Details for Patent: 9,078,814

Which drugs does patent 9,078,814 protect, and when does it expire?

Patent 9,078,814 protects LAZANDA and is included in one NDA.

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

Summary for Patent: 9,078,814

Title:	Intranasal spray device containing pharmaceutical composition
Abstract:	An intrasnal 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:	13/541,325
Patent Claim Types: see list of patent claims	Composition; Formulation; Device; Delivery;

United States Patent 9,078,814: A Detailed Analysis of Scope and Claims

Introduction

United States Patent 9,078,814, titled "Intranasal spray device containing pharmaceutical composition," is a patent that has significant implications in the field of pharmaceuticals, particularly in the delivery of medications via intranasal routes. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

Publication and Status

The patent, US9078814B2, was published on July 14, 2015, and is currently listed as "Expired - Fee Related," indicating that the patent has lapsed due to non-payment of maintenance fees[4].

Inventors and Assignees

While the specific inventors and assignees are not detailed in the provided sources, it is crucial to note that the patent's ownership and inventorship are key factors in understanding its development and commercialization.

Scope of the Patent

Technical Description

The patent describes an intranasal spray device designed for the delivery of fentanyl or a pharmaceutically acceptable salt thereof. The composition includes various components such as pectin, poloxamers (e.g., poloxamer 188 and poloxamer 407), antioxidants (e.g., sodium metabisulphite), chelating agents (e.g., edetic acid), preservatives (e.g., benzalkonium chloride), sweeteners (e.g., saccharin), and flavorings (e.g., peppermint)[4].

Medical Application

The intranasal spray is intended for the delivery of fentanyl, a potent opioid used for pain management. The device is designed to provide a rapid and effective method of administering this medication, which is particularly useful in emergency situations or for patients who have difficulty swallowing oral medications.

Claims of the Patent

Independent Claims

The patent includes several independent claims that define the scope of the invention. These claims typically cover the composition of the intranasal spray, the device itself, and the method of administration. For example:

• Claim 1 might cover the composition including fentanyl and specific excipients like pectin and poloxamers.
• Claim 2 could describe the intranasal spray device with specific structural features.
• Claim 3 might outline the method of preparing the pharmaceutical composition[4].

Dependent Claims

Dependent claims further narrow down the scope by adding additional limitations to the independent claims. These could include specific ratios of ingredients, particular types of preservatives, or detailed descriptions of the device's components.

Patent Scope Metrics

Independent Claim Length and Count

Research on patent scope often uses metrics such as independent claim length and independent claim count to measure the breadth of a patent. A study on patent scope metrics suggests that narrower claims at publication are associated with a higher probability of grant and a shorter examination process than broader claims[3].

Application to US9078814B2

For US9078814B2, analyzing the length and count of independent claims can provide insights into the patent's scope. If the independent claims are concise and few in number, it may indicate a more focused and narrower scope, potentially reducing the likelihood of disputes over patent breadth.

Patent Landscape

Related Patents and Prior Art

The patent landscape for intranasal drug delivery devices is complex, with numerous patents covering various aspects of such devices. Prior art keywords listed for US9078814B2 include "fentanyl," "spray device," "intranasal spray," and "pectin," indicating that these elements are critical in distinguishing this patent from prior art[4].

Competing Technologies

Other patents and technologies in the field of intranasal drug delivery may offer competing solutions. For instance, patents covering different types of nasal sprays, alternative delivery mechanisms, or other pharmaceutical compositions could be relevant.

Legal and Regulatory Considerations

Patent Office Procedures

The U.S. Patent and Trademark Office (USPTO) is responsible for granting patents and ensuring that they meet the criteria of novelty, non-obviousness, and utility. The process involves a thorough examination of the patent application, including review of prior art and assessment of the claims' validity[1].

Potential for Small Claims Patent Court

There has been discussion and study on the feasibility of a small claims patent court, which could impact how patent disputes, including those related to US9078814B2, are handled. Such a court would aim to provide a more streamlined and cost-effective process for resolving patent disputes, particularly for smaller entities[2].

Commercial and Market Implications

Market Demand

The demand for effective pain management solutions, especially those that offer rapid and convenient administration, drives the market for intranasal fentanyl delivery devices. The commercial success of US9078814B2 would depend on factors such as regulatory approval, market competition, and the ability to meet patient needs effectively.

Licensing and Litigation

Patents like US9078814B2 can be subject to licensing agreements and litigation. The scope and claims of the patent play a crucial role in these processes. Broader claims might increase licensing and litigation costs, while narrower claims could reduce these risks[3].

Key Takeaways

• Patent Scope: The patent covers a specific intranasal spray device for fentanyl delivery, with detailed compositions and structural features.
• Claims Analysis: Independent and dependent claims define the scope, with metrics like claim length and count providing insights into patent breadth.
• Patent Landscape: The patent is part of a broader landscape of intranasal drug delivery technologies, with competing solutions and prior art considerations.
• Legal and Regulatory: The patent is subject to USPTO procedures and potential small claims patent court processes.
• Commercial Implications: Market demand, regulatory approval, and licensing/litigation considerations are crucial for the commercial success of the patent.

FAQs

What is the primary use of the intranasal spray device described in US9078814B2?

The primary use is for the intranasal delivery of fentanyl or a pharmaceutically acceptable salt thereof for pain management.

What are the key components of the pharmaceutical composition in US9078814B2?

The composition includes fentanyl, pectin, poloxamers, antioxidants, chelating agents, preservatives, sweeteners, and flavorings.

Why is the scope of a patent important?

The scope of a patent, defined by its claims, determines the extent of protection and can impact licensing, litigation, and the overall commercial viability of the invention.

What is the current status of US9078814B2?

The patent is listed as "Expired - Fee Related," indicating it has lapsed due to non-payment of maintenance fees.

How does the patent landscape affect US9078814B2?

The patent landscape includes other intranasal drug delivery technologies and prior art, which can influence the patent's validity, licensing potential, and market competition.

Sources

1. U.S. Patent and Trademark Office (USPTO) | USAGov
2. U.S. Patent Small Claims Court | ACUS
3. Patent Claims and Patent Scope - Search eLibrary :: SSRN
4. Intranasal spray device containing pharmaceutical composition | Google Patents

Drugs Protected by US Patent 9,078,814

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	9,078,814		Y
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-002	Jun 30, 2011		DISCN	Yes	No	9,078,814		Y

Foreign Priority and PCT Information for Patent: 9,078,814

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 9,078,814

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