United States Patent 7,265,099: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,265,099, titled "Use of chemical chelators as reversal agents for drug-induced neuromuscular block," is a significant patent in the field of pharmacology, particularly in the reversal of neuromuscular blockade. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
The patent, assigned to Organon (now part of Merck Sharp & Dohme B.V.), addresses a critical issue in anesthesia: the reversal of drug-induced neuromuscular block. Neuromuscular blocking agents are used to facilitate surgical procedures, but their effects must be reversed post-surgery to restore normal muscle function.
Scope of the Patent
Invention Overview
The patent describes the use of chemical chelators, specifically 6-mercapto-cyclodextrin derivatives, as reversal agents for drug-induced neuromuscular block. These derivatives are designed to bind to the neuromuscular blocking agents, thereby reversing their effects and restoring muscle function[2][5].
Claims
The patent includes several claims that define the scope of the invention:
- Independent Claims: These claims define the broadest scope of the invention. For example, Claim 1 might describe the use of a specific 6-mercapto-cyclodextrin derivative for reversing neuromuscular block.
- Dependent Claims: These claims are narrower and build upon the independent claims. They might specify particular methods of administration, dosages, or specific neuromuscular blocking agents that the chelators can reverse[5].
Claims Analysis
Independent Claims
The independent claims are crucial as they set the broadest boundaries of what is protected by the patent. For instance, a claim might read:
"A method for reversing drug-induced neuromuscular block, comprising administering a 6-mercapto-cyclodextrin derivative to a patient."
This claim is broad and covers the core concept of the invention.
Dependent Claims
Dependent claims provide additional specificity and serve as fallback positions in case the independent claims are challenged. For example:
"The method of claim 1, wherein the 6-mercapto-cyclodextrin derivative is administered intravenously."
These claims ensure that even if the broader claim is invalidated, the patent still protects specific embodiments of the invention.
Patent Landscape
Related Patents
The patent landscape around US 7,265,099 includes several related patents that protect various aspects of the same or similar inventions:
- US RE44,733 E: This reissued patent also covers 6-mercapto-cyclodextrin derivatives as reversal agents for drug-induced neuromuscular block. It has a broader scope and is set to expire in January 2026[2][5].
- US 6,949,527 B2: This patent, now expired, also dealt with 6-mercapto-cyclodextrin derivatives but focused on different aspects of their use and formulation[2].
Patent Expiration and Generic Launch
The patent US 7,265,099 itself has expired, with its last maintenance fee paid in 2019. The expiration of this and other related patents opens the door for generic versions of the drug to be developed and launched. The estimated generic launch date for Bridion, a drug that uses these reversal agents, is January 27, 2026, based on the remaining patent protections[2].
Legal Activities and Patent Challenges
The patent has undergone several legal activities and challenges:
- Maintenance Fees: Payments of maintenance fees were made to keep the patent in force until its expiration.
- Correspondence Address Changes: There were changes in the correspondence address, which is a common administrative update.
- Patent Issue Date Used in PTA Calculation: The patent issue date was used in calculating the patent term adjustment, which can affect the patent's expiration date[2].
Measuring Patent Scope
The scope of a patent can be measured in various ways, including the length of the first independent claim and the number of words in the claims. Generally, longer claims indicate a narrower scope, as they specify more conditions that must be met to infringe the patent. In the case of US 7,265,099, the first independent claim sets a broad scope, while subsequent dependent claims narrow it down[3].
Industry Impact
The invention protected by US 7,265,099 has significant implications for the medical field, particularly in anesthesia. The use of 6-mercapto-cyclodextrin derivatives as reversal agents provides a safe and effective way to restore muscle function after surgery, enhancing patient safety and recovery times.
Expert Insights
According to patent attorneys, broad patents like US 7,265,099 offer more protection against infringers because they are harder to design around. Thomas Kulaga, a patent attorney, notes that "broad patents typically offer more protection against infringers than a narrow patent" because they are "oftentimes very hard to design around"[3].
Conclusion
United States Patent 7,265,099 is a critical patent in the field of neuromuscular block reversal. Its scope and claims define a broad and specific protection for the use of 6-mercapto-cyclodextrin derivatives. The patent landscape, including related patents and legal activities, highlights the complexities and challenges in maintaining and enforcing patent rights.
Key Takeaways
- Patent Scope: The patent's scope is defined by its independent and dependent claims, with the first independent claim setting the broadest boundaries.
- Related Patents: Other patents, such as US RE44,733 E, protect similar inventions and have different expiration dates.
- Patent Expiration: The patent has expired, paving the way for generic versions.
- Industry Impact: The invention has significant implications for patient safety and recovery in anesthesia.
- Legal Activities: Various legal activities, including maintenance fee payments and address changes, have been undertaken.
Frequently Asked Questions (FAQs)
What is the main invention protected by US 7,265,099?
The main invention is the use of 6-mercapto-cyclodextrin derivatives as reversal agents for drug-induced neuromuscular block.
When did the patent expire?
The patent has expired, with its last maintenance fee paid in 2019.
What is the estimated generic launch date for Bridion?
The estimated generic launch date for Bridion is January 27, 2026, based on the remaining patent protections.
How is the scope of a patent typically measured?
The scope of a patent can be measured by the length of the first independent claim, with longer claims indicating a narrower scope.
Why are broad patents considered more protective?
Broad patents are considered more protective because they are harder to design around, offering more comprehensive protection against infringers.
