United States Patent 4,308,264: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,308,264, titled "Stabilized, dilute aqueous preparation of 1α,25-dihydroxycholecalciferol for neonatal administration," is a significant patent in the field of pharmaceuticals, particularly concerning vitamin D3 preparations. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention Overview
The patent, issued to the inventors associated with Teijin Limited, describes a method for stabilizing 1α,25-dihydroxycholecalciferol, a biologically active form of Vitamin D3, in an aqueous solution. This stabilization is crucial for neonatal administration, especially in treating conditions like neonatal hypocalcemia[4].
Scope of the Invention
The scope of the invention is focused on creating a stable aqueous preparation of 1α,25-dihydroxycholecalciferol. Here are the key aspects:
Stabilization Method
The patent outlines a method using a combination of ingredients to stabilize the vitamin D3 compound. This includes the use of chelating agents like disodium edetate, antioxidants such as ascorbate, and nonionic surfactants to maintain the stability of the solution in various conditions[4].
Clinical Application
The invention is specifically designed for neonatal administration, addressing the need for a stable and effective form of Vitamin D3 in treating neonatal hypocalcemia. The preparation can be administered intravenously or orally, although the patent notes that continuous infusion is more common than bolus injection[2].
Claims of the Patent
The claims of the patent are critical in defining the scope of protection. Here are some key claims:
Claim 1
The first claim describes the stabilized, dilute aqueous preparation of 1α,25-dihydroxycholecalciferol, specifying the components such as the vitamin D3 compound, a chelating agent, an antioxidant, and a nonionic surfactant[4].
Claim 2
This claim details the specific concentrations of the ingredients, including the vitamin D3 compound, chelating agent, and antioxidant, which are essential for maintaining stability[4].
Claim 3
This claim addresses the method of preparation, including the steps involved in mixing the ingredients and ensuring the stability of the solution[4].
Patent Landscape
Understanding the patent landscape is crucial for assessing the impact and relevance of this patent.
Related Patents
Other patents related to vitamin D3 preparations and stabilization methods exist. For example, European Patent 0 390 930 B1 discusses similar stabilization methods but highlights limitations in the original U.S. patent specification, such as the need for an inert atmosphere[2].
Global Patent Family
The patent is part of a global patent family, with corresponding patents filed in other countries. The Global Dossier service provided by the USPTO allows users to view the file histories of related applications from participating IP Offices, which can be useful in understanding the international scope of this invention[1].
Competing Technologies
Other companies and researchers have developed alternative methods for stabilizing vitamin D3 compounds. These competing technologies may offer different approaches to stabilization, such as using different chelating agents or surfactants, which could potentially challenge the claims of this patent[3].
Patent Analytics and Claim Coverage
To fully understand the value and coverage of this patent, patent analytics tools can be employed.
Claim Coverage Matrix
A Claim Coverage Matrix can help identify which patents and claims are actively protecting the intellectual property related to this invention. This matrix can also highlight gaps or opportunities in the patent portfolio[3].
Scope Concepts
Categorizing patents by scope concepts, such as the stabilization method or the use of specific ingredients, can provide a powerful tool for filtering and analyzing large numbers of patent claims. This approach helps in determining whether a particular scope concept is applicable to a target product or method[3].
Legal Status and Expiration
The patent has expired, which means that the technology described is now in the public domain. This expiration can impact the competitive landscape, as other companies can now use the described methods without infringing on the original patent[4].
Practical Implications
The expiration of this patent has several practical implications:
Public Domain
With the patent in the public domain, other pharmaceutical companies can develop similar stabilized aqueous preparations of 1α,25-dihydroxycholecalciferol without needing to obtain a license or pay royalties[4].
Innovation
The public domain status can spur further innovation, as researchers and companies can build upon the original invention without the constraints of patent protection.
Key Takeaways
- Stabilization Method: The patent describes a specific method for stabilizing 1α,25-dihydroxycholecalciferol in aqueous solutions.
- Clinical Application: The invention is tailored for neonatal administration, particularly for treating neonatal hypocalcemia.
- Claims: The patent includes detailed claims about the composition and method of preparation.
- Patent Landscape: The patent is part of a global patent family, and its expiration has significant implications for the pharmaceutical industry.
- Patent Analytics: Tools like Claim Coverage Matrix and scope concepts can help in analyzing and managing the patent portfolio.
FAQs
What is the main purpose of United States Patent 4,308,264?
The main purpose of this patent is to describe a method for stabilizing 1α,25-dihydroxycholecalciferol in an aqueous solution for neonatal administration.
What are the key components of the stabilized solution?
The key components include the vitamin D3 compound, a chelating agent like disodium edetate, an antioxidant such as ascorbate, and a nonionic surfactant.
Is the patent still in force?
No, the patent has expired, which means the technology described is now in the public domain.
How does the expiration of this patent impact the pharmaceutical industry?
The expiration allows other companies to develop similar preparations without needing a license or paying royalties, potentially spurring further innovation.
What tools can be used to analyze the patent landscape related to this invention?
Tools such as the Claim Coverage Matrix and scope concepts can be used to analyze and manage the patent portfolio related to this invention.
Sources
- USPTO: "Search for patents - USPTO" - https://www.uspto.gov/patents/search
- European Patent Office: "STABLE AQUEOUS PREPARATION OF ACTIVE VITAMIN D 3" - https://patentimages.storage.googleapis.com/a5/6a/c7/199284a91966c6/EP0390930B1.pdf
- Schwegman Lundberg & Woessner: "Patent Analytics | Intellectual Property Law" - https://www.slwip.com/services/patent-analytics/
- Google Patents: "US4308264A - Stabilized, dilute aqueous preparation of 1α,25-dihydroxycholecalciferol for neonatal administration" - https://patents.google.com/patent/US4308264A/en
