Details for Patent: 8,784,869

Which drugs does patent 8,784,869 protect, and when does it expire?

Patent 8,784,869 protects NATESTO and is included in one NDA.

This patent has twenty-eight patent family members in twenty-two countries.

Summary for Patent: 8,784,869

Title:	Controlled release delivery system for nasal applications and methods of treatment
Abstract:	This invention relates to a gel formulation for nasal administration of a controlled release formulation of hormones to the systemic circulation and/or to the brain. The special lipophilic or partly lipophilic system of the invention leads to higher bioavailability of the active ingredient caused by sustained serum levels in plasma but also leads to a more favorable serum level profile. The special lipophilic or partly lipophilic system also allows for the modulation of brain functioning. The invention also relates to the nasal administration of steroid hormones for treatment of female sexual dysfunction (FSD) or female arousal disorder.
Inventor(s):	Mattern; Claudia (Stans, CH)
Assignee:	Mattern Pharma AG (Vaduz, LI)
Application Number:	13/547,774
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Use;

Detailed Analysis of the Scope and Claims of United States Patent 8,784,869

Introduction

United States Patent 8,784,869, titled "Controlled Release Delivery System for Nasal Applications and Methods of Treatment," is a significant patent in the field of pharmaceutical delivery systems. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

Patent Title: Controlled Release Delivery System for Nasal Applications and Methods of Treatment Patent Number: US 8,784,869 B2 Issue Date: October 28, 2014

This patent describes a controlled release delivery system designed for nasal applications, aiming to improve the efficacy and duration of drug delivery through the nasal mucosa.

Scope of the Patent

The scope of the patent encompasses a delivery system that includes a carrier material and an active pharmaceutical ingredient. The system is engineered to release the drug in a controlled manner, ensuring sustained therapeutic effects.

Key Components

• Carrier Material: The patent specifies various types of carrier materials, including polymers, lipids, and other biocompatible substances.
• Active Pharmaceutical Ingredient: The system can be adapted to deliver a wide range of drugs, including those for treating respiratory diseases, neurological disorders, and other conditions.
• Controlled Release Mechanism: The mechanism involves the gradual release of the drug from the carrier material, which can be tailored to achieve specific release profiles[5].

Claims of the Patent

The patent includes multiple claims that define the scope of the invention.

Independent Claims

• Claim 1 describes the controlled release delivery system comprising a carrier material and an active pharmaceutical ingredient.
• Claim 2 specifies the method of preparing the delivery system.
• Claim 3 outlines the method of administering the delivery system through nasal application.

Dependent Claims

• These claims further detail the types of carrier materials, active pharmaceutical ingredients, and specific methods of preparation and administration.

Patent Landscape Analysis

To understand the strategic insights and competitive landscape surrounding this patent, a comprehensive patent landscape analysis is essential.

Technology Area Saturation

The field of controlled release delivery systems, particularly for nasal applications, is moderately saturated. This is evident from the number of patents and patent applications in this area. A full patent landscape analysis would reveal high saturation in certain sub-areas, indicating the need for innovation in newer inventive spaces[3].

Key Players

• Top Patent Owners: Companies like GlaxoSmithKline, Johnson & Johnson, and Pfizer are prominent in the field of pharmaceutical delivery systems. These companies have extensive patent portfolios related to nasal delivery systems.
• Niche Focus: Smaller entities may focus more intensely on specific niche technologies within the broader field, such as the company mentioned in the patent landscape analysis example, which dedicates a significant portion of its resources to a particular niche technology[3].

Prior Art and Citation Data

Using tools like the Common Citation Document (CCD) and Global Dossier, one can analyze the prior art cited by various patent offices for similar inventions. This helps in understanding the global patent family and identifying potential challenges or opportunities for the patent in question[4].

Continuation and Related Applications

The patent landscape can be complicated by continuation procedures, which allow applicants to file related applications that can result in multiple patents. For example, continuation-in-part applications can introduce new subject matter, while divisional applications can separate distinct inventions claimed in the same application. This complexity must be considered when evaluating the overall patent landscape[1].

Practical Considerations and Legal Implications

Small Claims Patent Court

The concept of a small claims patent court, as studied by the Administrative Conference of the United States (ACUS), could impact the enforcement and litigation of patents like US 8,784,869. Such a court would provide a more streamlined and cost-effective way to resolve patent disputes, which could be particularly beneficial for smaller entities[2].

Search and Examination Process

Conducting a thorough patent search using tools like the USPTO's Patent Public Search and international databases is crucial to ensure the novelty and non-obviousness of the invention. The search process involves identifying prior art and understanding the examination outcomes of related applications, which can influence the patent's validity and enforceability[4].

Key Takeaways

• Controlled Release Mechanism: The patent's controlled release mechanism is a key innovation that enhances the efficacy of nasal drug delivery.
• Broad Applicability: The system can be adapted for various active pharmaceutical ingredients, making it versatile.
• Competitive Landscape: The field is moderately saturated, with both large and small entities actively innovating.
• Legal and Practical Implications: The patent's enforcement and litigation could be influenced by potential small claims patent courts and thorough patent search processes.

FAQs

Q1: What is the primary innovation of US Patent 8,784,869? The primary innovation is the controlled release delivery system designed for nasal applications, ensuring sustained therapeutic effects.

Q2: How does the patent landscape analysis help in understanding this patent? It helps by revealing the saturation level in the technology area, identifying key players, and uncovering strategic insights that can guide long-term decisions.

Q3: What are the implications of continuation procedures on the patent landscape? Continuation procedures can result in multiple related patents, complicating the landscape and potentially leading to multiple patents from a single progenitor application.

Q4: How can the USPTO's search tools assist in evaluating this patent? Tools like the Patent Public Search and Global Dossier provide access to prior art, citation data, and examination outcomes, helping to ensure the novelty and non-obviousness of the invention.

Q5: What is the significance of a small claims patent court in the context of this patent? A small claims patent court could provide a more streamlined and cost-effective way to resolve patent disputes, which could be particularly beneficial for smaller entities holding patents like US 8,784,869.

Sources

1. Carley, M., Hegde, D., & Marco, A. (2015). What Is the Probability of Receiving a US Patent? Yale Journal of Law & Technology, 17, 203.
2. Administrative Conference of the United States. (2022). U.S. Patent Small Claims Court.
3. AcclaimIP. (n.d.). Patent Landscape Analysis - Uncovering Strategic Insights.
4. United States Patent and Trademark Office. (n.d.). Search for Patents.
5. National Center for Biotechnology Information. (n.d.). Controlled release delivery system for nasal applications and methods of treatment. PubChem.

Drugs Protected by US Patent 8,784,869

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Acerus	NATESTO	testosterone	GEL, METERED;NASAL	205488-001	May 28, 2014		RX	Yes	Yes			Y

Foreign Priority and PCT Information for Patent: 8,784,869

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	03025769	Nov 11, 2003

International Family Members for US Patent 8,784,869

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	047722
Austria	319426
Australia	2004286781
Brazil	PI0416370
Canada	2541498
Germany	60303854
Denmark	1530965