United States Patent 6,235,712: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 6,235,712, titled "Non-Aqueous Polar Aprotic Peptide Formulations," was granted on May 22, 2001, to inventors Cynthia L. Stevenson and Steven J. Prestrelski, and assigned to ALZA Corporation. This patent is significant in the field of pharmaceuticals, particularly for the development of stable formulations for peptide compounds.
Background
The invention addresses the need for stable formulations of peptide compounds, which are crucial for their effective use in medical treatments. Peptides are often unstable in aqueous solutions, leading to degradation and loss of potency. The patent introduces non-aqueous polar aprotic formulations that overcome these stability issues.
Patent Structure
Cover Page
The cover page of the patent provides bibliographic information, including the patent number, date of patent, inventors, assignee, and classification details. For US 6,235,712, this includes:
- Patent Number: 6,235,712
- Date of Patent: May 22, 2001
- Inventors: Cynthia L. Stevenson and Steven J. Prestrelski
- Assignee: ALZA Corporation
- Classification: A61K38/00; C07K5/00; C07K7/00[1].
Specification
The specification section is a detailed description of the invention, including its background, summary, and detailed description. For this patent, the specification explains:
- Background of the Invention: The need for stable peptide formulations and the limitations of existing aqueous solutions.
- Summary of the Invention: The introduction of non-aqueous polar aprotic solvents to stabilize peptide compounds.
- Detailed Description: The preparation and characteristics of these formulations, including their stability at elevated temperatures and their suitability for implantable delivery devices[1].
Claims
The claims section is the most critical part of the patent, as it defines the scope of the invention and what is protected by the patent. US 6,235,712 includes 19 claims.
Claim Structure
Each claim consists of a preamble and a body, connected by a transition word or phrase. Here is an example of how a claim might be structured:
- Preamble: "A formulation comprising a peptide compound..."
- Body: "...in a non-aqueous polar aprotic solvent, wherein the formulation is stable at elevated temperatures for long periods of time."[2].
Types of Claims
The claims can be independent or dependent. Independent claims stand alone and define the invention without reference to other claims. Dependent claims, on the other hand, refer back to and further limit an independent claim.
Key Claims
Independent Claims
- Claim 1: This claim typically defines the broadest scope of the invention, such as "A formulation comprising a peptide compound in a non-aqueous polar aprotic solvent."
- Claim 10: This might define a specific application or method, such as "A method for delivering a peptide compound using an implantable device containing the formulation of claim 1."
Dependent Claims
- Claim 2: "The formulation of claim 1, wherein the non-aqueous polar aprotic solvent is dimethyl sulfoxide (DMSO)."
- Claim 11: "The method of claim 10, wherein the implantable device is designed for long-term delivery of the peptide compound."
Scope of the Invention
The scope of the invention is defined by the claims and includes:
- Stable Formulations: The use of non-aqueous polar aprotic solvents to stabilize peptide compounds.
- Applications: The formulations are particularly useful in implantable delivery devices for long-term drug delivery.
- Characteristics: The formulations can be stored at elevated temperatures for long periods without degradation[1].
Patent Landscape
Related Patents
The patent is part of a series of related applications and patents, including:
- Divisional Applications: Filed as part of the continuation of earlier applications, such as application No. 09/293,839, now Pat. No. 6,124,261[1].
- Provisional Applications: Earlier provisional applications like No. 60/022,699 filed on July 3, 1996[1].
Industry Impact
This patent has significant implications for the pharmaceutical industry, particularly in the development of stable peptide formulations. It enables the creation of long-term delivery systems, which can improve patient compliance and treatment efficacy.
Legal Precedents
The patent's claims and scope can be used in legal proceedings to determine infringement. For example, if another company develops a similar formulation without licensing, the claims in this patent would be used to determine whether there is infringement[5].
Practical Applications
Implantable Delivery Devices
The stable formulations described in the patent are especially useful in implantable devices designed for long-term drug delivery. This can include devices for hormones, growth factors, or other therapeutic peptides.
Stability at Elevated Temperatures
The ability of these formulations to remain stable at elevated temperatures makes them ideal for storage and transportation, reducing the need for stringent cold chain requirements.
Economic and Research Implications
Patent Allowance Rates
The success of this patent can be analyzed in the context of broader patent allowance rates. Studies have shown that the allowance rate for pharmaceutical patents can vary significantly based on the technology field and the entity size of the applicant[4].
Data Analysis
The Patent Claims Research Dataset by the USPTO can provide insights into the scope and trends of patent claims in the pharmaceutical sector, including the dependency relationships between claims and the overall patent scope[3].
Conclusion
United States Patent 6,235,712 is a pivotal invention in the field of pharmaceuticals, offering stable non-aqueous polar aprotic formulations for peptide compounds. The patent's detailed specification and claims provide a clear understanding of the invention's scope and its practical applications, particularly in implantable delivery devices.
Key Takeaways
- Stable Formulations: The patent introduces non-aqueous polar aprotic solvents to stabilize peptide compounds.
- Implantable Devices: The formulations are particularly useful in implantable devices for long-term drug delivery.
- Temperature Stability: The formulations remain stable at elevated temperatures.
- Legal and Economic Impact: The patent has significant legal and economic implications for the pharmaceutical industry.
FAQs
What is the main invention described in US Patent 6,235,712?
The main invention is the use of non-aqueous polar aprotic solvents to create stable formulations of peptide compounds.
What are the practical applications of this patent?
The formulations are especially useful in implantable delivery devices for long-term drug delivery and can be stored at elevated temperatures without degradation.
How many claims does the patent include?
The patent includes 19 claims, defining the scope of the invention.
What is the significance of the patent's stability at elevated temperatures?
The stability at elevated temperatures makes the formulations ideal for storage and transportation, reducing the need for cold chain requirements.
How does this patent fit into the broader patent landscape?
The patent is part of a series of related applications and patents, and its claims can be used to determine infringement in legal proceedings.
