United States Patent 6,524,555: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 6,524,555, titled "Metered dose inhaler for salmeterol," is a significant patent in the pharmaceutical and medical device sector. This patent, issued to Glaxo Group Limited, pertains to a specific design and formulation of a metered dose inhaler (MDI) for the drug salmeterol, which is commonly used in the treatment of asthma and chronic obstructive pulmonary disease (COPD).
Background
Salmeterol is a long-acting beta2-adrenergic receptor agonist (LABA) that helps to relax the muscles in the airways, improving breathing. The development of an effective MDI for salmeterol was crucial for delivering this medication in a controlled and efficient manner.
Patent Overview
Publication Number and Authority
The patent number is US6524555B1, and it was issued by the United States Patent and Trademark Office (USPTO)[4].
Prior Art and Legal Status
The patent was filed on October 25, 1999, and granted on February 18, 2003. As of the current date, the patent has expired due to fee-related issues[4].
Claims
Key Claims
The patent includes several key claims that define the scope of the invention:
- Claim 1: A metered dose inhaler comprising a canister containing a formulation of salmeterol, a fluorocarbon propellant, and optionally a fluoropolymer and a pharmaceutical excipient.
- Claim 2: The inhaler of claim 1, where the formulation includes salmeterol in a concentration range that ensures stability and efficacy.
- Claim 3: The inhaler of claim 1 or 2, where the fluorocarbon propellant is selected from a group including 1,1,1,2-tetrafluoroethane and 1,1,1,2,3,3,3-heptafluoropropane[4].
Claim Scope and Concepts
The claims are categorized into several scope concepts that help in understanding the protection provided by the patent:
- Formulation: The patent covers specific formulations of salmeterol with various propellants and excipients, ensuring the stability and efficacy of the drug.
- Propellant: The use of fluorocarbon propellants is a critical aspect, as these propellants are essential for the delivery mechanism of the MDI.
- Pharmaceutical Excipients: The inclusion of pharmaceutical excipients to enhance the stability and performance of the formulation is also covered[4].
Patent Landscape
Related Patents and Applications
The patent landscape for MDIs and salmeterol formulations is complex, with numerous patents and applications filed by various companies. Here are a few key points:
- Global Dossier: Using the Global Dossier service provided by the USPTO, one can view the patent family for this specific application, including related applications filed at participating IP Offices. This helps in understanding the broader patent landscape and potential overlaps or conflicts[1].
- International Search: Searching international patent databases such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO) can reveal similar or competing inventions in other jurisdictions[1].
Competing Technologies
Other companies have developed similar MDIs for salmeterol or other LABAs, which may pose competition:
- Alternative Propellants: Some patents focus on alternative propellants, such as hydrofluoroalkanes (HFAs), which are considered more environmentally friendly compared to chlorofluorocarbons (CFCs)[5].
- Different Formulations: Other formulations may include different excipients or co-solvents to enhance the stability and delivery of the drug.
Patent Analytics
Claim Coverage Matrix
To fully understand the protection provided by this patent, a Claim Coverage Matrix can be used. This matrix categorizes the patents and claims by scope concepts, such as the type of propellant, formulation, and excipients. This helps in identifying gaps or opportunities in the patent portfolio:
- Scope Concepts: The matrix would categorize claims based on high, medium, or low value to the company, indicating current, potential future, or less significant protections[3].
Claim Charts
Interactive claim charts generated by tools like ClaimScape® can help in reviewing the patent coverage with technical experts. These charts can quickly identify whether a particular scope concept is applicable to a target product or method, highlighting gaps in current coverage and future design opportunities[3].
Practical Implications
Manufacturing and Licensing
The expiration of this patent means that the specific formulation and design described can now be used by other manufacturers without infringing on the original patent. This opens up opportunities for generic or biosimilar versions of the MDI.
Research and Development
For companies looking to develop new MDIs or improve existing ones, understanding the claims and scope of this patent is crucial. It can guide the development of new formulations or delivery mechanisms that do not infringe on existing patents.
Key Takeaways
- Patent Expiration: The patent has expired, allowing for the use of the described formulation and design by other manufacturers.
- Claim Scope: The patent covers specific formulations of salmeterol with fluorocarbon propellants and pharmaceutical excipients.
- Patent Landscape: The landscape includes numerous related patents and applications, both domestically and internationally.
- Patent Analytics: Tools like Claim Coverage Matrix and Claim Charts are essential for understanding the protection and identifying gaps or opportunities.
FAQs
Q: What is the main subject of United States Patent 6,524,555?
A: The main subject is a metered dose inhaler (MDI) for the drug salmeterol.
Q: What is the current legal status of this patent?
A: The patent has expired due to fee-related issues.
Q: What are the key components covered by the claims of this patent?
A: The key components include the formulation of salmeterol, fluorocarbon propellants, and optional pharmaceutical excipients.
Q: How can companies use the information from this patent now that it has expired?
A: Companies can use the described formulation and design to develop their own MDIs without infringing on the original patent.
Q: What tools can be used to analyze the claims and scope of this patent?
A: Tools such as Claim Coverage Matrix and Claim Charts can be used to analyze the claims and identify gaps or opportunities in the patent portfolio.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Unified Patents - JP-6524555-B2: https://portal.unifiedpatents.com/patents/patent/JP-6524555-B2
- SLWIP - Patent Analytics: https://www.slwip.com/services/patent-analytics/
- Google Patents - US6524555B1: https://patents.google.com/patent/US6524555B1/und
- PubChem - Patent US-5261538-A: https://pubchem.ncbi.nlm.nih.gov/patent/US-5261538-A
