United States Patent 6,903,083: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 6,903,083, titled "Stabilized hydroxyvitamin D," is a significant patent in the pharmaceutical sector, particularly in the field of vitamin D formulations. This patent, assigned to Bone Care International LLC and later sold to Genzyme Corporation, has been a subject of interest and litigation. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
Invention Overview
The patent describes a stabilized 1α-hydroxyvitamin D (SHVD) composition, which is particularly suited for pharmaceutical formulations. This invention addresses the stability issues associated with hydroxyvitamin D, making it more viable for therapeutic use[4].
Filing and Grant Dates
The patent was filed on July 18, 2000, and granted on May 31, 2005. This timeline is crucial for understanding the patent's validity and any potential bars to patentability[2][4].
Scope of the Patent
Claims
The patent includes multiple claims that define the scope of the invention. These claims cover various aspects of the stabilized hydroxyvitamin D composition, including its chemical structure, formulation, and methods of preparation. The claims are divided into independent and dependent claims, with the independent claims providing the broadest definition of the invention and the dependent claims narrowing down to more specific embodiments[4].
Key Claim Elements
- Composition: The patent claims a stabilized composition of 1α-hydroxyvitamin D, which includes specific chemical compounds and their formulations.
- Pharmaceutical Formulations: The claims also cover various pharmaceutical formulations that incorporate the stabilized hydroxyvitamin D, such as capsules, tablets, and solutions.
- Methods of Preparation: The patent includes claims related to the methods of preparing the stabilized hydroxyvitamin D, which involve specific steps and conditions to ensure stability[4].
Patent Claims Analysis
Claim Construction
The construction of the claims is critical for determining the scope of the patent. In patent litigation, the court often interprets the claims to determine whether an accused product or process infringes the patent. For example, in the context of the '083 patent, the claims must be construed to determine whether generic versions of the stabilized hydroxyvitamin D formulation infringe the patent[2].
Claim Dependency
The dependent claims build upon the independent claims, adding specific limitations that narrow the scope of the invention. For instance, a dependent claim might specify a particular concentration of the stabilized hydroxyvitamin D in a pharmaceutical formulation. Understanding the dependency between claims is essential for assessing the overall scope of the patent[4].
Patent Landscape
Related Patents and Applications
The '083 patent is part of a larger patent family that includes other related patents and applications. Using tools like the Global Dossier provided by the USPTO, one can access the file histories of related applications from participating IP Offices, which helps in understanding the broader patent landscape[1].
Prior Art and Citation Data
The Common Citation Document (CCD) application consolidates prior art cited by all participating offices for the family members of a patent application. This tool is useful for identifying prior art that may be relevant to the '083 patent, helping to assess its novelty and non-obviousness[1].
Litigation and Disputes
Infringement and Validity Challenges
The '083 patent has been involved in several litigation cases, particularly regarding infringement and validity challenges. For example, in a case involving Bone Care International LLC and Genzyme Corporation, defendants argued that the patent was invalid or not infringed by their generic drug. The plaintiffs disputed these claims, leading to a detailed examination of the patent's validity and scope[2].
On-Sale Bar
One of the significant disputes surrounding the '083 patent involves the "on-sale" bar under 35 U.S.C. § 102(b). This provision bars patentability if the invention was on sale or offered for sale more than one year before the filing date. The parties disagreed on whether certain transactions constituted a "sale" in a commercial law sense, which is a critical factor in determining the patent's validity[2].
Economic and Research Implications
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents, including those related to the '083 patent. This dataset can be used to analyze trends in patent scope and claims, offering insights into the strategic use of patents in the pharmaceutical industry[3].
Economic Impact
The stabilization of hydroxyvitamin D has significant economic implications, particularly in the treatment of conditions related to vitamin D deficiency. The patent's impact on the market and the development of generic alternatives can be analyzed using economic research datasets and studies on patent scope and innovation[3].
Key Takeaways
- Stabilized Hydroxyvitamin D: The patent covers a stabilized composition of 1α-hydroxyvitamin D, addressing stability issues in pharmaceutical formulations.
- Claims and Scope: The patent includes multiple claims defining the composition, formulations, and methods of preparation, with dependent claims narrowing down the scope.
- Litigation: The patent has been involved in disputes over infringement and validity, including challenges related to the "on-sale" bar.
- Patent Landscape: The patent is part of a larger family, and tools like the Global Dossier and CCD application help in understanding related patents and prior art.
- Economic Impact: The patent has significant economic implications in the pharmaceutical industry, particularly in the treatment of vitamin D-related conditions.
FAQs
What is the main invention described in the '083 patent?
The main invention is a stabilized 1α-hydroxyvitamin D (SHVD) composition, particularly suited for pharmaceutical formulations.
Who are the current and former owners of the '083 patent?
The patent was originally assigned to Bone Care International LLC and later sold to Genzyme Corporation.
What is the significance of the "on-sale" bar in the context of the '083 patent?
The "on-sale" bar under 35 U.S.C. § 102(b) is significant because it determines whether the invention was on sale or offered for sale more than one year before the filing date, which could bar patentability.
How can one access related patents and prior art for the '083 patent?
Tools like the Global Dossier and the Common Citation Document (CCD) application provided by the USPTO can be used to access related patents and prior art.
What economic implications does the '083 patent have?
The patent has significant economic implications in the pharmaceutical industry, particularly in the treatment of conditions related to vitamin D deficiency, and its impact can be analyzed using economic research datasets.
Sources
- USPTO: Search for patents - USPTO.
- BNA: IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN ...
- USPTO: Patent Claims Research Dataset - USPTO.
- Google Patents: US6903083B2 - Stabilized hydroxyvitamin D - Google Patents.
