Details for Patent: 10,369,109

Summary for Patent: 10,369,109

Title:	Abuse-proofed dosage form
Abstract:	A solid administration form, protected from parenteral abuse and containing at least one viscosity-increasing agent in addition to one or more active substances that have parenteral abuse potential. The agent forms, when a necessary minimum amount of an aqueous liquid is added, on the basis of an extract obtained from the administration form, a preferably injectable gel that remains visually distinct when introduced into another quantity of an aqueous liquid.
Inventor(s):	Bartholomaeus; Johannes (Aachen, DE), Kugelmann; Heinrich (Aachen, DE)
Assignee:	GRUNENTHAL GMBH (Aachen, DE)
Application Number:	16/032,533
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,369,109
Patent Claim Types: see list of patent claims	Formulation; Compound; Dosage form;

Analyzing the Scope and Claims of United States Patent 10,369,109

Introduction

United States Patent 10,369,109, titled "Abuse-proofed dosage form," is a significant innovation in the pharmaceutical industry, particularly in the realm of drug abuse prevention. This patent, issued to protect a novel dosage form, is crucial for understanding how patent claims and scope are defined and how they fit into the broader patent landscape.

Patent Overview

The patent describes a solid dosage form designed to prevent parenteral abuse of pharmaceutical active ingredients, such as opiates, opioids, tranquilizers, and other narcotics. The dosage form includes at least one viscosity-increasing agent that, when mixed with a minimum quantity of aqueous liquid, forms a gel that remains visually distinguishable and cannot be easily dispersed or administered parenterally[4].

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 solid dosage form containing at least one viscosity-increasing agent and one or more active ingredients with potential for abuse. The dosage form is designed such that when extracted with a minimum quantity of aqueous liquid, it forms a gel that remains cohesive and cannot be easily dispersed[4].

• Claim 2: This claim specifies the method of treating a disease or disorder using the dosage form, emphasizing the prevention of abuse by ensuring the active ingredients are not easily injectable[4].

Dependent Claims

Dependent claims further narrow down the scope by adding specific details to the independent claims. For example:

• Claim 3: This claim specifies the types of active ingredients, such as opiates, opioids, tranquilizers, and stimulants, and the preferred form of the dosage, such as a tablet or oral osmotic therapeutic system[4].

Scope of the Patent

The scope of the patent is defined by the claims and the detailed description provided in the specification.

Key Components

• Viscosity-Increasing Agents: The patent emphasizes the use of viscosity-increasing agents to form a gel that prevents parenteral abuse. This is a critical component that distinguishes this invention from other dosage forms[4].

• Active Ingredients: The patent specifies that the dosage form contains active ingredients with potential for abuse, such as opiates and opioids. This narrows the scope to a specific class of pharmaceuticals[4].

• Method of Administration: The method of administration is also a key aspect, ensuring that the dosage form is not easily injectable and thus prevents abuse[4].

Patent Landscape

Related Patents and Prior Art

The patent landscape for abuse-proofed dosage forms is extensive, with several related patents and prior art references.

• Prior Art: The patent references prior art such as U.S. Pat. Nos. 4,612,008, 4,765,989, and 4,783,337, which describe oral osmotic therapeutic systems. However, the current patent introduces a novel use of viscosity-increasing agents to prevent abuse[4].

• Competing Patents: Other patents, such as those related to melt granulation processes or other abuse-deterrent formulations, may be part of the broader landscape but do not directly overlap with the specific claims of this patent[5].

Global Dossier and International Search

To fully understand the patent landscape, one would need to consult the Global Dossier and search international patent offices. This would reveal related applications and patents filed in other jurisdictions, ensuring that the invention is novel and non-obvious on a global scale[1].

Search Tools and Resources

Patent Public Search

Tools like the USPTO's Patent Public Search can be used to find existing patents and published patent applications related to this invention. This helps in identifying prior art and understanding the scope of similar patents[1].

Common Citation Document (CCD)

The Common Citation Document (CCD) application can provide a consolidated view of citation data from participating IP offices, helping to identify any overlapping or related patent applications[1].

Practical Implications

Licensing and Litigation

The scope and claims of this patent have significant implications for licensing and litigation. The clear definition of the invention and its components can help in negotiating licensing agreements and defending against potential infringement claims[3].

Innovation Incentives

The patent's focus on preventing drug abuse aligns with broader public health goals. By granting patents for such innovations, the system incentivizes further research and development in this critical area[3].

Metrics for Patent Scope

Research on patent scope often uses metrics such as independent claim length and independent claim count. For this patent, the claims are relatively specific, indicating a narrower scope that is more likely to be granted and less likely to face lengthy examination processes[3].

Conclusion

United States Patent 10,369,109 is a significant contribution to the field of pharmaceuticals, particularly in the prevention of drug abuse. The detailed analysis of its claims and scope highlights the importance of viscosity-increasing agents and the specific method of administration. Understanding this patent within the broader patent landscape is crucial for innovators, legal practitioners, and policymakers.

Key Takeaways

• Specific Claims: The patent includes specific claims that define the scope of the invention, focusing on viscosity-increasing agents and the method of administration.
• Prior Art: The patent references prior art but introduces a novel use of viscosity-increasing agents.
• Global Landscape: Consulting the Global Dossier and international search tools is essential for understanding the global patent landscape.
• Practical Implications: The patent has significant implications for licensing, litigation, and innovation incentives.
• Metrics for Scope: The patent's claims are relatively specific, indicating a narrower scope.

FAQs

Q1: What is the main innovation of United States Patent 10,369,109? The main innovation is the use of viscosity-increasing agents in a solid dosage form to prevent parenteral abuse of pharmaceutical active ingredients.

Q2: How does the patent prevent drug abuse? The patent prevents drug abuse by forming a gel that remains visually distinguishable and cohesive when mixed with aqueous liquid, making it impossible to administer parenterally.

Q3: What are the key components of the dosage form? The key components include viscosity-increasing agents and active ingredients with potential for abuse, such as opiates and opioids.

Q4: How does this patent fit into the broader patent landscape? The patent is part of a larger landscape of abuse-deterrent formulations but is distinguished by its specific use of viscosity-increasing agents.

Q5: What tools can be used to search for related patents? Tools such as the USPTO's Patent Public Search, Global Dossier, and Common Citation Document (CCD) can be used to search for related patents.

Sources

1. USPTO: "Search for patents - USPTO"
2. ACUS: "U.S. Patent Small Claims Court"
3. SSRN: "Patent Claims and Patent Scope"
4. Google Patents: "US10369109B2 - Abuse-proofed dosage form"
5. Unified Patents: "US-20110092515-A1 - Melt Granulation Process"

Drugs Protected by US Patent 10,369,109

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

Foreign Priority and PCT Information for Patent: 10,369,109

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	102 27 077	Jun 17, 2002
Germany	102 50 083	Oct 25, 2002

International Family Members for US Patent 10,369,109

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	411007
Australia	2003237944
Cyprus	1108682
Germany	10250083
Germany	50310649