Details for Patent: 9,814,705

Which drugs does patent 9,814,705 protect, and when does it expire?

Patent 9,814,705 protects LAZANDA and is included in one NDA.

This patent has thirty-five patent family members in twenty-four countries.

Summary for Patent: 9,814,705

Title:	Intranasal spray device containing pharmaceutical composition
Abstract:	An intranasal spray device contains a composition for the intranasal delivery of fentanyl or a pharmaceutically acceptable salt thereof to an animal includes an aqueous solution of fentanyl or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable additive selected from (i) a pectin and (ii) a poloxamer and chitosan or a salt or derivative thereof; provided that when the composition comprises a pectin it is substantially free of divalent metal ions; and which, in comparison to a simple aqueous solution of fentanyl administered intranasally at the same dose, provides a peak plasma concentration of fentanyl (C.sub.max) that is from 10 to 80% of that achieved using a simple aqueous solution of fentanyl administered intranasally at an identical fentanyl dose. A method for treating or managing pain by intranasally administering the composition is also disclosed.
Inventor(s):	Watts; Peter James (Nottingham, GB), Castile; Jonathan David (Nottingham, GB), Lafferty; William Columbus Ian (Leicestershire, GB), Smith; Alan (Nottingham, GB)
Assignee:	Depomed, Inc. (Newark, CA)
Application Number:	14/747,289
Patent Claim Types: see list of patent claims	Composition; Formulation; Delivery; Device;

United States Patent 9,814,705: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 9,814,705, titled "Intranasal spray device containing pharmaceutical composition," is a significant patent that addresses the intranasal delivery of pharmaceuticals, specifically fentanyl or its pharmaceutically acceptable salts. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background and Purpose

The patent focuses on an intranasal spray device designed for the efficient delivery of fentanyl, a potent opioid used for pain management. The invention aims to provide a convenient, non-invasive method for administering this medication, which is crucial for patients requiring rapid pain relief.

Scope of the Patent

Pharmaceutical Composition

The patent describes a pharmaceutical composition that includes fentanyl or its pharmaceutically acceptable salts. This composition is formulated to be delivered intranasally, ensuring rapid absorption and onset of action[1].

Intranasal Spray Device

The intranasal spray device is a critical component of the patent. It is designed to deliver a precise dose of the pharmaceutical composition directly into the nasal cavity. The device must ensure consistent and reliable dosing, which is essential for the safe and effective administration of fentanyl[1].

Claims of the Patent

Independent Claims

The patent includes several independent claims that define the core aspects of the invention. These claims cover:

• The pharmaceutical composition itself, including fentanyl and its salts.
• The intranasal spray device, detailing its structure and functionality.
• The method of administering the composition using the spray device[1].

Dependent Claims

Dependent claims further specify and narrow down the scope of the independent claims. These include details such as:

• The concentration of fentanyl in the composition.
• The presence of additional ingredients like pectin.
• The specific design features of the spray device, such as the nozzle and reservoir[1].

Key Components and Features

Fentanyl and Its Salts

Fentanyl is a highly potent opioid, and the patent covers its use in various salt forms, which can affect its solubility and stability in the pharmaceutical composition[1].

Pectin

Pectin, a natural polymer, is mentioned as a potential component of the composition. It can act as a thickening agent or help in the controlled release of fentanyl[1].

Aqueous Solution

The patent describes the composition as an aqueous solution, which is crucial for intranasal delivery. This ensures that the fentanyl is easily absorbed through the nasal mucosa[1].

Patent Landscape

Prior Art and Related Patents

The patent landscape for intranasal drug delivery devices is extensive. Prior art includes various patents related to intranasal spray devices and pharmaceutical compositions for opioids. The USPTO's Patent Public Search tool and Global Dossier service can be used to identify related patents and understand the broader landscape[4].

Competing Technologies

Other companies and inventors have developed similar intranasal delivery systems for opioids. Analyzing these competing technologies through patent analytics can help identify gaps and opportunities in the market[3].

