Details for Patent: 10,052,334

Which drugs does patent 10,052,334 protect, and when does it expire?

Patent 10,052,334 protects BYFAVO and is included in one NDA.

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

Summary for Patent: 10,052,334

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):	Wilhelm-Ogunbiyi; Karin (Simmerath, DE), Borkett; Keith (Houghton Camps, GB), Tilbrook; Gary Stuart (Huntingdon, GB), Wiltshire; Hugh (Digswell, GB)
Assignee:	PAION UK LTD. (Histon Cambridge, GB)
Application Number:	15/792,636
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

Understanding the Scope and Claims of United States Patent 10,052,334

Introduction

United States Patent 10,052,334, titled "Dosing regimen for sedation with CNS 7056 (remimazolam)," is a patent that outlines a specific dosing regimen for the use of the ultra-short-acting benzodiazepine CNS 7056 in combination with an opioid, typically fentanyl, for sedation purposes. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape.

Patent Overview

The patent, assigned to PAION DEUTSCHLAND GMBH, describes a method for inducing and maintaining sedation using CNS 7056, a fast-acting benzodiazepine, in conjunction with an opioid. This combination is administered intravenously and is designed to achieve mild to moderate sedation without the need for mechanical or manual ventilation, although supplemental oxygen supply is possible[4].

Claim Scope

The claims in this patent are critical as they define the boundaries of the invention and what is protected under the patent.

Independent Claims

• The patent includes claims that describe the dosing regimen, including the administration of CNS 7056 and an opioid within a specific time frame. For example, the claims specify that the time frame between the administration of CNS 7056 and the opioid should not be longer than 10 minutes, preferably not longer than 8, 5, or 3 minutes, and most preferably less than 2 minutes[4].

Dependent Claims

• Dependent claims further detail the method of administration, such as the fixed dose of CNS 7056 and the opioid, and the adjustment of the dosing regimen based on the patient's sedation level, as assessed by the MOAA/S score[4].

Key Elements of the Claims

• Administration Route: Both CNS 7056 and the opioid are administered intravenously, either concomitantly or sequentially.
• Dosing Regimen: The dosing regimen is adjusted to maintain a mild to moderate sedation level, with top-up doses given based on the patient's sedation status.
• MOAA/S Score: The sedation level is assessed using the MOAA/S score, with adjustments made to the dosing interval to maintain the desired level of sedation.
• Pharmaceutical Formulations: The patent also covers the use of pharmaceutically acceptable solvents, such as water, ethanol, and acetic acid, for the formulation of CNS 7056 and the opioid[4].

Importance of Claim Scope

The scope of the claims in a patent application is crucial for several reasons:

• Protection: A well-defined claim scope ensures that the invention is adequately protected from infringement.
• Validity: Overly broad claims can be easier to invalidate, as they may not meet the written description requirement or may fall under the abstract idea exception[3].
• Enforcement: Clear and specific claims make it easier to enforce the patent against potential infringers.

Patent Landscape

The patent landscape for sedation regimens and benzodiazepine-opioid combinations is complex and evolving.

Prior Art

• The patent must distinguish itself from prior art, which includes other sedation regimens and combinations of benzodiazepines and opioids. The claims must be novel and non-obvious over existing prior art[1].

International Patent Offices

• The global patent landscape includes similar patents and applications filed in other countries. For example, the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO) provide searchable databases that can reveal similar inventions and prior art[1].

Related Patents

• Other patents related to sedation regimens and benzodiazepine-opioid combinations can provide insights into the state of the art and potential areas for innovation.

Search and Analysis Tools

To navigate the patent landscape effectively, several tools and resources are available:

• Patent Public Search: This tool provided by the USPTO allows for advanced searches of prior art and related patents[1].
• Global Dossier: This service provides access to the file histories of related applications from participating IP Offices, helping to identify patent families and prior art[1].
• Common Citation Document (CCD): This application consolidates citation data from multiple IP Offices, making it easier to visualize prior art citations[1].

Practical Implications

Understanding the scope and claims of this patent is essential for several stakeholders:

• Inventors and Applicants: Ensuring that the claims are well-defined and anchored to the embodiments in the disclosure is crucial for obtaining a valid and enforceable patent.
• Practitioners: Healthcare professionals using this dosing regimen must adhere to the specified methods to avoid potential infringement issues.
• Competitors: Companies developing similar sedation regimens need to ensure their products do not infringe on the claims of this patent.

Key Takeaways

• The patent 10,052,334 protects a specific dosing regimen for sedation using CNS 7056 and an opioid.
• The claims are detailed and specify the administration route, dosing intervals, and adjustments based on sedation levels.
• Understanding the claim scope is crucial for patent validity, protection, and enforcement.
• The patent landscape includes prior art, international patents, and related inventions that must be considered.

FAQs

1. What is the primary focus of United States Patent 10,052,334?

   • The primary focus is on a dosing regimen for sedation using the ultra-short-acting benzodiazepine CNS 7056 in combination with an opioid.

2. How are CNS 7056 and the opioid administered according to the patent?

   • Both are administered intravenously, either concomitantly or sequentially, within a specific time frame.

3. What is the role of the MOAA/S score in the dosing regimen?

   • The MOAA/S score is used to assess the patient's sedation level, and the dosing regimen is adjusted accordingly to maintain mild to moderate sedation.

4. Why is the claim scope important in a patent application?

   • The claim scope defines the boundaries of the invention, ensures adequate protection, and affects the validity and enforceability of the patent.

5. What tools can be used to search and analyze the patent landscape for similar inventions?

   • Tools such as Patent Public Search, Global Dossier, and Common Citation Document (CCD) can be used to search and analyze the patent landscape.

Sources

1. USPTO - Search for patents
   • https://www.uspto.gov/patents/search
2. USA.gov - U.S. Patent and Trademark Office (USPTO)
   • https://www.usa.gov/agencies/u-s-patent-and-trademark-office
3. Rimon Law - The Importance of Getting the Claim Scope Right in a US Patent Application
   • https://www.rimonlaw.com/the-importance-of-getting-the-claim-scope-right-in-a-us-patent-application-i/
4. Google Patents - Dosing regimen for sedation with CNS 7056 (remimazolam)
   • https://patents.google.com/patent/US10052334B2/en
5. ACUS - U.S. Patent Small Claims Court
   • https://www.acus.gov/research-projects/us-patent-small-claims-court

Drugs Protected by US Patent 10,052,334

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						USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS

Foreign Priority and PCT Information for Patent: 10,052,334

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	10014366	Nov 8, 2010
	10014784	Nov 19, 2010
	10014819	Nov 22, 2010
	10014972	Nov 25, 2010

International Family Members for US Patent 10,052,334

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011328497
China	103347519
Denmark	2637662
Eurasian Patent Organization	024926
Eurasian Patent Organization	201390672
European Patent Office	2450039
European Patent Office	2637662