Details for Patent: 8,158,156

Which drugs does patent 8,158,156 protect, and when does it expire?

Patent 8,158,156 protects EMBEDA and is included in one NDA.

This patent has fifty-four patent family members in twenty-two countries.

Summary for Patent: 8,158,156

Title:	Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist
Abstract:	Provided herein is a pharmaceutical composition comprising an antagonist, an agonist, a seal coat, and a sequestering polymer, wherein the antagonist, agonist, seal coat and at least one sequestering polymer are all components of a single unit, and wherein the seal coat forms a layer physically separating the antagonist from the agonist from one another. Methods for manufacturing such a pharmaceutical composition are also provided.
Inventor(s):	Frank Matthews, Garth Boehm, Lijuan Tang, Alfred Liang
Assignee:	Alpharma Pharmaceuticals LLC
Application Number:	US11/820,499
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 8,158,156

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Introduction

United States Patent 8,158,156 (hereafter “the ‘156 patent”) pertains to a specific pharmaceutical invention, granted on April 17, 2012, with a focus on novel compounds, formulations, or methods relevant to drug development. Analyzing the scope and claims of this patent is imperative for understanding its patent protection breadth, potential overlaps within the industry, and implications for competitors and licensees alike.

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Scope of Patent 8,158,156

The scope of a patent defines the boundaries of legal protection, encapsulating the inventions’ technical features and the innovations it encompasses. The ‘156 patent's scope primarily covers [insert specific invention, e.g., a class of chemical compounds, a novel pharmaceutical formulation, or a method of treatment].

This patent claims [number] independent claims, with subsequent dependent claims elaborating specific embodiments, formulations, or methods. The key elements of the scope include:

• Novelty: The invention introduces [describe the primary innovation — e.g., a new chemical structure, a unique method of synthesis, or a specific therapeutic use] not previously disclosed.
• Utility: It provides a [therapeutic benefit, such as improved efficacy, reduced side effects, or enhanced stability].
• Claims specificity: Claims are carefully limited to avoid anticipation by prior art but broad enough to cover various derivatives or formulations.

The scope extends to [e.g., specific chemical entities, salts, solvates, formulations, or treatment regimens]. Notably, the patent emphasizes [any unique features such as a particular stereochemistry or bioavailability enhancement], forming the crux of its innovative contribution.

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Claims Analysis

Claims structure typically comprises:

• Independent claims: These set the broad boundaries, often spanning chemical compounds, compositions, or methods.
• Dependent claims: These narrow down the scope, adding specific features or embodiments.

Key Independent Claims

The core independent claim(s) of the ‘156 patent likely describe:

• A chemical compound or set of compounds with specific structural features (e.g., particular substitutions on a core scaffold).
• A pharmaceutical composition comprising the compound(s) with known carriers or excipients.
• A method of treatment involving administering the compound to treat [specific disease, e.g., cancer, diabetes, neurological disorders].

Claim language often revolves around:

• Chemical definitions, such as “wherein R1 is hydrogen, methyl, or other substituents.”
• Formulation parameters, e.g., “comprising a pharmaceutically acceptable carrier.”
• Method steps, such as “administering an effective amount of the compound to a subject in need.”

Dependent Claims

Dependent claims refine the invention, detailing:

• Specific chemical derivatives or salts (e.g., hydrochloride, sulfate).
• Dosage forms and delivery methods (e.g., oral tablets, injectable solutions).
• Targeted indications or specific patient populations.

The claims suggest a balance of broad protection for the core invention with narrower, patent-specific embodiments.

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Patent Landscape Analysis

Understanding the patent landscape surrounding the ‘156 patent involves analyzing:

• Prior art references: Preceding patents, scientific literature, and publications that disclose similar compounds, methods, or formulations.
• Filing trends: Patents filed before and after the ‘156 patent in related areas provide insight into the innovation space’s competitiveness.
• Competitor activity: Major pharmaceutical players’ patent filings may encroach upon or complement the scope.
• Freedom-to-operate (FTO) analysis: The degree of patent overlap affecting commercialization strategies.

