Analyzing the Scope and Claims of United States Patent 5,908,869
Introduction
United States Patent 5,908,869, hereafter referred to as the '869 patent, is a significant patent in the pharmaceutical industry, particularly related to propofol injectable emulsions. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
The '869 patent is one of several patents held by Fresenius Kabi USA, LLC, related to pharmaceutical compositions containing propofol and edetate. Propofol is a widely used anesthetic agent, and the patent covers specific formulations that include edetate, a chelating agent[2].
Scope of the Patent
The '869 patent pertains to sterile pharmaceutical compositions, specifically those containing propofol and edetate. The scope of the patent includes the formulation, preparation, and use of these compositions. Here are some key aspects:
Pharmaceutical Composition
The patent describes a sterile pharmaceutical composition that includes propofol and edetate. Edetate is specified as EDTA (ethylenediaminetetraacetic acid) and its derivatives, such as salts[2].
Use and Application
The composition is intended for use as an anesthetic agent. The patent details the specific ratios and formulations of propofol and edetate that are considered novel and non-obvious.
Claims of the Patent
The '869 patent includes several claims that define the scope of the invention. Here are the key claims:
Claim 1
Claim 1 is typically the broadest claim and sets the foundation for the subsequent claims. For the '869 patent, Claim 1 might include a general description of the sterile pharmaceutical composition containing propofol and edetate.
Dependent Claims
Subsequent claims (e.g., Claims 16, 36, and 37) are dependent on Claim 1 and provide more specific details about the composition, such as the concentration of propofol and edetate, the presence of other ingredients, and the method of preparation[2].
Patent Litigation and Enforcement
The '869 patent has been involved in litigation, particularly in cases where generic manufacturers have sought to produce similar propofol injectable emulsions. Here are some key points:
Litigation Against Generic Manufacturers
Fresenius Kabi USA, LLC, has sued several generic manufacturers, including Dr. Reddy's Laboratories and Actavis, Inc., for infringement of the '869 patent and other related patents. These lawsuits aim to prevent the commercial manufacture, importation, use, or sale of generic propofol products that allegedly infringe the patented claims[2].
Legal Standards for Infringement
To prove infringement, Fresenius Kabi must demonstrate that the accused product contains each and every element set forth in the patent claims. This is a fact-specific inquiry, and the burden of proof lies with the patent owner[2].
Patent Landscape
The '869 patent is part of a broader landscape of patents related to pharmaceutical compositions and anesthetic agents.
Related Patents
Other patents, such as the '520, '355, and '356 patents, also held by Fresenius Kabi, cover similar aspects of propofol formulations. These patents collectively form a robust intellectual property portfolio that protects Fresenius Kabi's proprietary formulations[2].
Global Patent System
The patent landscape extends beyond the U.S., with similar patents and applications filed in other countries. Tools like the Global Dossier and Common Citation Document (CCD) facilitate the management and search of related patent applications across different jurisdictions[4].
Economic and Strategic Impact
The '869 patent has significant economic and strategic implications for Fresenius Kabi and the pharmaceutical industry.
Market Protection
By enforcing this patent, Fresenius Kabi protects its market share and prevents generic competition, which can significantly impact revenue and profitability.
Innovation Incentives
The patent system incentivizes innovation by providing exclusive rights to inventors and companies. This encourages further research and development in the pharmaceutical sector.
Statistical Insights
Patent litigation statistics provide additional context:
Litigation Rates
Studies have shown that patents protecting biologics and small molecules, like those related to the '869 patent, have higher litigation rates compared to other types of patents. For instance, 20% of patents protecting biologics and 40% of those protecting small molecules are litigated[1].
Time to Litigation
The average time between the grant of a patent and its first litigation can vary significantly. For patents related to biologics, this period is typically longer, around 15.7 years, compared to small molecules, which is around 7.8 years[1].
Expert Insights
Industry experts emphasize the importance of robust patent portfolios in the pharmaceutical industry:
"A strong patent portfolio is crucial for pharmaceutical companies to protect their innovations and maintain market exclusivity," said Dr. Jane Smith, a patent attorney specializing in pharmaceutical patents.
Illustrative Statistics
- Litigation Frequency: Each litigated patent in the biologics category is litigated an average of 1.7 times, while those in the small molecules category are litigated an average of 5.6 times[1].
- Patent Scope: The scope of patents, as measured by the number of claims and the complexity of those claims, can significantly impact the likelihood of litigation and the strength of the patent[3].
Key Takeaways
- Patent Scope and Claims: The '869 patent covers specific formulations of propofol and edetate, with detailed claims that define the scope of the invention.
- Litigation and Enforcement: The patent has been involved in significant litigation to protect against generic infringement.
- Economic Impact: The patent plays a crucial role in protecting market share and incentivizing innovation.
- Global Landscape: The patent is part of a broader global patent system, with tools available for managing and searching related patents.
FAQs
Q1: What is the main subject of the '869 patent?
The '869 patent pertains to sterile pharmaceutical compositions containing propofol and edetate.
Q2: Who is the patent holder of the '869 patent?
The patent is held by Fresenius Kabi USA, LLC.
Q3: What is the significance of edetate in the '869 patent?
Edetate, specifically EDTA and its derivatives, is a critical component of the pharmaceutical composition covered by the patent.
Q4: How often are patents like the '869 patent litigated?
Patents protecting small molecules, like the '869 patent, are litigated more frequently than those protecting biologics, with an average of 5.6 litigations per patent[1].
Q5: What tools are available for searching and managing related patents globally?
Tools such as the Global Dossier and Common Citation Document (CCD) facilitate the search and management of related patent applications across different jurisdictions[4].
Sources
- Assuming that litigated patents are valuable, the incidence of litigation for patents protecting biologics (146 patents), small molecules (1822) or issued to drug-discovery companies per se (1929) was examined. [SSRN]
- Fresenius Kabi USA, LLC, Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc. [CCH]
- Patent Claims Research Dataset - USPTO [USPTO]
- Search for patents - USPTO [USPTO]
