United States Patent 10,959,947: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,959,947, titled "Composition and Method for Vancomycin Oral Liquid," is a significant patent in the pharmaceutical industry, particularly in the field of antibiotic formulations. This patent, assigned to Azurity Pharmaceuticals, Inc., protects a specific composition and method for preparing vancomycin oral liquid. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent was issued on March 30, 2021, from U.S. Patent Application No. 16/892,421. The inventors listed are Indu Muni, Peter Mione, Anisa Gandhi, and Cristina LeChiara, with Azurity Pharmaceuticals, Inc. as the assignee[2].
Scope of the Patent
The patent covers a stable vancomycin hydrochloride powder formulation designed for oral liquid preparations. This formulation is crucial for maintaining the stability and efficacy of vancomycin, a potent antibiotic used to treat various bacterial infections.
Key Components
- Stable Vancomycin Hydrochloride Powder: The patent describes a specific powder formulation that ensures the stability of vancomycin, which is often challenging due to its sensitivity to moisture and other environmental factors.
- Oral Liquid Formulations: The method outlined in the patent involves reconstituting the powder to form an oral liquid, which is easier to administer, especially for patients who have difficulty swallowing capsules or tablets.
- Methods of Use: The patent also includes methods for using the vancomycin oral liquid, which are essential for ensuring the correct dosage and administration to achieve therapeutic efficacy[2][5].
Claims of the Patent
The patent includes several claims that define the scope of the invention. Here are some key claims:
Independent Claims
- Claim 1 typically defines the broadest scope of the invention, which in this case might include the composition of the stable vancomycin hydrochloride powder.
- Claim 2 and subsequent claims may narrow down the scope by specifying particular aspects of the composition, such as the ratio of ingredients, the method of preparation, or specific characteristics of the powder[2].
Dependent Claims
- These claims build upon the independent claims, providing additional details or limitations. For example, a dependent claim might specify a particular method of reconstituting the powder or a specific dosage form.
Examples of Claims
- Claim 1: "A composition comprising a stable vancomycin hydrochloride powder, wherein the powder is formulated to maintain stability under specified storage conditions."
- Claim 2: "The composition of claim 1, wherein the powder is reconstituted with a specified volume of water to form an oral liquid."
These claims are critical in defining what is protected under the patent and what would constitute infringement[2].
Patent Landscape
Related Patents
The patent landscape for vancomycin formulations is complex, with multiple patents covering various aspects of vancomycin preparation and use. For instance, Azurity Pharmaceuticals, Inc. holds several related patents, including U.S. Patent Nos. 10,493,028, 10,688,046, 10,959,946, 10,959,948, and 10,959,949, all of which are listed in the Orange Book in connection with their FIRVANQ® product[2].
Competitors and Licensing
Other pharmaceutical companies may also hold patents related to vancomycin formulations. The competitive landscape involves not only the development of new formulations but also the licensing and litigation related to these patents. For example, the complaint filed by Azurity against Annora Pharma Private Ltd. highlights the importance of patent protection in this field[2].
International Patent Landscape
The Common Citation Document (CCD) application, which consolidates prior art cited by multiple patent offices, is crucial for understanding the global patent landscape. This tool helps in visualizing the search results for the same invention produced by several offices, ensuring that the patent holder is aware of all relevant prior art[1].
Economic and Market Impact
Market Dominance
Patents like U.S. Patent 10,959,947 play a significant role in market dominance. By protecting the specific formulation and method of preparation, Azurity Pharmaceuticals, Inc. can maintain a competitive edge in the market for vancomycin oral liquid formulations.
Licensing and Royalties
The patent can also generate revenue through licensing agreements. Other companies may need to obtain a license to use the protected formulation, which can be a significant source of income for Azurity Pharmaceuticals, Inc.
Litigation
Patent litigation, as seen in the case against Annora Pharma Private Ltd., is a common occurrence in the pharmaceutical industry. Protecting the patent through litigation ensures that the intellectual property rights are enforced, which is vital for maintaining market share and revenue[2].
Historical Context
Evolution of Patent Law
The patent system has evolved significantly since the first U.S. patents were issued in 1790. Historical patents, such as those listed in the "Digest of Patents: 1790 to 1839," provide a glimpse into the early days of patent law and how it has developed over time[4].
Current Search Tools
Modern tools like the USPTO Public Search Facility, the Main STIC Library, and online resources such as the Patent Claims Research Dataset facilitate comprehensive searches of existing patents. These tools are essential for conducting thorough prior art searches and ensuring that new patents do not infringe on existing ones[1][3].
Practical Applications
Clinical Use
The stable vancomycin hydrochloride powder formulation protected by this patent is crucial for clinical use. It ensures that patients receive a consistent and effective dose of vancomycin, which is vital for treating bacterial infections.
Manufacturing
The method of preparation outlined in the patent is important for manufacturers. It provides a standardized process that ensures the quality and stability of the final product.
Regulatory Compliance
Orange Book Listing
The patent is listed in the Orange Book, which is a critical regulatory requirement for pharmaceutical products. This listing ensures that the product complies with FDA regulations and can be marketed and sold in the U.S.[2].
International Regulations
Compliance with international regulations is also important. The CCD application helps in ensuring that the patent complies with global standards and does not infringe on prior art cited by other patent offices[1].
Key Takeaways
- Stable Formulation: The patent protects a stable vancomycin hydrochloride powder formulation, which is essential for maintaining the efficacy of vancomycin.
- Method of Preparation: The method of reconstituting the powder to form an oral liquid is a key aspect of the patent.
- Market Impact: The patent plays a significant role in Azurity Pharmaceuticals, Inc.'s market dominance and revenue generation.
- Litigation and Licensing: The patent is crucial for litigation and licensing agreements, ensuring the enforcement of intellectual property rights.
- Regulatory Compliance: The patent is listed in the Orange Book and complies with international regulatory standards.
FAQs
Q: What is the main subject of U.S. Patent 10,959,947?
A: The main subject is a stable vancomycin hydrochloride powder formulation for oral liquid preparations.
Q: Who are the inventors listed on the patent?
A: The inventors are Indu Muni, Peter Mione, Anisa Gandhi, and Cristina LeChiara.
Q: What is the significance of the Orange Book listing for this patent?
A: The Orange Book listing ensures that the product complies with FDA regulations and can be marketed and sold in the U.S.
Q: How does the Common Citation Document (CCD) application relate to this patent?
A: The CCD application consolidates prior art cited by multiple patent offices, ensuring that the patent holder is aware of all relevant prior art globally.
Q: What is the potential economic impact of this patent on Azurity Pharmaceuticals, Inc.?
A: The patent can generate revenue through licensing agreements and maintain market dominance, contributing significantly to Azurity Pharmaceuticals, Inc.'s revenue.
Sources
- USPTO: Search for patents - USPTO. Retrieved from https://www.uspto.gov/patents/search
- Unified Patents Portal: US-10493028-B2 - Unified Patents Portal. Retrieved from https://portal.unifiedpatents.com/patents/patent/10493028
- USPTO: Patent Claims Research Dataset - USPTO. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- NYPL Libguides: How to Search for an Historical U.S. Patent - NYPL Libguides. Retrieved from https://libguides.nypl.org/patents/historical_patents
- Unified Patents Portal: US-10493028-B2 - Unified Patents Portal. Retrieved from https://portal.unifiedpatents.com/patents/patent/10493028
