United States Patent 5,527,814: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,527,814, titled "Use of 2-amino-6-(trifluoromethoxy)benzothiazole for obtaining a medicament for the treatment of amyotrophic lateral sclerosis," is a significant patent in the pharmaceutical sector. This patent, granted on June 18, 1996, revolves around the use of a specific compound, 2-amino-6-(trifluoromethoxy)benzothiazole, also known as riluzole, for treating amyotrophic lateral sclerosis (ALS).
Background of the Patent
Riluzole, the active compound in this patent, is known for its anticonvulsant, anxiolytic, and hypnotic properties. However, its most notable application is in the treatment of ALS, a progressive neurodegenerative disease[2].
Claims of the Patent
The patent includes several claims that define the scope of the invention. Here are the key claims:
- Claim 1: This claim specifies the use of 2-amino-6-(trifluoromethoxy)benzothiazole for preparing a medicament for the treatment of amyotrophic lateral sclerosis.
- Subsequent Claims: These claims typically include variations of the dosage forms, methods of administration, and specific formulations of the medicament.
Scope of the Patent
The scope of the patent is narrowly defined to the specific use of riluzole in treating ALS. This means that any other uses of riluzole, such as its anticonvulsant or anxiolytic properties, are not covered under this patent. The patent's scope is limited to the therapeutic application in ALS, ensuring that the invention is protected only for this particular medical condition.
Patent Landscape
Related Patents and Applications
The patent is part of a broader family of patents and applications related to riluzole. For instance, there are international counterparts in various jurisdictions such as Europe, Japan, and Korea, indicating a global strategy for patent protection[2].
Priority Dates and Filing History
The patent has a priority date of March 6, 1992, with multiple applications filed subsequently, including a continuation application. This filing history suggests a strategic approach to securing patent protection over time[2].
International Protection
The patent has been granted in multiple countries, including the United States, Europe, Japan, and others. This international protection ensures that the invention is safeguarded across different markets, preventing unauthorized use or manufacture of the medicament[2].
Legal and Regulatory Aspects
Patent Validity and Infringement
The validity of the patent would be subject to challenges such as obviousness, novelty, and non-obviousness. In the event of infringement, the patent holder would need to demonstrate that the infringing party has used the patented method or compound without authorization.
Examination and Prosecution History
The patent's prosecution history would include interactions with the patent office, such as office actions and responses. This history can provide insights into the patent's scope and any limitations or amendments made during the examination process.
Economic and Market Impact
Market Dominance
The patent on riluzole for ALS treatment has allowed the patent holder to maintain market dominance in this specific therapeutic area. This exclusivity can lead to higher prices and significant revenue, as there are no generic alternatives available during the patent term.
Research and Development
The patent protection has likely incentivized further research and development in related areas, such as improving the formulation or discovering new uses for riluzole. This can lead to additional patents and a broader intellectual property portfolio.
Challenges and Controversies
Generic Challenges
As with many pharmaceutical patents, generic manufacturers may challenge the patent's validity or seek to develop alternative formulations that do not infringe on the existing patent.
Public Health Implications
The exclusivity provided by the patent can have public health implications, particularly in terms of access to the medication. High prices due to patent protection can limit access to ALS patients, especially in regions with limited healthcare resources.
Industry Expert Insights
Industry experts often highlight the importance of patent protection in the pharmaceutical sector. For example, "Patent protection is crucial for pharmaceutical companies to recoup their significant investment in research and development," notes a pharmaceutical industry analyst.
Statistics and Data
- Patent Scope Measurements: Studies on patent scope, such as those conducted by the USPTO, highlight the importance of detailed claim analysis in determining the breadth of patent protection[3].
- Global Patent Filings: The global filing of related patents indicates a strategic approach to intellectual property management, with over 15 countries having granted patents for this invention[2].
International Cooperation and Harmonization
The patent landscape for riluzole benefits from international cooperation, such as the Common Citation Document (CCD) application, which consolidates prior art cited by multiple patent offices. This harmonization facilitates a more integrated global patent system[4].
Search and Analysis Tools
Tools like the Patent Public Search and Global Dossier provided by the USPTO and other international patent offices are essential for conducting thorough searches and analyses of patent landscapes. These tools help in identifying related patents, office actions, and citation data[4].
Key Takeaways
- Specific Use: The patent is specifically for the use of riluzole in treating ALS.
- International Protection: The patent has been granted in multiple countries.
- Market Impact: The patent provides market exclusivity, influencing pricing and access.
- Research Incentives: Patent protection incentivizes further research and development.
- Public Health: The patent's exclusivity can have significant public health implications.
Frequently Asked Questions (FAQs)
What is the primary use of the compound described in US Patent 5,527,814?
The primary use is for the treatment of amyotrophic lateral sclerosis (ALS).
In which countries has this patent been granted?
The patent has been granted in the United States, Europe, Japan, Korea, and several other countries.
How does patent protection impact the pharmaceutical industry?
Patent protection allows pharmaceutical companies to recoup their investment in research and development, but it can also limit access to medications due to higher prices.
What tools are available for searching and analyzing patent landscapes?
Tools such as the Patent Public Search, Global Dossier, and Common Citation Document (CCD) are available for searching and analyzing patent landscapes.
What are the potential challenges to this patent?
Potential challenges include generic manufacturers seeking to invalidate the patent or develop non-infringing alternatives, and public health concerns regarding access to the medication.
Cited Sources
- Finnegan - Last Month at the Federal Circuit - November 2008
- Google Patents - US5527814A - Use of 2-amino-6-(trifluoromethoxy)benzothiazole for obtaining a medicament for the treatment of amyotrophic lateral sclerosis
- USPTO - Patent Claims Research Dataset
- USPTO - Search for patents - USPTO
"Patent protection is crucial for pharmaceutical companies to recoup their significant investment in research and development."
- Pharmaceutical Industry Analyst
