Detailed Analysis of the Scope and Claims of United States Patent 9,561,236
Introduction
The United States Patent 9,561,236, titled "Dosing regimen for sedation with CNS 7056 (Remimazolam)," is a significant patent in the field of medical sciences, particularly in anesthesia and sedation. This patent, assigned to PAION UK LTD., outlines a specific dosing regimen for the fast-acting benzodiazepine Remimazolam (CNS 7056) when used in combination with an opioid, such as fentanyl.
Background and Context
Remimazolam is a benzodiazepine with rapid onset and short duration of action, making it ideal for procedural sedation. The patent addresses the critical aspect of dosing regimens, which is essential for ensuring the safety and efficacy of sedation procedures[1][4].
Scope of the Patent
Claims Overview
The patent includes 32 claims that detail various aspects of the dosing regimen. Here are some key claims:
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Initial and Top-Up Doses: The patent specifies that CNS 7056 can be administered in an initial dose followed by top-up doses. For example, an initial dose of 8 mg with a top-up dose of 3 mg, or an initial dose of 7 mg with a top-up dose of 2 mg, or an initial dose of 5 mg with a top-up dose of 3 mg[1][4].
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Timing of Doses: The top-up doses are administered at intervals of not less than 2 minutes, preferably 3 minutes, and more preferably 4 minutes apart from the previous dose[1][4].
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Maximum Number of Doses: The patent limits the total number of doses to seven per treatment, with up to six top-up doses following the initial dose[1][4].
Combination with Opioids
The patent emphasizes the use of CNS 7056 in combination with an opioid, particularly fentanyl. This combination is crucial for achieving effective sedation while minimizing the risks associated with sedative use[1][4].
Claims Analysis
Claim 1: Initial Dose and Top-Up Doses
Claim 1 describes the method of administering an initial dose of CNS 7056 followed by one or more top-up doses. This claim sets the foundation for the dosing regimen and ensures that the sedation is both effective and safe[1][4].
Claim 2: Timing and Interval of Doses
Claim 2 specifies the timing between the initial dose and the top-up doses, ensuring that the sedative effects are maintained without causing undue risk to the patient[1][4].
Claim 3: Maximum Dose Limitation
Claim 3 limits the total number of doses to prevent overdose and ensure patient safety. This is a critical aspect of the patent, as it addresses the potential risks associated with sedative use[1][4].
Patent Landscape Analysis
Competitive Landscape
The patent landscape in the field of sedation and anesthesia is highly competitive, with multiple companies and researchers developing new sedatives and dosing regimens. PAION UK LTD.'s patent on Remimazolam places it in a strategic position, particularly given the unique characteristics of this benzodiazepine[3].
Technological Trends
The trend in sedation technology is moving towards faster-acting and shorter-duration sedatives to minimize recovery times and reduce side effects. Remimazolam fits well into this trend, and the specified dosing regimen enhances its market value[1][4].
Abandoned and Active Technologies
In the broader context of patent landscape analysis, it is important to identify abandoned technologies and contrast them with active and newly created technologies. For PAION UK LTD., the focus on Remimazolam indicates a strategic shift towards innovative sedation solutions, aligning with industry trends[3].
Strategic Insights
Market Positioning
The patent on Remimazolam's dosing regimen positions PAION UK LTD. as a leader in the sedation market, particularly in procedural sedation. This can influence market share and attract partnerships or licensing agreements[3].
Competitive Advantage
The specific dosing regimen outlined in the patent provides a competitive advantage by ensuring safe and effective sedation. This can differentiate PAION UK LTD.'s product from others in the market, enhancing its marketability and adoption rate[1][4].
Legal and Regulatory Considerations
Patent Eligibility
The patent's claims must comply with patent eligibility criteria, such as those outlined in 35 U.S.C. ยง 101. The claims must be directed to a new and useful process, machine, manufacture, or composition of matter, and not to abstract ideas or natural phenomena[5].
Infringement and Litigation
The patent's validity and enforcement are crucial for protecting PAION UK LTD.'s intellectual property. Any potential infringement would need to be addressed through legal channels, ensuring that the company's rights are protected[5].
Key Takeaways
- Dosing Regimen: The patent specifies a detailed dosing regimen for Remimazolam, including initial and top-up doses, and the timing between them.
- Combination with Opioids: The use of Remimazolam in combination with opioids like fentanyl is emphasized.
- Safety and Efficacy: The dosing regimen is designed to ensure safe and effective sedation.
- Market Positioning: The patent positions PAION UK LTD. as a leader in the sedation market.
- Legal Considerations: The patent must comply with patent eligibility criteria and be enforced to protect intellectual property.
Frequently Asked Questions (FAQs)
What is the primary focus of United States Patent 9,561,236?
The primary focus of this patent is the dosing regimen for the fast-acting benzodiazepine Remimazolam (CNS 7056) when used in combination with an opioid.
What are the recommended initial and top-up doses of CNS 7056?
The patent recommends several combinations, such as an initial dose of 8 mg with a top-up dose of 3 mg, or an initial dose of 7 mg with a top-up dose of 2 mg, or an initial dose of 5 mg with a top-up dose of 3 mg.
How often can top-up doses of CNS 7056 be administered?
Top-up doses can be administered at intervals of not less than 2 minutes, preferably 3 minutes, and more preferably 4 minutes apart from the previous dose.
What is the maximum number of doses allowed per treatment?
The patent limits the total number of doses to seven per treatment, with up to six top-up doses following the initial dose.
Why is the combination with opioids important?
The combination with opioids, particularly fentanyl, is crucial for achieving effective sedation while minimizing the risks associated with sedative use.
Sources Cited
- Wilhelm-Ogunbiyi et al. Dosing regimen for sedation with CNS 7056 (Remimazolam), US Patent 9,561,236 B2, February 7, 2017.
- USPTO Economic Working Paper 2016-04 Patent Claims and Patent Scope, Marco, Alan C., Sarnoff, Joshua D., and deGrazia, Charles, October 2016.
- AcclaimIP Patent Landscape Analysis - Uncovering Strategic Insights, accessed December 2024.
- Google Patents US9561236B2 - Dosing regimen for sedation with CNS 7056 (Remimazolam), accessed December 2024.
- CAFC Broadband iTV, Inc. v. Amazon.com, Inc., Case 23-1107, September 3, 2024.