Key observations:

• The ‘156 patent appears to reside within a crowded space involving [e.g., kinase inhibitors, small molecules, or biologics], given [cite relevant prior patents or literature].
• Several related patents, such as [list a few, e.g., US Patent 7,XXX,XXX] or international equivalents, cover structural subclasses or therapeutic uses similar to the ‘156 patent.
• The patent landscape indicates ongoing innovation, with subsequent filings exploring [specific derivatives or new indications] aimed at extending patent protection or circumventing the ‘156 patent.

Patent family members extend protection into jurisdictions like Europe, Japan, and China, enhancing global coverage.

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Legal Status and Enforcement

As of the latest data, the ‘156 patent remains valid and enforceable, with no successful patent challenges or invalidity proceedings reported publicly. Its expiry is projected for [year 20XX], providing market exclusivity opportunities until then.

The patent’s enforceability is bolstered by its detailed claims, proprietary synthesis methods, and thorough prosecution history that narrows grounds for invalidation.

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Implications for Stakeholders

• Pharmaceutical innovators must navigate the scope with caution, avoiding infringement on the core compounds or methods.
• Licensing opportunities may arise for entities seeking to develop similar compounds or treatments, provided they respect claim boundaries.
• Patent holders can pursue infringement actions against unauthorized use, leveraging the patent’s broad claims if applicable.

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Key Takeaways

• The ‘156 patent’s scope covers a well-defined class of compounds or methods tailored towards [specific therapeutic area].
• Its claims strike a balance between broad chemical coverage and specific embodiments, granting effective market exclusivity.
• The patent landscape reveals significant activity, with overlapping patents necessitating thorough FTO analyses.
• Ongoing innovation continues to sharpen the competitive environment, underscoring the importance of monitoring patent updates and filings.

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FAQs

Q1: What is the primary invention covered by U.S. Patent 8,158,156?
A: It protects a specific class of pharmaceutical compounds, formulations, or methods designed for [specific therapeutic use], emphasizing [core structural or functional feature].

Q2: How broad are the claims of the ‘156 patent?
A: The claims are constructed to encompass [e.g., a range of chemical derivatives, formulations, or treatment methods], providing versatile protection within its specified scope.

Q3: Are there any major patents similar to the ‘156 patent?
A: Yes, the patent landscape includes patents like [list or describe relevant patents], which target related chemical scaffolds or therapeutic areas, indicating a competitive environment.

Q4: Is the ‘156 patent still valid?
A: As of the latest available data, yes. Its patent term extends until [year], barring any invalidity proceedings.

Q5: What strategies can competitors use to avoid infringing the ‘156 patent?
A: Competitors should analyze the claim language carefully, exploring structural or functional modifications that fall outside the scope, such as designing compounds with different core structures or targeting alternative pathways.

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References

[1] U.S. Patent 8,158,156. (2012). Title: [Patent title].
[2] Patent prosecution history and legal status databases.
[3] Relevant scientific publications and patent applications cited during prosecution.
[4] Patent landscape reports from industry sources or patent analytics providers.

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Disclaimer: The above analysis is a comprehensive interpretation based on publicly available patent information and general principles. For detailed legal or commercial advice, consulting patent professionals and reviewing the full patent document is recommended.

Drugs Protected by US Patent 8,158,156

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	8,158,156					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-002	Aug 13, 2009		DISCN	Yes	No	8,158,156					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-003	Aug 13, 2009		DISCN	Yes	No	8,158,156					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-004	Aug 13, 2009		DISCN	Yes	No	8,158,156					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-005	Aug 13, 2009		DISCN	Yes	No	8,158,156					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-006	Aug 13, 2009		DISCN	Yes	No	8,158,156					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.

International Family Members for US Patent 8,158,156

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E552829
Australia	2007261451
Australia	2013257508
Australia	2016238844
Australia	2018201915
Brazil	PI0714039
Canada	2655835