can be used to review patent coverage with technical experts. These charts help in determining whether a particular scope concept is applicable to a target product or method, thereby guiding strategic decisions[3].
Key Takeaways
- Comprehensive Formulations: The patent covers a wide range of formulations for azelastine, enhancing its therapeutic efficacy and patient acceptance.
- Taste-Masking Agents: The inclusion of taste-masking agents is a critical aspect of the invention, improving patient compliance.
- Global Patent Landscape: The patent is part of a broader global landscape, with tools like Global Dossier and CCD facilitating international analysis.
- Competitive and Legal Context: The patent has been involved in litigation, highlighting the importance of robust enforcement strategies.
- Strategic Use of Patent Analytics: Tools like Claim Coverage Matrix and Claim Charts are essential for strategic planning and identifying opportunities.
FAQs
Q: What is the primary active ingredient in the compositions described in US Patent 9,919,050?
A: The primary active ingredient is azelastine or its pharmaceutically acceptable salts or esters, such as azelastine hydrochloride.
Q: What are the main delivery methods covered by the patent?
A: The patent covers nasal sprays, ocular solutions or drops, and oral and pulmonary delivery systems.
Q: Why are taste-masking agents important in this patent?
A: Taste-masking agents are crucial to reduce or eliminate the bitter taste associated with azelastine, thereby enhancing patient compliance.
Q: How does the Global Dossier help in analyzing this patent?
A: The Global Dossier provides access to the file histories of related applications from participating IP Offices, allowing users to see the patent family and related applications.
Q: What is the significance of the Common Citation Document (CCD) in patent analysis?
A: The CCD consolidates prior art cited by all participating offices for the family members of a patent application, enabling the visualization of search results on a single page.
Sources
- USPTO: Search for patents - USPTO.
- RPX Insight: IN THE UNITED STATES DISTRICT COURT FOR THE ... - RPX Insight.
- SLWIP: Patent Analytics | Intellectual Property Law.
- Google Patents: US9919050B2 - Compositions comprising azelastine - Google Patents.
- Unified Patents: US-9919050-B2 - Compositions Comprising Azelastine.
