United States Patent 7,790,199: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,790,199, titled "Modified release dosage forms of skeletal muscle relaxants," is a significant patent in the pharmaceutical industry, particularly in the field of controlled-release drug delivery systems. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Inventors and Assignees
The patent was granted to inventors associated with Aptalis Pharma Inc. (now part of Allergan plc), a company known for its innovative pharmaceutical products, including treatments for gastrointestinal diseases and other conditions[5].
Patent Description
The patent describes a system for the controlled-rate release of active substances, specifically skeletal muscle relaxants. The system involves a deposit core comprising the active substance and at least one release-modifying agent. This design allows for a controlled and sustained release of the drug, which is crucial for maintaining therapeutic efficacy over an extended period[4].
Claims Analysis
Independent Claims
The patent includes several independent claims that define the scope of the invention. For example, Claim 1 of the '199 patent is representative and outlines the core components of the modified release dosage form, including the deposit core and the release-modifying agent[2].
Dependent Claims
Dependent claims further specify the details of the invention, such as the types of release-modifying agents, the formulation of the deposit core, and the methods of manufacturing the dosage form. These claims help to narrow down the scope and ensure that the patent covers specific embodiments of the invention.
Patent Scope
Metrics for Measuring Patent Scope
Research suggests that patent scope can be measured using metrics such as independent claim length and independent claim count. Narrower claims, as seen in the '199 patent, are often associated with a higher probability of grant and a shorter examination process. This indicates that the patent office has carefully scrutinized and validated the claims, ensuring they are clear and not overly broad[3].
Impact on Innovation
The scope of the patent is crucial as it affects innovation and competition in the industry. A well-defined scope ensures that the patent does not stifle innovation by being overly broad, thus maintaining incentives for further research and development.
Patent Landscape
Related Patents and Applications
The '199 patent is part of a family of patents related to controlled-release drug delivery systems. Other patents, such as US Patent 7,829,121, also owned by Aptalis, cover similar technologies and are listed in the Orange Book for the product AMRIX®, which is approved for treating muscle spasms[5].
Global Dossier and International Filings
Using tools like the Global Dossier, one can see the patent family for this specific application, including related applications filed at participating IP Offices. This provides a comprehensive view of the international patent landscape and helps in understanding the global reach of the invention[1].
Prosecution History
Examination Process
The prosecution history of the '199 patent reveals the interactions between the inventors and the patent office during the examination process. This history can inform the meaning of the claims, even without explicit statements in the patent specification. For instance, the court has cited the prosecution history to interpret claim meanings in litigation involving this patent[2].
Litigation and Enforcement
Infringement Cases
The '199 patent has been involved in several infringement cases, notably against Apotex, which was later released from an infringement finding after claim construction. These cases highlight the importance of clear claim definitions and the need for robust patent enforcement strategies[5].
Industry Impact
Pharmaceutical Market
The controlled-release dosage forms described in the '199 patent have significant implications for the pharmaceutical market. These formulations can improve patient compliance, reduce side effects, and enhance the overall therapeutic efficacy of skeletal muscle relaxants.
Competitive Landscape
The patent landscape in this area is highly competitive, with several companies developing similar technologies. The '199 patent, along with related patents, positions Aptalis (now Allergan) as a key player in this market, influencing the direction of research and development in controlled-release drug delivery systems.
Search and Analysis Tools
USPTO Resources
Tools like the Patent Public Search, Global Dossier, and the Patent Examination Data System (PEDS) are essential for conducting thorough searches and analyses of patents like the '199 patent. These resources provide access to prior art, prosecution histories, and other critical information necessary for understanding the patent's scope and claims[1].
International Patent Databases
Access to Global Patent Information
Databases such as esp@cenet from the European Patent Office, PATENTSCOPE from WIPO, and others provide access to international patent information. This is crucial for assessing the global patent landscape and ensuring that innovations are not duplicated or infringed upon[1].
Key Takeaways
- Clear Claims: The '199 patent demonstrates the importance of clear and specific claims in defining the scope of an invention.
- Prosecution History: The prosecution history can significantly inform the interpretation of patent claims.
- Global Landscape: Understanding the global patent landscape is essential for navigating the complexities of international intellectual property.
- Industry Impact: The patent has a substantial impact on the pharmaceutical market, particularly in the area of controlled-release drug delivery systems.
- Litigation: The patent has been involved in significant litigation, highlighting the need for robust enforcement strategies.
Frequently Asked Questions (FAQs)
What is the main subject of United States Patent 7,790,199?
The main subject of the patent is a system for the controlled-rate release of skeletal muscle relaxants.
Who are the inventors and assignees of the patent?
The inventors are associated with Aptalis Pharma Inc. (now part of Allergan plc).
How can the scope of the patent be measured?
The scope can be measured using metrics such as independent claim length and independent claim count.
What is the significance of the prosecution history in interpreting patent claims?
The prosecution history can inform the meaning of the claims, even without explicit statements in the patent specification.
How does the patent impact the pharmaceutical market?
The patent improves patient compliance, reduces side effects, and enhances the therapeutic efficacy of skeletal muscle relaxants, positioning Aptalis (now Allergan) as a key player in the market.
Cited Sources:
- USPTO, "Search for patents - USPTO," USPTO Website.
- JD Supra, "Prosecution History Informs Claim Meaning Even Without ...," JD Supra Website.
- SSRN, "Patent Claims and Patent Scope - Search eLibrary :: SSRN," SSRN Website.
- Google Patents, "Modified release dosage forms of skeletal muscle relaxants," Google Patents Website.
- JD Supra, "Apotex Released from Infringement Finding After Claim Construction ...," JD Supra Website.
