United States Patent 7,879,349: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,879,349, titled "Cyanocobalamin low viscosity aqueous formulations for intranasal delivery," is a significant patent in the pharmaceutical sector, particularly in the field of vitamin B12 delivery. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Invention Description
The patent describes a method and formulation for the intranasal delivery of cyanocobalamin, a form of vitamin B12. The invention focuses on creating low viscosity aqueous solutions that are suitable for intranasal administration, enhancing the bioavailability and efficacy of vitamin B12[4].
Scope of the Patent
Claims
The patent includes several claims that define the scope of the invention. These claims cover various aspects, such as:
- The composition of the aqueous solution, including the concentration of cyanocobalamin and other ingredients like preservatives and buffers.
- The method of preparing the solution.
- The method of administering the solution intranasally.
- Specific formulations that include a combination of cyanocobalamin with other substances to enhance stability and bioavailability[4].
Key Components
- Cyanocobalamin: The primary active ingredient, which is a form of vitamin B12.
- Aqueous Solution: The formulation is specifically designed to be low viscosity, making it suitable for intranasal delivery.
- Preservatives and Buffers: Ingredients like benzalkonium chloride, chlorobutanol, and disodium hydrogen phosphate are included to maintain the stability of the solution[4].
Claims Analysis
Independent Claims
The patent includes independent claims that outline the core aspects of the invention. For example, Claim 1 might describe the composition of the aqueous solution, while Claim 2 might detail the method of preparation[4].
Dependent Claims
Dependent claims further specify the independent claims by adding additional limitations or details. These claims help to narrow down the scope and provide a clearer definition of what is protected under the patent.
Patent Landscape
Prior Art
The patent cites several prior art references, including U.S. Pat. No. 4,525,341, which discloses a method of administering vitamins intranasally but does not enable a specific formulation containing only cyanocobalamin[4].
International Patent Offices
To understand the global patent landscape, it is essential to search international patent databases. Resources like the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO) provide access to international patent applications and granted patents, which can help in identifying similar or related inventions[1].
Competitors and Litigation
The patent landscape also involves competitors and potential litigation. For instance, companies like Endo and Lupin have been involved in patent disputes over similar pharmaceutical products, highlighting the competitive nature of the industry[5].
Expiration and Legal Status
Patent Expiration
The patent's legal status is crucial for understanding its current validity. As of the latest information, the patent has expired, which means that the protected formulation and methods are now in the public domain[4].
Impact of Expiration
The expiration of the patent allows other companies to manufacture and market similar formulations without infringing on the original patent. This can lead to increased competition and potentially lower prices for consumers.
Economic and Market Impact
Market Competition
The expiration of the patent can significantly impact market competition. Generic manufacturers can now enter the market with similar products, potentially reducing the market share of the original patent holder.
Consumer Benefits
Consumers may benefit from the increased competition through lower prices and a wider range of available products. However, the quality and efficacy of these generic products must be closely monitored to ensure they meet the same standards as the original patented formulation.
Technological Advancements
Innovation in Delivery Systems
The invention represented by this patent has contributed to advancements in intranasal delivery systems. Future innovations may focus on improving bioavailability, stability, and patient compliance.
Integration with Other Technologies
The use of machine translation and global dossier services, as provided by the USPTO and other international patent offices, can facilitate the integration of this technology with other global innovations, enhancing the overall efficiency of patent searching and management[1].
Regulatory Considerations
FDA Approval
Any new formulation or method of delivery must comply with FDA regulations. The FDA Orange Book, which lists approved drug products, is a critical resource for ensuring that new products meet regulatory standards[2].
Global Regulatory Compliance
For international markets, compliance with local regulatory bodies is essential. Resources like the USPTO's Global Dossier and international patent databases help in navigating these regulatory requirements[1].
Key Takeaways
- Patent Scope: The patent covers specific formulations and methods for intranasal delivery of cyanocobalamin.
- Claims Analysis: Independent and dependent claims define the protected aspects of the invention.
- Patent Landscape: The patent is part of a broader landscape involving international patent offices, competitors, and regulatory bodies.
- Expiration and Legal Status: The patent has expired, allowing for generic competition.
- Economic and Market Impact: Expiration can lead to increased competition and consumer benefits.
FAQs
What is the main invention described in US Patent 7,879,349?
The main invention is a method and formulation for the intranasal delivery of cyanocobalamin (vitamin B12) using a low viscosity aqueous solution.
What are the key components of the patented formulation?
The key components include cyanocobalamin, preservatives like benzalkonium chloride and chlorobutanol, and buffers such as disodium hydrogen phosphate.
Has the patent expired?
Yes, the patent has expired, which means the protected formulation and methods are now in the public domain.
How does the expiration of the patent affect the market?
The expiration allows generic manufacturers to enter the market, potentially increasing competition and reducing prices for consumers.
What resources are available for searching international patents related to this invention?
Resources include the European Patent Office (EPO), Japan Patent Office (JPO), World Intellectual Property Organization (WIPO), and the USPTO's Global Dossier service[1].
Cited Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- PharmaCompass - US Patent 7879349: https://www.pharmacompass.com/us-patent-7879349
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US7879349B2: https://patents.google.com/patent/US7879349B2/en
- Life Sciences Intellectual Property Review - Endo sues Lupin over nasal spray: https://www.lifesciencesipreview.com/americas/endo-sues-lupin-over-nasal-spray-2332
