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Patent landscape, scope, and claims: |
Analyzing the Scope and Claims of United States Patent 5,695,743
Introduction
United States Patent 5,695,743, titled "Aerosol Formulation Containing Salbutamol," is a significant patent in the pharmaceutical industry, particularly in the context of inhaler medications. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Patent Number and Title
- The patent number is 5,695,743, and the title is "Aerosol Formulation Containing Salbutamol."
Inventors and Assignees
- The inventors and assignees of this patent are crucial for understanding its ownership and development history. However, specific details about the inventors and assignees are not provided in the sources, but typically this information can be found in the patent document itself or through patent search databases like the USPTO's Patent Public Search[1].
Issue and Expiration Dates
- The patent was issued on December 9, 1997, and it has since expired, as patents generally have a term of 20 years from the filing date.
Claims Analysis
Claim Structure
- The claims of a patent define the scope of the invention and are critical for determining what is protected. For Patent 5,695,743, the claims would typically include a combination of independent and dependent claims. Independent claims stand alone and define the broadest scope of the invention, while dependent claims narrow down the scope by adding additional limitations[3].
Claim Content
- The claims of this patent would focus on the aerosol formulation containing salbutamol, a common bronchodilator used in inhalers for asthma and COPD. The claims might include specifics about the formulation composition, the method of preparation, and any unique characteristics of the aerosol.
Scope of the Invention
Technical Details
- The scope of the invention involves an aerosol formulation that includes salbutamol as the active ingredient. This formulation would be designed to be delivered via an inhaler, providing a specific therapeutic effect. The scope might also cover various aspects such as the concentration of salbutamol, the type of propellant used, and any additional ingredients that enhance the stability or efficacy of the formulation.
Therapeutic Use
- The primary therapeutic use of this invention is in the treatment of respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD). The aerosol formulation is designed to provide quick relief by delivering the medication directly to the lungs.
Patent Landscape
Related Patents and Applications
- The patent landscape around Patent 5,695,743 includes other patents related to inhaler formulations and devices. For instance, patents like those involved in the Teva vs. Amneal case, which deal with inhaler devices rather than drug formulations, highlight the complexity of the patent landscape in this field[2].
Global Dossier and International Filings
- To understand the global reach of this patent, one would need to look into the Global Dossier, which provides access to the file histories of related applications from participating IP Offices. This can reveal if similar patents were filed in other jurisdictions and their current status[1].
Legal and Regulatory Context
Orange Book Listings
- The legal context surrounding this patent is relevant, especially in discussions about Orange Book listings. The Orange Book is a list of approved drug products with therapeutic equivalence evaluations. Patents related to drug products can be listed here, but there are strict criteria for what can be included. For example, device patents that do not claim a drug substance or drug product should not be listed, as seen in the Teva vs. Amneal case[2][5].
Court Rulings and Appeals
- The expiration of Patent 5,695,743 in 2014 means it is no longer a factor in current legal disputes. However, similar patents and their listings in the Orange Book continue to be a subject of legal debate, as illustrated by the ongoing case involving Teva and Amneal.
Impact on the Pharmaceutical Industry
Generic Competition
- The expiration of Patent 5,695,743 has allowed for generic competition in the market for salbutamol inhalers. Generic versions of the drug can now be produced, which can lead to lower prices and increased accessibility for patients.
Innovation and R&D
- The patent's expiration also opens up opportunities for further innovation in aerosol formulations and inhaler technologies. Companies can build upon the existing knowledge and develop new products that may offer improved efficacy or convenience.
Conclusion and Key Takeaways
- Patent Expiration: Patent 5,695,743 has expired, allowing for generic competition and further innovation.
- Claims and Scope: The patent's claims would have focused on the aerosol formulation containing salbutamol, defining the scope of the invention.
- Legal Context: The patent landscape is complex, with ongoing legal debates about what can be listed in the Orange Book.
- Impact on Industry: The expiration has led to increased accessibility of salbutamol inhalers and potential for new innovations.
Key Takeaways
- Patent Search Tools: Utilize tools like the USPTO's Patent Public Search and Global Dossier to understand the patent landscape.
- Claims Analysis: Detailed analysis of patent claims is crucial for understanding the scope of protection.
- Legal and Regulatory Compliance: Ensure compliance with regulations regarding Orange Book listings to avoid legal disputes.
- Innovation Opportunities: Expired patents can open up new avenues for research and development.
- Generic Competition: Expiration of patents can lead to increased generic competition, benefiting consumers.
FAQs
Q: What is the significance of Patent 5,695,743 in the pharmaceutical industry?
A: Patent 5,695,743 is significant because it covers an aerosol formulation containing salbutamol, a common medication for respiratory conditions. Its expiration has allowed for generic competition.
Q: How can one search for detailed information about this patent?
A: You can use the USPTO's Patent Public Search tool or visit the USPTO Public Search Facility to access detailed information about the patent.
Q: What is the Orange Book, and why is it relevant to this patent?
A: The Orange Book is a list of approved drug products with therapeutic equivalence evaluations. Patents related to drug products can be listed here, but there are strict criteria for inclusion.
Q: What are the implications of the expiration of Patent 5,695,743?
A: The expiration allows for generic versions of the drug to be produced, increasing accessibility and potentially reducing prices.
Q: How does the Global Dossier help in understanding the patent landscape?
A: The Global Dossier provides access to the file histories of related applications from participating IP Offices, helping to understand the global reach and status of similar patents.
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