Details for Patent: 8,685,443

Which drugs does patent 8,685,443 protect, and when does it expire?

Patent 8,685,443 protects EMBEDA and TROXYCA ER and is included in two NDAs.

This patent has sixteen patent family members in twelve countries.

Summary for Patent: 8,685,443

Title:	Sequestering subunit and related compositions and methods
Abstract:	A sequestering subunit comprising an aversive agent and a blocking agent, wherein the blocking agent substantially prevents release of the aversive agent from the sequestering subunit in the gastrointestinal tract for a time period that is greater than 24 hours; a composition comprising a sequestering subunit in releasable form, wherein, optionally, the mechanical fragility of the sequestering subunit is the same as the mechanical fragility of the therapeutic agent in releasable form; a capsule or tablet comprising a sequestering subunit and a therapeutic agent; and a method of preventing abuse of a therapeutic agent.
Inventor(s):	Boehm; Garth (Westfield, NJ)
Assignee:	Alpharma Pharmaceuticals LLC (Bridgewater, NJ)
Application Number:	12/766,472
Patent Claim Types: see list of patent claims	Use; Dosage form;

United States Patent 8,685,443: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 8,685,443, titled "Sequestering subunit and related compositions and methods," is a patent that addresses innovative solutions in the field of pharmaceuticals, particularly in the prevention of drug abuse. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

Publication and Expiration

The patent, US8685443B2, was published on April 1, 2014, and its legal status indicates that it has expired due to fee-related issues[4].

Inventive Concept

The patent describes a sequestering subunit that incorporates an aversive agent and a blocking agent. The blocking agent prevents the premature release of the aversive agent, which is designed to deter the abuse of therapeutic agents. This invention is particularly relevant in the context of preventing the misuse of prescription drugs[4].

Scope of the Invention

Technical Details

The sequestering subunit is engineered to release the aversive agent over an extended period, typically greater than 24 hours. This prolonged release is a significant improvement over existing sequestered forms of aversive agents, which often suffer from osmotically-driven release issues. The invention includes various compositions and methods for incorporating these subunits into pharmaceutical formulations, such as tablets with multiple layers or single layers with dispersed subunits[4].

Applications

The primary application of this invention is in the prevention of drug abuse. By incorporating a sequestering subunit into a therapeutic agent, the invention aims to prevent the rapid release of the therapeutic agent, thereby reducing the potential for abuse. This is particularly important for drugs that have a high potential for misuse.

Claims of the Patent

Independent and Dependent Claims

The patent includes several claims that define the scope of the invention. These claims can be categorized into independent and dependent claims.

• Independent Claims: These claims stand alone and define the core aspects of the invention. For example, Claim 1 describes a sequestering subunit comprising an aversive agent and a blocking agent, where the blocking agent substantially prevents the release of the aversive agent[4].
• Dependent Claims: These claims build upon the independent claims and provide additional details or variations. For instance, dependent claims might describe specific formulations or methods of preparing the sequestering subunit.

Claim Construction

The claims are constructed to ensure broad protection for the inventive concept while also being specific enough to distinguish the invention from prior art. The use of terms like "sequestering subunit," "aversive agent," and "blocking agent" helps in defining the unique aspects of the invention.

Patent Landscape

Prior Art and Novelty

The patent landscape for US8685443B2 involves a thorough analysis of prior art to establish the novelty and non-obviousness of the invention. The Common Citation Document (CCD) application, which consolidates prior art citations from multiple patent offices, would be a valuable resource in this context[1].

International Patent Offices

To understand the global patent landscape, it is essential to search international patent databases. Resources like the European Patent Office's esp@cenet, the Japan Patent Office, and the World Intellectual Property Organization's PATENTSCOPE provide access to international patent applications and granted patents. This helps in identifying similar inventions or prior art that may exist globally[1].

Related Patents and Applications

Other patents and applications related to drug abuse prevention and pharmaceutical formulations can provide insights into the competitive landscape. For example, patents like EP-2422772-A2, which also describe sequestering subunits and related compositions, indicate a broader interest in this technological area[5].

Economic and Market Impact

Market Demand

The demand for solutions to prevent drug abuse is significant, given the public health concerns associated with prescription drug misuse. Patents like US8685443B2 play a crucial role in driving innovation in this area, potentially leading to new products that can help mitigate the drug abuse crisis.

Competitive Advantage

Holding a patent in this space can provide a competitive advantage to the patent holder. It allows them to exclusively market and sell products incorporating the sequestering subunit, thereby capturing a significant share of the market focused on drug abuse prevention.

Legal and Regulatory Considerations

Patent Expiration

The expiration of the patent due to fee-related issues means that the exclusive rights to the invention are no longer in effect. This opens up the technology for use by other entities, potentially leading to further innovation and competition in the market[4].

Regulatory Compliance

Any new products developed using this technology must comply with regulatory requirements. This includes obtaining approvals from regulatory bodies such as the FDA, which would involve demonstrating the safety and efficacy of the formulations.

Conclusion

United States Patent 8,685,443 represents a significant innovation in the field of pharmaceuticals, particularly in the prevention of drug abuse. The scope of the invention, as defined by its claims, provides a robust solution for deterring the misuse of therapeutic agents. Understanding the patent landscape and the broader economic and regulatory context is crucial for leveraging this technology effectively.

Key Takeaways

• Inventive Concept: The patent describes a sequestering subunit with an aversive agent and a blocking agent to prevent drug abuse.
• Scope and Claims: The claims define the core aspects of the invention, including specific formulations and methods.
• Patent Landscape: The global patent landscape includes similar inventions and prior art that must be considered.
• Economic Impact: The patent can drive innovation and provide a competitive advantage in the market.
• Legal Considerations: The patent's expiration and regulatory compliance are critical factors.

FAQs

What is the main purpose of the sequestering subunit described in US8685443B2?

The main purpose is to prevent the abuse of therapeutic agents by incorporating an aversive agent that is released over an extended period.

How does the sequestering subunit improve over existing technologies?

It reduces osmotically-driven release of the aversive agent and provides a longer prevention of release, typically greater than 24 hours.

What are the potential applications of this invention?

The primary application is in the prevention of drug abuse, particularly for prescription drugs with a high potential for misuse.

Why is it important to search international patent databases?

Searching international patent databases helps in identifying similar inventions or prior art globally, ensuring the novelty and non-obviousness of the invention.

What happens now that the patent has expired?

The expiration of the patent means that the exclusive rights to the invention are no longer in effect, allowing other entities to use the technology.

Sources

1. USPTO - Search for patents: https://www.uspto.gov/patents/search
2. PharmaCompass - US Patent 8685443: https://www.pharmacompass.com/us-patent-8685443
3. USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
4. Google Patents - US8685443B2: https://patents.google.com/patent/US8685443B2/en
5. PubChem - EP-2422772-A2: https://pubchem.ncbi.nlm.nih.gov/patent/EP-2422772-A2

Drugs Protected by US Patent 8,685,443

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-001	Aug 13, 2009		DISCN	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-002	Aug 13, 2009		DISCN	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-003	Aug 13, 2009		DISCN	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-004	Aug 13, 2009		DISCN	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-005	Aug 13, 2009		DISCN	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-006	Aug 13, 2009		DISCN	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED

International Family Members for US Patent 8,685,443

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2003270778
Australia	2009251081
Canada	2499550
China	1703200
Cyprus	1120720
Denmark	1551372