United States Patent 5,605,674: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 5,605,674, titled "Stabilized Aerosol Drug Formulation," is a significant patent in the pharmaceutical industry, particularly in the field of inhalable drug delivery systems. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention Overview
The patent, granted to Glaxo Inc., describes a method for making stabilized aerosol drug formulations and the formulations themselves, along with metered drug inhalers containing these formulations. This invention is crucial for delivering medications, such as those used for respiratory conditions like asthma and COPD, in a stable and effective manner[5].
Scope of the Patent
The scope of the patent encompasses several key aspects:
Method of Preparation
The patent details a specific method for preparing stabilized aerosol drug formulations. This involves combining the active pharmaceutical ingredient with a propellant and a stabilizer to ensure the formulation remains stable over time[5].
Formulations and Compositions
The patent covers various formulations that can be produced using the described method. These formulations are designed to maintain the integrity of the active ingredient and ensure consistent delivery through inhalation devices[5].
Metered Drug Inhalers
The invention also includes metered drug inhalers that contain the stabilized aerosol drug formulations. These inhalers are designed to deliver a precise dose of the medication with each use, ensuring consistent and effective treatment[5].
Claims Analysis
The claims of the patent are critical in defining the scope of protection and what constitutes infringement.
Independent Claims
The patent includes several independent claims that outline the core aspects of the invention. These claims typically cover the method of preparation, the composition of the formulations, and the metered drug inhalers themselves.
Dependent Claims
Dependent claims further specify and narrow down the scope of the independent claims. For example, they might detail specific types of propellants or stabilizers that can be used, or particular characteristics of the metered drug inhalers[5].
Patent Landscape
Understanding the patent landscape is essential for navigating the intellectual property rights surrounding this invention.
Related Patents and Applications
Other patents and applications in the same field can provide insights into the broader technological landscape. For instance, patents related to other inhalable drug delivery systems or formulations can indicate areas of innovation and competition[4].
Patent Family and Global Dossier
The patent family for US 5,605,674 includes related applications and grants in other jurisdictions. Using tools like the Global Dossier, one can access the file histories of related applications from participating IP offices, providing a comprehensive view of the patent family[4].
Citation Data and Prior Art
Analyzing citation data through tools like the Common Citation Document (CCD) can reveal how this patent has been cited by other patent applications and the prior art that was considered during its examination. This helps in understanding the patent's impact and its position within the broader technological context[4].
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 categorize the patents and claims by scope concepts, helping to identify which claims are actively protecting the intellectual property and where gaps or opportunities exist. This is particularly useful for managing a large portfolio of patents and ensuring comprehensive coverage[3].
Claim Charts and Scope Concepts
Interactive claim charts generated by tools like ClaimScape® can help technical experts review the patent coverage. These charts can highlight areas where the current coverage is strong or weak, and identify future design opportunities[3].
Patent Certifications and Expiry
The patent's status regarding certifications and expiry dates is crucial for understanding its current and future impact.
Paragraph IV Certifications
In the context of 505(b)(2) applications, the patent's status regarding Paragraph IV certifications is important. This involves certifications related to the patent's validity, enforceability, or infringement, which can affect the approval of generic or follow-on products[1].
Patent Expiry
The patent number 5,605,674 has expired, which means that the exclusive rights granted by this patent are no longer in effect. This opens up the technology for use by other entities without the need for licensing or infringement concerns[1].
Industry Impact and Examples
The impact of this patent can be seen in various industry applications.
Respiratory Medications
The stabilized aerosol drug formulations described in this patent have been widely used in respiratory medications. For example, inhalers for asthma and COPD often rely on similar formulations to ensure effective and consistent drug delivery[5].
Competitor Landscape
Companies like GlaxoSmithKline, which was the assignee of this patent, have developed numerous inhalable drug products based on similar technologies. Understanding the patent landscape helps these companies navigate competition and innovation in the field[4].
Key Takeaways
- Method and Formulations: The patent covers a method for preparing stabilized aerosol drug formulations and the compositions themselves.
- Metered Drug Inhalers: The invention includes metered drug inhalers designed to deliver precise doses of medication.
- Claims Analysis: Independent and dependent claims define the scope of protection.
- Patent Landscape: Understanding related patents, patent families, and citation data is crucial.
- Patent Analytics: Tools like Claim Coverage Matrix and Claim Charts help in managing and analyzing patent portfolios.
- Patent Certifications and Expiry: The patent has expired, affecting its current and future impact.
Frequently Asked Questions
What is the main invention described in US Patent 5,605,674?
The main invention is a method for making stabilized aerosol drug formulations and the formulations themselves, along with metered drug inhalers containing these formulations.
How does the patent impact the pharmaceutical industry?
The patent has significantly impacted the development of inhalable drug delivery systems, particularly for respiratory medications like those for asthma and COPD.
What tools can be used to analyze the patent landscape?
Tools such as the Global Dossier, Common Citation Document (CCD), and patent analytics software like ClaimScape® can be used to analyze the patent landscape.
Is the patent still in effect?
No, the patent has expired, which means the exclusive rights granted by this patent are no longer in effect.
How can companies ensure they do not infringe on similar patents?
Companies can use patent analytics tools to identify gaps in their current coverage and ensure that their products do not infringe on existing patents. They should also conduct thorough searches of prior art and related patents.
Cited Sources
- FDA Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products.
- United States Patent (19): US5993781.
- Patent Analytics | Intellectual Property Law: Schwegman Lundberg & Woessner, P.A.
- USPTO Patent Search: United States Patent and Trademark Office.
- Unified Patents Portal: US-5376359-A.
