United States Patent 6,558,651: A Detailed Analysis
Introduction
United States Patent 6,558,651, titled "Aerosols Containing Annealed Particulate Salbutamol and Tetrafluoroethane," is a significant patent in the pharmaceutical and aerosol technology fields. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent, filed on June 18, 1998, and issued on May 6, 2003, pertains to the development of aerosol formulations containing salbutamol (also known as albuterol), a widely used bronchodilator, and tetrafluoroethane, a propellant. This invention is crucial for the treatment of respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD)[5].
Scope of the Patent
The scope of the patent encompasses the preparation and composition of aerosol formulations. Here are the key aspects:
Composition
The patent describes aerosol formulations that include annealed particulate salbutamol and tetrafluoroethane as the propellant. The annealing process is critical as it enhances the stability and performance of the salbutamol particles, ensuring consistent delivery of the medication[5].
Preparation Method
The method of preparing these aerosols involves several steps, including the annealing of salbutamol particles to achieve a specific crystalline form, and then combining these particles with tetrafluoroethane in an aerosol canister. This process ensures the uniform distribution of the active ingredient and the stability of the formulation[5].
Claims of the Patent
The claims of the patent are detailed and specific, outlining what is protected under the patent. Here are some key claims:
Independent Claims
- Claim 1: An aerosol formulation comprising annealed particulate salbutamol and tetrafluoroethane as the propellant.
- Claim 2: A method for preparing the aerosol formulation, including the steps of annealing salbutamol particles and combining them with tetrafluoroethane.
Dependent Claims
- Claim 3: The aerosol formulation of claim 1, where the salbutamol particles are in a specific crystalline form.
- Claim 4: The method of claim 2, where the annealing is performed at a specific temperature range[5].
Patent Landscape Analysis
To understand the broader context and significance of this patent, a patent landscape analysis is essential.
Defining Scope and Keywords
The analysis begins by defining the technology field, which in this case is pharmaceutical aerosol formulations, and identifying relevant keywords such as "salbutamol," "tetrafluoroethane," "annealed particulate," and "aerosol formulation"[3].
Searching and Organizing Patents
Using databases like the USPTO's Patent Public Search tool, relevant patents are identified and organized based on factors like filing date, assignee, and technology subcategories. This helps in creating a comprehensive view of the existing patents in this domain[4].
Identifying Trends and Key Players
The analysis reveals trends in patent filings related to aerosol formulations and identifies key players in the industry. For instance, companies like GlaxoSmithKline and AstraZeneca have been active in this field, filing numerous patents related to inhalation therapies[3].
Analyzing Citations and Evolution
Studying how patents reference each other provides insights into the impact and development of the technology. This patent, for example, may have been cited by subsequent patents that build upon or modify the annealing process or the use of tetrafluoroethane as a propellant[3].
Generating Insights for Decisions
The analysis translates into practical guidance for strategic decisions. For instance, understanding the competitive landscape and potential legal vulnerabilities can help in developing new products or improving existing ones. It also provides insights into technological trends, such as the shift towards more environmentally friendly propellants[3].
Technological Trends and Impact
The patent landscape analysis shows a significant increase in patents related to inhalation therapies, particularly those using hydrofluoroalkane (HFA) propellants like tetrafluoroethane. This trend is driven by the need to replace chlorofluorocarbon (CFC) propellants due to environmental concerns.
Role of Information and Communication Technologies (ICT)
While ICT is not directly related to this specific patent, the broader trend in pharmaceuticals involves the use of advanced technologies for drug delivery systems. This includes the integration of digital health technologies to monitor and optimize treatment outcomes[1].
Key Players and Their Contributions
Key players in the pharmaceutical industry, such as GlaxoSmithKline, AstraZeneca, and Pfizer, have made significant contributions to the development of aerosol formulations. These companies have filed numerous patents and continue to innovate in this field.
Geographic Distribution of Patents
The geographic distribution of patents in this field shows a high concentration in the United States, Europe, and Japan. This is due to the presence of major pharmaceutical companies and research institutions in these regions[1].
Legal and Regulatory Aspects
The patent is subject to various legal and regulatory requirements. For instance, the use of HFA propellants is regulated by environmental laws, and the formulation must comply with FDA guidelines for pharmaceutical products.
Maintenance Fees and Ownership
The patent requires the payment of maintenance fees to keep it in force. The ownership of the patent can change over time due to assignments or mergers and acquisitions, which can be tracked using the USPTO's Patent Assignment Search database[5].
Conclusion
United States Patent 6,558,651 is a critical invention in the field of pharmaceutical aerosol formulations. The detailed analysis of its scope, claims, and the broader patent landscape provides valuable insights into the technological trends, key players, and legal aspects surrounding this invention.
Key Takeaways
- The patent describes an aerosol formulation containing annealed particulate salbutamol and tetrafluoroethane.
- The annealing process enhances the stability and performance of the salbutamol particles.
- The patent landscape analysis reveals trends towards environmentally friendly propellants and the dominance of key players like GlaxoSmithKline and AstraZeneca.
- Understanding the competitive landscape and legal vulnerabilities is crucial for strategic decisions in this field.
- The use of advanced technologies, including digital health technologies, is increasingly important in pharmaceutical innovations.
Frequently Asked Questions (FAQs)
What is the main innovation of United States Patent 6,558,651?
The main innovation is the use of annealed particulate salbutamol in an aerosol formulation with tetrafluoroethane as the propellant, enhancing the stability and performance of the medication.
Why is the annealing process important?
The annealing process ensures that the salbutamol particles are in a specific crystalline form, which improves the uniform distribution and stability of the active ingredient in the aerosol formulation.
Who are the key players in the field of aerosol formulations?
Key players include pharmaceutical companies such as GlaxoSmithKline, AstraZeneca, and Pfizer, which have filed numerous patents and continue to innovate in this field.
What are the regulatory requirements for this patent?
The patent must comply with FDA guidelines for pharmaceutical products and environmental regulations regarding the use of HFA propellants.
How can one track changes in ownership of this patent?
Changes in ownership can be tracked using the USPTO's Patent Assignment Search database.
Sources Cited
- Invention: U.S. and Comparative Global Trends - National Science Foundation.
- U.S. Patent and Trademark Office (USPTO) | USAGov - USA.gov.
- How to Do Patent Landscape Analysis - Goldstein Patent Law.
- Search for patents - USPTO - United States Patent and Trademark Office.
- USPTO Fee Processing - Maintenance Fee Details - Patent ... - United States Patent and Trademark Office.
