Details for Patent: 8,574,622

Which drugs does patent 8,574,622 protect, and when does it expire?

Patent 8,574,622 protects NATESTO and is included in one NDA.

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

Summary for Patent: 8,574,622

Title:	Controlled release delivery system for nasal applications
Abstract:	This invention relates to a pernasally administrable preparation for the controlled release of sexual hormones to the systemic circulation, in particular to a formulation which enables its active ingredient to be absorbed in a sustained manner providing a better bioavailability at very low doses and longer duration of action.
Inventor(s):	Mattern; Claudia (Stans, CH)
Assignee:	M & P Patent Aktiengesellschaft (Vaduz, LI)
Application Number:	13/194,928
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound;

Understanding the Scope and Claims of United States Patent 8,574,622

Introduction

United States Patent 8,574,622, titled "Testosterone Gel Formulation," is a patent that covers a specific formulation of testosterone gel. To delve into the scope and claims of this patent, it is essential to analyze the patent document, the claims, and the broader patent landscape.

Patent Overview

The patent, granted on November 5, 2013, pertains to a testosterone gel formulation designed for transdermal delivery. The invention aims to improve the bioavailability and stability of testosterone when administered through the skin.

Claims Analysis

Independent Claims

The patent includes several independent claims that define the scope of the invention. Here are some key aspects:

• Claim 1: This claim describes the testosterone gel formulation, specifying the components such as a lipophilic carrier, a hydrophilic carrier, and a gelling agent. The claim sets the foundation for the patent by outlining the essential elements of the formulation[5].

• Claim 2: This claim narrows down the formulation by specifying that the lipophilic carrier comprises an oil. This adds a layer of detail to the original claim, highlighting a particular embodiment of the invention[5].

Dependent Claims

Dependent claims further refine the independent claims by adding additional limitations or specifications. For example:

• Claim 3: This claim depends on Claim 1 and specifies that the testosterone gel formulation includes a particular type of gelling agent, such as a polysaccharide or a polyacrylate. This narrows the scope to specific types of gelling agents[5].

Scope of the Invention

The scope of the invention is defined by the combination of the independent and dependent claims. Here are some key points:

• Components: The patent covers a formulation that includes a lipophilic carrier, a hydrophilic carrier, testosterone, and a gelling agent. The specific types of these components can vary, but they must be present in the formulation[5].

• Application: The formulation is designed for transdermal delivery, which means it is applied to the skin to deliver testosterone into the bloodstream. This application method is a critical aspect of the invention[5].

• Improvements: The patent highlights improvements in bioavailability and stability of testosterone when delivered through this gel formulation. This suggests that the invention solves specific problems related to previous testosterone delivery methods[5].

Patent Landscape

To understand the broader patent landscape, it is important to consider several factors:

Prior Art

The patent landscape for testosterone gel formulations includes prior art that may have influenced the development of this specific invention. Prior art would include other patents and publications related to testosterone delivery systems, which the inventors would have needed to differentiate their invention from[5].

Related Patents

There are other patents related to testosterone formulations and delivery systems. These patents might cover different aspects such as different carriers, gelling agents, or application methods. For example, patents that focus on oral or injectable testosterone formulations would be outside the scope of this patent but still part of the broader landscape[5].

Litigation and Enforcement

The enforcement of this patent would involve ensuring that other companies do not infringe on the specific claims outlined in the patent. This could involve litigation if another company develops a similar testosterone gel formulation that falls within the scope of the claims.

Recent Developments in Patent Law

While the patent itself was granted in 2013, recent developments in patent law can impact how such patents are evaluated and enforced.

• Subject Matter Eligibility: Recent updates from the USPTO, such as the 2024 guidance on AI-related inventions, emphasize the importance of integrating judicial exceptions into practical applications. Although this patent does not involve AI, the principle of demonstrating practical applications and concrete technological improvements is relevant across various fields[1].

• Patent Quality and Examination: Efforts to improve patent quality, such as those recommended by the GAO, can affect how future patents are examined and granted. This includes analyzing the time needed for thorough patent examinations and adjusting performance incentives for examiners[4].

Key Takeaways

• Specific Components: The patent covers a testosterone gel formulation with specific components including a lipophilic carrier, a hydrophilic carrier, testosterone, and a gelling agent.
• Transdermal Delivery: The formulation is designed for transdermal delivery, improving bioavailability and stability of testosterone.
• Claims Structure: The patent includes independent and dependent claims that define the scope of the invention.
• Broader Landscape: The patent is part of a larger landscape of testosterone delivery systems, with prior art and related patents influencing its development and enforcement.

FAQs

1. What is the main purpose of the testosterone gel formulation covered by US Patent 8,574,622?

   • The main purpose is to improve the bioavailability and stability of testosterone when administered through the skin.

2. What are the key components of the testosterone gel formulation?

   • The key components include a lipophilic carrier, a hydrophilic carrier, testosterone, and a gelling agent.

3. How does the patent differentiate itself from prior art?

   • The patent differentiates itself by specifying a particular combination of components and their application in a transdermal delivery system.

4. What recent developments in patent law could impact the enforcement of this patent?

   • Recent updates on subject matter eligibility and efforts to improve patent quality could impact how this patent is enforced and how similar patents are granted in the future.

5. Why is the scope of the claims important in this patent?

   • The scope of the claims defines what is protected by the patent, ensuring that other companies do not infringe on the specific formulation and application method described.

Sources

1. Mintz, "Understanding the 2024 USPTO Guidance Update on AI Patent Eligibility"
2. ACUS, "U.S. Patent Small Claims Court"
3. USPTO, "Patent Claims Research Dataset"
4. GAO, "Intellectual Property: Patent Office Should Define Quality, Reassess Incentives"
5. US Patent 8,574,622, "Testosterone Gel Formulation"

Drugs Protected by US Patent 8,574,622

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	8,574,622		Y

Foreign Priority and PCT Information for Patent: 8,574,622

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

International Family Members for US Patent 8,574,622

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	047722
Austria	E319426
Australia	2004286781
Brazil	PI0416370
Canada	2541498
Germany	60303854
Denmark	1530965