Details for Patent: 10,195,210

Which drugs does patent 10,195,210 protect, and when does it expire?

Patent 10,195,210 protects BYFAVO and is included in one NDA.

This patent has twenty-one patent family members in sixteen countries.

Summary for Patent: 10,195,210

Title:	Dosing regimen for sedation with CNS 7056 (Remimazolam)
Abstract:	The invention relates to a dosing regimen for sedation with the fast-acting benzodiazepine CNS 7056 in combination with an opioid, in particular fentanyl, whereas CNS 7056 is given in a dose of 2 to 20 mg, preferably between 4 and 9 mg and most preferably between 5 and 8 mg.
Inventor(s):	Karin Wilhelm-Ogunbiyi, Keith Borkett, Gary Stuart Tilbrook, Hugh Wiltshire
Assignee:	Paion UK Ltd
Application Number:	US16/039,198
Patent Claim Types: see list of patent claims

Analyzing the Scope and Claims of United States Patent 10,195,210

Introduction

United States Patent 10,195,210, titled "Dosing regimen for sedation with CNS 7056 (Remimazolam) in combination with an opioid," is a significant patent in the field of pharmaceuticals, particularly in the area of sedation and analgesia. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Overview of the Patent

The patent, issued to PAION Deutschland GmbH, describes a dosing regimen for the ultra-short-acting benzodiazepine CNS 7056 (Remimazolam) when used in combination with an opioid, such as fentanyl, for sedation purposes. Here are the key aspects:

• Combination Therapy: The patent outlines the administration of CNS 7056 and an opioid, either concomitantly or sequentially, to achieve sedation without the need for mechanical or manual ventilation, although supplemental oxygen may be used[4].

• Dosing Regimen: The dosing regimen involves an initial bolus injection of CNS 7056 followed by top-up doses to maintain a desired level of sedation, measured by the MOAA/S score. The doses and intervals are adjustable based on the patient's response[4].

• Pharmacological Details: The patent specifies the pharmacologically acceptable solvents, salts, and solvates of CNS 7056 and the opioid, ensuring they do not interfere with the biological activity of the solute[4].

Scope of the Patent

The scope of the patent is defined by its claims, which are critical in determining the boundaries of the invention.

Independent Claims

• The independent claims focus on the method of administering CNS 7056 in combination with an opioid for sedation. For example, Claim 1 describes the method of administering a fixed dose of CNS 7056 and an opioid, with specific time frames for their administration to achieve the desired pharmacological effect[4].

Dependent Claims

• Dependent claims further specify the details of the dosing regimen, such as the range of doses for CNS 7056 (e.g., between 2 to 10 mg), the concentration of the bolus injection, and the adjustment of top-up doses based on the patient's sedation level[4].

Claim Language and Patent Scope

The claim language is crucial in defining the patent scope. Metrics such as independent claim length and independent claim count can be used to measure patent scope, as discussed in research on patent quality. Narrower claims, like those in this patent, are often associated with a higher probability of grant and a shorter examination process[3].

Prior Art and Citation Data

To understand the novelty and non-obviousness of the patent, it is essential to review prior art and citation data.

• Common Citation Document (CCD): This tool consolidates prior art cited by participating IP offices, helping to visualize the citation data for the patent family. This can be particularly useful in assessing the uniqueness of the dosing regimen described in the patent[1].

• Global Dossier: This service provides access to the file histories of related applications, including classification, citation data, and office actions. It helps in identifying any prior art or similar inventions that may have been considered during the examination process[1].

Patent Landscape

The patent landscape surrounding US 10,195,210 includes other patents and applications related to sedation and analgesia.

• Competing Patents: Other patents may exist that describe different dosing regimens or combinations of sedatives and opioids. Analyzing these patents can help in understanding the competitive landscape and potential infringement issues[1].

• Future Developments: The ongoing research and development in the field of sedation and analgesia may lead to new patents that either build upon or challenge the claims of US 10,195,210. Keeping an eye on new filings and grants is crucial for maintaining a competitive edge[1].

Practical Implications

The practical implications of this patent are significant for medical practitioners and pharmaceutical companies.

• Clinical Use: The dosing regimen described in the patent provides a clear guideline for healthcare professionals to administer CNS 7056 and opioids safely and effectively, ensuring optimal sedation levels without compromising patient safety[4].

• Commercial Impact: The patent protects the specific dosing regimen, giving the patent holder a competitive advantage in the market. This can influence the development and marketing of similar products by other companies[4].

Legal and Regulatory Considerations

The legal and regulatory environment surrounding this patent is also important.

• Patent Litigation: The potential for patent litigation arises if other companies develop similar dosing regimens. The study on a small claims patent court highlights the need for efficient dispute resolution mechanisms in such cases[5].

• Regulatory Approvals: The patent's claims must align with regulatory approvals and guidelines set by health authorities. Ensuring compliance with these regulations is crucial for the commercial success of the product[4].

Key Takeaways

• Specific Dosing Regimen: The patent describes a detailed dosing regimen for CNS 7056 in combination with an opioid, emphasizing the importance of precise administration times and doses.
• Pharmacological Details: The patent specifies acceptable solvents, salts, and solvates, ensuring the biological activity of the solute is not compromised.
• Patent Scope: The claims define the scope of the invention, with narrower claims associated with a higher probability of grant and shorter examination process.
• Prior Art and Citation Data: Tools like the CCD and Global Dossier help in assessing the novelty and non-obviousness of the patent.
• Practical Implications: The patent has significant implications for clinical use and commercial strategies in the pharmaceutical industry.

FAQs

1. What is the main focus of United States Patent 10,195,210?

   • The main focus is on a dosing regimen for sedation using CNS 7056 (Remimazolam) in combination with an opioid.

2. How is CNS 7056 administered according to the patent?

   • CNS 7056 is administered as a bolus injection followed by top-up doses, with the option of concomitant or sequential administration with an opioid.

3. What is the significance of the MOAA/S score in this patent?

   • The MOAA/S score is used to measure the level of sedation, guiding the adjustment of top-up doses to maintain mild to moderate sedation.

4. How does the patent protect the invention?

   • The patent protects the specific dosing regimen, including the doses, administration times, and pharmacological details, giving the patent holder a competitive advantage.

5. What tools can be used to assess the novelty of this patent?

   • Tools such as the Common Citation Document (CCD) and Global Dossier can be used to assess the novelty and non-obviousness of the patent by consolidating prior art and citation data.

Sources

1. USPTO - Search for patents[1]
2. USA.gov - U.S. Patent and Trademark Office (USPTO)[2]
3. SSRN - Patent Claims and Patent Scope[3]
4. Google Patents - US10195210B2[4]
5. ACUS - U.S. Patent Small Claims Court[5]

Drugs Protected by US Patent 10,195,210

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Acacia	BYFAVO	remimazolam besylate	POWDER;INTRAVENOUS	212295-001	Oct 6, 2020		RX	Yes	Yes	10,195,210					USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS

International Family Members for US Patent 10,195,210

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011328497
China	103347519
Denmark	2637662
Eurasian Patent Organization	024926