Intellectual Property Protection

Claim Coverage and Scope Concepts

To ensure comprehensive intellectual property protection, it is essential to analyze the claim coverage using tools like ClaimScape® software. This helps in categorizing patents by claims and scope concepts, making it easier to identify areas of protection and potential gaps[3].

Determining Inventorship

Correctly determining inventorship is crucial for the validity and enforceability of the patent. Errors in inventorship, especially those made with deceptive intent, can render the patent unenforceable. Therefore, thorough invention disclosure and accurate identification of inventors are vital[5].

Regulatory and Legal Considerations

USPTO Guidelines

The USPTO provides various resources for patent searching and analysis, including the Patent Public Search tool and the Global Dossier service. These resources are essential for understanding the regulatory environment and ensuring compliance with US patent laws[4].

International Harmonization

The Common Citation Document (CCD) application helps in consolidating prior art cited by multiple patent offices, facilitating international harmonization and making it easier to navigate the global patent landscape[4].

Market Impact and Future Directions

Market Need

The need for effective and safe pain management solutions is significant, and intranasal fentanyl delivery addresses a critical market need. This patent positions the inventor to capitalize on this demand by providing a unique and efficient delivery method.

Future Developments

Future developments may include refining the composition to improve stability and efficacy or designing new spray devices with enhanced user interfaces. Patent analytics can help in identifying future design opportunities and ensuring that new developments are protected[3].

Key Takeaways

• Pharmaceutical Composition: The patent covers a pharmaceutical composition containing fentanyl or its salts for intranasal delivery.
• Intranasal Spray Device: The device is designed for precise and reliable dosing of the composition.
• Claims and Scope: The patent includes independent and dependent claims that define the core aspects of the invention.
• Patent Landscape: The landscape includes prior art and competing technologies, necessitating thorough patent analytics.
• Intellectual Property Protection: Correct inventorship and comprehensive claim coverage are essential for patent validity.
• Regulatory Considerations: Compliance with USPTO guidelines and international harmonization are crucial.

FAQs

Q: What is the primary purpose of United States Patent 9,814,705?

A: The primary purpose is to provide an intranasal spray device for the efficient delivery of fentanyl or its pharmaceutically acceptable salts for pain management.

Q: What are the key components of the pharmaceutical composition?

A: The composition includes fentanyl or its salts, and may also include additional ingredients like pectin.

Q: How does the intranasal spray device ensure precise dosing?

A: The device is designed with specific features such as a precise nozzle and reservoir to ensure consistent and reliable dosing.

Q: Why is correct inventorship important for this patent?

A: Correct inventorship is crucial for the validity and enforceability of the patent, as errors or deceptive intent can render the patent unenforceable.

Q: What tools can be used to analyze the patent landscape for this invention?

A: Tools such as the USPTO's Patent Public Search, Global Dossier, and ClaimScape® software can be used to analyze the patent landscape and identify gaps and opportunities.

Sources

1. US Patent and Trademark Office. Intranasal spray device containing pharmaceutical composition. US Patent 9,814,705 B2.
2. USA.gov. U.S. Patent and Trademark Office (USPTO).
3. Schwegman Lundberg & Woessner. Patent Analytics.
4. US Patent and Trademark Office. Search for patents.
5. Oregon State University. Determining Inventorship for US Patent Applications.

Drugs Protected by US Patent 9,814,705

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-001	Jun 30, 2011		DISCN	Yes	No			Y
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-003	Dec 21, 2015		DISCN	Yes	No			Y
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-002	Jun 30, 2011		DISCN	Yes	No			Y

Foreign Priority and PCT Information for Patent: 9,814,705

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0300531.1	Jan 10, 2003

International Family Members for US Patent 9,814,705

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1635783		C300653	Netherlands
European Patent Office	1635783		CA 2014 00016	Denmark
European Patent Office	1635783		300653	Netherlands
European Patent Office	1635783		122014000024	Germany
European Patent Office	1635783		132014902242643	Italy
Australia	2004204381