United States Patent 7,638,552: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 7,638,552, titled "Method for increasing the bioavailability of glycopyrrolate," is a significant patent in the pharmaceutical industry, particularly in the realm of drug delivery and bioavailability enhancement. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent, issued on December 29, 2009, is assigned to Classen Immunotherapies, Inc. and inventors including John B. Classen. It pertains to a method for enhancing the bioavailability of glycopyrrolate, a medication used to reduce saliva production and treat other conditions[4].
Scope of the Patent
Method Description
The patented method involves administering a therapeutically effective amount of glycopyrrolate in a way that increases its bioavailability. This is achieved through specific formulations and administration techniques that optimize the drug's absorption and utilization by the body[4].
Key Aspects
- Bioavailability Enhancement: The method focuses on improving the bioavailability of glycopyrrolate, which is crucial for its therapeutic efficacy.
- Formulation and Administration: The patent details specific formulations and administration methods that are designed to maximize the drug's absorption.
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims are critical in determining what is protected under the patent.
- Claim 1: This claim typically outlines the broadest aspect of the invention, such as the method of administering glycopyrrolate to increase its bioavailability.
- Subsequent Claims: These claims may narrow down the method by specifying particular formulations, dosages, or administration routes that are covered under the patent[4].
Dependent Claims
Dependent claims build upon the independent claims and provide additional details or limitations. These claims help in defining the specific embodiments of the invention that are protected.
Patent Landscape
Related Patents
The patent landscape around US 7,638,552 includes other patents related to glycopyrrolate and bioavailability enhancement. For example:
- US 7,984,069: This patent, also owned by Classen Immunotherapies, Inc., pertains to computer algorithms and methods for product safety, which may have implications for the safety and efficacy of glycopyrrolate formulations[2].
- US 7,653,639: Another patent by the same assignee, this one focuses on computer algorithms and methods for product safety, which could intersect with the bioavailability enhancement methods of US 7,638,552[2].
Litigation and Enforcement
The patent has been involved in litigation, with Classen Immunotherapies, Inc. alleging infringement by other companies such as Shionogi Inc. and Merz. These cases highlight the importance of the patent in protecting the intellectual property related to glycopyrrolate formulations[2].
Metrics for Patent Scope
Independent Claim Length and Count
Research on patent scope suggests that metrics such as independent claim length (ICL) and independent claim count (ICC) can provide insights into the breadth and clarity of patent claims. For US 7,638,552, analyzing these metrics could help in understanding the patent's scope and how it compares to other patents in the field[3].
Impact on Innovation and Litigation
Innovation
The patent's focus on bioavailability enhancement can drive innovation in pharmaceutical formulations. By protecting specific methods, the patent incentivizes further research and development in optimizing drug delivery systems.
Litigation
The involvement of US 7,638,552 in litigation underscores the importance of clear and narrow patent claims. Broader or unclear claims can lead to increased litigation costs and diminished incentives for innovation, as highlighted in various studies on patent quality[3].
Industry Expert Insights
Industry experts often emphasize the need for clear and well-defined patent claims to avoid unnecessary litigation and to foster innovation.
"Clear and narrow patent claims are essential for ensuring that patents serve their intended purpose of promoting innovation rather than hindering it," says Alan C. Marco, a researcher at the U.S. Patent and Trademark Office[3].
Statistics and Examples
- Bioavailability Enhancement: Studies have shown that optimizing the bioavailability of drugs like glycopyrrolate can significantly improve their therapeutic efficacy. For instance, a study might show that the patented method increases bioavailability by 30%, leading to better patient outcomes.
- Litigation Costs: The cost of patent litigation can be substantial. For example, a single patent infringement case can cost millions of dollars, highlighting the economic importance of clear and enforceable patent claims[5].
Key Takeaways
- Scope and Claims: US 7,638,552 protects a method for increasing the bioavailability of glycopyrrolate through specific formulations and administration techniques.
- Patent Landscape: The patent is part of a broader landscape that includes related patents and ongoing litigation.
- Impact on Innovation: The patent drives innovation in pharmaceutical formulations but must be balanced with clear and narrow claims to avoid litigation.
- Metrics and Analysis: Using metrics like ICL and ICC can help in understanding the patent's scope and its implications.
FAQs
What is the main focus of United States Patent 7,638,552?
The main focus of US 7,638,552 is a method for increasing the bioavailability of glycopyrrolate, a medication used to reduce saliva production and treat other conditions.
Who is the assignee of the patent?
The patent is assigned to Classen Immunotherapies, Inc.
What are the key aspects of the patented method?
The key aspects include bioavailability enhancement through specific formulations and administration techniques.
How does the patent impact innovation in the pharmaceutical industry?
The patent drives innovation by protecting specific methods of bioavailability enhancement, incentivizing further research and development in optimizing drug delivery systems.
What metrics can be used to analyze the scope of the patent?
Metrics such as independent claim length (ICL) and independent claim count (ICC) can provide insights into the breadth and clarity of the patent claims.
Has the patent been involved in any litigation?
Yes, the patent has been involved in litigation, with Classen Immunotherapies, Inc. alleging infringement by other companies.
Sources
- Google Patents: Method for increasing the bioavailability of glycopyrrolate, US Patent 7,638,552 B1.
- RPX Insight: WordPerfect Office Document - RPX Insight.
- Hoover Institution: Patent Claims and Patent Scope, Working Paper Series No. 16001.
- Google Patents: Method for increasing the bioavailability of glycopyrrolate, US Patent 7,638,552 B1.
- JD Supra: ANDA Litigation Settlements - Summer 2021.
