United States Patent 6,919,092: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,919,092, hereafter referred to as the '092 patent, is a significant intellectual property asset in the pharmaceutical sector. This patent, like many others, has a complex landscape that includes its scope, claims, and the broader patent environment it operates within.
Background of the Patent
The '092 patent was granted on September 6, 2005, and is associated with Oxybutynin Chloride Extended-release Tablets, a medication used to treat overactive bladder. The patent is part of a series of patents held by Alza Corporation, which has since been involved in various legal and regulatory proceedings related to generic drug approvals[2].
Scope of the Patent
The scope of the '092 patent encompasses the formulation, composition, and method of delivery for Oxybutynin Chloride Extended-release Tablets. This includes specific details on the drug's extended-release mechanism, which is designed to provide a controlled release of the active ingredient over a prolonged period. The scope is critical in defining what aspects of the drug are protected under the patent and what would constitute infringement[2].
Claims of the Patent
The claims of the '092 patent are the heart of its legal protection. These claims outline the specific inventions or innovations that are protected. For pharmaceutical patents, claims often include:
- Composition claims: These define the specific formulation of the drug.
- Method of use claims: These describe how the drug is administered or used.
- Method of manufacture claims: These detail the process by which the drug is produced.
In the case of the '092 patent, the claims would likely include detailed descriptions of the extended-release formulation and the method by which it is manufactured and administered[2].
Patent Claims Analysis
To understand the '092 patent's claims in depth, one would need to analyze the parsed claims text, which can be obtained from datasets such as the Patent Claims Research Dataset provided by the USPTO. This dataset includes individually-parsed claims, claim-level statistics, and document-level statistics, which can help in understanding the dependency relationships between claims and the overall scope of the patent[3].
Patent Landscape
The patent landscape surrounding the '092 patent involves several key elements:
Related Patents
The '092 patent is part of a family of patents related to Oxybutynin Chloride Extended-release Tablets. Other patents in this family include 5,674,895, 5,840,754, 5,912,268, 6,124,355, and 6,262,115. These patents collectively protect various aspects of the drug's formulation, manufacture, and use[2].
Litigation and Regulatory Actions
The '092 patent has been involved in significant litigation. For instance, IMPAX Laboratories, Inc. filed an Abbreviated New Drug Application (ANDA) with paragraph IV certifications stating that the '092 patent was invalid, unenforceable, or would not be infringed by their manufacture, use, or sale of Oxybutynin Chloride Extended-release Tablets. This led to a lawsuit by Alza Corporation, which was eventually decided in favor of IMPAX Laboratories, Inc. through a summary judgment of non-infringement[2].
International Patent Filings
The patent landscape also includes international filings. The '092 patent may have corresponding patents in other countries, which can be searched through databases such as the European Patent Office's esp@cenet, the Japan Patent Office, or the World Intellectual Property Organization's PATENTSCOPE[4].
Search and Analysis Tools
Several tools are available for searching and analyzing patents like the '092 patent:
Patent Public Search
The USPTO's Patent Public Search tool provides enhanced access to prior art and can be used to search for patents, including the '092 patent, and understand its place within the broader patent landscape[4].
Global Dossier
The Global Dossier service allows users to view the file histories of related applications from participating IP Offices, which can be useful in understanding the international scope of the '092 patent[4].
Common Citation Document (CCD)
The CCD application consolidates prior art cited by all participating offices for the family members of a patent application, providing a comprehensive view of the patent's citations and references[4].
Impact on Generic Drug Approvals
The '092 patent has significant implications for generic drug approvals. Generic manufacturers must navigate the patent landscape carefully to avoid infringement. The paragraph IV certifications and subsequent litigation involving the '092 patent highlight the complexities and challenges in this process[2].
Expiration and Generic Entry
The expiration date of the '092 patent is crucial for generic drug manufacturers. Once the patent expires, generic versions of the drug can be approved and marketed without fear of infringement. The expiration date for this patent would typically be 20 years from the filing date, unless extended by regulatory actions or other factors[5].
Key Takeaways
- Scope and Claims: The '092 patent protects specific aspects of Oxybutynin Chloride Extended-release Tablets, including its formulation and method of delivery.
- Litigation: The patent has been involved in significant litigation, including a summary judgment of non-infringement in favor of IMPAX Laboratories, Inc.
- International Filings: Corresponding patents may exist in other countries, affecting global market strategies.
- Search and Analysis Tools: Various tools like Patent Public Search, Global Dossier, and CCD are available for comprehensive analysis.
- Impact on Generic Drug Approvals: The patent's expiration and the outcome of litigation significantly impact generic drug approvals.
FAQs
What is the '092 patent related to?
The '092 patent is related to Oxybutynin Chloride Extended-release Tablets, a medication for treating overactive bladder.
What are the key claims of the '092 patent?
The key claims include composition, method of use, and method of manufacture claims related to the extended-release formulation of Oxybutynin Chloride.
Has the '092 patent been involved in litigation?
Yes, the '092 patent was involved in a lawsuit by Alza Corporation against IMPAX Laboratories, Inc., which resulted in a summary judgment of non-infringement in favor of IMPAX.
How can one search for patents like the '092 patent?
One can use tools like the USPTO's Patent Public Search, Global Dossier, and Common Citation Document (CCD) to search and analyze patents.
What is the significance of the '092 patent's expiration date?
The expiration date marks when generic versions of the drug can be approved and marketed without fear of infringement, significantly impacting the pharmaceutical market.
Where can one find detailed information on the '092 patent?
Detailed information can be found through the USPTO's databases, the Patent Claims Research Dataset, and other patent search tools and resources.
Sources
- PatentsView: Data Download Tables.
- FDA: ANDA 76-745 IMPAX Laboratories, Inc.
- USPTO: Patent Claims Research Dataset.
- USPTO: Search for patents.
- DrugPatentWatch: Pharmaceutical drugs covered by patent 6,919,092.
